Issuu

Inside IP Venner Shipley’s Intellectual Property Magazine

www.vennershipley.co.uk

Spring/Summer 2022

Unitary Patents and the Unified Patent Court

PAGE 14

EPO Guidelines on Antibodies: an assessment of adherence

Cell and Gene Therapy Industry News

International Trade Marks Update

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European Intellectual Property Attorneys 1

What’s inside? Page 4 EPO Guidelines on Antibodies: an assessment of adherence

Matthew Handley and Kyle Burgess examine the updates to the EPO Guidelines for Examination, which now include a section devoted to the examination of antibody-related patent applications.

Page 6 Cell and Gene Therapy Industry News

With the cell and gene therapy industry booming around the world, Kirsty Dolphin looks at some of the major recent successes and deals.

Page 8 Priority Pitfalls to Avoid at the EPO

The first of two articles from George Hudson exploring some of the issues affecting the protection of components under the various UK and EU Community design regimes.

Page 20 Update to the EPO Guidelines 1 March 2022 Kathryn Rose and Nick Barrow explore some of the significant changes to the EPO Guidelines following the 1 March update.

Page 22 Controlling the Speed of Prosecution at the EPO

Emma Longland takes a close look at the rules that must be followed for a patent priority claim to be considered valid in Europe.

Henry Aldridge explores some of the available options for controlling the EPO’s timescales for processing applications.

Page 10 International Trade Marks Update

Page 24 Patently Obvious? The English High Court Considers Drug Development Practices in Teva v Bayer

Clare Turnbull and Vivek Patel explore some of the recent international trade marks updates including United Arab Emirates and Chile joining the Madrid Protocol.

Page 11 Expert Witnesses in Patent Cases – What’s Happening? James Tumbridge and Benedict Sharrock-Harris look at the appointments of Mr. Justice Meade and Mr. Justice Mellor and how expert use and evidence is evolving.

Page 14 Unitary Patents and the Unified Patent Court

After many a false start, Europe is finally on the verge of a radical overhaul of its patent system, with the bringing into being of the Unitary Patent (UP) and Unified Patent Court (UPC), Peter Thorniley explains.

Page 17 Design protection of Components

Robert Peake and Benedict Sharrock-Harris look at the October 2021 case of Teva UK Limited V Bayer Healthcare LLC.

Page 26 Moon Boot Kicked Out but Guerlain’s Lipstick Shapes Up

Camilla Sexton and Gloria Parmesan consider what a shape mark is and report on two recent cases looking at the shape of the Moon Boot and the Rouge G lipstick holder.

Page 28 VS News

A round-up of the latest Venner Shipley news.

www.vennershipley.co.uk

A word from the editor As the world is opening up again, we are looking forward to making plans to catch up with our contacts in person. A big talking point is definitely going to be the Unitary Patent and the Unified Patent Court, which after all these years is now almost certainly coming into effect in late 2022, or early 2023. Whilst not all of the details are finalised, in this issue Peter Thorniley provides a comprehensive review of the system and some of the most important things that applicants and patent holders need to consider before the system starts. A new set of European Patent Office Guidelines came into force on 1 March 2022, and Kathryn Rose and Nick Barrow provide a summary of the important changes. Also, Matt Handley looks in detail at the changes specifically related to antibodies. In other matters related to the EPO, Henry Aldridge has an article on controlling the speed of prosecution at the EPO, and Emma Longland runs through some important priority related issues in her article ‘"Priority Pitfalls to Avoid at the EPO”. The cell and gene therapy industry is thriving not only in the UK, but around the world. Kirsty Dolphin takes a look at some of the major successes and deals that have taken place in the last few months. No Inside IP edition would be complete without case law updates from our patents, trade mark and design teams, and this issue includes a wide variety of such articles. Clare Turnbull and Vivek Patel provide an update on International Trade Marks, and George Hudson explores some issues relating to design protection of components. Last but not least, our legal team explore the following legal questions: ”Expert Witnesses in Patent Cases – What’s Happening?” as well as “Patently Obvious? The English High Court Considers Drug Development Practices in Teva v Bayer”. A big thank you to all our contributing authors, and thank you for your time reading this and sharing our world of IP. I 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. I am, together with my colleagues across the UK and Germany, looking forward to seeing you soon and we are, as always, only an email or call away. Simon Taor Partner

About Venner Shipley: 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.

EPO Guidelines on Antibodies: an assessment of adherence In March 2021, the European Patent Office (EPO) Guidelines for Examination were updated to include a section devoted to the examination of antibodyrelated patent applications (Guidelines G-II, 5.6). This new section provided a much anticipated outline of the EPO requirements for different approaches to defining antibodies in patent claims (Guidelines G-II, 5.6.1) and helpful guidance in relation to the inventive step of antibodies in Europe (Guidelines G-II, 5.6.2). The new antibodies section of the EPO Guidelines was discussed in detail in our article “An antidote to antibody patent confusion in Europe”. Here we look at the effect the new Guidelines have had on the prosecution of antibody patent applications over the last year Antibodies are typically in the form of immunoglobulin G and comprise a Y-shaped protein consisting of two identical light chains and two identical heavy chains, each folded into constant and variable domains. Each of the heavy and light chain variable domains (referred to as VH and VL) contains three hypervariable regions, referred to as “complementaritydetermining regions” (CDRs), which together provide the antigen-specific binding interface. In the March 2022 revision of the EPO Guidelines, amendments to the antibody sections have been made. However, these changes are relatively minor, and appear to be generally intended only to more explicitly acknowledge the patentability of unconventional immunoglobulin structures, such as heavy-chain-only antibodies and antibody derivatives, such as antibody fragments, bispecific or multi-specific antibodies, and antibody fusion products. Since the introduction of the new antibody Guidelines in March 2021, the EPO has granted in the region of 300 patents relating to new antibodies 4

and antibody derivatives. We have analysed the claims of these granted patents to investigate how EPO Examiners have started implementing the new antibody Guidelines, and in the following brief review, a number of emerging trends and perspectives are discussed. As an initial observation, very few antibody patents granted since the introduction of the new Guidelines (less than 5%), define the antibodies in terms of their method of production, such as reciting an immunisation strategy, or on the basis of a deposited hybridoma. The vast majority (about 85%) of all antibody patents granted in this period define the antibody, at least in part, on the basis of an amino acid sequence of the antibody. Of these patents, about 55% recite in the granted claims the sequences of all six CDRs. A further 40% recite the full heavy and light chain variable domain sequences, and about 2% recite the full antibody sequence in the claims. In view of these figures, it seems that it is becoming increasingly challenging to obtain a broad scope of patent

protection, without reciting at least the sequences of all six CDRs.

Since the “introduction of

the new antibody Guidelines in March 2021, the EPO has granted in the region of 300 patents relating to new antibodies and antibody derivatives.

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The Guidelines state that it is possible to define an antibody on the basis of less than 100% sequence identity to the variable domains or CDRs when this feature is combined with a functional feature. This appears to be the most common approach taken by antibody patentees, and about 55% of granted patents define the antibody

www.vennershipley.co.uk using a combination of both a specific sequence and a functional property. Functional limitations typically include minimum antigen binding affinity, binding specificity, or blocking capability, for example. Using this approach, a number of patents have been granted using a broader sequence definition. In some examples, the antibody sequence is defined on the basis of percentage sequence identity (such as at least 90% sequence identity), or a maximum number of residue substitutions, relative to specific VH and VL sequences. Another approach that has been used successfully is to define a number of possible alternative sequences for each CDR, or the presence of conservative amino acid substitutions in specific positions of the CDRs. The Guidelines also provide scope for defining an antibody using less than all of the CDRs, if experimental support is provided to evidence that the omitted CDR(s) are not required for epitope binding. However, there do not appear to have been any patents granted that take advantage of this approach. This may be a reflection of the involvement of the CDRs in antibody binding, or it may be that applicants are unable to meet the high threshold for the level of evidence required. We may see more patents defining antibodies in this way in the future as this type of data become easier to obtain, and as applications are drafted and filed with the knowledge and certainty provided by the new antibody Guidelines in relation to the potential importance of this type of data. The Guidelines also provide for antibodies to be defined on the basis of the target antigen. Perhaps surprisingly, however, only a small proportion of the antibody patents granted since the introduction of the new Guidelines define the antibody on this basis. These patents represent only about 5% of the patents granted since the introduction of the antibody Guidelines. The Guidelines indicate that, for antibodies defined in this way, no sequence variability and no open language may be used in the definition of the antigen. Interestingly, however, Examiners do appear to

have been willing to relax these requirements for the antigen definition slightly. For example, patents have been granted in which the antibodies are defined on the basis of binding to an antigenic peptide that includes a specific sequence, or on the basis of binding to the same epitope as a comparable antibody.

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Matthew Handley mhandley@vennershipley.co.uk Kyle Burgess kburgess@vennershipley.co.uk

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Thus, it appears that defining an antibody on the basis of the target antigen may be a promising approach to obtain a potentially useful scope of protection. Again, this is an approach that we may see used more frequently in the future, as applications are drafted and filed in light of the new Guidelines. One of the clear messages from our analysis of patents granted since the introduction of the antibody Guidelines is that if at all possible, it would be advisable to obtain 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. If you would like more information about patenting antibodies, please check out our antibodies web page which also has our key team contacts should you wish to reach out.

Cell and Gene Therapy Industry News We have previously discussed the cell and gene therapy boom in the United Kingdom. The industry is thriving not only in the UK, but around the world, and here we take a quick look at some of the major successes and deals that have taken place in the last few months. Gene therapy deals As a quick reminder, gene therapy involves the transfer of genetic material, usually in a carrier or vector, into the appropriate cells for uptake of the genetic material. The vector can either be delivered outside the body (ex vivo treatment) where the targeted cells are removed from the patient and administered to cells before they are returned to the patient, or the vectors can be injected into the body (in vivo treatment). In March this year, Novartis entered into an agreement for Voyager Therapeutics' TRACER™ adenoassociated virus (AAV) capsids to use in potential gene therapies for three neurological diseases. Under the agreement, Novartis will have the right to evaluate novel capsids from the RNA-driven TRACER™ platform and to exercise options to license capsids for exclusive use in its development of AAV gene therapies directed to three targets. Novartis also has the right to license capsids for two additional disease targets under the same terms. Voyager Therapeutics’ TRACER™ screening platform is identifying improved vectors selected to target desired cells and tissues with greater specificity, at lower doses, and with reduced risk of off-target effects compared to conventional AAVs. Initial data demonstrates TRACER™-derived capsids have enhanced tropism for the central nervous system. In February 2022, Takeda signed a deal with Code Biotherapeutics, potentially worth up to US$2 billion, to develop gene therapies for rare diseases. The partnership will make use of Code Biotherapeutics’

3DNA non-viral, synthetic, genetic medicine delivery platform for a liver-directed programme, and also involves conducting additional studies for programmes directed to the central nervous system. 3DNA leverages targeting molecules (such as peptides, antibodies, and small molecules) which bind to cell surface proteins expressed on target cells. After binding to the target cell, the 3DNA is internalised into the cell via a receptor-mediated process. When utilised to deliver gene therapy, the gene construct then localises to the cell nucleus where a tissue specific promoter drives the expression of the desired protein.

