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CIPA JOURNAL Incorporating the transactions of the Chartered Institute of Patent Attorneys

January 2019 / Volume 48 / Number 1

An over-engineered solution? New disclosure rules for High Court litigation

PEB holds inaugural meeting with employers Julia Gwilt

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Supreme Court considers medical use claims

The economic importance of IP Rt Hon Lord Smith of Finsbury, IPReg

Julia Florence confirmed as CIPA’s new President

Remote year: there’s always a bright side Lucy Holloway

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Contents 13 18

12 UP FRONT

ARTICLES

President’s Address

Julia Florence 4

Supreme Court considers medical use claims Lucy Barnes & Ravi Srinivasan

New Vice-President

Richard Mair 5

A Brexit Presidency

Stephen Jones 9

Warner-Lambert v Actavis

32 36

Non-Institute Events Life Sciences Conference

Roxna Kapadia 39

Educating the Client

Y. Suzanne Orian

High Court litigation

New disclosure rules Chris Ryan

Council Minutes

EDUCATION

39 40

Books for review Institute Events

Lee Davies

NEWS

DECISIONS

PERSONAL

Going Remote

Cricket – season review

35 41 42

Announcements IP Inclusive events Yellow Sheet

Economic importance of IP

Chris Smith, Chair of IPReg 12

Overseas report

PEB holds inaugural meeting with patent attorney employers

25 26

Julia Gwilt

Amanda R. Gladwin

Manual of Patent Practice

January 2019 changes IPO update

Patent decisions

Beck Greener IPO decisions

Lucy Holloway

David Pearce EPO decisions

Bristows Trade marks

Andy Spurr

Bird & Bird

THE PINKS 45-64 Announcements; Courses & Events; International; Recruitment

Volume 48, number 1

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CIPA JOURNAL

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UP FRONT

CIPA JOURNAL Editor Deputy Editors Publications Committee Production and advertising Design Cover design Contact

Alasdair Poore Sean Gilday; Jeremy Holmes Bill Jones (Chairman) Iain Ross, 020 3289 6445, sales@cipa.org.uk Neil Lampert Jonathan Briggs editor@cipa.org.uk

Published on behalf of CIPA by Ross-Limbe Communications. The Institute as a body is not responsible either for the statements made, or for the opinions expressed in this Journal. No papers read before the Institute or extracts from its Proceedings may be published without the express permission of the Council and without the simultaneous acknowledgement of their source. CIPA Journal is sent to all members of the Institute as part of the benefits of membership. It is also available on subscription at £130 per annum (plus postage for overseas addresses: Europe £35, Other £70). Individual copies may be purchased at £14 (plus postage for overseas addresses: Europe £4, Other £6). The Editor welcomes the submission of articles, news and correspondence for possible publications including photographs, tables, charts, etc, when appropriate, and any contributions should be sent by email to editor@cipa.org.uk. Iain Ross (iain@ross-limbe.co.uk) will be pleased to discuss any queries regarding submissions and advertising. Copyright in material submitted for publication Material submitted to the CIPA Journal will be accepted for publication on condition that the author, or each of them, grants the Chartered Institute a non-exclusive licence to publish the material: i. in paper form first; and ii. after paper publication, also on its website www.cipa.org.uk, in the members’ area with the ability for members to download them. When sending material, the author(s) should confirm acceptance of this condition and also that the submission is free of any third-party rights or other encumbrances.

CIPA CONTACTS

Julia Florence President

Richard Mair Vice-President

Stephen Jones Immediate Past-President

Chris Mercer Honorary Secretary

Committee Chairs Business PracticeMatt Dixon; Computer Technology Simon Davies; Congress Steering John Brown; Constitutional Alasdair Poore; Designs & Copyright Alicia Instone; Education & Professional Standards Simone Ferrara; IP Commercialisation Catriona Hammer; IP Pro Bono Stephen Jones; Informals Sara Jane Paines; Internal Governance Catriona Hammer; International Liaison Richard Mair; Life Sciences Simon Wright; Litigation Vicki Salmon; Media & Public Relations Jerry Bridge-Butler; PEB Michael Yates; Patent Administrators Vicky Maynard; Patents Tim Jackson; Protected Titles Lee Davies; Regulatory Affairs Chris Mercer; Textbooks & Publications Bill Jones; Trade Marks Keith Howick. Membership Team Leader Dwaine Hamilton Membership Officer Frances Bleach Events Co-ordinators Grace Murray, Emma Spurrs

Past contributors The Institute is in the process of putting on its website past articles not covered by an express agreement as set out above. Any contributor wishing to object to their work being treated in this way should write to the editor at editor@cipa.org.uk.

