Page 4 Patents and recessions – How to recession proof your patent portfolio
Hannah Auger is looking how companies are considering their IP strategy for navigating the tricky economic times ahead.
Page 6 What to know before filing a patent application
Sudhakar Brodie talks through the steps of the process of protecting an idea from the benefits, to what everyone needs to know before filing a patent application and after the filing.
Page 10 Is less always more? Challenging the trend for simplicity in brand design
Clare Turnbull, Emma Bridgland and Vivek Patel take a look at companies adopting changes to their branding, particularly their logos and designs. Should you go for something simpler or go for something enforceable?
Page 12 IP Strategy: A digital health start-up story
Gary Whiting explores issues relating to IP strategy with the help of a digital health case study where disparate technologies may need to be brought together in order to bring a product to market.
Page 15 An update to the UPC
Peter Thorniley clarifies questions about the Unitary Patent System, which is expected to be launched in early 2023.
Page 16 Evolution or revolution? IP in the metaverse
Clare Turnbull, Alex Brown and Benedict SharrockHarris explain the metaverse and look at protecting IP and the options for enforcement.
Page 19 EPO Guidelines: To follow or not to follow?
Tim Russell and Rachel Challands discuss the Guidelines for Examination in the European Patent Office as a useful and familiar resource published by the EPO and explore recent Board of Appeal decisions highlighting that the Guidelines are guidance and not legally binding, for example, on the Boards of Appeal.
Page
Kirsty Dolphin reviews the partial patent waiver for COVID-19 vaccines.
Page 24
Robert Peake and Fabiana Atzeni are looking at the UK government’s National AI Strategy (the UK AI Strategy) based on three pillars: investment, ensuring that AI benefits all sectors and regions, and governance.
Page 26
Kirsty Dolphin, Sophie Newgas and Emma Longland summarise the changes of the new WIPO standard for sequence listings intending to bring about improvements, clarity, and uniformity to sequence listings.
The growth and spread of rechargeable batteries are reflected in an increase in patent applications in battery technologies, with patent applications originating in Japan showing a particularly marked increase over the last two decades. Pawel Piotrowicz and Anwar Gilani are having a closer look.
31
A famous name can be the source of enormous revenue, through licensing deals or the endorsement of third parties’ products and Yoann Rousseau answers how celebrities can protect their name.
The good news for antibody developers is that, in Europe at least, it is possible to obtain broad claims based on the target epitope, Anton Hutter and Matthew Handley report.
In this follow-up article, George Hudson explores some of the issues affecting the protection of components under the various UK and EU Community design regimes and in particular the “must-fit” and “must-match” exclusions and the repair clause.
Welcome to our Inside IP Autumn/Winter 2022 edition and welcome to Kirsty Dolphin as a Co-editor.
It certainly has been another tumultuous year. With COVID-19 still not a distant memory, Kirsty looks at whether or not a patent waiver for COVID-19 vaccines might be effective and explores both sides of the debate. Hannah Auger explores patents and recessions and how to recession proof your patent portfolio, Gary Whiting explores the key to success of a successful IP strategy by looking at a digital health case and Sudhakar Brodie talks through the steps of the process of protecting an idea from start to finish.
Pawel Piotrowicz and Anwar Gilani have a closer look at the increase in patent applications in battery technologies, with patent applications originating in Japan showing a particularly marked increase over the last two decades.
A series of articles covering the finding that recent Board of Appeal decisions seem to be more of a guidance than legally binding, summarising the change of the new WIPO standard for sequence listings and exploring the diverging approaches between the EPO and USPTO on antibody epitope claims round up our technical updates in this edition.
As the launch of the long awaited Unitary Patent System coming closer, Peter Thorniley clarifies questions about the Unitary Patent System. With the new system looking like it will come into force at the start of April, after years and years of speculation, it really is time to think about how your portfolio will be affected.
Our head of trade marks, Clare Turnbull, together with Alex Brown and Benedict Sharrock-Harris look at protecting IP and the options for enforcement in the metaverse, Yoann Rousseau provides suggestions on how celebrities can protect their name and Clare Turnbull, Emma Bridgland and Vivek Patel explore the challenging trend for simplicity in brand design together with a design attorney. Talking about designs, George Hudson also provides a round up of issues relating to design protection of components.
Robert Peake and Fabiana Atzeni in our legal team are looking at the UK government’s National AI Strategy (the UK AI Strategy) based on three pillars: investment, ensuring that AI benefits all sectors and regions, and governance.
A big thank you to all our contributing authors, and thank you for your time reading this and sharing our world of IP. We hope you find something of interest! If you have any further questions or would just like to discuss more on the UPC or anything else IP related, please do not hesitate to reach out to us. We are, together with our colleagues across the UK and Germany, looking forward to seeing you soon and we are, as always, only an email or call away.
We are an innovative intellectual property firm based in Europe. Our firm has a long history and a vast amount of experience in relation to all aspects of intellectual property.
As the United Kingdom potentially teeters on the edge of another recession, many companies are considering their IP strategy for navigating the tricky economic times ahead.
It is no secret that recessions often lead to a decline in patent filings. Between 2008 and 2009 the number of patent applications received by the European Patent Office (EPO) fell by 8.2% (see Figure 1).
There can be the perception that building a patent portfolio is costly and that during a recession it is prudent to keep expenditure low. However, IP budgets can be optimised by focusing on key future
patents require the payment of annual fees to keep them in force. It may be that some territories are no longer of interest and that substantial savings can be made by focusing on a core group of countries. It is equally important to consider the products covered by patents in the portfolio. Often,
However, a dip in filing numbers is usually short-lived and, if history is any guide, companies that invest in IP in a recession tend to come out the other side stronger than those who choose to wait for the economy to improve.
By way of case study, throughout the recession period of 2007 to 2009, Amazon's stock declined, putting the company’s upward trajectory in doubt. While the financial crisis was hurting its competition, Amazon decided to double down on innovation. It launched a whole suite of new products: Amazon Prime, Amazon Kindle, and Amazon Web Services (AWS), its cloud computing arm. By 2009 Amazon’s profits were up 68%, and each of these introduced products has become a major part of the Amazon business we see today.
development areas. Now is the best time for company owners to allocate their resources (both time and money) to building and managing their patent portfolios.
Below are some practical tips for managing patent portfolios during a recession:
1. Handling tighter IP budgets and careful portfolio pruning: It is inevitable that some difficult decisions may need to be made in order to reduce cost spending on IP budgets, in particular, the ongoing costs associated with maintaining granted IP rights. A first step should be to review the extent of territorial protection and consider whether protection is genuinely commercially useful in each country. In most countries,
the market has developed to such an extent that a patent applied for ten years ago, while still potentially in force for another decade, no longer provides commercially useful protection.
For pending applications, cost can be deferred to a later date by using appropriate tactics, such as different filing strategies, deferred examination, and making use of available extensions.
2. Focus on the future: Invest in products and services that you plan to rely on now and when the recession ends. In particular, prepare to invest your IP budget in upcoming flagship products that you hope to sell when times are good again. Once the economy rebounds, those
companies who have a solid and robust patent portfolio and a breakthrough product can sprint while their competitors slowly crawl. It helps to have a firstmover advantage as the recession ends in order to maintain and/ or grow your market share. However, it may be sensible to reduce patent filings for potential “blue sky inventions” for which there is no planned use in the future.
3. Acquiring IP: We recommend keeping an ear to the ground for any potential IP sell-offs. As competitors change strategy, and unfortunately some businesses fall casualty to the challenging economic times, watch out for any potential opportunities to acquire new IP – there may be deals to be had! Sweeping up IP, via fire sales or from administrators, can grant access to a protected area of the market that previously belonged to someone else. If you are unable to purchase IP yourself, then be sure to carefully watch out for who ownership of IP you are interested in transfers to, or for any IP rights which may have been allowed to completely lapse, so allowing you greater freedom to operate.
4. Monitor competitors: It can be helpful to set up patent watches to benchmark against owners of similar portfolios. Changes in pace of patent filings in particular technology areas may be used to determine your own strategy. Although patent applications are
not published until 18 months after filing, that information can reveal potential trends by competitors. By gaining strong intelligence on past inventive activity, future developments may be predicted. By seeking to protect such developments preemptively, businesses can gain considerable advantage over their competitors.
5. Get the creative juices flowing: Recessions are a great time to make use of time with scientists and engineers. As sales and product launches slow, inventors, who are often difficult to pin down, may have increased time to perform research and development and help with invention capture.
6. New market entrants: Watch out for new market entrants who may seek to capitalise on changing market conditions. New entrants to the market may be less respectful of any status quo established with reference to more long-standing competitors. Acting wisely against such newcomers is very important to prevent shrinking market shares.
If you would like to discuss this further, please contact Hannah Auger or your usual Venner Shipley attorney.
Invest in products and services that you plan to rely on now and when the recession ends
As the UK potentially teeters on the edge of another recession, many companies are considering their IP strategy for navigating the tricky economic times ahead.
Have you come up with an idea which you want to protect? In that case, you might be interested in filing a patent application. We have prepared a guide to help you through the process.
Generally, a patent can protect subject-matter which provides a technical effect, such as a more efficient motor, a method of manufacture of chemical, or a method for processing an image. However, not everything can be patented, notably, a business method, aesthetic creation, or computer algorithm with no physical effect are typically excluded from patentability.
In addition, to be patentable, an invention must meet two main criteria. First, it must be novel which means that it must have never been publicly disclosed anywhere in the world before the date on which the patent application is filed. Second, it must involve an inventive step which means that it must be more than just a minor or obvious modification of something that has already been disclosed to the public.
If you think your idea is not patentable, there may be other ways
to protect your idea. For example, an aesthetic creation may be protected using trade marks or designs and copyright , a computer algorithm with no physical effect may be protected under copyright law, and a business method may be kept secret using non-disclosure agreements (NDAs).
To find out more, please view our relevant services or contact us to find out if your idea is protectable
A patent provides the rights holder with the ability to prevent anyone else from making, importing, selling, storing for sale, offering to sell, or using a product covered by the patent, or performing or offering to perform a process covered by the patent within the relevant territory for a maximum of 20 years from the filing date. Therefore, obtaining a patent enables you to prevent competitors from imitating your invention without your authorisation.
Being in control of the production and use of your invention helps you to build goodwill around the quality of your product or process to improve your business’s reputation and public image.
As the owner of a patent, you do not have to, or be the only one to, make the patented product or perform the patented process — you can license others to do so and collect revenue from the negotiated royalties. Alternatively, you can sell ownership of the patent through assignment. Due to the control over the invention provided by a patent and the ability to make money solely from owning a patent, developing a patent portfolio increases the valuation of a business.
If a competitor owns a patent covering an element of your product or process, obtaining a patent can be used as a bargaining tool for crosslicensing to lower royalties charged by the other patent holder and secure freedom to operate for your business.
Furthermore, filing a patent application may provide security for an investor as a granted patent results in a monopoly in the market.
Profits earned from patented inventions are also subject to a lower rate of corporation tax in the United Kingdom using the Patent Box scheme.
we recommend minimising your meetings with others before speaking to a patent attorney.
Patent attorneys are also able to perform a search of the state of the art to find out if the invention appears to be new and inventive, as well as provide a freedom to operate opinion to discover whether there are any active patents which cover elements of the invention.
Patent protection cannot be obtained at the same time as keeping the invention a secret from competitors. A requirement of the patent application is that it must enable a skilled person in the relevant field to make the product or perform the process. The patent application will also be published 18 months after filing unless it is withdrawn beforehand. A patent is a monopoly right provided by the government in exchange for the publication of information about the invention which might otherwise be kept secret.
Congratulations on devising a patentable idea which appears new and inventive. The next steps will enable you to protect that idea and garner investment.
The first step is to provide a patent attorney with a detailed description of your invention to enable them to draft a description, claims, and figures of the invention for the patent application. It is not allowed to add new information to your patent application after the filing date. Therefore, it is very important that the patent application contains a detailed description of the invention including all possible embodiments.
A patent application will only be granted if it covers subject-matter that is new and inventive at the filing date. Therefore, it is very important that the invention is kept secret before filing the patent application. A publication of the invention before the date of filing will result in the invention not being considered new in many jurisdictions and so will prevent the invention from being patented there.
You can discuss the invention before filing so long as there is implicit or explicit confidentiality. If you are unsure if there is explicit confidentiality, you can ask people to sign an NDA . To avoid the risk of others publicising the invention,
Another aspect to consider is the commercial benefit of obtaining a patent and whether the time scales and costs incurred are appropriate for the product or process life cycle and expected revenue. For example, a patent is suited to protect a product or process which is easy to copy but difficult to develop and will be commercialised for a long period of time. Successfully commercialising a product or process is not guaranteed by obtaining patent protection — patent protection is necessary to control competition, but focus is also needed on marketing and attracting investment.
Claims are a series of statements which specifically define the invention and, in a granted patent, they set out precisely what the patent protects and therefore, what actions done by third parties would constitute infringement of the patent. Claim 1 is generally the most important claim and provides the broadest definition of the invention. In order to form the basis for the best possible protection for your invention, the claims should describe not only the invention as you envisage it, but also the general underlying principle or concept of your invention, so they also cover alternatives or equivalents.
The cost and time for drafting and filing a patent application depends on the complexity of the invention and the territory in which protection is sought.
You will have to decide where you would like protection for your
I want to file a patent application, what now?
Filing a patent application may provide security for an investor as a granted patent results in a monopoly in the market.
What should I know before filing a patent application?
invention. You can select to file patent applications in specific national offices such as in the United Kingdom and United States, file a regional patent application such as a single European patent application covering up to 39 countries, or file a single international (PCT) patent application which will provide you with approximately 30 months to decide which national or regional patent offices to enter the application into.
You can also make use of the 12-month priority period after an initial filing to delay filing additional applications in other territories without affecting the patentability of the invention. Using the priority period and/or the 30-month period after filing a PCT patent application are useful if time is needed to assess the commercial potential of the invention and patent after securing a filing date.
After filing the patent application, the invention can be disclosed without the need for confidentiality which makes it easier to attract potential investors. Due to the ability to claim priority from an initial filing, any subsequent applications in different territories relating to the same subject-matter filed within 12 months will be examined for novelty and inventive step based on the state of the art at the time of filing the initial application. Therefore, publications of the invention subsequent to the initial filing will not be prejudicial to future filings.