...gene therapy “involves the transfer of genetic material, usually in a carrier or vector, into the appropriate cells for uptake of the genetic material.

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PerkinElmer, Inc. announced that its SIRION Biotech business, experienced in gene and cell therapy and vaccine development, and the Centre for Genomic Regulation, an international biomedical research centre located in Barcelona, entered into an agreement to jointly develop new generation AAV vectors for type 1 and type 2 diabetes gene therapy in the pancreas. The end goal is to develop AAV vectors that target specific pancreatic cell types and contain payloads that express therapeutic genes under control of cell-specific regulatory elements.

This new approach aims to increase the precision, safety, and efficacy of future AAV-based gene therapies for diabetes. Novartis has entered into a definitive agreement to acquire all of the outstanding share capital of Gyroscope Therapeutics for US$800 million upfront, gaining the experimental AAV2-based gene therapy GT005. This one-time treatment, which is delivered under the retina, is currently in mid-stage development for patients with geographic atrophy (GA). GA is a chronic, progressive degeneration of the macula and leads to permanent loss of vision. BioMarin Pharmaceutical Inc. and Skyline Therapeutics announced a multi-year global strategic collaboration for the discovery, development, and commercialisation of AAV gene therapies to treat genetic cardiovascular diseases. The partnership will leverage Skyline Therapeutics' AAV gene therapy platform to develop innovative gene therapies, with a focus on genetic dilated cardiomyopathies, a group of progressively advancing, devastating diseases where the ventricles of the heart dilate and cannot efficiently pump blood. There are currently no targeted treatment options. Astellas Pharma Inc is teaming up with Dyno Therapeutics to develop next-generation AAV vectors for gene therapy directed to skeletal and cardiac muscle. The partnership will rely on Dyno Therapeutics' AI-based CapsidMap™ platform to create AAV capsids with optimised tissue targeting and immuneevading properties, while also

www.vennershipley.co.uk improving packaging capacity and manufacturability. Under the agreed terms, Dyno Therapeutics will design novel AAV capsids with improved functional properties, while Astellas Pharma Inc will oversee preclinical, clinical, and commercialisation activities, including manufacturing, of gene therapy candidates using the capsids. Spark Therapeutics, a member of the Roche Group, and CombiGene announced the signing of an exclusive collaboration and licensing agreement for CombiGene’s CG01 project, a gene therapy which aims to treat drug resistant focal epilepsy. The agreement provides Spark Therapeutics with an exclusive, worldwide licence to develop, manufacture, and commercialise CG01. CombiGene will continue to execute certain aspects of the preclinical programme in collaboration with Spark Therapeutics. Epilepsy is a major global medical problem and CG01 is a unique gene therapy candidate aimed at this large patient population.

New approved ex vivo treatment In February of this year, it was reported that the NHS had struck a confidential deal for what is thought to be the most expensive drug developed to date. Orchard Therapeutics’ gene therapy Libmeldy™ is used to treat an extremely rare condition, metachromatic leukodystrophy (MLD), which causes severe damage to a child's nervous system and organs. Around five babies are born with the disorder in England every year. MLD is a rare inherited disorder in which there is a mutation in a gene needed to make an enzyme called arylsulfatase A (ARSA), which breaks down substances called sulfatides. As a result, sulfatides build up and damage the nervous system and other organs, causing symptoms such as walking difficulties, gradual mental deterioration, and eventual death. The active substance in Libmeldy™ is stem cells (CD34+ cells), derived from the patient’s own bone marrow or blood, that have been modified via a lentiviral vector to contain a copy

of the gene to make ARSA and can then divide to produce other sorts of blood cells. The one-off treatment has a list price of £2.8 million but can be offered on the NHS after the health service negotiated a confidential discount.

New clinical trials LEXEO Therapeutics, a clinical-stage gene therapy company advancing a diverse pipeline of AAV-based gene therapy candidates for genetically defined cardiovascular and central nervous system diseases, announced that the United States’ Food and Drug Administration (FDA) cleared its Investigational New Drug (IND) application for LX2006. LX2006 is an AAV-based gene therapy candidate designed to intravenously deliver a functional frataxin gene for the treatment of Friedreich's ataxia cardiomyopathy via restoration of mitochondrial function in myocardial cells.

Epilepsy is “a major global

medical problem and CG01 is a unique gene therapy candidate aimed at this large patient population.

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uniQure announced the dosing of the first two patients in its European clinical trial of AMT-130, a potential one-time gene therapy approach for the treatment of Huntington's disease. The clinical trial is taking place at several sites in Poland, the UK, and Germany. AMT-130 is uniQure's first central nervous system focused gene therapy product consisting of an AAV5 vector carrying an artificial micro-RNA specifically tailored to silence the huntingtin gene. Using AAV vectors to deliver micro-RNAs directly to the brain for non-selective knockdown of the huntingtin gene represents a highly innovative and promising approach to treating devastating Huntington's disease.

of genetically defined neurological conditions, announced that its IND application for its lead candidate, SBT101 for the treatment of adrenomyeloneuropathy (AMN), was cleared by the FDA. SBT101 is the first AAV-based gene therapy in development specifically designed for people living with AMN, an adult-onset degenerative spinal cord disease caused by mutations in the ABCD1 gene.

Cell therapy news Chimeric antigen receptor (CAR) T-cell therapy works by genetically engineering an individual’s T-cells to recognise and destroy cancer cells. In February 2022, it was reported in Nature that two of the first patients to be treated with such therapy still possess cancer-killing cells a decade later with no sign of their illness returning. Both patients were suffering from chronic lymphocytic leukaemia when they had CAR T-cell therapy in 2010, and achieved complete remission within months of treatment, meaning all signs and symptoms of their leukaemia disappeared. When the researchers examined the patients’ blood, they could still identify CAR T-cells that were capable of proliferating and killing cancer cells. This promising finding suggests CAR T-cell therapy may constitute a “cure” for certain blood cancers.

Kirsty Dolphin kdolphin@vennershipley.co.uk

SwanBio Therapeutics, a gene therapy company advancing AAVbased therapies for the treatment

Priority Pitfalls to Avoid at the EPO The recent consolidated referral to the Enlarged Board of Appeal at the European Patent Office (EPO) (G1/22 and G2/22) will mean another close look at the rules that must be followed for a patent priority claim to be considered valid in Europe. A brief report on the subject of that referral can be found here, but it is likely to be some time before the Enlarged Board’s answers to the referred questions are published. In the meantime, the case is a reminder of how strict the EPO can be when assessing a priority claim, and how easy it can be to inadvertently lose the benefit of priority. The following provides some important points to consider, and errors to avoid, when the intention is, or may be, to rely on a priority claim in a patent or application at the EPO.

Fixed at the filing date Article 4A(1) of the Paris Convention is enacted as Article 87(1) in the European Patent Convention (EPC), and provides some bare bones requirements for a valid priority claim. It is important to remember that these more formal requirements are generally assessed as of the filing date of the subsequent (i.e. priority claiming) European application. If it is found during prosecution or opposition proceedings at the EPO, for example, that the priority claim was not validly made because the applicant was not the same as, nor the successor in title to, the applicant for the priority application on the filing date of the European application (see below), then there is often very little, if anything, that can be done to rectify the situation and recover the priority claim. It is therefore vital to make a correct priority claim on the filing date. Particular pitfalls can arise when the European application or patent is derived from an International application. In such cases, the International application might be filed by an applicant or attorney from a jurisdiction other than Europe, who might be balancing many other concerns and so have given only

minimal thought to the possible resultant European application. However, if the requirements for priority are not met when filing the International application, it could be fatal to the eventual European application or patent. To rectify this, it might be possible to request a correction of the original application documents, but the requirements for a correction can be arduous. A correction is generally required rather than an amendment, because a correction is considered to have effect from the date on which the error was made (“ex tunc”), i.e. the date on which the subsequent application was filed, whereas an amendment is considered to have effect from the date on which the request for the amendment was accepted (“ex nunc”).

Check the applicant details The priority right to an earlier patent application may only be enjoyed by the applicant of the earlier application or their successor in title. This is one of the strict priority requirements at the EPO. If the applicant of the subsequent European, priority claiming, application is not the same as the applicant for the priority application, then the applicant of the subsequent application must be ready to explain how they have become successor in title for the priority rights. In such cases, the transfer of the priority right can have occurred by any legal means, according to the relevant local law applicable to the priority rights, but if the priority claim is challenged then the onus will

be on the owner of the subsequent application or patent to show that the transfer had occurred before the subsequent application was filed. In addition, if there is more than one applicant for the priority application, then the priority rights of all the applicants must be accounted for. In other words, either all the same applicants must be listed on the subsequent application as on the priority application when the subsequent application is filed, or the owners of the subsequent application or patent must be able to show how the priority rights of any applicants “missing” from the subsequent application were transferred to an applicant that was listed on the subsequent application. This can be a particular pitfall when emphasis is placed on indicating correct (or, at least, intended) ownership of the invention rather than the priority rights. For example, there may have been a reassessment of the inventors for the invention, or a parent company may have decided that a different subsidiary company should have ownership of the invention, such that it is felt that different applicants have ownership of the invention in the subsequent application. However, it must be remembered that priority right is a completely separate and severable right to ownership of the invention described in the patent. A priority right may be obtained simply by being listed as an applicant on an application, whereas assessment of the ownership of the invention defined in the priority (and subsequent) application will be determined by inventor contributions

www.vennershipley.co.uk and any obligations they have to assign their rights in their invention(s). The importance of getting the applicants right on the filing date of the subsequent application was perhaps most starkly underscored by the fate of a large part of the portfolio of early CRISPR patents owned by the Broad Institute, Massachusetts Institute of Technology, and Harvard University. With decision T844/18, the Board of Appeal of the EPO revoked the first of many patents in the portfolio for lack of novelty following loss of the earliest priority claims. The priority claims were lost because the Broad Institute, MIT, and Harvard could not show that they owned the priority rights of one of the applicants listed on the priority applications.