Chief Executive Lee Davies Head of Media and Public Affairs Neil Lampert Executive Assistant Charlotte Russell Communications Officer Kristina Grinkina Head of Qualifications Angelina Smith Head of Finance Spurgeon Manuel Finance Officer Paul Brown Office Supervisor Lea Weir-Samuels

Editorial deadline dates for receiving submissions are on the 10th of the preceding month. Please contact editor@cipa.org.uk to discuss any ideas for articles or submissions.

General enquiries 020 7405 9450; mail@cipa.org.uk; www.cipa.org.uk

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President’s Address At the AGM on Wednesday 5 December 2018, Julia Florence was confirmed as CIPA’s new President. We wish Julia every success as she receives the presidential baton from Stephen Jones on 1 January 2019. This editorial is based on Julia’s address made at the AGM.

lthough Stephen Jones has another few weeks to survive as President, this is obviously an opportune time to thank him for all he has achieved in the last 15 months. As we’ve heard in his address (see page 5), Brexit, and its potential impact on IP and the profession has continued to be a major focus for Stephen (as it was for his predecessor Tony Rollins) as well as a number of the CIPA committees. Stephen has been a tireless ambassador for CIPA, promoting the status of the profession both around the world, and here in the UK, and ensuring that CIPA is able to make its influence felt at the highest levels of government. In addition to this high-profile work, Stephen has also put a tremendous amount of work into the IP Pro Bono scheme and into CIPA’s relationship with IPReg, and I know that he intends to stay in touch with both of these groups. Thank you Stephen, for leaving CIPA in such good shape. Looking to the coming year I am very pleased to welcome both the new and returning members of Council and thank you all for offering your time and expertise to support CIPA. On a personal note I’m happy to see Anna Denholm, the first female president of CIPA, and a former colleague of mine, returning to the fold. Anna’s arrival brings the number of women on Council to seven – I think that’s an all-time high! If we go on at this rate, Volume 48, number 1

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we should have parity by 2024 – I look forward to it! I am also delighted to welcome Richard Mair as Vice-President for 2019 – your experience in the international arena will be invaluable, and I know that we will work well together. It is a great honour for me to be stepping up to the role of President

Julia Florence

it is important to keep our eyes on the Brexit ball, and its aftermath, whatever that may be. I will therefore be working with the other officers and relevant committees to ensure that we continue to press for the most favourable IP outcomes, and to communicate the position clearly to our members as well as to the IP community outside the UK. In April 2019, CIPA will be spearheading an IP Roadshow (together with CITMA and the UK IPO) in three US cities: Washington, Boston and San Francisco, and I am looking forward to taking part in those visits, when we will hopefully be able to provide

The government is keen to negotiate trade deals outside the EU and we need our voice to be heard in relation to the IP aspects of such agreements. from 1 January, and I have a lot to live up to – not only Stephen, but Catriona Hammer, Andrea Brewster, Tony Rollins – all formidable recent Presidents who have made very positive and lasting contributions to CIPA. And I am pleased to say they are all still on Council to keep me on the straight and narrow. So how am I going to follow this? I hope I will not disappoint you by saying that I am not planning any major new initiatives (at least not yet!). I think that in these uncertain and challenging times

more clarity on the Brexit effects. And I would particularly like to thank Tony who has been instrumental in setting up and organising these meetings. We know that following Brexit the UK government is keen to negotiate trade deals outside the EU and we need our voice to be heard in relation to the IP aspects of such agreements. I am pleased to say that we are already engaged with DIT/IPO on this (led by Catriona and the commercialisation committee) and it will be vital to maintain this throughout the coming year. JANUARY 2019