Within approximately six months of filing, a search report from the patent office should be received detailing the state of the art found relating to the claims of the application and containing any objections against the application.
If the claims are not considered to be new and inventive, the claims may have to be amended and potentially narrowed to exclude products or processes known at the time of filing. These amendments should be done while maintaining a broad claim scope to avoid overly limiting the potential scope of protection.
Depending on what limitations of the claims are commercially acceptable and the nature of the objections, an examination report may later be received from the patent office maintaining the objections or presenting further objections. There can be a handful of rounds of written communication with exam reports being received from the patent office and responses from the applicant and their patent attorney being filed regarding the objections. Each round results in the application becoming closer to grant, takes around six months, and incurs service fees of approximately £1,200 depending on the complexity of the objections.
If the examiner agrees that the claims as filed or as amended are novel and inventive, a patent will be granted, otherwise the patent application will be refused following a final oral proceedings between the examiner and patent attorney. Most patent applications will either be granted or refused within a period of approximately four years from filing.
Once the patent is granted, it can be enforced immediately to stop others from commercialising the invention or to obtain damages/licensing fees for acts started from the point at which the application was published (which is usually 18 months after filing).
Renewal fees are also due for the patent application or patent which vary depending on where the patent application is filed. Renewal fees have to be paid to maintain the patent application or patent.
Although there are costs and timescales involved with obtaining patent protection, a patent provides control over how your invention is commercialised, improves your business’s public image, and helps generate investment. Firms that own IP rights, such as patents, have on average 20% higher revenue per employee than firms that do not according to an analysis performed in February 2021.
If you are interested in obtaining protection for your idea, please contact us here
Chambers UK 2023
Intellectual Property: Patent & Trade Mark Attorneys
“ The Venner Shipley team have very good knowledge and experience. They take a very commercial and pragmatic approach, and respond swiftly.”
Throughout the years we have seen many companies adopt changes to their branding, particularly their logos and designs.
Looking at the examples shown in this article (BBC, Instagram, GSK and Starbucks), you might ask, “Why the change?”
There is no simple answer to this and a number of factors are likely to be involved.
A company needs to keep up with marketing trends and its competitors. Technology has a major influence and it is important for a business to keep up with these trends or it is likely to be left behind.
When a brand grows, expands, and develops, it is natural for a company to want to change alongside this success. This goes beyond tweaking the font or colour scheme and extends to the motivations and ethos of a company. Content such as logos, designs, and videos may also change to keep up with these ongoing core values.
One of the biggest trends seen in recent years is companies adopting a simplistic approach to their brands, to convey a clear message to consumers. A simple logo is likely to create an instant impact as it allows a consumer to readily identify a brand’s character and may work better in various social media formats that require the use of icons. However, with the potential benefit of a simpler rebrand or brand refresh comes the risk that the logo is so pared down that it lacks any protectable elements, or worse, becomes similar to a competitor’s branding and risks infringing those rights.
It is important to review your IP assets when contemplating a rebrand or brand refresh. Before investing time and resources, it is essential to consider the legal implications involved and carry out checks and searches to make sure the changes will not infringe third party rights, as well as to consider the inherent capability of the new logo to perform the essential function of a trade mark to identify the source of the products, be they goods or services, as those of its owner. In the case of a rebrand, additional
protection will be needed. For a brand refresh, the existing trade mark protection in place may be sufficient to protect the changes made, although this is unlikely unless the changes made are minor.
A rebrand or brand refresh is likely to require further IP assets that go beyond a trade mark for your new logo. These may include, for example, further trade marks for variations of the logo such as , perhaps, an animated version, designs, domain names, and social media handles. Copyright protection should also be considered.
A logo can be protected with a registered design in the United Kingdom and Europe. Registered designs can protect the appearance of the whole or a part of a product resulting from the features of, in particular, the lines, contours, colours, shape, texture, and/or materials of the product itself and/or its ornamentation. Although there are limitations as to what features of a “product” can be protected, both logos and icons can be protected, along with graphical user interfaces (GUIs) including animated GUIs.
The fact that two-dimensional designs are protectable in the UK and Europe means that it is possible to obtain protection to a GUI per se, without showing any hardware (for example, a smartphone or tablet) in the design drawings. This is in contrast with registered design requirements in some foreign jurisdictions, for example, China and the United States, where it is necessary to depict the GUI displayed on a device screen (although some jurisdictions, such as the US, permit that the device is disclaimed by being shown in dashed lines).
The maximum life of a registered design is 25 years from filing, renewable every five years, and it is generally unlikely that a design registered 25 years ago would still be the same when the term comes to an end. This contrasts with trade mark protection which never ceases provided the registration is renewed every ten years. One benefit of filing a registered design, in addition to your trade mark, for your logo, icon, or GUI, is that they can offer complementary protection to one another. A registered design has no use requirement and it is the design that is protected, without limitation to the class or category of goods that is specified on filing.
Trade marks and designs should be considered to be complementary rights because a design application must be novel on filing, so potentially an earlier unregistered design might be used to invalidate a registered design. Novelty is not a pre-requisite for trade mark protection, but a simple logo may lack the necessary distinctiveness to be capable of registration as a trade mark. However, design registrations are not examined as to the quality of the design, so provided the design meets the basic formalities requirements set by the relevant authority, registration should be straightforward.
Copyright subsists in a work as soon as it has been created. It is generally not registered, so independent evidence of creation including the date of creation will be needed, and the quality of the work is a relevant factor in determining whether the logo qualifies for copyright protection. For both designs and copyright, authorship is also relevant as the first owner of both unregistered design right and copyright will be the creator and not the commissioner, unless there is a contractual arrangement in place to the contrary.
1966 1927 2022
Of course, brand refreshes do not always work. For example, the Ford motor company commissioned a brand refresh in 1966 and this logo was proposed: It was rejected by Henry Ford II and the logo has changed little in a century.
Coca Cola have chosen not to play around with their logo either: Original 2022
If you choose to have a complete rebrand, it is important to look at any existing IP assets you already own and whether to continue protecting them, at least during the transitional period while moving to the new branding. You will want to continue to benefit from the goodwill created by your business in the previous branding so some thought must be given to ways of transitioning to a new brand so that the experience is seamless for the consumer, while fully protecting your rights throughout.
Keeping up with marketing trends through a brand refresh or rebrand requires significant thought and planning — our team can assist you in managing this effectively and efficiently.
Clare
vpatel@vennershipley.co.uk
Technology start-ups often outsource the development of some aspects of their products. This can be particularly true in the digital health space, where disparate technologies may need to be brought together in order to bring a product to market. While this approach has many advantages, it can complicate the development of an IP strategy. This article explores issues relating to IP strategy with the help of a digital health case study.
May Diagnostics is a spin-out company that has been set up to commercialise developments made by teams within two different University departments. The first team (headed by Professor Johnson) has developed a biological process that can isolate samples relevant to a disease. The second team (headed by Dr Elizabeth May) has developed a diagnostic process that exploits the discoveries of Professor Johnson’s team to provide a reliable test for whether an individual has the disease.
Dr May is a leading member of May Diagnostics, but Professor Johnson and his team have not joined the company, preferring to dedicate their time to academia.
The newly formed company is developing an IP strategy.
As shown in Figure 1, the product being developed by May Diagnostics has three key parts:
• The biological process developed by Professor Johnson’s team.
This process uses a mechanical device to extract a sample from a patient.
• The diagnostic process developed by Dr May’s team. This process obtains information relating to the sample and then uses a data processing backend to enable a diagnosis to be obtained.
• A mobile phone application (App) that controls the diagnostic process and provides user interfaces (both to patients and to medical professionals).
development of the App has been outsourced to Keir IT, a specialist App developer. The mechanical product that underpins the biological process has been designed by Professor Johnson’s team, but product development assistance is being obtained from a further company (Davey Mechanical Services).
There are many ways in which May Diagnostics might develop a business to exploit this technology. The appropriate IP strategy should be dependent on the general business strategy.
It is common to develop a proof of concept and then seek to exit the business – May Diagnostics has decided that this is its preferred approach. An appropriate IP portfolio including protection for the underlying technology may form a significant part of the value of the business for a potential buyer.
FIG. 1: The May Diagnostics product
May Diagnostics has decided to focus product development efforts on the diagnostic process, including the data processing backend. The
An alternative strategy would be for May Diagnostics to bring the product to market (either alone or with a partner). In this scenario, branding (and therefore trade mark protection) may be key. Also, the App (developed
by Keir IT) and the mechanical device (developed by Professor Johnson and Davey Mechanical Services) would be central to the products actually being sold — IP rights for those products may then assume greater significance.
As May Diagnostics intends to exit the business following the development of a proof of concept, an IP strategy should be developed to support this business strategy. Nevertheless, it may be useful to have a degree of flexibility. Opinions regarding the appropriate business strategy may develop over time. An IP strategy is a long-term strategy that should be able to evolve as business strategy evolves.
In addition to developing a business strategy, May Diagnostics should consider the needs of other stakeholders in the project when developing an IP strategy.
Dr May and Professor Johnson are the leading academics behind the technology. Dr May’s interests are likely to be similar to May Diagnostics’ interests (although not necessarily identical). The position of Professor Johnson could be more complicated. Professor Johnson has played a major role in the development of the technology underlying May Diagnostics’ business and may feel some “ownership” of the technology, regardless of the legal position. Professor Johnson may well develop the technology further and is likely to publish relevant papers. Such papers may limit the ability of May Diagnostics to patent the underlying technology (which may limit the attractiveness of the company to other parties at the end of the proof of concept phase). It may be wise to include Professor Johnson in the project in some capacity (for example, as a consultant). In any event, any legal rights that are owned by Professor Johnson should be transferred to May Diagnostics at an early stage.
The University (as employers of key academics) may well be the first owner of some IP rights. Thus, May Diagnostics should liaise with the University (for example, via the University’s Technology Transfer Office). It is likely that the University will encourage May Diagnostics in the development of the technology and may be able to offer both
practical and financial assistance. For example, in the event of a difficulty in the relationship between any of the academics and May Diagnostics, the University may be able to offer assistance.
Keir IT and Davey Mechanical Services are commercial enterprises and have interests in their respective contributions to the project. Any IP developed by those parties should be transferred to May Diagnostics. Some sensitivity may be required here. For example, Kier IT may be keen to retain the right to re-use some of the modules of the App in projects for other clients (and may have re-used earlier modules when developing the App for May Diagnostics). A clear agreement should be reached so that all parties know where they stand.
The IP portfolio should restrict the ability of competitors to take advantage of the work of May Diagnostics and its partners by developing similar products and services. Thus, when developing an IP portfolio, it is useful to consider how the IP portfolio would be viewed by such competitors. For example, protecting concepts using copyright and registered designs might prevent a competitor from directly copying May Diagnostics’ solutions, but would offer little or no protection against the development of alternative solutions to the same problems. Further, an extensive patent portfolio might limit the scope of a competitor to offer competing products, but only if the relevant patents are obtained in the countries of interest to that competitor.
If May Diagnostics intends to bring a product to market, then customers also become stakeholders. These include patients, medical professionals, and health companies or bodies (such as the National Health Service in the United Kingdom). Customers ultimately want to make use of, and have confidence in, the products and services they are using. Freedom to operate and brand protection may be key issues to such customers — granted patents may also help to give credibility.
Finally, of course, the interests of investors and potential buyers of the business should be considered. This is of critical importance given May Diagnostics’ intended business strategy.
Having considered its own business strategy and the needs of other stakeholders, May Diagnostics is in a position to develop an IP strategy. Such a strategy might answer the following questions:
• Why IP should be obtained?
• What IP should be obtained?
• When and where IP should be obtained?
• How risks can be mitigated?
Those issues are discussed in turn below.
May Diagnostics intends to exit the business having developed a proof of concept. The IP strategy should assist with this by providing an attractive IP portfolio to sell with the business. A good IP portfolio can also enable product differentiation and assist with gaining prestige and credibility. Ultimately, the IP portfolio should enable a buyer of May Diagnostics to limit the ability of competitors to provide similar products and services.
There are a wide range of IP rights that may be relevant to this project. Relevant IP rights include:
• Copyright (protecting creative works, including computer software);
• Trade Marks (protecting branding, such as product and company names);
• Patents (protecting technical functionality);
• Designs (protecting what products look like); and
• Confidential information/knowhow (concerning the control of distribution of information).
IP for the biological process might include registered designs and trade marks protecting aspects of the
mechanical device, patents directed to the underlying biological concepts or to features of the mechanical device, and confidential information/ know-how that may be retained within Professor Johnson’s or Dr May’s teams. Patents directed to the underlying biological process may be one of the key IP rights developed in this project. Note that registered designs may be of limited value since May Diagnostics is intending to develop a proof of concept only and products may well be redesigned before being marketed.
IP relating to the diagnostic process might include copyright in computer software, confidential information (for example, relating to the data processed by the data processing backend), and patents covering the algorithms implemented by the diagnostic process. It should be noted that restrictions on the patenting of mathematical methods, computer programs, and diagnostic methods practised on the human body may limit the scope of patents that might be obtainable.
IP relating to the App may include copyright in the underlying software code, registered designs and copyright in the user interfaces, and trade marks relating to branding of the App. However, IP relating to the App may be of limited value if future design iterations are likely to change the look and feel of the product.
Delaying filings for registered IP rights (particularly patent applications) delays costs. However, delay risks concepts being disclosed and thereby preventing valid patents from being obtained. A particular issue for May Diagnostics is that academics involved in the project will be keen to publish their work. Accordingly, early filing of patent applications for core concepts is probably advisable.
Registered designs should perhaps be delayed until close to product launch (since designs change). Indeed, if a proof of concept is developed (rather than a commercial product), registered design protection may not be required at all.
Trade mark protection should be considered before brand reputation is built. Not conducting detailed
trade mark searches may be a costly mistake as it can be expensive to rebrand later if problems emerge.
Start-up companies have limited resources available when developing IP portfolios. One way in which limited funds can be stretched is to limit the IP portfolio to key jurisdictions. For example, patents may only be obtained in a small number of countries. While attractive in the short term, if the geographical scope of the IP portfolio does not meet the needs of stakeholders (such as potential investors or buyers), then this may significantly limit the value of the IP portfolio (and potentially the entire company). It may make sense to obtain core IP rights in a wide range of countries, with other IP rights being obtained in a subset of those countries.