Beware intervening disclosures Of course, loss of a priority claim cannot, on its own, result in the loss of an application or patent. In order for the priority claim to be relevant there must be an intervening disclosure, that is a disclosure citable for novelty and/or inventive step having a date between the filing date of the priority application and the filing date of the subsequent application. In many instances, such as in the Broad Institute et al. CRISPR case mentioned above, intervening disclosures have been made by third parties, so that there seems to be little that can be done by applicants about them. However, there are two points in particular that are within the control of the applicants and are important in the context of intervening disclosures. Firstly, the priority claim will only be valid for the subject-matter of the claims that is the same as the subjectmatter disclosed in the priority application. The EPO performs a strict analysis as to whether the subjectmatter is the same. If the disclosure of the subsequent application is broader than that of the priority application, such that the priority application only discloses some specific embodiments of the claims of the subsequent application, then the priority claim will only be considered valid for those specific embodiments. The priority claim will be considered invalid for any subject-matter encompassed by the claims that was not disclosed in

the priority application. This concept of the subject-matter of the claims having only “partial priority” has been affirmed by the Enlarged Board in G1/15. Secondly, any of the inventor’s own disclosures made between the priority date and the filing date of the subsequent application (i.e. intervening disclosures) will be citable against the subsequent application to the extent that the priority claim is invalid. These two points can, together, lead to a potential pitfall, particularly when a priority application is filed as a matter of urgency to mitigate the effects of an imminent inventor disclosure. For example, an academic applicant may be about to present their work at a conference, or to have their article published in a journal. In an attempt to mitigate the effects of that disclosure, a simple priority application may be quickly filed including the information about to be disclosed, with the intention of later filing a subsequent application having more details of alternative ways in which the invention may be carried out. However, if the priority application only really provides the specific embodiments of the inventor’s disclosure, but the intention is to provide a more generalised statement of the invention in the subsequent application, then a “partial priority” situation will arise. The claims of the subsequent application will contain two different groups of subjectmatter, the specific embodiments from the priority application, which will have a valid claim to the priority date, and any other embodiments of the generalised disclosure, which will not have the benefit of the priority date. Any of the more generalised subjectmatter not disclosed in the priority application will be susceptible to an attack based on the inventor’s intervening disclosure, because it will not have a valid claim to priority and instead will take the filing date of the subsequent application. The inventor’s intervening disclosure could not, of course, be used for a novelty attack because anything disclosed therein would presumably also be disclosed in the priority application and so fall within the

part of the claims having the valid claim to priority. But, the intervening disclosure would be citable for inventive step purposes against the other embodiments of the generalised disclosure not present in the priority application and, if the generalisation might be considered obvious to try from knowledge of the specific embodiment, the inventive step attack is likely to be successful. It is therefore important to try to avoid this potential pitfall either by including information about the generalisation in the priority application, or by avoiding publication of the intervening disclosure completely. Otherwise, the filing of the priority application might provide false confidence.

Don’t hold back Finally, a priority application is often filed quite early in the life of an invention. It can be difficult to know at that point exactly what the essential features and information are that are needed to define and work the invention, and inventors can be worried about overstating the requirements or unnecessarily disclosing information. However, applicants should be cautious when withholding information, as a valid priority claim at the EPO requires that the priority application discloses all the features of the invention defined in the subsequent application, and also that it provides an enabling disclosure of the invention. This means that while the inventors might feel more comfortable keeping some information back, this should only be done knowingly and with caution.

Emma Longland elongland@vennershipley.co.uk

International Trade Marks Update United Arab Emirates joins the Madrid Protocol On 28 December 2021, the United Arab Emirates became the 109th member to join the Madrid Protocol. This made the UAE the third country from the Gulf States to join the International system, alongside Bahrain and Oman. The Madrid Protocol is an International system for obtaining trade mark protection. It provides a simplified and cost-effective approach to owners wishing to register their trade marks in multiple territories and is an alternative to filing individual national trade mark applications. Together with the savings in upfront filing costs afforded by the system, another cost benefit is a single renewal fee, and recordal of changes to ownership or name and address of the owner at a single office. An International trade mark registration can be regarded as a bundle of national rights centralised for formalities’ purposes, but giving its owner the same rights and remedies as a national trade mark registration.

The addition “of the UAE to the

Madrid Protocol makes protection in the UAE more accessible and will allow owners in these sectors to protect their brands more readily.

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The UAE is an important country for brand owners looking to protect their intellectual property rights. The country is evolving in a variety of sectors, including luxury goods and a variety of services in business development, financial services, IT

services, tourism, construction, and property development. The addition of the UAE to the Madrid Protocol makes protection in the UAE more accessible and will allow owners in these sectors to protect their brands more readily. Protecting the UAE via the Madrid Protocol system presents a significant cost saving opportunity in one of the most expensive trade mark territories in the world. It enables trade mark owners to reduce their administrative costs and responsibilities when filing a trade mark application in the UAE. The International system also allows multi-class applications, another benefit over the single class national system currently in place in the UAE. If you are looking to expand your protection of an existing application or registration to include UAE, please do not hesitate to get in touch with one of our trade mark attorneys who will be happy to assist.

Southern Cone protection options expand Chile will join the Madrid Protocol as the 11th member on 4 July 2022, joining its South American neighbours Brazil and Colombia, and boosting protection options for its principal industries of mining, agriculture and wines. Chile is a significant producer of metals and minerals and is the second largest producer worldwide of lithium, for which global demand remains consistently high.

27 March 2022. Jamaica is the third Commonwealth Caribbean member to join the International system, alongside Antigua & Barbuda and Trinidad & Tobago. Jamaica is a country well known for its spices, sauces, beverages, music and tourism. This presents an opportunity for owners to protect their brand in an exciting, developing territory. The addition of Jamaica to the International system will strengthen and simplify options for protecting brands in an important country in the region. Cape Verde will join the club on 6 July 2022 and will bring the total number of members to 128. Cape Verde, off the West Coast of Africa, is formed of 10 islands, and has a population on its 9 inhabited islands of less than 600,000. It is an emerging tourist destination and has historic links to Portugal. It is not yet clear whether an International Registration extending to Cape Verde will be recognised by the local authorities due to a lack of implementation of the necessary local legislation, a problem in some African countries. If you are interested in protection in Cape Verde or indeed any territory, our trade mark attorneys can advise you on the best strategy to adopt.

Protection of trade marks in Chile using the Madrid Proptocol is likely to increase the speed of registration, bearing in mind that an International Application must be examined by local offices within 18 months of filing of the application.

Clare Turnbull cturnbull@vennershipley.co.uk

Island Members

Vivek Patel vpatel@vennershipley.co.uk

Jamaica recently became the 110th member of the Madrid Protocol and entered the International system on

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Expert Witnesses in Patent Cases – What’s Happening? Since their appointments to the High Court bench in 2020 and 2021 respectively, Mr. Justice Meade and Mr. Justice Mellor have made a point of considering the use of expert evidence in patent cases. They have both, especially Meade J., commented on the value of expert evidence and provided guidance on the instruction of experts. Here we offer a summary of how the use of expert evidence is evolving. The functions and duties of experts The main function of an expert witness in a patent case is to assist the Court. An important difference between England and other jurisdictions is that there are clear rules on the impartiality of the expert with a focus on their duty to the Court ahead of pure client interest. This can surprise some people who are used to their experts being purely hired for their pro client views. The duty to the Court takes precedence over any duty to the party instructing and paying them, and they must focus on explaining the technology or process in question to the Court, and in particular, offer their views on the knowledge of the hypothetical “Skilled Person” to assist the Court in determining the “Common General Knowledge” (CGK).

How can they help and avoid hindsight? In Philip Morris v BAT¹, Meade J. said that there is a difference between asking an expert witness the open question “What would the Skilled Team do?” and (for example) the closed question “Would it be obvious to use a gathered sheet of tobacco?”. The latter risks introducing hindsight, which ought to be avoided. As mentioned in our article about Mellor J.’s decision in Teva v Bayer², when an expert is opining on the validity (especially in relation to obviousness) of a patent, it is

extremely important that the expert view is not unduly affected by hindsight. Mellor J. said that hindsight can affect the obviousness case if, for example, an expert (knowing of the “target”) appears to be looking for ways to avoid taking a particular step or making a particular choice towards the target, when the Court concludes that the Skilled Person would consider the step or choice differently and, having considered it dispassionately, would decide to take the step or choice. It is important for expert witnesses to concentrate on the real-world approach of the Skilled Team (comprising those skilled in the art or made up of Skilled Persons). They must explain how they believe a Skilled Team would likely undertake testing along several parallel paths. Mellor J. criticised the approach of Bayer’s expert, finding that his report placed too much emphasis on theory in hindsight, and this blighted the expert’s attempt to make it appear that the Skilled Team would not undertake the test in question. This approach was subsequently followed by Meade J. in Optis v Apple³. The views of Meade J. build on the earlier work of Lord Justice Arnold when he sat in the High Court and offered guidance for the instruction of experts on avoiding hindsight in Medimmune v Novartis⁴. Arnold J. (as he then was) said that when the expert is instructed, the order in which they are taken through the

matters and materials is important, and confirmed the approach in that case whereby the expert was first asked to consider the prior art, then the priority documents, and then the patents in question. This structure ensures the expert arrives at the patent with the relevant material and CGK in mind. Meade J. agreed with this in broad terms in his decision in Fisher and Paykel v Flexicare⁵ where he observed that, in a perfect world, it would be best for experts to be asked about the CGK, then shown the prior art, and only then shown the patent in question, so that they would not be influenced by hindsight. However, it would seem there is a recognition that this is not always how instructions will be given, nor is it mandatory, because his wording suggests that while this is the best method for instruction, it is not a requirement. Indeed, in some cases it may not even be possible, as the expert might well already know what the invention of the patent in suit is, for example from the patentee's commercial use of such⁶. Further, it is quite understandable that, when looking for an expert, early references to the patent to determine if the expert knows the subject area sufficiently to be an expert is understandable. There are also times when this approach, of so-called “sequential unmasking” is unfeasible. Meade J. gave an example of such in Promptu v Sky⁷, noting that the patentee had 11

maintained a number of dependent claims, and so Meade J. said it was inevitable that not all of them could be covered in the fullest depth in the expert’s first reports. He said that sequential unmasking was impossible after the first report, as the expert would at that point have knowledge of the patent in question before drafting the second (and, in this case, the third) reports. Meade J. took the potential for hindsight into account, but considered it a minor factor given the situation and the fact that the parties for the most part agreed on the CGK. Meade J. also said that an expert could not be accused of hindsight just because their instructing solicitors had directed them to review specific parts of the prior art, or to discuss specific parts of the CGK in their report⁸. This is particularly the case where the alternative would lead to a long and rambling report which would not assist the Court. He suggested that the risk of hindsight was not necessarily fatal or even serious, as long as the expert acknowledges the pointer(s) that they received and provides evidence as to why that particular area of the prior art was of interest. In that particular case, the specific area of prior art in question was common ground between the parties. Meade J. said⁹ that some directing of the expert was common sense, as the alternative would be unworkable. He said that it would not usually be sensible to ask an expert “What was the common general knowledge in your field at the time?” without some additional guidance, as that would lead to far more information being provided by the expert than would be relevant to the matter at hand. So while it is acceptable to direct an expert to certain parts of the CGK or the prior art, there is also a risk in doing such if the expert misses something in the wider CGK or prior art. If an expert does not consider parts of either in their report, then they are open to cross-examination on those absences. As Arnold J. (as he then was) said in Medimmune¹⁰, if an expert thinks a particular passage is ambiguous and therefore best ignored, the solicitors instructing that expert should persuade them to include that passage in the report. If they do not, opposing counsel may

well cross-examine the expert on the passage and potentially accuse them of failing in their duty to the Court.