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NEWS

Overseas report International treaties Berne Convention (Protection of Literary and Artistic Works) On 24 October 2018, the Government of the Republic of the Hashemite Kingdom of Jordan deposited a declaration according to which it avails itself of the facilities provided for in Articles II and III of the Appendix to the Berne Convention during the ten-year period expiring on 10 October 2024. The declaration entered into force, with respect to Jordan on 24 October 2018. Marrakesh Treaty (Access to Published Works for the Visually Impaired) On 21 November 2018, the Government of the Kingdom of Saudi Arabia deposited its instrument of accession to the Marrakesh Treaty. The Treaty will enter into force, with respect to Saudi Arabia, on 21 February 2019. Belize On 9 November 2018, the Government of Belize deposited its instrument of accession to the Beijing Treaty. The date of entry into force of the Treaty will be notified when the required number of ratifications or accessions is reached. On 9 November 2018, the Government of Belize also deposited its instrument of accession to the Geneva Act of the Hague Agreement, the Marrakesh Treaty, the WIPO Copyright Treaty and the WIPO Performances and Phonograms Treaty. The Act and treaties will enter into force, with respect to Belize, on 9 February 2019. Dr Amanda R. Gladwin (Fellow), GSK

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OVERSEAS • PEB

PEB holds inaugural meeting with patent attorney employers

he PEB met with employers from 11 organisations at CIPA’s offices on 29 November 2018. The purpose of the meeting was to discuss four issues of strategic importance to the PEB. First, we wished to hear employers’ views about the standard, content and style of the examinations we offer, to set alongside candidates’ views on the same issues, which we collect via annual surveys. Second, we wished to explore approaches that could be adopted to improve the quality of support and guidance offered to candidates during their training. Third, we wished to understand more about the rationale behind decisions about which qualification route to follow at Foundation level – higher education and/or examination only routes. Finally, in order to help the PEB plan for the future, we wished to understand more about medium and longerterm recruitment trends in the profession that might impact on candidate numbers.

Standard, content and style There was broad agreement that the standard, content and style of the Qualifying Examinations were largely appropriate, but with some discussion about whether or not it was justifiable for the UK examinations to be deemed as more demanding than the European Qualifying Examinations and whether, in FD4 in particular, the time available for candidates was sufficient. Discussion about marking complex examinations consistently and setting valid examination papers, highlighted the challenges facing the PEB. It was suggested that the ‘race to qualify’ and the impact of market forces was leading to an increase in inappropriate early examination entries, with a subsequent impact on performance. The evidence of this effect is illustrated in recent analyses of examination performance. [See July-August [2018] CIPA 7]

Support & guidance for candidates There was agreement that there is generally less support offered by CIPA and the Informals network, in particular there has

been a significant reduction in the tutorials available. Many of the larger firms are now organising their own tutorials and training and thus the impact is greatest on the small firms. It was noted, however, that any tutorial and training programmes from CIPA depends critically on volunteers from within the profession and that without volunteers coming forward and without CIPA putting in place appropriate coordinating structures, there is limited opportunity for longer-term improvements taking place. The importance of ‘training the trainers’ was highlighted and this is another initiative that has stalled. On the positive side, the recent FD4 webinar [https:// tinyurl.com/y7m87nr3] and the mentoring scheme for repeat failers of FD4 have been well received. It was agreed that it would be desirable to extend these successes to the other finals examinations, particularly FD1.

Routes to qualification at Foundation level Most organisations reported that the routes supported tend to be based on historical precedence rather than more recent strategic decision. It was noted that market forces, rather than educational benefits are increasingly driving student preferences and decisions about which route to follow, despite the suggestion made by some employers that the examination-only route provided a better basis for progression to Final Diploma examinations.

Recruitment trends There was a strong belief that numbers within the profession are likely to remain stable or to increase over time.

Next steps Both PEB and those employers present agreed that the meeting had been useful, and that opportunities for continued dialogue should be pursued. Julia Gwilt (Fellow) www.cipa.org.uk

08/01/2019 19:42:29

Warner-Lambert v Actavis Supreme Court considers medical use claims. By Lucy Barnes and Ravi Srinivasan

he Supreme Court in the UK handed down its decision in Warner-Lambert v Actavis on 14 November 2018 (and a copy of the complete decision is available1). The Supreme Court considered the following issues in its judgment: 1. how much data is required in the application as originally filed to support a second medical use claim; and 2. the circumstances under which “cross label use” for the patented indication of a drug sold by a competitor company can constitute infringement of a second medical use claim.