There are lots of parties involved in the project. Any of those parties could potentially own at least some IP rights in the project. Addressing ownership of IP rights at an early stage is advisable for many reasons. For example, memories are clear, collaborations are still working, and external pressure (such as from potential investors) is less significant. Clarifying issues of ownership when May Diagnostics is seeking to exit the business is certain to be more difficult and more expensive.
“Freedom to operate” refers to the freedom to market the products and services developed by May Diagnostics (which can be restricted by the IP rights of others). This will be an important issue to any company considering investing in, or buying, May Diagnostics. A full freedom to operate analysis is a difficult and expensive task and is beyond the means of many start-up companies. However, a lack of knowledge of the IP landscape in the relevant technical field (such as major companies within the field and their attitudes to IP) is likely to make potential investors or buyers nervous.
The project includes a number of software products. Software developers often make use of Open Source Software (OSS). Caution is required here since the use of OSS typically comes with obligations that may be unattractive to potential
investors and buyers. While May Diagnostics has a degree of control over software code developed inhouse, significant care is needed to ensure that outsourced software development (for example, during App development by Keir IT) does not result in OSS restrictions being imported into the product.
This article explores issues relating to IP strategy using a digital health case study. As discussed, understanding general business strategy and the needs to key stakeholders can help in the development of an IP strategy that ultimately results in the creation of an appropriate IP portfolio and the identification and mitigation of key risks.
As a final thought, I note that IP strategies often place more focus on the development of IP portfolios than on the mitigation of risk. This can be a mistake. Understanding and mitigating IP risks can significantly strengthen a company’s IP position and can be impressive to investors.
gwhiting@vennershipley.co.uk
It seems increasingly likely that the long gestation of the Unitary Patent (UP) and Unified Patent Court (UPC) system is finally reaching its conclusion, with an official start date provisionally scheduled for 1 April 2023, meaning a sunrise period would start on 1 January 2023.
The new system will represent the most wide-ranging change to the European patent system since the adoption of the European Patent Convention in 1977, offering the chance to litigate patents in multiple European jurisdictions in a single procedure and a process for obtaining a unitary patent right in those countries. However, this is fundamentally a new package of options bolted on to the structures already in place; the complexity of the changes and the slow-burn to final adoption has led to some overreach in expectations. In the excitement and noise surrounding the dawn of a new era, here are some key points which will not change:
At heart, the UP/UPC is trying to complete a process of harmonisation that has remained partial since the founding of the European patent system. The key to originally achieving this partial harmonisation was to recognise a distinction between pregrant and post-grant proceedings. The European Patent Office (EPO) was set up to handle prosecution up to grant, and had a limited role postgrant (with the significant exception being Opposition procedure - also unaffected by the introduction of the UP/UPC system).
The UP/UPC is designed to complete harmonisation by addressing postgrant issues, and so does not affect the EPO’s existing role. The EPO will have a new role maintaining the register of UPs, and is certainly an interested party in the development of the European patent system, but users of the office will see no change in the prosecution procedure up to grant.
2. There is no change to the ability to obtain or enforce patents in countries that are not participating in the UP/UPC system
17 countries are likely to take part in the UP/UPC system when it starts. This means that the majority of the 38 European Patent Convention nations will not be part of the system, at least initially. The countries not taking part include a mixture of EU and non-EU nations - amongst them the UK, Spain and Poland – the route for obtaining patents in those countries through the EPO process remains the same, as does enforcement through the relevant national courts.
3. The transition period has no consequence outside of the participating states
The transition period is a complex beast. In essence, it allows a soft start to the use of the UPC, ensuring patent proprietors retain the option to use existing courts in UPC participating countries if they prefer
for a limited period (7 years initially, although there is the possibility for this to be extended). However, while this does mean that after the period ends the new system will be somewhat more rigid, this transition by its nature only applies to countries participating in the UP/UPC system. There will be no change to the routes to grant (including via the EPO) in European countries not participating in the UP/UPC, or indeed to postgrant litigation procedures in those countries, once the transition period ends.
Peter Thorniley pthorniley@vennershipley.co.ukIt is probably helpful to provide some definitions for the various terms that this article will use.
The Metaverse:
If the internet is a way of connecting with others as well as obtaining and providing information, the metaverse can be considered to be a more interactive three-dimensional approach to the internet and the virtual world it opens up. The metaverse enables users to have virtual experiences either simulating the real world or enabling interaction with worlds which cannot exist in “real space,” often using virtual and/or augmented reality. At present, various companies are competing to provide metaverse platforms.
Blockchain:
A blockchain is essentially a digital ledger and provides a way of recording transactions carried out in respect of a particular asset. It can be used for cryptocurrency transactions as well as dealing (transactions) in non-fungible tokens (NFTs).
Non-Fungible Tokens (NFTs):
NFTs are, in their most basic form, a piece of data demonstrating the transactional record of a virtual asset held within a digital file. NFTs record this information on a blockchain. NFTs can be sold and traded but they are not of themselves the asset; they are merely a record of the asset. The asset itself, which could be a virtual product such as a pair of sunglasses, a watch, or a piece of clothing, does not exist in the conventional sense
and so the NFT is a way of enabling the virtual asset to be purchased, sold, traded, or in other ways moved around the metaverse. An NFT provides a public Certificate of Authenticity or proof of ownership but as the ownership is defined by the blockchain, and that blockchain has no record of the ultimate real world owner, dealings in the NFT are still somewhat complex and uncertain in this rapidly developing area.
What does this mean for IP?
So how does IP work in both virtual and real world spaces, now that
assets such as consumer goods, which have traditionally been thought of only in tangible terms, can also have a value in the metaverse? Let’s look at an example.
The English company Sunnies manufactures high quality sunglasses for sale globally. Its target market is Generation Z and it recognises that this target market will be highly interested in the metaverse. Sunnies therefore decides to partner with a company specialising in high quality digital graphics to introduce a range of sunglasses in the metaverse alongside its real world sunglasses, both to promote its real world
We all know that we live in a rapidly changing world and that since the worldwide web arrived on the scene just 31 years ago, computer technology has developed exponentially. The latest development in that evolution is the metaverse.
sunglasses and to license use of its metaverse versions. The metaverse sunglasses will be limited in number and each of the individual pairs of sunglasses, to retain the exclusivity cachet Sunnies wishes to promote. Each metaverse pair will be embedded in an individual NFT and its record can be viewed via blockchain. The virtual sunglasses can be seen in the metaverse and picked up and worn using virtual reality equipment, but their real value is as a collectible asset.
Sunnies’ sunglasses are a premium product and each pair is sold with a Certificate of Authenticity in the real world. For the metaverse sunglasses, this is not necessary because the NFT provides a Certificate of Authenticity through blockchain transactions.
Making sure that your IPR is being protected properly
Trade Marks
Sunnies sells its limited edition metaverse sunglasses under specific names. Each of the names should be protected with a trade mark registration. It is an interesting question as to whether a virtual world or metaverse version of a product should be protected in the same category (class) of goods as the real world equivalent or in the class covering downloadable goods. In our example, the class is the same and so this becomes a moot point as it makes sense to cover both the real and virtual product in your specification. There have been calls for regulation of the metaverse, which some argue is something of a digital Wild West, and this may well prompt a revision to the current practice on protection of virtual assets in the metaverse. For now, given the uncertainty and lack of case law on this subject, we suggest protecting the downloadable goods as
well as the real world goods, and for older registrations which pre-date the metaverse, filing for downloadable goods to ensure protection is in place. We are seeing more and more businesses adopting this strategy.
Each of the Sunnies’ sunglasses designs across the range has an attractive shape and configuration and these aesthetic qualities of both the real world and virtual products should be protected by registered designs. For the physical sunglasses, registered design protection is straightforward using established registered design regimes. However, the question arises as to the extent of protection afforded by these regimes for the equivalent virtual sunglasses.
For some time now, registered design protection has been available for various different forms of digital designs such as digital icons, graphical user interfaces (including animated GUIs), display screen layouts, video games, animated characters, virtual environments, and other visible elements of a computer program. Furthermore, registered design classification systems (i.e. indications of product category required upon filing a registered design application) are mostly required only for formality purposes, such as categorising and searching within a designs registry, and do not restrict the scope of protection afforded by the design registration.
In view of the above, and that current design legislation does not give exhaustive lists of infringing activities of a registered design, the latest commentary is that a registered design for a product, such as Sunnies’ sunglasses, should provide protection against third parties using such designs in the metaverse as well as in the real world. Furthermore, petitions have been submitted by various professional bodies for forthcoming legislative amendments to clarify that registered design protection extends to “any physical or virtual… item…” to avoid doubt in this area. Until the situation is confirmed through legislation or case law, and following guidance at least from the European Union Intellectual Property Office, our current advice for clients seeking protection for their designs, regardless of whether the intended use is only in a virtual environment
or in both the real and the virtual world, is to indicate both the physical and virtual product indication on the design application.
Unregistered design rights will also be relevant in the metaverse but this is a complex subject worthy of its own article and is not covered here.
As well as adverts on television and online, Sunnies also advertises in the metaverse itself, both for its digital and real world sunglasses. For these adverts, Sunnies commissioned a catchy jingle. The composer of the jingle assigned the copyright in the jingle to Sunnies. This would be an example of copyright works from outside the real world being uploaded to, and used in, the metaverse.
People can also use software to create copyrighted works within the metaverse. An example of this is Sunnies’ digital sunglasses. These are built inside the metaverse and are considered an artistic work (just as drawing/animation of such sunglasses outside the metaverse would be).
Copyright arises automatically on the creation of the work, without the need for registration. On this basis, copyright subsists in works created in, or uploaded to, the metaverse in the same way that it would in the real world.
It is hard to envisage patent protection for the NFTs themselves as they are files containing digital information, but as this is a fastmoving area of technology, we will be keeping a keen eye on the possibilities for patent protection. In the same way that, for years now, patent regimes around the world have been tackling the thorny issue of how and whether to grant patent protection for software-related technology, similar challenges are envisaged for new technology invented around NFTs and the metaverse.
Using our example, Sunnies discovers that a German gaming company, Spiele, is offering a digital version of Sunnies’ best-selling sunglasses, protected with trade marks for
sunglasses and design registrations, in a popular online and downloadable game and wishes to prevent that unauthorised use. Let’s look at Sunnies’ options.
Enforcing IP rights in the metaverse is not much different to enforcing them anywhere else online. In many cases it can be difficult to tell who the infringing party actually is (although this is potentially easier with blockchain maintaining a record of transfers of ownership of metaverse products). However, in this case, Sunnies knows that Spiele is the suspected infringer. If Sunnies did not know, it would have to attempt to find out, perhaps by contacting the metaverse platform holder directly.
When dealing with enforcement online, there has been a rise in private enforcement processes. For example, Facebook Marketplace has a complaints procedure that allows rights owners to have infringing products removed. It may well be that the metaverse will have a similar process that Sunnies could potentially use.
Another option in dealing with unauthorised use is, counterintuitively, to authorise the use. A significant amount of originally unauthorised material on YouTube is allowed to remain available in exchange for the rights holder taking a cut of the profits. In this case, Sunnies could license Spiele to sell the digital sunglasses, either for a cut of each sale or for a fixed sum. Licences in the real world tend to be territorial (for example, for a specific country or worldwide). We will have to wait and see whether metaverse specific licences will materialise or whether the metaverse will be segmented to allow country-specific licences to still function.
If neither of these approaches achieves a satisfactory outcome, then Sunnies could potentially bring a court claim against Spiele. However, as with other claims with regard to online infringement, this could lead to some arduous and complex jurisdiction arguments.
• When considering protecting your IP rights, it is now worth considering protecting all tangible assets as both tangible assets
and as their digital equivalents. Although at the present time this will apply to consumer goods, it is likely to begin to apply to many more products as virtual reality and augmented reality become more and more engrained into our everyday lives.
• In terms of enforcement, not enough is yet known about the terms and conditions of the metaverse. However, if it is similar to enforcement on the internet more generally, then best options are likely to be either negotiating with the infringer or through the metaverse platform holder’s private enforcement mechanisms.
• The metaverse is at the cutting edge of technology and so the position with regard to IP rights could change very suddenly as technology evolves. Companies in the retail business (especially designer products) should keep a close eye on what is happening to ensure that their brands continue to be well protected.
Clare Turnbull cturnbull@vennershipley.co.uk
Alex Brown abrown@vennershipley.co.uk
Benedict Sharrock-Harris bsharrock-harris@vennershipley.co.uk
Most will be familiar with the Guidelines for Examination in the European Patent Office (Guidelines) and will be used to seeing European patent attorneys quote them both during examination and opposition proceedings before the EPO. The Guidelines are a useful resource published by the EPO setting out, from the EPO’s perspective, the approach that should be adopted before the EPO. However, recent Board of Appeal decisions have highlighted that the Guidelines are guidance and not legally binding, for example, on the Boards of Appeal.
As the name suggests, the Guidelines serve to “give instructions on the practice and procedure to be followed in the various aspects of the examination of European applications and patents in accordance with the European Patent Convention and its Implementing Regulations.” While generally useful in practice, it is prudent to remember that the Guidelines merely provide guidance and aim to serve as a basis for illustrating the law and practice before the EPO. A careful approach should therefore be taken on the over reliance and influence of the Guidelines, at the expense of case law and the European Patent Convention (EPC) itself.
Precedence at the EPO is a nuanced concept. While not legally binding in the strict sense, the Guidelines do carry influence and legal force. The Guidelines themselves state:
As a general rule, parties may expect the EPO to act in accordance with the Guidelines until such time as they – or the relevant legal provisions – are amended.
This raises a number of questions. Does the term “general rule” elevate the persuasive nature of the Guidelines, and suggest that they can reasonably be expected to be relied upon until some notional point in the future when they may (or may not) be amended? How much certainty can be placed on the Guidelines in their current form? If a case hinges on a point that is in conflict with the Guidelines, is the applicant facing a steep uphill battle from the outset or is there some scope for manoeuvre? In essence, it seems that the Guidelines are more or less binding on first instance Examiners and oppositions yet are only taken into account by Boards of Appeal to the extent that if their decisions diverge from the Guidelines they should explain their reasoning.