Does the expert need the same precise experience as the Skilled Person? In patent cases, there is a risk that a party will challenge the credentials of the expert witness for the other side and argue that they are not suitably qualified to provide expert evidence for certain parts of the case. Interestingly, Meade J. has been clear that approximation of the notional Skilled Person is not essential in an expert; as he said in Philip Morris¹¹, it is well established that the assessment of expert evidence in patent cases is not an exercise in determining which expert in fact approximates more closely to the notional Skilled Person. Indeed, it is not problematic that a specific expert may be cleverer or more inventive than the Skilled Person (and indeed may have themselves a number of patents in similar fields in their name), as long as they can put themselves in the shoes of the Skilled Person, or the “notional uninventive addressee”, as Meade J. said in Add2 v Dspace¹². Nor is it necessarily an issue if the expert has less direct experience in the specific field but can still adequately present opinions on the notional Skilled Person in that field, whether by tangential experience or by reading relevant literature. As Meade J. said in Merck Sharp and Dohme Ltd v Wyeth LLC¹³, it is well established that the expert’s precise approximation to the notional Skilled Person is not the key question, so long as they are able to assist the Court to identify the CGK and the attitude and approach of the ordinary Skilled Person in their field. Although it can be noted that the opinions of experts tend to be given less weight when they do not have real-world experience of the matters in hand and there is limited literature to draw upon. For example, in Alcon v Aspire¹⁴, Meade J. said that he found one expert team to be more convincing because of one of the experts’ real-world experience with the subject matter in question. He said it was not the sole factor, but it was a contributory factor. He also commented on the challenges of the situation where the literature was limited in Add2¹⁵, and discussed how

one of the experts was not in the field at the priority date but had attempted to put himself in the position of the notional Skilled Person by research and reading literature. However, in that case, there was little published in the field. This meant, that while the judge commended the expert’s care and professionalism in finding out what he could, he thought that the expert could not be an authority on the mind-set of the Skilled Person at the time.

What counts as CGK? In Teva UK Ltd v AstraZeneca AB¹⁶, Mr. Justice Sales confirmed that CGK includes statements in standard reference works and leading journal articles. In addition, he considered the recognition of reliability of the source was important, despite what some said at the time, and referred to a number of “primary articles” which he described as “academic articles…sufficiently prominent in the main academic journals in the field”, were part of the CGK. This starting place was not surprising, but he then described two further categories of CGK – “secondary articles” and “tertiary articles”. He described secondary articles as being a range of articles that were not leading journals in the field and would not have been likely to have been read by the notional Skilled Person in the ordinary course of keeping himself up to date, but which could be part of the CGK because such materials would have been quickly identified by any person conducting a literature search and review. At the time of that decision, some considered that it was a widening of the CGK, viewing it as no longer requiring the source to be generally reliable and contrary to what Mr. Justice Laddie said in Raych’m Corp's Patents¹⁷: “The common general knowledge is the technical background of the notional man in the art against which the prior art must be considered. This is not limited to material he has memorised and has at the front of his mind. It includes all that material in the field he is working in which he knows exists, which he would refer to as a matter of course if he cannot remember it and which he understands is generally regarded as sufficiently reliable to use as a foundation for further work or to help understand the pleaded prior art. This does not mean that everything on the shelf which is capable of being

www.vennershipley.co.uk referred to without difficulty is common general knowledge nor does it mean that every word in a common text ithers either. In the case of standard textbooks, it is likely that all or most of the main text will be common general knowledge. In many cases common general knowledge will include or be reflected in readily available trade literature which a man in the art would be expected to have at his elbow and regard as basic reliable information.” With this background in mind, the approach to CGK by the current judges when they rely on expert evidence as to exactly what information forms part of the CGK is interesting. In Alcon¹⁸, the claimants disputed the methodology that the defendants’ expert had used to assess that certain information was part of the CGK at the time. However, Meade J. said it is not necessary or realistic to prove exactly by what route the Skilled Person would find or access CGK, and it may well be enough to show that the information is contained in a number of well-known reference-type works. Indeed, the judge was critical of the attempt by Alcon to argue that some texts were too general and known to form part of the CGK. The judge stated that he rejected Alcon’s approach of: “[S]eeking to rule out general publications merely on the basis that they were general. For example, Rang & Dale’s Pharmacology (2nd Ed, 1991) was a general pharmacology work, and Shields Textbook of Glaucoma (3rd Ed, 1992) was a relatively general medical work about glaucoma, but that does not mean that the skilled addressee would not look to them, in addition

to more specialist works, or that they could not form part of the evidence proving common general knowledge. In any event, the former referred to the Coleman classification, though both had a tone consistent with my finding above that the whole field was in an early stage of development.” Meade J., it seems, takes a pragmatic approach to the knowledge base of experts and CGK, and in general to the instruction of experts. He accepted in Alcon, for example, that as the date in question for considering the CGK was more than 20 years prior, it was reasonable for the expert’s instructing solicitors to provide reference works to the expert for them to opine on.

Other points to note The final point for this article is to remember that expert opinion should always be supported by facts. In expert reports, every assertion should be supported by citations. If this does not happen, as in Merck¹⁹, the judge is likely to take a very dim view. In that case, Meade J. criticised part of the expert’s report as “speculative ideas” which “should not have [been] advanced without some proper support.” Complementing this, Mellor J. stressed in Fisher that the reasons that an expert comes to a decision is even more important than the decision itself. In that case the expert’s evidence was very thin on each piece of prior art in relation to the reasons for the Skilled Person getting to the idea of one of the claims. The judge was consequently concerned that

the expert was reaching the same goal from a very different starting point, and he considered that it was an issue where the expert had not “fully articulated different and independent reasons for each citation.” In consequence, Mellor J. gave less weight to that expert’s conclusions when he came to give his judgment.

Conclusion When instructing experts, it is important to remember their function – they are there to assist the Court. They can draw on a wide range of common sources to determine CGK, but you must guard against hindsight risk, and instructing solicitors need to think about the order in which they present material to an expert. There is no point in attempting to have them gloss over ambiguous sections in their report, as that would be picked up in cross-examination and the Court needs to know if there is some ambiguity in the CGK or prior art. Nor should the expert provide evidence which is not supported by cited facts. In short, considerable time and preparation should go into the proper instruction of your experts.

James Tumbridge jtumbridge@vennershipley.co.uk Benedict Sharrock-Harris bsharrock-harris@vennershipley.co.uk

1. Philip Morris Products SA v RAI Strategic Holdings Inc [2021] EWHC 537 (Pat) at 186. 2. Teva Pharmaceutical Industries Ltd v Bayer Healthcare LLC [2021] EWHC 2690 (Pat) at 113. 3. Optis Cellular Technology LLC v Apple Retail UK Ltd [2021] EWHC 1739 (Pat). 4. Medimmune Ltd v Novartis Pharmaceuticals UK Ltd [2011] EWHC 1669 (Pat) at 118. 5. Fisher and Paykel Healthcare Ltd v Flexicare Medical Ltd [2020] EWHC 3282 (Pat) at 20. 6. Ibid. 7. Promptu Systems Corp v Sky UK Ltd [2021] EWHC 2021 (Pat) at 16. 8. Ibid at 15(i). 9. Above n. 5 at 22. 10. Above n. 4 at 112. 11. Above n. 1 at 12. 12. Add2 Research and Development Ltd v DSpace Digital Signal Processing and Control Engineering GmBH [2021] EWHC 1630 (Pat) at 17. 13. [2020] EWHC 2636 (Pat) at 30. 14. Alcon Research LLC, Alcon Pharmaceuticals Limited v Actavis Group PTC EHF, Accord-UK Limited, Pharmathen SA, Aspire Pharma Limited [2021] EWHC 1026 (Pat) at 25. 15. Above n. 12 at 13. 16. [2014] EWHC 2873 (Pat) 17. [1998] RPC 31 18. Ibid. at 75. 19. Above n. 13 at 44.

Unitary Patents and the Unified Patent Court After many a false start, Europe is finally on the verge of a radical overhaul of its patent system, with the bringing into being of the Unitary Patent (UP) and Unified Patent Court (UPC). However, while the philosophical underpinnings of this change are based on simplicity, the practical implementation will be anything but, at least initially. That said, there is nothing to fear, and perhaps a great deal to gain, for those who are able to navigate it effectively. The following is a brief guide to the key points to note. Current status The so-called “Provisional Application Period” for the UP/UPC system came into effect on 19 January 2022. This allowed the formation of various bodies necessary to complete the preparations for the system to go live, in particular the Administrative Committee of the UPC which will formally adopt the Rules of Procedure of the UPC and oversee a process for hiring judges and other practical arrangements. The start date for the new system will be the first day of the fourth month after Germany formally completes its ratification process, which will provide users with some official notice before the system is in place. At present, the Administrative Committee has hinted that the start date may be as soon as October 2022, although commentators generally consider this ambitious, and it would not be surprising if this were delayed by a few months.

The case for change Currently, the European patent system which has proved so effective over the years is based on the European Patent Convention (EPC), which established the European Patent Office (EPO) and a harmonised approach to prosecution of patent applications to grant (and some post-grant procedure, notably Oppositions). However, this was only ever conceived as part of the story. Obtaining patent rights is useful only if those rights can in principle be

effectively enforced. While the EPO has been a huge success providing a harmonised European approach to the first part, Europe has to date lacked a central body able to offer the latter. As a consequence, “European patents” today are in fact a bundle of national rights. After grant at the EPO, a patent is “validated” in one or more European states, and then enforced individually in each of those states. There is a cost to this, even in the absence of any active patent enforcement: the cost of validation varies from country to country, although costs have fallen in many states since the London Agreement in 2000 led to a significant reduction in translation requirements in many states; and granted patents must be renewed annually in each validated state. Once patents are enforced, the costs of multiple proceedings in separate countries are clearly undesirable (albeit in practice generally avoided) and still worse is the possibility of conflicting decisions on the same patent rights in different jurisdictions. In a platonic ideal world, a single grant process would lead to a single patent enforced by a single court system. In reality, the shadow of this ideal we see by the flickering firelight is not so geometric in form.

A new Europe The European patent system is full of “you know it when you see it” fudges and shortcuts. The EPO will ask you to prove you solved

a “technical” problem but will not define “technical”. However, the real elephant in the room is the word “Europe” itself, which has a geographical definition but is often used as shorthand for the European Union. Neither of these match either the European patent system today, or the parts of Europe covered by the UP and UPC. The EPC, and thus the EPO, covers 38 states, including all of those in the EU and ten others, including the United Kingdom as well as countries like Switzerland, Norway, and Turkey. The proposed changes have no impact on any existing EPO activity. As such, these countries will continue to cooperate in all European patent procedure up to grant. While EU membership is irrelevant to the current European patent system, only EU members will be taking part in the new elements. The driving forces behind the UP/UPC project are in tune with those of the EU. If you want a single market across the EU, with common rules applied, then it is logical to wish to see intellectual property rights applied in a harmonised manner. Today, goods on the market in, for example, Germany may infringe a European patent, while the same goods in a neighbouring EU state may not, for no more complex a reason than the patent has not been validated there. As such, the market on each side of the border is not the same. One might expect therefore, that the UP and UPC would be EU-

www.vennershipley.co.uk wide institutions. Indeed, this was the original intention. However, history has led us to a different point. EU-wide agreement could not be reached, and so a process of “Enhanced Cooperation” among a subset of EU states was used to progress the project. In the end, the UP and UPC will not cover all EU states, but a coalition of the willing, which will include, for example, France, Germany, Italy, and the Netherlands, but will not include, for example, Spain and Poland. With even theoretically willing countries not all having completed their ratification process, the system is expected to start with 17 countries as illustrated

The distinction between the geographical scope of the European patent system we are accustomed to and that of the new system is the core understanding necessary to taking informed decisions on how to respond.

UPs For participating EU member states (at present, the 17 states indicated in the map above), it will be possible for a single patent to be granted on request in place of the existing system of multiple national validations. This will provide a unitary right in place of the existing system, and the practical aim here is to reduce costs, specifically those incurred at validation and in subsequent renewals.