In caveating their scope and interpretation, the Guidelines explicitly state that:
“The Guidelines cannot cover all possible occurrences and exceptions in every detail, but must be regarded as general instructions that may need to be adapted to the individual case.” and
"It should be noted also that the Guidelines do not constitute legal provisions.”
This reflects the fact that the Guidelines, as instructions, are nonbinding in respect of decisions of the Boards of Appeal, as highlighted in Article 23(3) EPC.
“In their decisions the members of the Boards shall not be bound by any instructions and shall comply only with the provisions of this Convention.”
This echoes the overriding principle that for the ultimate authority on practice in the EPO, it is necessary to refer to the EPC itself.
So, when should one follow the interpretation and “general instructions” of the Guidelines and what degree of certainty can be placed on those instructions? What guidance do they offer when they may need to be “adapted to the individual case”? As evidenced by recent case law, the Guidelines can remain out of step with Board of Appeal decisions.
Selection inventions have historically been a fruitful source of case law for the EPO. While the Guidelines do provide valuable guidance regarding selection inventions, updates to the Guidelines can lag behind changes to established case law of the Boards of Appeal.
Recent decisions regarding the novelty of purity inventions highlight one such inconsistency.
T 990/96 – increasing purity is conventional
Increased purity of a chemical compound falls under the concept of a selection invention before the EPO. Historically, novelty of purity inventions was regarded as a special
case, and novelty was destroyed if the prior art disclosed the chemical compound and its method of manufacture, regardless of whether the claimed degree of chemical purity was disclosed in the prior art or not.
This was the view taken by the Board of Appeal in decision T 990/96 (dated 12 February 1998) that reasoned that “since conventional methods for the purification of low molecular weight organic compounds are generally part of his common knowledge….a [prior art] disclosure makes normally available this compound to the public in the sense of Article 54 EPC in all desired grades of purity.”
While in T 990/96, the Board of Appeal recognised that exceptional situations may arise and justify a different conclusion, i.e. that, for example, all previous attempts to achieve a certain degree of purity by means of conventional purification processes have failed, the burden of proof lay on the applicant in such circumstances. The fact that the prior art failed to explicitly disclose the claimed purity does not, in itself, constitute proof that the claimed purity could not be achieved using conventional methods.
Seeking guidance and referring to the Guidelines on this point, one might consider that this was the end of the story regarding the novelty of purity inventions as GL, Part G, Chapter VI, 7 states:
“A known compound is not rendered novel merely because it is available with a different degree of purity if the purity can be achieved by conventional means (see T 360/07).”
However, this appears not to be as cut and dried as it seems with two recent Board of Appeal decisions, T 1085/13 and T 0043/18, apparently conflicting with this statement.
T 1085/13 and T 0043/18 –supplementation of the prior art
In decision T 1085/13, dated 9 February 2018, the Board of Appeal found that the decision reached in T 990/96 was not compatible with well-established principles of novelty developed by the Enlarged Board of Appeal in decisions G2/88 and G2/10. Decision T 0043/18, dated 1 June 2022, closely aligns and follows the reasoning of T 1085/13 to reach the same conclusion.
Briefly, in T 1085/13, claim 1 was directed towards amorphous lercanidipine hydrochloride having a purity of at least 99.5%. In its objection of lack of novelty, the Examining Division relied on the reasoning of T 990/96 and held that because the applicant had not shown that all prior attempts to achieve the claimed level of purity had failed, the prior art anticipated the claimed purity level. Thus, the claim was not novel.
In contrast, the Board of Appeal in T 1085/13 considered the rationale of T 990/96 to not be in line with the case law developed by the Enlarged Board of Appeal, in particular decisions G 2/88 and G 2/10. Both G 2/10 and G 2/88 required at least an implicit disclosure of all features of a claim in a prior art disclosure for said prior art disclosure to be novelty destroying.
Applying this reasoning, the Board of Appeal found that “a claim defining a compound as having a certain purity therefore lacks novelty over a priorart disclosure describing the same compound only if the prior art discloses the claimed purity at least implicitly, for example by way of a method for preparing said compound, the method inevitably resulting in the purity as claimed.”
The Board of Appeal further stated that the claim does not lack novelty if the disclosure of the prior art needs to be supplemented, for example by suitable further purification methods, to allow the skilled person to arrive at the claimed purity. Interestingly, the Board of Appeal went on to reason that whether such further purification methods are within the common general knowledge of the skilled person is irrelevant to the question of novelty and is instead to be considered in the assessment of inventive step.
An analogous situation can be found in T 0043/18. The claim in dispute was directed towards a purer dosage form of oxycodone hydrochloride and was rejected by the Opposition Division for lack of novelty based on the reasoning outlined in T 996/90. Decision T 1085/13 was only published after the Opposition Division’s decision and was subsequently cited by the patentee on appeal. Interestingly, it appears that the same Technical Board of Appeal (3.3.02) presided over both cases.
Ultimately (and perhaps unsurprisingly), the Board of Appeal
in T 0043/18 followed the reasoning and conclusions set forth in T 1085/13 in relation to the assessment of novelty, in particular that the prior art would need to be supplemented with suitable further purification methods in order to (potentially) arrive at the claimed purity. Claim 1 was thus held novel over the prior art.
The Board of Appeal’s conclusion that the question of whether such further purification methods are within the remit of the common general knowledge of the skilled person is not relevant to novelty is an interesting one. The shift to evaluating this in relation to the assessment of inventive step parallels the shift seen in the “purposive selection” test when assessing the patentability of a sub-range selected from a broader numerical range of the prior art. It is no longer a requirement of novelty for the selection from the sub-range to be a “purposive one.” Instead this is now a question of inventive step, as outlined in the Guidelines:
“Decision T 261/15 confirmed that the requirement for a sub-range to represent a purposive selection is a matter of inventive step and not necessary for establishing novelty (see also G VI, 8).”
It is curious to note that the Guidelines have been updated to reflect this case law on the “purposive selection” test, yet they remain strangely out of sync for purity inventions, with decision T 1085/13 published over four years ago. The current Guidelines are on an annual revision cycle, with an updated version now published each March. Time will tell if future iterations of the Guidelines apply the new reasoning and provide further clarity and certainty to applicants regarding the assessment of purity inventions before the EPO.
Turning away from selection inventions, further points of contention between the Guidelines and the case law of the Boards of Appeal can be found in the requirements for description amendments at the EPO.
In March 2021, the updated Guidelines introduced significant and stringent changes to the
requirements for amendments to the description before a European patent application could be granted. While the 2022 update has softened somewhat in this respect, there remains a heavy burden placed on applicants to amend a patent application’s description to ensure that the description is consistent with the claims.
However, the case law in this area tells a slightly different story and is far from settled. On the one hand, decision T 1989/18, dated 16 December 2021, concluded that there is no legal basis in the EPC to require that the description must be brought into line with the claims. Notably, this decision contradicted earlier decisions, such as T 1808/06, on which the wording of the Guidelines appears to have been largely based, where it was held that the description must be adapted so that the claims are supported by the description, citing Article 84 EPC.
Naturally, T 1989/18 was a welcome decision for applicants, particularly in light of the strict and somewhat onerous requirements stated in the Guidelines, and offered a glimmer of hope that Examiners may not adhere so strictly to the Guidelines. However, it is notable that the subsequent update of the Guidelines in March 2022 did not substantially change following T 1989/18, perhaps reflecting the fact that this remains an isolated decision. Thus, the description amendment requirements (if following the Guidelines) remain burdensome.
Furthermore, recent decisions such as T 1024/18 and T 0120/20 (among others) contrast with the finding in T 1989/18 and seem to affirm the instructions of the Guidelines, with the Board of Appeal in T 0120/20 specifically stating that they did not follow decision T 1989/18.
The requirement for description amendments is an ongoing point of contention and the case law is far from settled on this subject. Further referrals to the Boards of Appeal are likely and perhaps even a referral to the Enlarged Board is on the horizon.
The Guidelines are a useful and familiar resource to applicants and proprietors of European patents and
applications. However, as evidenced by recent decisions, in some circumstances a cautious approach should be taken when relying on them.
When an application is important, it is worth taking a moment to consider if the conventional approach suggested by the Guidelines could be challenged in any way, even if the guidance is based on so-called “wellestablished EPO case law.” As we have seen from the decisions described above, the established approach can be challenged at appeal level and ultimately the case law changed.
If you would like assistance assessing if any particular case could benefit from such an approach, please contact your usual Venner Shipley attorney who would be happy to help, if necessary, along with our EPO Board of Appeal experts.
Tim Russell trussell@vennershipley.co.uk
Rachel Challands rchallands@vennershipley.co.uk
In the article, we concluded that in view of significant manufacturing challenges, and the need for any new party to conduct clinical trials, it would seem that a patent waiver/ crown use/compulsory licensing would be unlikely to significantly speed up manufacture and vaccine inequality. At the time of writing the previous article, little progress had been made in reaching any World Trade Organisation (WTO) patent waiver terms.
However, in June 2022, the WTO announced a compromise text, striking a deal on a partial patent waiver for COVID-19 vaccines. The decision gained consensus among its members, including the United Kingdom and the European Union.
The agreement is narrower than the initial proposal made by South Africa and India in October 2020 and does not currently cover diagnostics and therapeutics. Thus, treatments such as antibodies and antivirals are exempt, as are COVID-19 testing kits. The waiver allows developing countries to authorise the use of patented compositions and processes for the manufacture of COVID-19 vaccines without the consent of the rights holder in order to produce vaccines for domestic markets and eligible countries. This will take place via a compulsory licence that will be obtained through an accelerated procedure. Patent holders will be compensated as compulsory licences guarantee royalties to their holders. The idea is to facilitate the obtaining of compulsory licences for certain patents, although this does require that member countries already have such a mechanism in their national laws.
The waiver covers a five-year period and states that the WTO will consider
its extension to diagnostics and therapeutics within six months. The WTO Director General, Ngozi OkonjoIweala, argues that the compromise text will “contribute to ongoing efforts to deconcentrate and diversify vaccine manufacturing capacity.”
However, parties on both sides of the debate are unhappy with the present agreement. Some charities, such as Oxfam and Médecins Sans Frontières, and countries such as India, South Africa, Pakistan, Indonesia, Egypt, and Tanzania have argued that it does not go far enough and have called for it to be extended to diagnostics and therapeutics later this year. It is however noted that many COVID-19 treatments for example, are used to address other diseases. Meanwhile, The International Federation of Pharmaceutical Manufacturers & Associations has argued that it undermines innovation and rather than IP being a barrier, gaps in infrastructure and trade barriers are more significant reasons why vaccines have not been administered equitably worldwide.
While South Africa is pleased with the move, the government has also admitted that the manufacture of vaccines is a daunting task. “To scale up the production on the continent, further partnerships will be needed including access to know-how and technologies,” the South African government said in a statement.
We have seen wealthy nations discarding expired vaccines and developing countries turning down donations due to a lack of demand, so how effective the waiver will be remains to be seen. Its success may well rest on the willingness of rights holders to transfer their relevant know-how, particularly related to vaccine manufacture.
Waiver or no waiver, it seems that the COVID-19 vaccine litigation space is about to get very interesting. Platform mRNA technologies were patented many years before the pandemic and battles are breaking out.
In October 2020, Moderna announced that it would not enforce its patent rights pertaining to COVID-19 vaccines globally in order to allow the creation and distribution of vaccines during the pandemic. However, now that the crisis has diminished, Moderna has reversed this policy in developed countries. From March 2022, all IP rights were declared fully enforceable except in 92 low- and middle- income countries (known as Advance Market Commitment, or AMC, countries).
At the end of August 2022, Moderna filed a patent lawsuit against Pfizer and partner BioNTech related to their COVID-19 vaccine. The lawsuits, deposited in the United States District Court for the District of Massachusetts and the Regional Court of Düsseldorf in Germany, allege that mRNA technology Moderna developed before the pandemic, patents filed between 2010 and 2016, was copied . The lawsuits are seeking unspecified financial damages.
Moderna Chief Legal Officer, Shannon Thyme Klinger, is quoted as saying: “Outside of AMC 92 countries, where vaccine supply is no longer a barrier to access, Moderna expects Pfizer and BioNTech to compensate Moderna for Comirnaty's ongoing use of Moderna's patented technologies.” (Comirnaty® being the Pfizer/BioNTech vaccine that we have become so familiar with in recent times.)
“We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and
In our Autumn/Winter 2021 edition of Inside IP, we looked at whether or not a patent waiver for COVID-19 vaccines might be effective and we explored both sides of the debate.
patented during the decade preceding the Covid-19 pandemic,” Moderna chief executive Stephane Bancel says.
In Germany, Moderna has asserted EP 35 90 949 and EP 37 18 565.
Moderna’s press release states: “First, Pfizer and BioNTech took four different vaccine candidates into clinical testing, which included options that would have steered clear of Moderna’s innovative path. Pfizer and BioNTech, however, ultimately decided to proceed with a vaccine that has the same exact mRNA chemical modification to its vaccine as Spikevax®. Moderna scientists began developing this chemical modification in 2010 and were the first to validate it in human trials in 2015.”
It goes on: “Second, and again despite having many different options, Pfizer and BioNTech copied Moderna’s approach to encode for the full-length spike protein in a lipid nanoparticle formulation for a coronavirus. Moderna scientists developed this approach when they created a vaccine for the coronavirus that causes Middle East Respiratory Syndrome (MERS) years before COVID-19 first emerged.”
Moderna is only seeking damages, not an injunction, in order to maintain vaccine supply. The unspecified damages sought from Pfizer and BioNTech are to be calculated
only from March of this year. Nevertheless, these figures would still be substantial, considering Pfizer projected its 2022 revenue to be approximately US$32 billion from Comirnaty® alone. Furthermore, no damages are being sought in relation to sales to AMC 92 countries.
Pfizer and BioNTech are expected to defend their position with BioNTech noting that “BioNTech's work is original, and we will vigorously defend against all allegations of patent infringement. BioNTech also values and respects valid and enforceable intellectual property rights of others and remains confident in its intellectual property.”