Requests for “unitary effect” will be filed at the EPO within a month of the grant date. In comparison, at present proprietors have up to three months after grant to validate in each participating member state. As a result, patent applicants will need to be aware of their intended strategy in good time in order to make informed decisions. It will not be obligatory to opt for UPs even in those countries where

it is available. The existing national validation route will continue to exist. For example, an applicant may choose to obtain a UP and also to validate in one or more countries where the UP does not apply, or simply to continue with their existing practice, validating only in those states of interest. In making this decision, cost may be the primary consideration, but it is also worth bearing in mind that UPs can only be litigated through the UPC, which is as yet an untested system. UPs are, by design, an “all-or-nothing” system, so if the UPC revokes a UP that decision will be effective in all states. Similarly, unlike the current system, it will not be possible to trim renewal costs by reducing the geographical coverage of a UP.

The table below illustrates the proposed UP renewal fees. These costs are broadly in line with the current costs associated with renewals in four member states. As such, significant cost savings will be made in comparison with current validation procedure across the 17 member states covered by the UP. However, in practice, many applicants do not currently employ such a broad validation strategy, and the true benefit may be increased coverage for a similar cost to current strategies in many cases. Year

Unitary Patent (EUR)

105

145

315

475

630

815

990

1,175

1,460

1,775

2,105

2,455

2,830

3,240

3,640

4,055

4,455

4,855

Total

35,555

* Based on national renewal fees as at 1 January 2020.

What is the UPC? The UPC is the litigation aspect of the system. It is a centralised court system (albeit there will be divisions of the UPC in various locations) to replace the current independent national courts for participating member states. Ultimately, the aim is that all patent litigation for those states will be handled by the UPC, but initially a hybrid system will exist. The UPC will at first instance have a central division based in Paris and Munich (and likely a third location – this was originally to be London but since the UK is no longer taking part this will need to change). There will

also be a number of local divisions in individual member states and regional divisions set up by groupings of those states. In board terms, infringement actions may be brought in the local or regional division where the infringement occurs or where the defendant is domiciled, while revocation actions would initially be brought in the central division. At each division, a panel of judges will hear a case. Each panel will be international in nature, with the aim of ensuring consistency between the different divisions. Nevertheless, it may be expected that some local character will be present in proceedings. One aspect of the UPC that will be watched closely is the possibility of “bifurcation”, the splitting of procedures handling infringement and revocation actions on the same case. Procedurally, it will be at a local/ regional division’s discretion whether, when a counterclaim for revocation is made to an infringement action they are hearing, to handle both aspects together themselves, refer both to the central division, or to split them by referring only the revocation to the central division. Defendants in infringement actions will be keen that decisions on infringement are not reached without validity having been tested. It is expected that such an outcome will be rare if it occurs at all, but practical implementation will be closely monitored. As noted above, all UPs will be litigated through the UPC. However, this is not the limit of the UPC’s jurisdiction. Ultimately, the intention is that all European patents validated in the conventional way in participating states will also be subject to the UPC’s exclusive jurisdiction. Nevertheless, there will be a transitional period of seven years (this could in theory be extended) during which that jurisdiction is not exclusive and those bringing proceedings will have a choice of the UPC or existing national courts for such patents. Moreover, in that time, patent proprietors will also have the choice

to opt-out individual patents from the system entirely, perhaps to avoid the possibility of central revocation at an untested tribunal.

Opt-outs The option to opt-out from the jurisdiction of the UPC is designed to address the concerns of patentees nervous to subject their assets to the decisions of an untested body in its infancy, particularly as this could lead to a central revocation of the case across all participating member states. There will be an option to opt back in if the patentee later considered it desirable. It is important to note that this opt-out procedure will apply to existing portfolios of European patents as well as those granted in future. Of course, litigation for those states that do not participate in the new system, both within and outside the EU and including the UK, will continue as at present. Opt-outs will be possible in the socalled “sunrise” period that will start three months before the actual start date of the UPC. In principle, this sunrise period could even start as early as July 2022, hence this decision may come around quickly. In terms of the practicalities, an opt-out can only be registered on behalf, and with the authority, of all of the actual proprietors of the patent, who may differ from the registered proprietors if ownership changes after grant have not been recorded. The opt-out procedure requires a declaration that the patent proprietors listed in the optout application are entitled to be registered as such, so as a practical matter it will be important that care is taken to ensure the chain of title is understood. As well as granted patents, optouts can also be filed for pending applications. If a UP is then later requested, this will in effect cancel the opt-out, since UPs cannot be opted out of the UPC.

The role of the UK Due to its exit from the EU, the UK will no longer take part in the UP or UPC. However, this does not affect the UK’s participation in the EPC or the EPO, so patents in the UK will continue to be available through this route. Moreover, European patent attorneys based in the UK will also have full rights to handle matters relating to UPs and rights of representation at the UPC. As such, Venner Shipley’s offices in the UK and Germany will continue to be well-placed to serve the interests of clients throughout the European patent landscape.

Decisions to make Patent applicants and proprietors need to take a view on how valuable they consider the possibility of UPs to be to their business, and potentially how threatening they consider UPC central revocation to be to their existing assets. The key decision points in the near term will be on the issues of whether to obtain UPs and whether to opt-out existing patents, and non-unitary patents in future, from the UPC. In making these decisions it will be important to bear in mind all stakeholders. In particular, where licence agreements are in place, or anticipated, due care will be required to ensure that the terms of such agreements are clear on these points. Please get in touch with your usual Venner Shipley contact for more information or advice, or email upc@vennershipley.co.uk.

Peter Thorniley pthorniley@vennershipley.co.uk

www.vennershipley.co.uk

Design protection of components This is the first of two articles exploring some of the issues affecting the protection of components under the various UK and EU Community design regimes. Components can include “durable” spare parts that are only replaced after damage or wear (e.g. a car body panel) and also “consumable” components that are regularly replaced by the user following depletion (e.g. a coffee pod). European lawmakers were wary of granting manufacturers a monopoly on the sale of spare parts incorporated into their products. For example, if vehicle manufacturers were able to protect all aspects of car components (e.g. bumpers and body panels) using design protection, then the manufacturers would effectively have a monopoly on the sale of replacement components, which could severely restrict competition in the spare parts aftersales market and thus the choice of the consumer. In view of this, European Designs Regulation no. 6/2002 (which gives rise to the Registered Community Design and Unregistered Community Design) and European Designs Directive 98/71/EC (which is implemented by EU Member States to give rise to national registered design law) were both drafted to include a number of limitations on the scope of protection that is available to spare parts. We will look at some of these limitations in this article, namely the visibility requirement for component parts of complex products and also the exclusion of features that are dictated purely by technical function (which of course will also affect other categories of designs). A follow-up article will discuss the “must-match” exclusion, the related repair clause, and the “must-fit” exclusion.

Overview of different design regimes Following Brexit, the 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 designs 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. We will also not look at the various national design rights that are available in each Member State. However, most aspects of national registered design law are substantively harmonised by the Designs Directive and remain mostly aligned with the UK system, although there are some important exceptions such as the repair clause (which varies considerably between different Member States) and we will

discuss this in our follow-up article. The visibility requirement for component parts of complex products and the exclusion of features that are dictated purely by technical function discussed in this article apply to all of the UK and Community design regimes discussed above with the exception of the UKUDR.

Component parts of complex products There is a requirement that “a design applied to or incorporated in a product which constitutes a component part of a complex product shall only be considered to be new and to have individual character… if the component part, once it has been incorporated into the complex product, remains visible during normal use of the complex product”, and then only “to the extent that those visible features of the component part are in themselves new and have individual character” (Art. 4(2) of the Regulation and Art. 3(3) of the Directive). A “complex product” is defined as “a product which is composed of at least two replaceable component parts permitting disassembly and reassembly of the product” (Art. 3(c) of the Regulation and Art. 1(c) of the Directive). The exclusion will therefore prevent the protection of features of a component that are not visible during normal use of the product into which the component is incorporated. Normal use is defined as “use by the end user; but does not include any maintenance, servicing or repair work in relation to the product” (Art. 4(3) of 17

the Regulation and Art. 3(4) of the Directive). This would therefore clearly exclude protection of, say, internal components of a vehicle that are only visible during repair of the vehicle by a mechanic. However, the boundaries of what constitutes “normal use” is considered by many to be unclear, and is currently the subject of a referral to the CJEU (C472-21) from a dispute in the German courts between Monz Handelsgesellschaft International (Monz) and Büchel.

(1) Is a component part incorporating a design a ‘visible’ component… if it is objectively possible to recognise the design when the component is mounted, or should visibility be assessed under certain conditions of use or from a certain observer perspective?

This CJEU referral concerns Monz’s German Registered Design No. 402011004383-0001 that was filed with a single view showing the underside of a bike saddle (shown below). Büchel filed an application for a declaration of invalidity of the design, on the basis that the underside of the saddle, which is a component part of a complex product, is not visible during normal use of the bicycle and therefore is ineligible for design protection.

a. When assessing the ‘normal use’ of a complex product by the end user… is it the use intended by the manufacturer of the component part or complex product that is relevant, or the customary use of the complex product by the end user?

Monz’s German design no. 402011004383-0001:

The validity of the registered design hinges on what is meant by “visible during normal use by the end user”. In one interpretation, protection is limited to only features that are visible from the perspective of the end user (i.e. the person riding the bicycle, which would exclude the underside of the saddle) or only under certain conditions of “use”, in which case the design would likely be found invalid. However, another interpretation of the exclusion would be that all features which are visible once the component has been mounted to the product and the product is in a condition for use are protectable, regardless of whether the features are visible from the perspective of the person using the product (for example, the underneath of the saddle is still visible by crouching down next to the bicycle). The case has been referred to the CJEU with the following questions: 18

to be valid despite the cartridges not being visible when housed in the printer. Samsung’s RCD no. 001200687-0001:

(2) If the answer to Q1 is that visibility under certain conditions of use or from a certain observer perspective is the decisive factor:

b. What are the criteria for assessing whether the use of a complex product by the end user constitutes a ‘normal use’? It will be interesting to see the outcome of this CJEU referral, and also whether UK courts decide to adopt a similar position. Another factor that needs to be taken into account is whether the component is actually a “component part of a complex product” within the meaning of the exclusion. The provision was drafted with the original intention of applying to the internal components of vehicles in order to prevent car manufacturers obtaining a monopoly on the spare parts aftersales market. However, the exclusion has since been applied to the components of all manner of complex products, the bike saddle discussed above being just one example. Nevertheless, in some decisions it has been held that “consumable” components are not caught within the exclusion and thus are eligible for design protection, even if not visible during use. For example, in the case of Samsung Electronics v Maxperian (ECLI:NL:RBDHA:2016:14383) the District Court of The Hague, in its capacity as a Community designs court, found that printer toner cartridges are not a component part of a complex product, reasoning that a printer sold without such cartridges would still be a complete product. Therefore, two of Samsung’s RCDs (no. 001200687-0001 and 0008535510001) to toner cartridges were held

More recently, in Miele v Green label (R 299/2021-3) the EUIPO Board of Appeal found that vacuum cleaner bags are not a “component part of a complex product” and, in view of this, held that Miele’s RCD (no. 0009920780003) was valid despite the fact that the bags are not visible when mounted within the vacuum cleaner. This is in contrast to an earlier Board of Appeal decision (R 568/2019-3) in which it was found that Vorwerk Elektrowerke’s RCD (no. 0001249120001) was invalid on the grounds that a vacuum cleaner bag is a component part of a complex product and therefore, since it is not visible during normal use, could not be afforded design protection. In the later Miele decision, the Board came to a different conclusion on the grounds that the earlier decision had not taken into consideration that: (i) there is an independent market for vacuum cleaner bags; and (ii) there is a Locarno class, 09-05, dedicated to “vacuum cleaner bags” and thus it “would be nonsensical to include a term as a product indication, but subsequently to deny protection for an RCD relating thereto under all circumstances”. The first point is an important one, and on the whole patent offices and courts have attempted to draw a distinction between nonvisible features of parts that are only replaced through damage/ wear, and thus do not attract design protection, and non-visible consumable components that are regularly replaced by the end user and for which there are independent distribution channels, and thus for which protection may be possible. In the Miele case, the Board gave light bulbs, batteries, film reels and café capsules as other examples of consumables that would likely not

www.vennershipley.co.uk be considered component parts of complex products within the meaning of the exclusion. The second point regarding the Locarno classification system is more difficult to follow. Whether or not a design is valid should be determined based on the facts of the particular case and, in any event, the Locarno classification also includes, for example, product indications for “Engine pistons”, “Exhaust manifolds for combustion engines” and “Sparking plugs for motors” in class 15-01, and “Washer reservoirs for vehicles” in class 12-16”. In many instances it is difficult to see how these components could attract design protection if not visible during normal use of the complex product within which the component is incorporated irrespective of whether a particular Locarno class exists. Miele’s RCD no. 000992078-0003:

Vorwerk Elektrowerke’s RCD no. 000124912-0001:

There is clearly still some uncertainty as to the extent of the exclusion, and offices have at times shown slightly irregular reasoning to justify protecting consumables based on the wording of the current law. In view of this, as part of Venner Shipley’s response to the UKIPO’s recent design

consultation, we proposed that the definition of component parts is clarified.

Technical function Another provision that will often affect the protection of spare parts is the exclusion from protection of “features of appearance of a product which are solely dictated by its technical function” (Art. 8(1) of the Regulation and Art. 7(1) of the Directive). The idea behind this limitation is that technical function is protected under the patent system and thus should not be subject to design protection, which should be limited to covering appearance (and note that registered design applications are not substantively examined in the same way as patent applications and the 25-year term of registered design protection is longer than the 20-year term available for patents). Only features of the component part or article that are deemed to be dictated solely by technical function fall within the exclusion, whilst the remaining features of the design may still merit protection. Usually a component will inherently perform some technical function, and therefore careful consideration should be given to what is actually protected once purely functional features of the component are disregarded. Over time, two different tests developed for determining whether a feature is dictated solely by its technical function. The first approach is known as the “multiplicity of forms” test, where if the feature may take more than one form and still achieve the same function then it is not excluded from protection. The second approach is the “no aesthetic consideration” test, wherein the intent of the designer when creating the design is the deciding factor; if the designer considered the visual aspects of the feature when conceiving the design and the feature was not selected by the designer only for its technical function then the feature is not excluded from protection. The CJEU considered the merits of these two approaches in Doceram v CeramTec (C‑395/16), in which the validity of a number of Doceram’s RCDs (no. 000242730-0001 to 0017) to various configurations of centering pins for welding was contested

on the grounds that the features of appearance of the products in question were dictated solely by their technical function. The CJEU held that the “no aesthetic consideration” test was the correct one. Doceram’s RCD no. 000242730-0001, 0003 and 0005:

The court noted that adopting the “multiplicity of forms” test would be problematic because a single economic operator would be able to obtain several registrations as a Community design of different possible forms of a product incorporating features which are exclusively dictated by technical function, and thus gain a monopoly over the technical function (in the case at issue, Doceram held seventeen different Community Design registrations to different shapes of centering pin). However, the court did note that “all objective circumstances” should be taken into account when assessing whether aesthetic considerations were taken into account when incorporating a feature into a design, and that these included information on its use or the existence of alternative designs which fulfil the same technical function (i.e. the “multiplicity of forms” test could still be a factor, just not the only factor that is considered). Stay tuned for our next article in which we will look at the “must-fit” and “must-match” exclusions and the related repair clause.

George Hudson georgehudson@vennershipley.co.uk

Update to the EPO Guidelines 1 March 2022 The first updated version of the Guidelines for Examination according to the new revision cycle came into force on 1 March 2022 (Guidelines). The updates are intended to reflect recent changes to European Patent Office (EPO) practice and some of the more significant changes are set out below. General practice Designation of inventor

Every application must designate the inventor and recent amendments have changed the requirements for providing the inventor address. The Guidelines clarify that the place of residence of the inventor is regarded as the city or municipality where the inventor permanently resides and not the province or region (A-III, 5.3). If the inventor address is not correct, then the designation will not be considered as validly filed. However, in the event of any deficiencies, the applicant is given 16 months from the date of filing or priority date to remedy the deficiency before the European patent application is refused (A-III, 5.4).

Priority document retrieval under the World Intellectual Property Organization (WIPO) Digital Access Service (DAS) Under European practice, it is necessary to file a copy of the previous application from which priority is claimed (priority document). Traditionally, the EPO included in the file, free of charge, a copy of the priority document retrieved via DAS in respect of EP, Chinese, Korean, and United States applications.

Following the changes announced on 13 November 2021, the Guidelines now reflect that a copy of the priority document will only be included at the request of the applicant. Although this is only a small change, it does in fact put the burden of request on the applicant. So it is important to remember to 20

make such a request, providing the relevant DAS code for the priority document, in order to avoid receiving a notice of deficiency from the EPO and, in the worst case, a loss of priority (A-III, 6.7).

Partial priorities

The Guidelines have been updated to include new text integrating the teaching of G1/15 and, in particular, more detailed examples are provided on how partial priority is assessed. Partial priority refers to a situation in which only a part of the subjectmatter of a claim is entitled to the priority date of a previous application. The changes detail the steps for assessing whether the subject-matter within a generic “OR” claim is entitled to partial priority. The new text provides an example in which the priority document discloses the use of a specific composition, whereas the application claims the use of a composition defined in more generic terms. In an “OR” claim, the subject-matter of the specific composition is entitled to the priority date, whereas the alternative subject-matter to the generic composition is not and therefore has the filing date of the application as the priority date (FVI, 1.5).

Description amendments

The EPO received considerable feedback following the 2021 changes to the Guidelines that brought in stricter expectations on the applicant to amend the description to conform to the claims. In response, the Guidelines have been updated to moderate

these requirements. Nevertheless, the burden on the applicant to make such amendments is still maintained, despite recent case law that has thrown into question the legal basis for such a requirement (T1989/18). The amended wording now emphasises that the description and/or drawings should not be inconsistent with the subjectmatter for which protection is sought. The applicant is required to remove any such inconsistencies, either by deletion or by marking embodiments as not falling within the subject-matter for which protection is sought (F-IV, 4.3). Examples of such inconsistencies are now provided, which include the presence of an alternative feature that is broader or different to, or simply incompatible with, a feature of the independent claim. The updates also clarify that “it is not an inconsistency when an embodiment comprises further features which are not claimed as dependent claims as long as the combination of the features in the embodiment is encompassed by the subject-matter of an independent claim. Similarly, it is not an inconsistency when an embodiment fails to explicitly mention one or more features of an independent claim as long as they are present by reference to another embodiment or implicit.” Where there is a borderline case, the benefit of the doubt is now given to the applicant. In order to remove any such inconsistencies, the Guidelines still maintain that a generic statement is not sufficient; rather, amendments have to refer to “specific embodiments (e.g. “Embodiments X and Y are not

www.vennershipley.co.uk encompassed by the wording of the claims but are considered as useful for understanding the invention”).” Similarly, “features required by the independent claims may not be described using wording such as “preferably”, “may” or “optionally”.” These terms must be removed to avoid making a mandatory feature of an independent claim appear as being optional. The updates also emphasise that claim-like clauses must be deleted or amended, otherwise they may lead to a lack of clarity on the subject-matter for which protection is sought (F-IV, 4.4).

Computer-implemented inventions Mathematical methods

The patentability of mathematical methods has relevance to many artificial intelligence (AI) inventions through the implementation of machine learning algorithms. In the Guidelines, further clarification is provided regarding the principles of assessing such patentability (GII, 3.3). In respect of mathematical methods, for the assessment of inventive step, technical character must be taken into account. According to the Guidelines “A mathematical method may contribute to the technical character of an invention, i.e. contribute to producing a technical effect that serves a technical purpose, by its application to a field of technology and/or by being adapted to a specific technical implementation”. The Guidelines provide further examples on claims directed to a specific technical implementation of a mathematical method (GII, 3.3), clarifying that in such circumstances a mathematical method may contribute to technical character “if the mathematical method is designed to exploit particular technical properties of the technical system on which it is implemented to bring about a technical effect such as efficient use of computer storage capacity or network bandwidth” or by implementing “the execution of data-intensive training steps of a machine-learning algorithm to a graphical processing unit (GPU) and preparatory steps to a standard central processing unit (CPU) to take advantage of the parallel architecture of the computing platform.”

In particular, regarding AI inventions, the Guidelines now provide an example of the assessment of inventive step according to COMVIK in respect of a claim having distinguishing features directed to computational models and algorithms related to AI (G-VII, 5.4.2.5). The Guidelines make clear that the implementation of “algorithms related to artificial intelligence are, on their own, of an abstract mathematical nature”. In other words, when taken in isolation, such features are non-technical. However, where the computational model and algorithm is directly used in the control of a specific technical process, this is regarded as a technical application. As such, in the example provided, “the differentiating feature contributes to producing a technical effect serving a technical purpose and thereby contributes to the technical character of the invention. Therefore, it is taken into account in the assessment of inventive step.” Although this does not, of course, guarantee that the solution provided by the algorithm is not found to be obvious.

Simulations

Simulations also fall under the category of mathematical methods, such that when they are at least partially implemented on a computer the subject-matter as a whole is not excluded from patentability. Simulations are therefore examined according to the same criteria as any other computer-implemented invention. To this end, the Guidelines now reflect the important concepts that came from G1/19, which confirmed the application of COMVIK to computer-implemented inventions. The changes are intended to clarify how inventive step is to be assessed, particularly with respect to simulations. As described above, it is necessary to determine the technical character of such features.

“[In] a “purely numerical” simulation, the underlying models and algorithms may contribute to the technical character of the invention by their adaptation to a specific technical implementation or by an intended technical use of the data resulting from the simulation.” “Calculated numerical data reflecting the physical state or behaviour of a system or process existing only as a model in a computer usually cannot contribute to the technical character of the invention, even if it reflects the behaviour of the real system or process adequately.”