Both Pfizer/BioNTech and Moderna are already facing other lawsuits relating to their respective mRNA platforms. Moderna is in an ongoing dispute with the US National Institutes of Health over the credit for key patents relating to mRNA technology and in July, German biotech company, CureVac, filed a lawsuit against BioNTech claiming it violated patents linked to the engineering of certain mRNA molecules. Pfizer and BioNTech quickly responded with a complaint in a US district court, seeking a judgment that they did not infringe US patents held by CureVac and, at the start of September, Pfizer and BioNTech filed proceedings at the High Court
of England and Wales, seeking a judgment that their mRNA COVID-19 vaccine does not infringe CureVac’s European patents.
The litigation will be interesting to watch develop as such an order of magnitude and prevalence in the public domain are rarely seen.
Kirsty Dolphin kdolphin@vennershipley.co.ukAI technologies are transforming industries and impacting economic landscapes and legal frameworks worldwide. The UK government is committed to making AI a central part of the country’s industrial strategy and growth, and in September 2021 published its National AI Strategy (the UK AI Strategy) based on three pillars: investment, ensuring that AI benefits all sectors and regions, and governance.
In a previous article for Inside IP, we looked at the draft Artificial Intelligence Act of the European Commission (the AI Act), which is making its way through the legislative process and is not expected to be in place before 2024 at the earliest. The AI Act represents an ambitious attempt to set out a cross-sectoral regulatory approach to the use and development of AI systems across the European Union by prescriptive legislation with extra-territorial application.
In July 2022, as part of the UK AI Strategy, the UK government published its AI Regulation Policy Paper, setting out its proposals for a decentralised approach to regulation of the use of AI technologies – this would include roles for governments, regulators, technical standards bodies, and industry. The government paper positions its proposals as being context-specific, coherent, risk-based, proportionate, and adaptable.
The UK AI Strategy is the culmination of recommendations, reports, and shared strategies from across various UK institutions, regulators, and organisations that play a key role in reviewing the AI governance landscape. In June 2019, the House of Lords appointed the Select Committee on Artificial Intelligence to “consider the economic, ethical and social implications of advances in artificial intelligence.” In its report, “AI in the UK: ready, willing and able?”, the Select Committee concluded that
blanket AI-specific regulation would be inappropriate, finding that “existing sector-specific regulators are best placed to consider the impact on their sectors of any subsequent regulation which may be needed.”
In contrast with the EU approach, which comprises a single framework with a fixed list of risks associated with the development and use of AI, the UK’s more flexible approach seeks to address AI risk in a more targeted way, via existing regulators, including the Information Commissioner’s Office (ICO), the Financial Conduct Authority, and the Competition and Markets Authority.
The UK approach is directed by a strong belief that a fixed list of AI risks could quickly become outdated, impeding flexibility, whereas a decentralised approach seeks to leverage the expertise of regulators within their respective domains. As stated in the AI Regulation Policy Paper:
“[We] think this is preferable to a single framework with a fixed, central list of risks and mitigations. Such a framework applied across all sectors would limit the ability to respond in a proportionate manner by failing to allow for different levels of risk presented by seemingly similar applications of AI in different contexts. This could lead to unnecessary regulation and stifle innovation. A fixed list of risks also could quickly become outdated and does not offer flexibility. A centralised approach would also
not benefit from the expertise of our experienced regulators who are best placed to identify and respond to the emerging risks through the increased use of AI technologies within their domains.”
The UK approach also diverges from that of the AI Act by eschewing reliance on a single definition of AI; this is a logical consequence of the two different approaches. A centralised piece of legislation aiming at harmonising the law of 27 EU Member States calls for a technical definition that will need to be applied across all sectors, industries, and AI applications. By contrast, the UK stated in its proposal that it is the use of AI which should be the focus of regulation, rather than the technology itself . Once it was concluded that “[AI] is a general purpose technology”, its universal definition became less relevant in a sector-based approach.
Nonetheless, the UK is set to guide regulators by providing more detailed definitions based on the core characteristics and capabilities of the relevant AI. The AI Regulation Policy Paper suggested that the two general characteristics that would bring AI systems within the scope of regulation are the “adaptiveness” and “autonomy” of the technologies:
• An “adaptive” system is trained on data and operated according to patterns and connections which are not easily discernible to humans. The clear difficulty
arising out of an adaptive system is explaining the logic or intent by which an output has been produced. An implication of this would be in all cases where “there is an expectation that a decision should be justifiable in easily understood terms - such as legal dispute.”
• An “autonomous” system can operate without the ongoing control of a human operator, highlighting the issue of assigning responsibility for actions taken by AI systems.
There are AI systems that would be considered to be of both varieties, for example, a self-driving car control system is both autonomous and adaptive.
The decentralised proposition in the UK AI Strategy could lead to disparities in the approaches between regulators on similar issues. Having acknowledged such a challenge, the UK government has not ruled out that further legislation may be needed, in particular to address the potential for overlap and coordination between the different regulators.
The UK approach also includes the development of a set of cross-sectoral principles, which regulators will be tasked with implementing within their respective remits:
1. Ensure that AI is used safely: regulators will be required to take a context-based approach in assessing any risk AI can pose to safety in their respective sectors and formulate a proportionate approach to managing this risk.
2. Ensure that AI is technically secure and functions as designed: regulators shall ensure that consumers and the public have confidence in the proper functioning of AI systems.
3. Make sure that AI is appropriately transparent and explainable: individuals should be able to understand why an AI-enabled process has come to a particular decision. This could present challenges, as AI technology may not provide reasoning fully understandable to individuals. The AI Regulation Policy Paper suggests that decisions that cannot be explained might be prohibited by the relevant regulator. For
example, a tribunal decision would be of such significance for an individual that an explanation of its underlying reasoning would be indispensable.
4. Embed considerations of fairness into AI: in order to ensure a proportionate and pro-innovation regulation, each regulator will determine in the context of their own sector and domain what amounts to fairness.
5. Define legal persons’ responsibility for AI governance: accountability for the outcomes produced by AI and legal liability must rest with an identifiable legal person.
6. Clarify routes to redress or contestability: the use of AI should not remove an affected individual’s or group’s ability to contest an outcome that may result in a material impact on people’s lives.
The potential for gaps in the regulatory framework, and for inconsistency and overlap between regulators, are to be addressed in a forthcoming White Paper to be published by the Office for Artificial Intelligence (established to implement the national strategy for AI) by the end of 2022.
A key advantage for the UK approach compared with that of the EU is the agility with which legislation can be progressed. The AI Act is still a considerable time away from being finalised and it will then need to be approved by all the EU Member States and implemented, including the establishment of new regulatory bodies. We have already seen indications that existing regulators – the European Data Protection Board and national data protection regulators in the EU Member States – are seeking to secure a remit for oversight of the AI Act. The UK government, by contrast, has the ability to move quickly in advancing its lighter touch approach to regulating AI.
In September 2021, the UK government launched a consultation “Data: a new direction” to inform the government’s approach to updating
data protection laws following the UK’s departure from the EU. Responses were received from the ICO and domestic and overseas organisations. The consultation addressed, among other things, the use of AI-powered automated decision-making in light of the need for organisations working on AI tools to have space to experiment without causing harm to the public. The consultation asked for views on whether organisations should be able to use personal data more freely for the purpose of testing and training AI.
In parallel with the AI Regulation Policy Paper, the government released the Data Protection and Digital Information Bill in July 2022 (the Data Protection Bill) . The Data Protection Bill proposes a series of amendments to Article 22 of the UK GDPR (which is identical to Article 22 of the EU GDPR), re-working the approach to focus on specific safeguards for individuals rather than a general right not to be subject to solely automated decision-making.
Further changes to the approach in Article 22 of the EU GDPR were also proposed, however the future of such reforms is uncertain. An announcement was made on 3 October 2022 by the Secretary of State for Digital, Culture, Media and Sport, Michelle Donelan, that: “[we] will be replacing GDPR with our own business and consumer-friendly, British data protection system,” with the new legislation drawing the “best bits” from other data protection regimes such as Israel, Japan, South Korea, Canada, and New Zealand.
We shall be monitoring the progress of regulatory proposals in the AI space, and will provide further updates in due course, including via our regular Data Blast on data protection and privacy related matters.
rpeake@vennershipley.co.uk
Fabiana Atzeni fatzeni@vennershipley.co.uk
Although the “Big Bang” might be considered to relate to the start of the universe for many, this is not the case for patent attorneys and those at the World Intellectual Property Organisation (WIPO). Instead, this relates to 1 July 2022, the date on which the new WIPO standards for sequence listings came into force.
These changes have been anticipated for some time and are intended to bring about improvements, clarity, and uniformity to sequence listings. Here, we will cover some of the changes and key factors to be aware of.
ST.26 is the new sequence listing requirement set by WIPO, replacing the previous requirement, Standard ST.25 (ST.25), which was adopted in 2009. The requirement sets the standard for the presentation of nucleotide and amino acid sequence listings in patent applications and must be followed in order to avoid potential formality and added matter objections.
All new applications, including priority and priority claiming applications, must use ST.26 compliant sequence listings if a sequence listing is to be filed. However, use of ST.26 in divisional applications is a matter of national law (most Intellectual Property offices will require ST.26 compliant sequence listings) as we discuss further below.
ST.26 is a more thorough and complex set of requirements than ST.25, and so transferring data between the two formats will require manual intervention.
The new sequence format is an XML file format and provides more information about each sequence, such as the type of molecule for nucleic acid sequences.
The criteria for a sequence to be included in a listing has changed. There is a new minimum sequence length of ten specifically defined nucleotides or four specifically defined amino acids, and shorter sequences must not be included in the listing. The definitions of amino acids and nucleotides have been expanded, meaning that more sequence types are now covered, and “u” is no longer used as a symbol, so that uracil in RNA is represented by “t” rather than “u.”
Insertions and substitutions have been clarified, for example, they can be included as feature annotations of a sequence provided that they are independent of each other. If any insertion or substitution sequences themselves meet the minimum sequence length criteria, they should additionally be listed as their own separate sequences with their own sequence ID.
ST.26 has a new feature known as the “mol_type,” in which the subtype of the molecule is denoted. Options in this field include “genomic DNA,” “mRNA,” and “tRNA,” among others, but non-naturally occurring sequences (synthetic constructs) must be indicated as “other RNA” or “other DNA” and naturally occurring in vivo sequences of unknown subtype
should be indicated as “unassigned RNA” or “unassigned DNA.”
“Mixed mode” sequences, which include the nucleotide and accompanying protein sequence, are no longer possible, but instead nucleotide sequences can be listed to include the feature “CDS” which can identify coding sequences and be qualified with the “translation.”
The protein sequence itself however should be given its own ID. Amino acids are now represented by a single capital letter rather than three-letter codes.
Finally, bibliographic data is limited to one applicant, optionally one inventor, and details of the earliest priority application only.
How is the change being dealt with in different territories?
The UK Intellectual Property Office (UKIPO) has taken a relatively relaxed approach to the change. For example, divisional applications for which the parent application comprises an ST.25 listing may also use ST.25 listings after 1 July 2022.
If the application includes a noncompliant sequence listing, then after identification during preliminary
examination the applicant will have 15 months from the filing date to provide a compliant sequence listing, and this will not delay publication.
In contrast to the UKIPO, the European Patent Office (EPO) requires that such divisional applications must have ST.26 compliant listings, as must applications filed by reference to earlier applications.
Likewise, the United States Patent and Trademark Office has announced that the ST.26 standard will be required for continuing and divisional applications, and ST.26 is required for any application with a filing date on or later than 1 July 2022, regardless of an earlier priority claim.
All new international (PCT) applications including biological sequence listings must include the sequence listing in the ST.26 file format from 1 July 2022. However, for PCT applications filed before 1 July 2022 but entering the national or regional phase after 1 July 2022, the ST.25 standard still applies.
With the EPO’s requirement that divisional applications require ST.26 compliant listings regardless of the format of the parent application’s listing, parent application sequence listings in ST.25 format may need to be changed into ST.26 format for the divisional application. This could generate issues due to the EPO’s strict requirement that a divisional application does not add matter over the disclosure of the parent application. As noted above, ST.26 requires more information than ST.25 listings so addition of this information could extend the subject-matter beyond that originally disclosed in the parent application. Added matter might also be a concern when there is a lack of clarity in the earlier ST.25 sequence listing, and this lack of clarity is addressed by the ST.26 listing.
The EPO has advised that potential added matter problems can be avoided by adding the parent ST.25 sequence listing to the description of the divisional application when it is filed, and then subsequently filing the ST.26 sequence listing for search purposes only, rather than as part of the description. However, an additional fee may fall due if the
required ST.26 sequence listing is filed after the divisional application filing date, and excess page fees may increase if the ST.25 listing of the parent is added to the description. Neither is ideal for the applicant.
Although the new XML file format is user-friendly and applicants may use any XML-editing tool, it is recommended to use the WIPO Sequence desktop tool, which has been designed to handle the complicated data associated with the new ST.26 requirements. Sequences may be validated using the same tool, but WIPO Sequence Validator, a web service, has been designed for patent offices to check the compliance of filed sequence listings with the ST.26 standard.
The new ST.26 standard introduces a multitude of new requirements and changes. Though the new WIPO sequence application is helpful for navigating these changes, care must be taken with the new features, especially when converting an ST.25 compliant listing to be ST.26 compliant. This is particularly true when preparing sequence listings for divisional applications, due to the potential added matter issues highlighted above.
Kirsty Dolphin kdolphin@vennershipley.co.uk Sophie Newgas snewgas@vennershipley.co.uk Emma Longland elongland@vennershipley.co.uk
Just over 30 years ago, in 1991, Sony launched a camcorder containing the first commercial rechargeable lithium ion battery. Rechargeable batteries have come a long way since then – in awarding the 2019 Nobel Prize in Chemistry to the inventors of the original lithium ion battery, the awarding committee noted that lithium ion batteries have “revolutionised our lives.” Today rechargeable batteries are ubiquitous in portable electronic devices and are a crucial part of the move to cleaner and more efficient energy, from electric vehicles to domestic energy storage.
The growth and spread of rechargeable batteries are reflected in an increase in patent applications in battery technologies, which have grown at a much faster rate than patent applications overall (Figure 1). Battery patent applications originating in Japan show a particularly marked increase over the last two decades (Figure 2) .
A range of different types of rechargeable batteries (for example, metal ion, metal, metal-air, and redox flow) are being developed for a range of different fields of application. Each of these fields has its own battery requirements driving battery research and associated patent filings. For example, the challenges in research and development of smartphone batteries are quite different to those of electric vehicle batteries. A specific example is solid vs. liquid electrolytes for the automotive sector, discussed in more detail by our colleague Jack Rogan
Therefore, it is informative to look at not only the overall trend for battery filings but also trends within specific sectors.
Focusing on the automotive sector, there has been an increase in patent applications classified under International Patent Classification (IPC) codes for electric vehicles and charging, monitoring, and controlling batteries for electric vehicles (see Figures 3-5 for the numbers of published European patent applications).
Figure 3: EP A publications with IPC code B60L50/00 - Electric propulsion with power supplied within the vehicle
Figure 4: EP A publications with IPC code B60L53: Methods of charging batteries, specially adapted for electric vehicles; Charging stations or onboard charging equipment therefor; Exchange of energy storage elements in electric vehicles
Figure 5: EP A publications with IPC code B60L58 - Methods or circuit arrangements for monitoring or controlling batteries or fuel cells, specially adapted for electric vehicles
Figure 6
Until about five years ago, at least one-third of all European patent applications published in these areas were attributed to Japanese applicants. While the most recent figures still show that Japanese applicants are filing roughly between one in four and one in six applications, what is noticeable is the step change in the number of applications being filed by Chinese applicants. The number of applications published in the name of Chinese applicants in some areas has trebled in successive years.
These trends in the automotive sector are within the disciplines of electrical engineering and software. Growth of patent filings in other disciplines can be seen by comparing changes in the technology classifications for Patent Cooperation Treaty applications over the last ten years in the broad field of secondary batteries (Figure 6).
Increases are particularly pronounced in the following areas, encompassing a diverse range of technical disciplines:
H01M10/052 – Lithium accumulators
H01M10/42 – Methods or arrangements for servicing or maintenance of secondary cells or secondary half-cells
H01M4/62 – Selection of inactive substances as ingredients for active masses, for example binders, fillers.
Commercially successful technologies are often accompanied by extensive patent litigation. Examples include the recent patent infringement claims filed by Moderna against Pfizer and BioNTech in relation to the mRNA technology used in COVID-19 vaccines, and the socalled smartphone patent wars that accompanied the rise in popularity of smartphones. In the case of battery technology, however, the range of different battery types and fields of application set out above point to a possible future of sector-specific battery patent litigation or sectorspecific patent pooling.
This makes it all the more important for patent applicants to draft patent applications in a way that maximise the chances of success during patent prosecution and any subsequent litigation. For patent applicants with an interest in patent protection in Europe this is illustrated by recent
case law for battery inventions which highlight pitfalls specific to European patent law.
In the chemistry and materials area, T 0144/20 relates to a polymeric battery separator containing, inter alia, the presence of microfibres for high tensile strength. The Board of Appeal found that although microfibres can be selected so as to improve tensile strength, the “mere presence” of microfibres as recited in the claim at issue was not enough to achieve this effect. Consequently, the claim was found to lack an inventive step in the absence of the feature or features necessary to solve the problem of achieving a high tensile strength across the scope of the claim.
This decision is in line with longestablished case law of the Boards of Appeal that if inventiveness of a claimed invention is based on a given technical effect, then that technical effect should be achievable over the whole area claimed. These precedents are from outside the area of battery technology – indeed, for chemical inventions, much of the case law comes from the field of pharmaceuticals – but this decision demonstrates that legal principles developed in these other fields will be applied to the field of batteries unless there is a good reason not to do so.
Similarly, in the field of battery charging in T 2787/19, a claim to a system for recharging of a robot cleaning system was refused based on long-established case law on the strict requirement for amendments to a claim to find “direct and unambiguous” in the disclosure of the application as filed. In this case, the application disclosed a robot cleaner using sound as a basis for triangulation for the cleaner to find its way back to a charging base when the cleaner battery charge falls below a pre-set value. The Board of Appeal found that the amended claim recited a general triangulation using sound whereas the basis relied on for this amendment discloses a specific form of sound-source localisation. The amendment was therefore found to be an unallowable “intermediate generalisation” in line with established case law.
Applicants also need to take care with terminology, especially when translating into English, and interpretation of features. For
example, in T 2696/18 , the applicant/ appellant argued that a claim was distinguished over the prior art because the claim recited a “charging station” implying that it was stationary, such as a charging station for an electric vehicle, whereas the prior art disclosed a “charging circuit.” The Board of Appeal did not agree with the appellant.
Patent applications for rechargeable batteries are growing at a significantly faster rate than patent applications as a whole, and as rechargeable batteries become ever more widespread, it can be expected that patent litigation will follow as patent owners seek to establish and protect their positions within their market sector. Patent applicants filing in this space and with an interest in the European market should be mindful of the patent validity issues that are in some cases unique to Europe.
Anwar Gilani agilani@vennershipley.co.uk
One of Andy Warhol’s best-known quotes is that, in the future, everyone will be world-famous for 15 minutes. There are doubts as to whether he really coined the phrase, but it seems that nowadays more and more people reach celebrity status, even if only for a short period. Alongside more traditional celebrities (writers, singers, actors, or athletes), a number of individuals have, through socalled “reality TV shows” or social media, become famous almost overnight.
A famous name can be the source of enormous revenue, through licensing deals or the endorsement of third parties’ products. However, the high level of attention celebrities receive can attract fraudsters trying to capitalise on someone’s name to sell their own products or services. How can celebrities protect their name in such instance?
In contrast to other jurisdictions, in the United Kingdom celebrities cannot use “image rights,” “rights to privacy,” or “right of personality” to control the use of their name, image, or likeness. They can, however, rely on statutory or common law legal rights, such as passing off and trade mark law to prevent the use (or the registration as a trade mark) of their name in relation to unauthorised products or services. We discuss these actions below.
For completeness, other claims may be available. For example, a celebrity may claim defamation or breach of contract, complain to the Advertising Standards Authority in relation to an advertisement using their name or image without permission, or file a domain name complaint for the cancellation or transfer of a domain using their name. Since these claims either require additional offences (such as slander or the breach of a contract) or follow specific policies and procedures (which merit an
article all to themselves), they have been omitted from the scope of this article.
The tort (i.e. the wrongful act) of passing off protects the goodwill associated with a business, its goods, or its services. Goodwill has been defined as “the attractive force which brings in custom” to a business (IRC v Muller & Co.'s Margarine Ltd [1901] AC 217). At its simplest, passing off occurs when a business misleads customers into believing that its goods are those of another supplier, in order to benefit from the goodwill of that other supplier.
A successful passing off claim requires the claimant to prove that: (i) it has built-up goodwill in its goods, services, name, or mark; (ii) there has been a misrepresentation by the defendant, leading customers to believe that the defendant’s goods or services are those of the claimant (or goods or services the claimant has approved); and (iii) this results (or is likely to result) in damage.
Can a celebrity, whose name is used on goods (or for services) without consent, successfully claim passing off? This has not always been the case. For a long time it was held that, in the absence of a common field of activity between the claimant’s and the defendant’s goods and services,
there was no misrepresentation. In McCulloch v Lewis A May [1947] 2 All E.R. 845 , a famous radio presenter (known as “Uncle Mac”) brought a passing off claim against the defendant, which was using the name “Uncle Mac” to promote its cereals. The claim was dismissed because there was no connection between the claimant’s business (presenting radio programmes) and the defendant’s business (selling cereals) and thus no misrepresentation. More surprisingly, in Lyngstrad v Anabas Products Ltd [1977] FSR 62 , the pop group Abba failed to prevent a defendant from using the name “Abba” on a variety of goods (T-shirts, badges, and key rings). The passing off claim was dismissed on the basis that Abba had not established goodwill in trading in those goods. There was no common field of activity between the claimant’s and the defendant’s activities and thus no misrepresentation.
This changed thanks to the Irvine v Talksport [2003] EWCA Civ 423 case, involving the then Formula 1 driver Eddie Irvine and the radio broadcaster Talksport. Without Eddie Irvine’s consent, Talksport had promoted its services through a photograph showing him holding a portable radio with the Talksport name and logo on it. The photograph had been doctored (the original photograph showed Eddie Irvine holding a mobile phone) and clearly implied that he had endorsed the radio station.
Eddie Irvine had established reputation and goodwill, he was a well-known racing driver, and, more importantly, the public was aware that he was involved in various endorsement and sponsorship deals. The main question was whether misrepresentation had occurred despite an apparent lack of connection between the parties’ activities. The judge acknowledged that it was common practice for celebrities to exploit their names (and images) by way of endorsements and that this extended to fields outside a celebrity’s field of expertise. Misrepresentation took place because the public had been misled into believing that Eddie Irvine had endorsed (or was associated with) the defendant’s services. This damaged Mr. Irvine’s ability to monetise his name (or likeness) for other products and services and thus amounted to passing off.
In Fenty v Arcadia [2015] EWCA Civ 3 (22 January 2015), the popstar Rihanna sued the retailer Topshop for passing off after it had sold a T-shirt emblazoned with a photograph of her. Rihanna had built-up goodwill, she had her own range of clothing at a competitor’s retail shop called River Island, and had been involved in other endorsement deals. As with the Irvine case, the discussion circled around the false endorsement claim: would the public be misled into believing that Rihanna had endorsed the Topshop T-shirt? In this instance, it was held that, based on the facts of the case (Rihanna had also been involved in Topshop promotions in the past), a substantial number of customers would have assumed there was a connection with the Topshop product and the false endorsement claim succeeded.
It should be noted that the above two cases related to the use of celebrities’ images and not their name. However, the same principles equally apply.
The fact that the tort of passing off has adapted to cover false endorsement claims is welcome, however, it does not mean that any unapproved use of a celebrity’s name (or image) on products (or in relation to services) will automatically lead to a successful passing off claim. Passing off cases rely heavily on the evidence submitted by the parties
and claimants willing to protect their famous name still need to prove goodwill, misrepresentation, and damage.
demonstrate goodwill in its mark and rights are established as soon as the mark proceeds to registration. Furthermore, while in a passing off case a claimant must prove misrepresentation even if the other side uses the same mark, in the case of a defendant using a mark identical to the claimant’s registered mark (and for identical goods or services) confusion does not need to be proven. For completeness, there are specific limits to the claimant’s rights, for example in the case of comparative advertising.
In most cases, a celebrity should not have issues proving goodwill, however, it should not be assumed that the notoriety of a name is by itself proof of goodwill. In the Irvine and Rihanna cases, both celebrities were known for licensing the right to use their images. This helped their claims because there was an expectation from the public that products bearing their images had likely been endorsed. Other celebrities (for example, politicians who have never licensed their name or image) may struggle to prove goodwill, misrepresentation, and damage.
Another potential hurdle could come from the name itself. It may be harder for a celebrity, whose name is commonly used among the public, to prove that a product bearing their name gives rise to the false message that these products have been endorsed. For example, and this is just speculative, it may be easier to prove misrepresentation if the name used is “Rihanna” than if it is “Tom Jones” or “Chris Evans.”
A registered trade mark gives its owner a proprietary right, which can be used to prevent third parties from using the same mark in relation to the goods and services covered by the registration. Provided a risk of confusion exists, a trade mark owner can also prevent the use of names that are similar to the registered mark, in relation to similar goods or services.
Owning a registered trade mark confers many advantages. A trade mark owner does not need to
Many celebrities have registered their names as trade marks. Using some of the examples discussed above, the names “Rihanna” and “Eddie Irvine” were both registered as trade marks in the UK (although, in the case of “Eddie Irvine” the marks were registered in a slightly stylised format and have since lapsed). Had the defendants to these cases used the names “Rihanna” and “Eddie Irvine” as opposed to images of the celebrities, the claimants may have claimed trade mark infringement alongside passing off.
As shown above, a trade mark registration gives its owner rights that can be proven and enforced more easily than with a passing off claim, however, the registration of a famous name as a trade mark is not without hurdles.
The registration of a mark will be refused if the relevant trade mark office considers that the mark is not sufficiently distinctive (the public will not perceive it as an indicator of trade origin) or is descriptive of the goods and services covered.
The registration of a famous name as a trade mark could prove difficult if the relevant office considers that it describes the goods and services covered. For example, the European Union Intellectual Property Office (EUIPO) refused the registration of the name “George Orwell” as a trade mark for goods such as (among others) “printed matter” and “multimedia recordings and publications.” The EUIPO took the view that customers would see the name “George Orwell” as a descriptive indication of the subject of these goods (for example,
In most cases, a celebrity should not have issues proving goodwill; however, it should not be assumed that the notoriety of a name is by itself proof of goodwill.
a book about George Orwell). The applicant may yet succeed – the case has been appealed to the Grand Board of Appeal of the EUIPO, which at the time of writing, has not yet issued its decision.
The UK Intellectual Property Office (UKIPO) adopts a more conciliatory approach. It acknowledges that, when used in relation to certain goods or services, the public will see the name of a famous individual as an indication that the goods or services are about the person, rather than an indication of the trade origin. However, the UKIPO considers (as per its examination guide) that, “the names of famous individuals may serve as trade marks for goods and services such as printed publications, musical recordings, films, videos, TV programmes etc. on the basis that they are likely to imply some form of commercial control, and that the release/marketing of such goods and services has been authorised by the famous individual.” This approach is welcomed; it would seem unfair that the registration of a name as a trade mark would prove to be harder on account of the fame enjoyed by that name. In fact, it is worth noting that, while the EUIPO has refused the application “George Orwell,” the same mark has been successfully registered in the UK for a variety of goods, including “printed matter” and “multimedia recordings and publications,”
Notwithstanding the above, trade mark applicants should exert caution when drafting the list of goods and services that will be used for their trade mark application. The UKIPO may still refuse an application to register a famous name as a trade mark if it considers the mark descriptive of the goods. For example, Sir Alex Ferguson’s application to register his name as a trade mark was refused for goods such as “photographs, posters and stickers” on the basis that the mark would be interpreted as merely descriptive of the subject-matter of these goods (defined as “image carriers”), such as posters about Sir Alex Ferguson.