Biotechnology and chemistry The formal requirements for filing sequence listings have been updated. In particular, the Guidelines (A-IV, 5) have broadened the allowable format for sequence listings to encompass the new WIPO standard (ST.26). The updates clarify that every sufficiently long nucleotide or amino acid sequence needs to be listed in the sequence listing, even if it is a fragment of another disclosed sequence. Furthermore, the Guidelines (A-IV, 5.1) also clarify the difficulties in filing a sequence listing as a missing part according to Rule 56 European Patent Convention (EPC) and in what circumstances the applicant should expect a communication requesting that they file a compliant sequence listing under Rule 30(3) EPC.

Kathryn Rose krose@vennershipley.co.uk Nick Barrow nbarrow@vennershipley.co.uk

For example, the Guidelines set out that: “Computer-implemented simulations that comprise features representing an interaction with an external physical reality at the level of their input or output may provide a technical effect related to this interaction.”

Controlling the Speed of Prosecution at the EPO If you are familiar with prosecution at the European Patent Office (EPO), you will likely have had times where it is acting more slowly or quickly than you would like. While applicants have limited control over the EPO’s timescales for processing applications, the EPO has made some options available for influencing the speed at which it handles each application. This article is intended to outline some of the available options. Speeding up There are various reasons to speed up the prosecution of an application, from early enforceability to attracting more investment with a granted patent. Beyond the obvious option of responding to communications as quickly as possible rather than waiting for deadlines, there are a number of other options available to further accelerate prosecution.

File a PACE request A PACE request can be used to request accelerated examination. It can be filed at any time during examination and only requires a simple form, with no official fee and no reasons needed for the request. Once filed, the EPO will usually strive to issue its next office action within three months of receipt, and all subsequent office actions within three months of each response. However, this is “only where practically feasible and subject to the workload of the search and examining divisions”. Technically, a PACE request can also be filed for accelerated search. However, under its Early Certainty from Search initiative, the EPO now always strives to issue the search reports quickly (within six months of filing). Hence, a PACE request for accelerated search will often have no effect. It is also worth noting that PACE requests cannot be used too often. The EPO has stated that “Applicants requesting accelerated prosecution for all or most of their applications 22

will, as a rule, be required by the EPO to limit the number of their PACE requests by making a selection.” Pros

Cons

No official fee

Theoretically should not be requested too often – only for a limited number of applications

Simple form Can be requested at any time during examination No reasons needed for the request

File a PPH request Similarly to PACE, the Patent Prosecution Highway (PPH) is a programme that can be used to accelerate examination of European patent applications and is free of charge.

PPH request is based – it will perform its own search and examination and come to its own conclusions. Hence, it is not apparent that a PPH request has any particular positive effect over what a PACE request provides. Pros

Cons

No official fee

Stricter requirements for acceptance than PACE but tends to have the same acceleration effect

Waive the invitation to indicate the applicant’s desire to proceed further

Unlike PACE, PPH does require reasons to be given as to why the PPH request should be accepted. Specifically, it is necessary to include a declaration of correspondence to the allowed claims of a counterpart application at a participating office. See here for a list of participating offices.

Ordinarily, if the request for examination has been made before issuance of the search report, the EPO will issue an invitation under Rule 70(2) of the European Patent Convention (EPC) to indicate whether the applicant wishes to proceed further with the application and shall give them the opportunity to comment on the search report and to amend the description, claims, and drawings.

PPH requests also have stricter time requirements than PACE requests – the PPH request must be filed before substantive examination has begun. Our experience is that, if accepted, a PPH request accelerates proceedings to a similar extent as a PACE request. Our experience is also that the EPO does not tend to simply follow the decision of the office on which the

If the right to receive this communication is waived, the Examining Division can assume responsibility on transmittal of the search report. As a result, instead of the search report being accompanied by a written opinion, it can theoretically be accompanied (or shortly followed) by a communication under Rule 71(3) EPC with the text

www.vennershipley.co.uk intended for grant (assuming the Examining Division does not have any objections and has been able to carry out its search for conflicting European applications according to Article 54(3) EPC). Pros

Cons

No official fee

No opportunity to consider the results of the search and decide whether to proceed with examination

Theoretically can result in a Rule 71(3) EPC communication being issued with the search report

Request early processing (Euro-PCT applications only) The EPO has a 31-month deadline from the priority date of a PCT application to enter the European phase. Ordinarily, if all the acts necessary to enter the European phase are completed prior to the 31-month deadline, the EPO will not process or examine the application until expiry of this deadline. To avoid this situation, it is possible to request early processing. This is very simple and can be done by checking a box on the form used to enter the European phase. In this case, the EPO will be able to process and examine the application prior to the expiry of the 31-month deadline. Pros

Cons

No official fee Very simple

Waive the Rule 161/162 EPC communication (EuroPCT applications only) Once a Euro-PCT application enters the European phase, the EPO issues a Rule 161/162 EPC communication. This sets a six-month time limit to file any voluntary amendments if desired (as well as requiring a mandatory response to the EPO’s objections in the international stage if it acted as the international search authority (ISA)). In order to skip this procedural step, it is possible to waive the Rule 161/162 EPC communication. As with a request for early processing, filing this waiver is very simple and can be done

by checking a box on the form used to enter the European phase (and paying any necessary excess claims fees for the existing claims). However, if the EPO acted as the ISA, it is also necessary to file a substantive response to the EPO’s objections from the international stage for the waiver to take effect. Pros

Cons

No official fee

Deprives the applicant of the opportunity to make voluntary amendments at this stage

Very simple

Slowing down There are legitimate reasons to try to slow down the prosecution of an application, including to delay costs, to keep amendment options open, or to keep a patent pending that might ultimately be refused. When looking to slow down prosecution, you should of course make full use of the periods set for responding to each official communication and not use any of the actions discussed above that accelerate prosecution. While there are not many formal options available for slowing down prosecution, some are available.

delayed by a few months – the EPO cannot perform a search until claims are present. This is not an option that we recommend for most applications given the strict added subject-matter requirements at the EPO. Specifically, to comply with Article 123(2) EPC, it would be necessary for the entire subject-matter of the claims to already be included in the previously filed description. This is, however, a useful delaying tactic for divisional applications. The subject-matter of a divisional application cannot extend beyond the content of the parent as filed. As a result, provided the entire content of the parent application is included in the divisional application as initially filed (e.g. by adding the subjectmatter of the claims of the parent to the description of the divisional), there is no risk in filing the claims late (because the total contents that can be included in the divisional application have already been decided by the parent and the claims cannot add anything further). Pros

Cons

No official fee

Not recommended for most applications due to the added subject-matter risks

Request an extension It is not possible to request extensions of time for responding to all types of communication issued by the EPO, but it is possible to do so for many types. A common example is an examination report. A two-month extension will normally be granted on request, without any official fee or reasons for the request being needed, provided the total period set does not then exceed six months. The total period can be extended beyond six months, but only in exceptional circumstances.

File the claims late Strictly, the filing of claims is not required at the EPO to obtain a date of filing. If no claims are included in the application on filing, the EPO will issue an invitation under Rule 58 EPC inviting the application to file the claims within two months.

Summary As discussed above, there are numerous tactics that can be used for controlling the speed of prosecution of your European application, both to speed it up and to slow it down.

Henry Aldridge haldridge@vennershipley.co.uk

By waiting for this invitation from the EPO before filing the claims, the prosecution of the application can be 23

Patently Obvious? The English High Court Considers Drug Development Practices in Teva v Bayer On 8 October 2021, Mr. Justice Mellor handed down his judgment in (1) Teva Pharmaceutical Industries Limited (2) Teva UK Limited v Bayer Healthcare LLC [2021] EWHC 2690 (Pat). The decision follows existing case law to find that the chemical formulation of a drug developed by Bayer (a salt form of sorafenib, sorafenib tosylate, used in the treatment of cancer) was the obvious outcome that would result from the routine drug development by the hypothetical Skilled Team (comprising individuals skilled in the art). This follows the previous Supreme Court decision in Actavis v ICOS¹, in which the Court arrived at a similar conclusion. While there were other claims for the use of sorafenib tosylate salt orally, or the use for the treatment of cancer, claim 12 of the patent in suit, EP (UK) 2305255 (Patent), was for the chemical formulation for the sorafenib tosylate salt per se.

Obvious actions for the Skilled Team Would the Skilled Team attempt to formulate a soluble form of sorafenib? In Teva v Bayer, the closest prior art was an article about sorafenib in the journal Endocrine-Related Cancer, entitled “Discovery of a novel Raf kinase inhibitor”, written by authors from Onyx, Bayer, and Chiron. The judgment refers to this article as “Lyons” (after one of the principal authors); Lyons was published prior to the priority date of the Patent. Lyons disclosed the preliminary results of phase I clinical trials for sorafenib. Lyons referenced the dosage and chemical structure of the drug (and that it had been successful for oral administration in humans),

but did not disclose that sorafenib tosylate salt was the salt form of sorafenib that was used. Indeed, Lyons did not mention which salt form of sorafenib had been used in the trials. In para. 126, Mellor J. found that: “Lyons provided the Skilled Team with a strong (but not irresistible) motivation to investigate this chemical entity with a view to identifying a formulated drug, preferably for oral administration to humans. The point is that from the starting point of Lyons, the Skilled Team (and the Skilled Formulator in particular) had their CGK routine tests, considerations and analysis to work with.” Consistent with the tests set out in Windsurfing² and Pozzoli³, the Skilled Team was held to include a person skilled in drug formulation (the Skilled Formulator). Accordingly, the crucial question to be answered was: In the standard course of drug development, would the Skilled Team have tested and selected sorafenib tosylate for clinical formulation? If so, then sorafenib tosylate per se would be obvious.

Given that Lyons disclosed to the Skilled Formulator that a sufficiently soluble formulation of sorafenib was possible, the judge was not persuaded by the defendant’s expert’s suggestion that the Skilled Team would have found overcoming the low solubility level of sorafenib to be “an extremely challenging project” (para. 127) and that this would have meant that seeking to identify a suitably soluble sorafenib salt would not have been obvious. The Skilled Team would know that a soluble salt form of sorafenib must exist, because an orally administered tablet was used in the clinical trials described in Lyons. The Skilled Formulator, Mellor J. concluded, would therefore have been motivated to carry out a salt screen to identify and find that suitably soluble form. Would the Skilled Team have used the tosylate salt in its salt screen? This is the question at the heart of this case (as confirmed by the judge at para. 129). Mellor J. paid close attention to each party’s expert, and quoted each at length in his judgment; he eventually concluded

www.vennershipley.co.uk that it was likely that the Skilled Team would have tested tosylate as part of its salt screen. While the prior art would have raised some concerns over the use of the tosylate, the judge found that this alone was not a sufficient reason for the Skilled Team not to have tested such. He said that: “It is far more likely that they would have said to themselves “we cannot make any firm theoretical predictions, so let’s get on and make a selection of salts and test them” (para. 165).

It is far more “likely that they

would have said to themselves “we cannot make any firm theoretical predictions, so let’s get on and make a selection of salts and test them.