The outcome of a trade mark application will very much depend on the facts of the case, the goods and services for which protection is sought, and how famous the name is (for example, the UKIPO did accept the registration of the mark “George Orwell” for “photographs, posters
and stickers”). In some instances, it may be preferable to commence use of the mark on the relevant goods to ensure the public sees the name as an indicator of origin, before trade mark protection is sought, or if possible, to act proactively and seek protection at an early stage in a celebrity career.
Third parties can oppose the registration of a new trade mark if they own prior rights for the same mark or a similar mark and a risk of confusion exists. It may seem strange but achieving celebrity status does not guarantee that the registration of a famous name as a trade mark will not be blocked. For example, when the pop singer Miley Cyrus tried to register the EU trade mark “Miley Cyrus” her application was opposed by the owner of an earlier trade mark registration for “Cyrus.” When Lionel Messi tried to register a trade mark, which included his surname “Messi,” the application was opposed by the owner of a prior trade mark registration for “Massi.” In both cases, the applicants eventually succeeded and registered their trade marks (although it took Lionel Messi nine years).
It is possible that the reputation of an individual will help in defending an opposition. For example, in the Messi case (which related to an EU trade mark application), it was held that Messi was so famous even nonfootball fans would know who he was. This resulted in a likely association with the mark “Messi” and prevented a risk of confusion with the prior mark “Massi.” Notwithstanding the above, many cannot claim to be as famous as Messi and trade mark applicants should always conduct searches prior to the filing of their mark, so as to determine whether the new application conflicts with prior rights (and how the risk of conflict can be reduced).
A trade mark can be revoked (in full or for some of the goods and services covered) if there has been no genuine use for a continuous period of five years. Trade mark applicants may be tempted to include as many goods and services as possible in their application, to broaden the protection that will be offered to a mark. However, if there is no
subsequent use of the mark for all the goods and services covered, the trade mark registration may be at risk of revocation for the unused goods and services in the future.
Finally, it is worth noting that the registration of a UK trade mark will not, in itself, block third parties’ trade mark applications for identical or confusingly similar marks. Trade mark owners should monitor the UK Trade Mark Register and put in place a watch service to ensure they are notified of potentially conflicting trade mark applications, enabling them to take swift action.
The registration of a famous name as a trade mark is highly recommended to protect it against unauthorised use by third parties. However, one should not assume that reaching celebrity status guarantees a successful trade mark registration. As with any other marks, applicants must carefully plan their trade mark protection, in terms of scope of coverage for the new mark but also to minimise the risks of objections and opposition.
Antibody patents are one of the most valuable of all intellectual property rights, with the annual global therapeutic monoclonal antibody market expected to be worth $300 billion (USD) by 2025 according to a recent report . Obtaining patent protection for antibodies involves different challenges in different jurisdictions, but the good news for antibody developers is that, in Europe, at least, it is possible to obtain broad claims based on the target epitope. In the U.S., on 3 November 2022, the Supreme Court granted a petition by Amgen for a review that could influence the breadth of allowable epitope patent claims, as we discuss below.
A Antibody patents are one of the most valuable of all intellectual property rights, with the annual global therapeutic monoclonal antibody market expected to be worth $300 billion (USD) by 2025 according to a recent report . Obtaining patent protection for antibodies involves different challenges in different jurisdictions, but the good news for antibody developers is that, in Europe, at least, it is possible to obtain broad claims based on the target epitope. In the U.S., on 3 November 2022, the Supreme Court granted a petition by Amgen for a review that could influence the breadth of allowable epitope patent claims, as we discuss below.
Antibodies are Y-shaped tetrameric protein molecules consisting of two heavy (H) and two light (L) di-sulphidelinked polypeptide chains. Each of the H- and L-chains has a variable domain (termed VH and VL), and each of the VH and VL domains include complementarity determining regions (CDRs), that determine the antibody’s
binding specificity to the target part of the antigen molecule (i.e. the epitope).
Many antibody patent applications are directed not to conventional antibodies per se, but to antibodyrelated technologies, including, for example, truncated, bi-specific, and drug-conjugated antibodies, antibody fusion proteins, and cell surface receptors, such as chimeric antigen receptors (known as CARs) comprising antibody protein domains.
Patent protection for antibodies per se, on the other hand, may be obtained using patent claims that define the antibodies on the basis of their structural and/or functional properties, their use, for example, in specific medical treatments, and/ or their method of production. In practice, to provide robust protection for a valuable antibody, all of these approaches are likely to be used in separate patent applications, with different filing dates where appropriate, in order to maximise the scope and duration of the patent rights.
claims
Both in Europe and the U.S., antibody patent claims that refer directly and exclusively to the amino acid sequences of the antibodies provide potentially the most robust patent protection for specific antibodies, albeit at the expense of claim breadth. Such claims may, for example take the form of: “An isolated antibody comprising a VL domain comprising the amino acid sequence of SEQ. ID. No. 1 and a VH domain comprising the amino acid sequence of SEQ ID. No. 2.”
The European Patent Office (EPO) takes the view that if the inventive step of the claimed antibodies is based on an improved binding affinity, then the full VH and VL domain sequences of the antibody must be recited in the claim. Broader antibody structure-based patent claims may be possible at the EPO, however, if the inventive feature of the antibodies relates to a different
surprising advantage, such as, for example, an improved therapeutic property, a reduced toxicity or immunogenicity, or an unexpected species cross-reactivity. In such cases, it may be possible to obtain patent protection for an antibody that is structurally defined on the basis of the CDR sequences only. In most cases, all six CDRs must be recited in the claims, although it is theoretically possible to claim fewer than six CDRs, for example, if appropriate supporting data are available, or if the claim additionally includes a functional limitation.
Broader antibody structure-based patent claims are also potentially allowable in both Europe and the U.S., as long as the specification includes an appropriate level of supporting data. For example, if the data are available, then it may be possible to obtain patent claims for sequences based on a level of sequence identity, variability in specific regions, or alterations in selected amino acids of the antibody. Such data could include, for example, evidence that certain amino acid residues in the antibody sequence are not involved in binding to the specific antigen, and/or that particular residues may be substituted without affecting the binding properties of the antibody or the claimed technical effect.
requirement, for all patent specifications. To meet the written description requirement, a patent specification must demonstrate that the inventors were in possession of the claimed invention at the filing date of the patent application. To meet the enablement requirement, a patent specification must provide sufficient information for a person skilled in the art to practice the claimed invention without having to engage in undue experimentation.
The USPTO previously used the “antigen test” in which a functional antibody would satisfy the written description requirement if the patent specification adequately described the target antigen, usually on the basis of the amino acid sequence, and if the production of the claimed antibodies was conventional or routine; even if the specification did not include a structural definition of the claimed antibodies.
claims based on the target antigen (Epitope Claims)
In general, the broadest antibody patent claims are those based on the function of the antibody, such as the target epitope to which the antibody specifically binds. For example, such claims may have the form “An isolated antibody that binds to epitope X”.
This type of patent claim, which is sometimes referred to as an “epitope claim”, has historically been widely used because it provides the possibility of obtaining broad protection for any antibody binding to the same epitope, regardless of the antibody sequence.
Claims in this format, however, based on the specific binding properties of the antibody, have become progressively more difficult to obtain in the U.S. In the U.S., 35 U.S.C.S. § 112 sets forth (i) a written description requirement, and (ii) an enablement
In a number of recent decisions, however, the Federal Circuit has undermined and subsequently disposed of the antigen test. The recent decision of the Federal Circuit in Amgen v. Sanofi (No. 20-1074, Fed. Cir. 2021) confirmed the threshold for the written description requirement for functional antibody claims. The Federal Circuit found that claims directed to anti-PCSK9 antibodies defined only by their target epitope placed an excessive burden on the skilled person, on the basis that they would have to screen millions of antibody candidates to determine which antibodies were encompassed by the functional definition of the claim. This is despite the patentsin-suit providing the sequences of at least 20 example antibodies, and the 3D structures of two of the antibodies, including structures showing how these antibodies bind to epitopes on the PCSK9 receptor to thereby prevent binding of the ligand to the receptor.
Amgen subsequently filed a petition for the U.S. Supreme Court to review the decision, arguing that that the Federal Circuit’s standard for enablement is “impossible to satisfy”, and that it requires the claims to be enabled throughout their full scope, even if there is no evidence that there are any particular embodiments that would require undue experimentation. According to Amgen, the appropriate standard is
the provision of sufficient disclosure to be able to make and use the invention, which does not require disclosure throughout the entire scope of the claims.
The fact that the Supreme Court granted Amgen’s petition for a review is interesting given that the United States Solicitor General had recommended that the Court deny the petition. The Supreme Court granted a review with respect to the following question presented in Amgen’s petition:
2. Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, 35 U.S.C. §112, or whether it must instead enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial “‘time and effort,’” Pet.App. 14a (emphasis added).
In essence, the Court will consider the balance between the claim scope that a patent applicant may be entitled to expect in view of the contribution that their invention makes to the art, versus the need to avoid the inhibitory effect of overly broad claims on future development of related, but undisclosed, embodiments.
For the time being, a high bar for the written description and enablement requirements exists, and it is extremely challenging to achieve grant of a functional antibody (epitope) claim in the U.S. However, antibody developers will be pleased to hear that this is not necessarily true for Europe, where it is still possible to obtain broad epitope claims, at least in principle. Inventive step, rather than sufficient disclosure, is likely to present more of a challenge in Europe in relation to epitope claims, however. The EPO takes the view that a claim to a new antibody binding to a known target does not involve an inventive step unless the antibody provides a surprising technical effect (EPO Guidelines II-5.6.2).
That said, the EPO’s Guidelines for Examination explicitly permits the definition of an antibody in a patent claim using various different functional parameters, including the target antigen or epitope (G.II, 5.6.1). Moreover, such claims are not only theoretically allowable, but have been tested and survived scrutiny by the EPO Boards of Appeal.
For example, in T 1964/18, the claimed antibody was defined on the basis of specifically blocking the NKG2A receptor which inhibits natural killer (NK) cells but not the related, activatory, receptors NKG2C and E, and binding the same epitope on NKG2A as a deposited antibody, such that binding of the antibody to its target on a NK cell activates NK-cell killing. The prior art cited in relation to inventive step differed from the claimed antibody in that it additionally bound the NKG2C and NKG2E receptors, as well as NKG2A. The Board of Appeal thus considered the question of whether it would have been obvious to modify the prior art antibodies to block only the activity of NKG2A, as claimed, and not NKG2C and NKG2E.
Based on a teaching in the prior art that blocking all three receptors with an antibody would lead to NK cell activation, the Board of Appeal found that a skilled person would not have been motivated to produce antibodies that specifically bind NKG2A, but not NKG2C or HKG2E. Accordingly, the broad functional epitope claim was found to be inventive. The allowed claim read:
1. A monoclonal antibody or a fragment thereof characterized by:
a. specifically binding to NKG2A, wherein the antibody or fragment is characterized by binding the same epitope on NKG2A as the antibody produced by the cell deposited at the CNCM under accession number I-3549;
b. not specifically binding to human NKG2C;
c. not specifically binding to human NKG2E;
d. not binding, via its Fc region, to a human Fc gamma receptor; and
e. when bound to NKG2A on a human NK cell, causing said NK cell to lyse a target human cell bearing HLA-E or Qalb on the target cell surface, when said target cell comes into contact with said NK cell.
Currently, in the U.S., in the corresponding patent application, similar functionally defined epitope claims were not considered allowable, for failing to satisfy the written description requirement. Related U.S. patent applications are still in prosecution, but the only patent claims that have been granted in the U.S. relate to a method of treatment comprising the use of the antibody defined on the basis of all six CDR sequences (US 10,160,810), and a cell line capable of specifically producing the antibody (US 8,993,319).
Clearly, Applicants face increasingly distinct and sometimes conflicting challenges when attempting to protect antibody inventions across different jurisdictions, presenting particular challenges when drafting patent specifications. One clear message, however, is that the specification should include as many different examples of the claimed antibodies as possible, and evidence that the antibodies meet the functional requirements. Ideally, the example antibodies should be as
diverse as possible, highlighting the importance of consistent features, such as specific amino acid residues, that are conserved across the various examples.
If at all possible, it would be advisable to generate and include experimental data relating to the interaction of the antibody with the target epitope, or residues of the antibody involved in binding the antigen, as this type of information is likely be very helpful to support the validity and inventive step of the claimed antibodies, in all jurisdictions. In Europe specifically, these data would make it possible to claim not only the amino acids of the antibody’s CDRs that bind to the target antigen, but also those residues constituting the epitope itself. Moreover, information on whether the epitope is a linear or conformational epitope can also be valuable, both as a way of potentially distinguishing over prior art antibodies, and, if associated with a surprising technical effect, also to support an inventive step.
Antibody patent applications should, therefore be drafted in such a way that they provide the possibility of achieving the broadest available scope of protection in different territories, including broad epitope claims in Europe.
If you would like more information about patenting antibodies, please contact our specialist Antibody Team, who would be happy to assist. We have considerable experience in drafting and prosecuting antibody patent applications, and also in proceedings before the European Patent Office Opposition Divisions and Boards of Appeal concerning opposed antibody patents. Please also let us know if you would like to receive our regular antibody newsletter.
Matthew Handley mhandley@vennershipley.co.uk Anton Hutter ahutter@vennershipley.co.ukIn the previous edition of Inside IP we discussed some of the limitations on the protection of components (including spare parts and consumables) under the United Kingdom and European Union Community design regimes. We looked at the visibility requirement for component parts of complex products and also the exclusion of features that are dictated purely by technical function. In this follow-up article, we will now explore the “must-fit” and “must-match” exclusions and the repair clause.
To recap, the various UK and EU Community design regimes can broadly be put into three categories:
1. Registered design rights, namely the UK Registered Design (UKRD) and Registered Community Design (RCD), which remain mostly harmonised although the UK now has the option to deviate from EU law (and aspects of both the UK and EU design systems are currently under separate review).
2. Unregistered rights based on the Community system, namely the Unregistered Community Design (UCD), the UK Continuing Unregistered Design (UKCUD) (which provides continuing protection in the UK for UCDs that came into force before the end of the Brexit transition period in January 2021), and the UK Supplementary Unregistered Design (UKSUD) (a new right that mirrors the provisions of the UCD to provide a corresponding scope of protection in the UK).