”

As mentioned above, the patent claim in question was for sorafenib tosylate per se. Therefore, if the hypothetical Skilled Team knew that a soluble form of sorafenib existed, and they would have included tosylate in their salt screen to find such, then the sorafenib tosylate was obvious. The judge made it clear that it is not certain that a Skilled Team might not choose to include tosylate in its salt screen, but it is likely that most Skilled Teams would have done so: “I am quite sure if one compared a number of real skilled teams side by side, having read Lyons and faced with sorafenib, they would select different ranges of salts to test in a first or second tier, albeit with considerable overlap. Some teams who found unpromising results in the first and second tier screen would continue past a second tier screen, others might not. I bear in mind that some real teams might never have selected the tosylate salt for inclusion (depending on their particular experience), but I am satisfied that most

would. Above all, the inclusion of the tosylate salt would have been the result of standard and routine considerations. For all the reasons set out above, I find claim 12 of the Patent invalid for obviousness. Teva’s claim succeeds.”

Hindsight is a wonderful thing The judge was very insistent that illegitimate hindsight should not be a factor in this analysis: “I remind myself however that the Skilled Team, when selecting the salts to include in their salt screen, would not have focussed on tosylate in particular, either to include it or to exclude it, and such focus carries a very distinct risk of introducing illegitimate hindsight into the analysis.” (para. 100). In this case, each side accused the other of relying on hindsight – either looking for reasons that the Skilled Team would have included tosylate in the salt screen or looking for reasons that it would have been excluded. Taking into account the evidence of both experts, the judge found that, even without hindsight, to the Skilled Team reading Lyons, the Patent claim was obvious and thus invalid.

Be careful what you publish It might be said that Bayer’s difficulties in the matter were of its own making, having published Lyons; had the paper not been published ahead of the priority date of the Patent, then the evidence relied upon at trial would not have been sufficient information for the hypothetical Skilled Team to seek out the sorafenib tosylate, and the obviousness arguments would have failed.

Whether something was “obvious to try”; 2. Whether the research was routine in nature; 3. The burden and cost of the research programme; 4. The necessity for and the nature of value judgments during a research programme; 5. The existence of alternative or multiple paths of research; 6. The motivation of the Skilled Person to undertake certain tasks; 7. Whether the results of the research were unexpected or surprising; 8. The need to avoid hindsight; 9. Whether the feature of the claimed invention is an added benefit in the context in which the claimed invention is obvious for another purpose; and 10. The fact that there is no blanket prohibition on dosage regime patents, but that there has been relaxation in the rules in relation to the assessment of the inventive step of these patents. The Court was faced with an assertion by Bayer that Teva sought to place outsized reliance on the decision of Birss J. (as he then was) in Hospira v Genetech⁵ as a means to avoid strict adherence to the Actavis analysis. Mellor J. concluded that the approaches in those cases were not at odds with one another, as the obviousness analysis should not be applied in a mechanical way, but rather that each case should be treated in accordance with the facts at hand, taking into account, inter alia, the factors set out above.

Obviousness is in the details The Supreme Court in Actavis⁴ set out a list of factors as to whether certain steps (such as the testing of sorafenib tosylate in Teva v Bayer) were obvious. These include:

Robert Peake rpeake@vennershipley.co.uk Benedict Sharrock-Harris bsharrock-harris@vennershipley.co.uk

1. [2019] UKSC 15 2. Windsurfing International Inc v Tabur Marine (Great Britain) Limited [1985] RPC 59 3. Pozzoli SPA v BDMO SA [2007] EWCA Civ 588 4. Above n. 1. 5. [2014] EWHC 3857 (Pat)

Moon Boot Kicked Out but Guerlain’s Lipstick Shapes Up What are shape marks? Section 1 of the Trade Marks Act 1994 specifically includes “the shape of goods or their packaging” within the definition of a trade mark. It also provides that a mark must be “capable of distinguishing goods of one undertaking from those of other undertakings.” If a shape is common in the trade, or has become so, it cannot perform that essential function of identifying the brand owner. Consumers will simply see it as another example of the product in question and will use other visual markings, such as words or logos, in order to identify the brand. Examples of “pure” shapes (without additional markings) which have made the grade include the shapes shown at 1 and 2 below registered respectively for chocolate and cereal preparations. Two recent decisions of the General Court of the European Court of Justice reached contrasting conclusions on whether the specific shapes under consideration could be validly registered marks. (1)

(2)

Moon Boot Tecnica Group SpA (Tecnica) registered the shape of its Moon Boot product in the European Union in 2011 for (among others) footwear and various parts of footwear, being soles, heelpieces and uppers. The registered mark is:

Tecnica successfully sued a Swiss company for trade mark infringement based on its EU registration and the defendant hit back, filing an action for the registration to be struck off. It claimed the mark was not capable of distinguishing trade origin in the marketplace and was invalidly registered. The Cancellation Division and Board of Appeal agreed. Tecnica took this to the General Court but lost again and its registration was partially cancelled insofar as the footwear goods were concerned. The decision is here. The General Court referred to accepted principles in shape mark law. Critical here was the point that where a shape mark consists purely of the appearance of the product

www.vennershipley.co.uk itself (without additional markings), it will only be allowed onto the register or to remain on the register if it departs significantly from the norms or customs of the sector. That conclusion does not require other identically shaped products to be on the marketplace. It is a lesser test and the shape will fail if it is “similar to variants of the product which are usually available on the market”. Tecnica failed to clear this hurdle. Evidence of 15 or so other similar boots was presented. For technical reasons, Tecnica also failed in its attempt to file evidence of distinctiveness acquired through use of the mark which might have seen it over the line. Thus, despite arguably being the first and most famous aprés-ski boot of its kind, Tecnica’s shape registration was struck off. Its registration for the words MOON BOOT endures.

Rouge G lipstick holder The French cosmetics house Guerlain fared better in its quest to register the shape of its Rouge G lipstick case. In 2018, Guerlain filed an EU trade mark application seeking registration for the shape of its lipstick case shown below:

The application was refused. As in the Moon Boot case, the norms and customs of the commercial sector were the relevant consideration. The EU trade mark office concluded at first instance and on appeal that the shape did not depart sufficiently from these. Consumers were used to seeing lipsticks packaged in multiple different shapes including oval and semi-cylindrical shapes. The Rouge G shape would not stand out; it would simply be perceived as another variant of these shapes and could not therefore exclusively identify lipsticks produced by Guerlain. Guerlain disagreed and appealed to the General Court which found in Guerlain’s favour. The decision can be found here and here. The General Court stressed that mere novelty of a shape or a high-quality design does not automatically equate to trade mark distinctiveness. However, Guerlain’s shape was sufficiently different to others already on the market. The Rouge G shape was not, as claimed by the EU trade mark office, semi-cylindrical but instead reminiscent of a boat hull or bassinet. It had no straight lines and could not stand up vertically. The “notch” was also an unusual feature. Accordingly, the shape was uncommon and differed from the sector norms even where the sector is already characterised by a wide variety of shapes. Consumers would be “surprised” by the easily memorable shape of this case which was therefore capable of indicating trade origin.

shows it is achievable provided the shape in question is sufficiently unusual and different from the sector norms. Once registered, it is important to police and enforce rights to ensure that protection is not eroded by similarly shaped marks entering the marketplace, as happened to Tecnica. If that is done, the benefit of an ongoing shape trade mark registration is particularly powerful, not least because this protection can outlast patent, design, or copyright protection. It is potentially a very valuable addition to the intellectual property portfolio of a business.

Camilla Sexton csexton@vennershipley.co.uk Gloria Parmesan gparmesan@vennershipley.co.uk

Comment Shape marks are notoriously difficult to register but Guerlain’s success

Venner Shipley news Legal Directory Success We have been recognised once again by World Trademark Review in their World’s Leading Trademark Professionals rankings for prosecution and strategy and enforcement and litigation. The WTR 1000 focuses exclusively on trademark practice and has firmly established itself as the definitive ‘go-to’ resource for those seeking world-class legal trademark expertise. WTR 1000 2022 commented “already a powerful force in the UK trademark prosecution sphere, Venner Shipley’s practice was boosted recently through its merger with Brookes IP. Thanks to this expansion of personnel and clients, plus the growth of its Munich offering, the firm has enjoyed a successful year despite recent challenges”.

International Trademark Association Conference Our Trade Mark and Designs team, comprising David Birchall, Alex Brown, Jane Martin, James Tumbridge, Clare Turnbull, and Yoann Rousseau attended the 2022 International Trademark Association (INTA) conference in Washington, D.C., from April 30 – May 4 2022. INTA is a global association of brand owners and professionals dedicated to supporting trademarks and complementary intellectual property (IP) to foster consumer trust, economic growth, and innovation, and committed to building a better society through brands. Our team had a successful trip meeting and networking with a number of peers and colleagues from the IP world. It was great to meet so many of you on the trip! If you didn't get a chance to catch up with us in Washington but would still like to discuss anything IP with us, please don't hesitate to get in touch by contacting us at mail@vennershipley.co.uk.

Venner Shipley shortlisted in three categories at the 2022 Managing IP Awards We are delighted to announce we have been shortlisted for three awards at this year’s Managing IP Awards, taking place 15 June. We have been nominated in the following categories: • • •

European Firm of the Year – Patent Prosecution Firm of the Year - Trademark Contentious (Patent & Trademark Attorney Firms) Firm of the Year - Patent Prosecution

Congratulations to all other firms who have also been shortlisted for awards, we look forward to (hopefully) a great night of celebrating next month.

Want to join our team? We currently have a number of different job opportunities available across our different offices and are always on the lookout for friendly and ambitious candidates. Check out our current vacancies here.

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Exam success We are delighted to announce a number of recent exam successes on what has been an outstanding year of results for our trainees and associates. UK Patent Exams A huge well done to our associates on their latest UK patent exams results with Louis Jolliffe passing the FD1 – Advanced IP Law and Practice exam and James Plunkett, Louis Jolliffe, Nusrat Rahman, Emma Bridgland, Emma Lonnen and Robert Holbrook successfully passing, FD4 – Infringement and Validity. Congratulations especially to Louis Jolliffe and James Plunkett who are now registered as patent attorneys in the UK. EPO pre-EQE Some fantastic results across the board from our trainees with Tasmin Bluck, Alan Brunier, Rachel Challands, Hugh Crook, William Grace, Alexandra Gregory, Carine Makendi, Mark Pearce, Sophie Newgas and Charlotte Wilding all successfully passing the EPO’s pre-EQE exam. Queen Mary Certificate in IP Law Finally, many congratulations to Thomas Bridgwater, Carine Makendi, Sophie Newgas, Joseph O’Leary and Alexandra Trodd who all passed the Queen Mary Certificate in IP Law with distinction. Partner, Jonathan Hewett commented: “We are extremely proud of all those above on their recent exam passes. We understand the pressures these exams can put onto our associates with having to study alongside their day-to-day responsibilities at the firm, and this year’s outstanding results are a credit to them and their hard work – we look forward to watching their careers grow at Venner Shipley”. Many congratulations to all those below on their results.

Louise Jolliffe

James Plunkett

Nusrat Rahman

Emma Bridgland

Emma Lonnen

Robert Holbrook

Tasmin Bluck

Alan Brunier

Rachel Challands

Hugh Crook

William Grace

Alexandra Gregory

Carine Makendi

Mark Pearce

Sophie Newgas

Joseph O'Leary

Charlotte Wilding

Thomas Bridgwater

Alexandra Trodd 29

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Help or advice If you would like more information or advice on any of the topics covered in this issue please contact us. We will be happy to answer any of your questions.

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© 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.

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