3. The UK Unregistered Design Right (UKUDR), which is quite different to the other design systems discussed above and more closely resembles UK copyright law.
This article does not consider other forms of IP rights that may be relevant to the protection of components, including patents, copyright, and trademarks, and we will not look at the various national
design rights that are available in individual EU Member States.
The UK unregistered design right does not protect “features of shape or configuration of an article which… are dependent upon the appearance of another article of which the article is intended by the designer to form an integral part” (section 213((b)(ii) of the Copyright, Designs and Patents Act 1988). This is known as the “mustmatch” exclusion because it excludes from protection features of an article that are necessary to aesthetically match with another article. The exclusion only applies to these mustmatch features and therefore other features of the article would not be excluded from design protection.
To give an example of the mustmatch exclusion, take the case of a car body panel – the features of the panel that are necessary to match with the remainder of the vehicle would be excluded from protection. The idea behind this is to prevent manufacturers from having a monopoly on the sale of spare parts. In the example above, a consumer would want a replacement body panel to match the vehicle. Granting a vehicle manufacturer design protection to such features of the panel would, therefore, essentially give the manufacturer a monopoly on the aftermarket sale of spare parts, which is viewed as being anticompetitive.
The Community Designs Regulation 6/2002 (CDR) (which gives rise to RCDs and UCDs) at Article 110 states “protection as a Community design shall not exist for a design which constitutes a component part of a complex product… for the purpose of the repair of that complex product so as to restore its original appearance”. As such, in contrast to the UKUDR discussed above, must-match features are protectable under the Community registered and unregistered systems, but it is not an infringement for a third party to reproduce such features for the purposes of repairing a complex product to its original appearance.
Whether or not must-match features should be subject to design protection was a contentious issue at the time the Community design laws were drafted, with particular pushback from the automotive industry. The repair clause that made it into the final legislation can be viewed as a watered-down version of the mustmatch exclusion and, as we will see below, is applied relatively narrowly by the courts.
The Community Designs Directive 98/71/EC (Designs Directive) (which is implemented by EU Member States to give rise to national registered design rights) does not include a corresponding repair clause or mustmatch exclusion. Instead, Article 14 of the Directive states that “Member States shall maintain in force their existing legal provisions relating to the use of the design of a component part
used for the purpose of the repair of a complex product so as to restore its original appearance and shall introduce changes to those provisions only if the purpose is to liberalise the market for such parts”. This means that individual EU Member States can remove or weaken any must-match exclusion and/or strengthen any repair clause that is already in place, but are prohibited from doing the opposite. This is therefore an area where EU design law between EU Member States is not harmonised. For example, in 2021, France finally introduced a repair clause for suppliers who had originally manufactured a component on behalf of vehicle manufacturers, as well as a repair clause for all vehicle glazing components, and limited the term of protection for other types of vehicle components to ten years (rather than the usual 25 years). In contrast, several EU Member States, such as Portugal and Romania, still do not have a repair clause.
The UK enshrined the repair clause at section 7A(5) of the UK Registered Designs Act 1949 (although the UK now has the power to remove the clause). However, there is no such repair clause for the UKSUD that was introduced following Brexit to mirror the protection afforded by the UCD. This is interesting because the UCD does include a repair clause. Third parties seeking to repair/restore an article in the UK and looking to rely on the repair clause to avoid infringement of a UKRD will therefore need to consider very carefully whether they would nevertheless still infringe the corresponding UKSUD (and which, being an unregistered right, subsists automatically).
The CJEU examined the scope of the repair clause in the joined cases of Acacia v Audi/Porsche (C-397/16 and C-435/16). Acacia sold wheel rims that fell within the scope of RCDs owned by Audi and Porsche but argued that the sale of the wheel rims was exempted by the repair clause and thus there was no infringement.
The Court held that a component part must have an identical appearance to the part that it is replacing in the complex product (i.e. the wheel rims would need to be identical with those being replaced) in order to fall within the repair clause. The Court also ruled that a third party selling such a spare part has a duty of diligence to inform the downstream user (e.g. on the product, packaging, and/or catalogue) that the part incorporates a design of which they are not the holder and is intended exclusively to be used for the purpose of the repair of the complex product so as to restore its original appearance. The third party also has a duty of diligence to ensure through appropriate means (e.g. contractual obligations) that downstream users do not intend to use the component parts in a way that is not for the purposes of repair, and the third party must refrain from selling the part where they know or ought reasonably to know that it will be used for any other purpose. In the present case, the fact that Acacia had stamped “not OEM” on the rims and had indicated that the rims were sold for repair only was ultimately not deemed sufficient to comply with these duties and therefore the sale of the rims infringed the RCDs.
Another provision that affects the protection of spare parts is the “mustfit” exclusion. Article 8(2) of the CDR recites “a Community design shall not subsist in features of appearance of a product which must necessarily be reproduced in their exact form and dimensions in order to permit the product in which the design is incorporated or to which it is applied to be mechanically connected to or placed in, around or against another product so that either product may perform its function”. This exclusion is common to all of the registered and unregistered design regimes we have discussed so far.
In essence, the exclusion prohibits the protection of features of an article
that are required to interconnect with another article. A common example is that of a plug and socket, wherein the three (or two, depending on where you are reading this from!) prongs of a power plug and corresponding socket holes are necessary to enable an interconnection and thus would be excluded from design protection. The exclusion only applies to the features that fall within the must-fit provision, and therefore a design may nevertheless be valid if it includes other features that contribute to the novelty and individual character of the article.
It is easy to see how the must-fit exclusion is relevant to the protection of spare parts. Returning to our vehicle analogy, a fastening feature of a car wheel rim that mates with a corresponding fastening feature of the wheel would be excluded from protection, while the remaining features of the wheel rim would not be excluded from protection under the must-fit provision.
Interconnecting features of modular systems are exempted from the must-fit exclusion, with Article 8(3) of the CDR reciting “Notwithstanding paragraph 2 [the must-fit exclusion], a Community design shall under the conditions set out in Articles 5 and 6 subsist in a design serving the purpose of allowing the multiple assembly or connection of mutually interchangeable products within a modular system”. Therefore, features of interchangeable products that are necessary to interconnect with other products in a modular system can be protected. As an example, the features of stackable garden chairs that allow for the chairs to be stacked on top of each other would likely fall within the exemption and thus would be protectable because each chair is arguably an interchangeable product.
Interconnecting features of a product that fall within the must-fit exclusion under Article 8(2) CDR may also fall within the Article 8(1) CDR exclusion which, as we discussed in our previous article, prohibits the protection of features that are solely dictated by technical function. Indeed, the function of allowing for a part to be interconnected to another part can be viewed as being
inherently technical in nature, albeit the feature may still not fall foul of the exclusion if it can be demonstrated that the feature is not dictated solely by technical function (i.e. if there were aesthetic considerations that went into the design of the feature, following the CJEU decision in Doceram v CeramTec, C 395/16, that we looked at previously).
The interplay between the must-fit and technical function exclusions was explored by the EU General Court in Lego A/S v EUIPO (T 515/19). In this case, the European Union Intellectual Property Office Board of Appeal had previously found that Lego’s RCD to a toy building brick was invalid. The Board of Appeal identified the following features of the design: (i) the row of studs on the upper face of the brick; (ii) the row of smaller circles on the lower face of the brick; (iii) the two rows of bigger circles on the lower face of the brick; (iv) the rectangular shape of the brick;
(v) the thickness of the walls of the brick; and (vi) the cylindrical shape of the studs. The Board of Appeal held that all of the features were solely dictated by the technical function of the building brick, namely assembly with/disassembly from other bricks of the set, and that therefore the RCD was invalid in view of the Article 8(1) technical function exclusion.
On appeal to the EU General Court, it was found that the design was in fact valid because the Board of Appeal had overlooked creative aspects of the RCD, in particular the smooth surface on either side of the row of four studs on the upper side which were not dictated solely by technical function and thus did not fall within the technical function exclusion.
More interestingly, the Court also held that the benefit of Article 8(3) (i.e. the modular system exemption) could be relied on in respect of all interconnection features that fall within Article 8(2) (the must-fit exclusion), even if these features would otherwise fall foul of Article 8(1) (the technical function exclusion).
The decision therefore appears to significantly increase the protection afforded to modular components, and has scope to allow for interconnecting features of this special category of components to be protected even if no aesthetic considerations went into creating such features, which seems to run contrary to the entire purpose of the design system.
The design system remains a powerful tool for the protection of components, but rights holders will need to carefully consider each of the exclusions when preparing design applications and when enforcing the various design rights available under the UK and Community systems. As we have seen, there are a number of different exclusions from design protection, and this remains a complex area of design law.
It is also important to remember that for registered designs it will usually be highly preferable to file an application showing the component in isolation (rather than the entire product incorporating the part) if protection is desired to the component per se. In contrast, the CJEU has ruled that UCD protection for a component part
Ferrari FXX K
can subsist automatically even if the component is only publicly disclosed along with the product into which it is incorporated. This was confirmed in Ferrari SpA v Mansory Design & Holding GmbH C-123/20, in which published images of Ferrari’s FXX K supercar were deemed sufficient to establish UCD protection to the V-shaped element on the bonnet.
For third parties, great care should be taken before relying on the exclusions or repair clause as a defence against infringement of design rights, particularly in view of the relatively narrow interpretation of many of the provisions and the fact that several different rights may be in play, some of which do not include certain defences (for example, the repair clause is omitted from the UKSUD and the national registered design rights of a number of EU Member States).
Finally, the outcome of the EU Commission’s review of the Designs Directive is due later this year. It will be interesting to see if the Commission recommends harmonising the spare parts provisions for national registered design rights, and we will be sure to report the outcome in due course.
George Hudson ghudson@vennershipley.co.uk
We have been awarded one of the European Impact Cases of the Year at the 2022 Managing IP Awards, for our work on G1/19 (EPO).
The annual awards are presented to firms, individuals and companies behind the most innovative and challenging IP work of the past year, as well as those driving international markets. The European Impact Cases of the Year awards recognises standout cases across the whole of Europe that have created a lasting impression within the industry, driving change and influencing future decisions.
Managing Partner, Pawel Piotrowicz has played an intrinsic role in G1/19, one of the most followed, high-tech European, Enlarged Board of Appeal cases held over the last two years. His early involvement and advisory role in the case means that he is the go-to patent attorney on the patentability of computer-implemented simulations.
Our legal team regularly provides updates on various cases covering a wide range of industries and technical areas. A round up of the most recent ones are:
• Entitlement and The Importance of Assignment Formalities – lessons from Jones v Irmac Roads
• C-C-C-Combo Breaker! –Combination products and the SPC regulation
• Only Fools and Copyright – Is there Copyright in Fictional Characters?
• Patents Court confirms power to grant injunctions for patents prior to grant – but not in this case, and maybe no others either…
• Expert Witnesses in Patent Cases – What’s Happening?
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For the fourth year in a row, we have maintained our Tier 1 ranking for patents in the 2023 edition of the Legal 500. We also achieved recognition for our trade mark attorney team, and for our legal team for patents (contentious and non-contentious), and trade marks, copyright & designs.
Chambers UK has once again ranked Venner Shipley in its 2023 edition. Clients comment that “Venner Shipley are very good at managing complex IP work in a timely manner. They are clear in communicating the nuances of current and future protection to various stakeholders.”
We have once again been ranked in IAM Patent 1000: The World’s Leading Patent Practitioners for Litigation and Prosecution in the UK, as well as being recognised for our success at the European patent office.
Launched by The Royal Foundation of the Duke & Duchess of Cornwall and Cambridge in 2021, the Earthshot Prize launches a global search for eco-innovators with solutions to the five ‘Earthshot’ goals every year between 2021 and 2030. These are simple but ambitious goals grounded in science, which if achieved by 2030 will improve life for us all for generations to come. Not only will the breakthrough emergent solutions help to repair and regenerate the planet, the Award will also nurture the eco-innovators to grow their impact.
The five winners chosen each year will be awarded a one million-pound prize, helping move forward at least 50 solutions to the world’s greatest environmental problems by 2030. The five Earthshot objectives and awards categories are:
• Protect and restore nature
• Clean our air
• Revive our oceans
• Build a waste-free world
• Fix our climate
The Prize aims to turn the current pessimism surrounding environmental issues into optimism, by highlighting the ability of human ingenuity to bring about change, and inspiring collective action.
With the 2022 prizewinners announced, the nomination process for 2023 is about to kick off soon so it is a great opportunity to get your IP secured as alongside numerous other aspects intellectual property is one of them.
The Chartered Institute of Patent Attorneys (CIPA), which is an official nominating body for the prize, plays a vital role in advising the Earthshot organisers on all intellectual property issues and states that: "Nominations must be beyond idea stage, have tested their solution in-field or with target audiences and must be at a ‘tipping point’ for scaling their impact within the next five years. Therefore, the best nominees will likely be close to the end of the patenting process, or already have patents in place." This includes performing due diligence on the finalists and providing advice on intellectual property issues.
The Earthshot website outlines how: "The selection process will prioritise solutions that are beyond idea stage, with working prototypes or proven effectiveness, ready to be scaled or replicated rapidly. Nominations are assessed in terms of the inspiring stories behind them, their inclusivity, equity and benefits for humans, their impact on the Earthshots, and the ability for this impact to be scaled."
We are keen to put our clients and contacts forward and whereas, the Earthshot Award should not be the only reason for protecting your intellectual property, the £1 million prize money is certainly an incentive and we are looking forward to providing you with a free initial consultation and put you forward for an award.
We are delighted to announce exam success for our associates on what continues to be a great year of exam results for our firm.
Congratulations to Associates, Emma Bridgland, Andy Heap, Robert Holbrook and Nusrat Rahman who are now fully qualified European Patent Attorneys. Nusrat and Andy are also now dual qualified, having both UK and European qualifications.
Partner, Jonathan Hewett comments: “It is great to announce we have had further exam success from our associates in what has been one of best years for exam results. We are extremely proud to be able to support and nurture internal talent, with their hard work recognised in these great results. Well done all!”
Could your invention be in with a chance of a £1
© Venner Shipley LLP 2022
This newsletter is for general information for our clients. Its contents are not a complete statement of the law on any subject. Professional advice should be sought before any course of action is pursued.