Warner-Lambert v Actavis: the dispute The dispute between Warner-Lambert and Actavis concerned the drug pregabalin. This drug was marketed by WarnerLambert under the tradename Lyrica® for three indications (epilepsy, generalised anxiety disorder and neuropathic pain). Patent protection for pregabalin per se expired in October 2013, and an SPC covering the product had been allowed to lapse. However, Warner-Lambert held a second medical use patent containing “Swiss-style” claims covering one of the three indications (neuropathic pain). The relevant claims are set out below: Claim 1: Use of [pregabalin] or a pharmaceutically acceptable salt thereof for the preparation of a pharmaceutical composition for treating pain. Claim 3: Use according to claim 1 wherein the pain is neuropathic pain. Volume 48, number 1

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Dispute on validity The dispute on validity was focused on claim 3. It was common ground that pregabalin did in fact have efficacy in treating neuropathic pain. However, the parties differed on whether or not that activity was made plausible from the results in the patent specification as originally filed. The patent specification contained credible animal data showing that pregabalin had efficacy against inflammatory pain (a different pain type to neuropathic pain). Before the Supreme Court, it was accepted that inflammatory pain and neuropathic pain could arise from different biological mechanisms, but that both pain types could in principle arise from central sensitization. Thus, central sensitization was a biological mechanism, which could in principle (but need not necessarily) mediate both inflammatory pain and neuropathic pain. Warner-Lambert argued that, given that (a) the patent specification contained credible results showing efficacy against inflammatory pain and (b) there was one mechanism in common between inflammatory pain and peripheral neuropathic pain, it was plausible from the results in the patent specification that pregabalin would indeed have efficacy against peripheral neuropathic pain. It further argued that claim 3 should be interpreted as limited to peripheral neuropathic pain, or alternatively that support for peripheral neuropathic pain should be sufficient to support a claim to neuropathic pain generally. Actavis, in contrast, argued that the results in the patent specification showing activity against inflammatory pain did not prove that pregabalin was targeting central sensitization. It could be working via an entirely different mechanism, JANUARY 2019

CIPA JOURNAL

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High Court litigation New disclosure rules for High Court litigation. By Chris Ryan

Existing procedures In my article on recoverable costs (April [2018] CIPA 16) in litigation I commented, in passing, on the difficulties litigators face in having inconsistent procedures operating in different parts of the court system. One aspect of procedure that I did not mention there was the disclosure process. But it is certainly one where differences exist and, as this article is intended to demonstrate, the differences are being accentuated. In the Intellectual Property Enterprise Court (IPEC), for example, the traditional rules on “standard disclosure” have been replaced by a regime under which disclosure is: 1. limited to specific disclosure i.e. the Court will only order disclosure on particular issues and or document categories; and even then 2. an order will only be made if a cost/benefit test is satisfied (i.e. the likely assistance of the material in question to the Judge in reaching a decision on the issue outweighs the likely cost of producing it)1. It is generally accepted that the streamlined procedures in IPEC, of which the disclosure rules form a part, has been successful. But when the Rules Committee came to draft rules for Shorter Trials Scheme2 it opted for a different disclosure system under which: 1. no disclosure will be ordered unless a party requests particular documents or classes of document at least 14 days before the case management conference; 2. in deciding whether any such request must be complied with the Court will “have regard to how narrow and specific the request is, whether the requested documents 18

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are likely to be of significant probative value and the reasonableness and proportionality of any related search required”; and 3. the list of any documents required or agreed must include “a brief description of the steps the party has taken to locate the document agreed or ordered to be disclosed.” For the IP litigator this left the traditional rules for “standard disclosure” applying only to cases (in either the Patents Court or the Intellectual Property List of the Chancery Division) likely to last for longer than the four-day maximum3 for a case in the Shorter Trials List. The rules on standard disclosure, it will be recalled, require disclosure of all documents, relevant to any issue shown from the statements of case to be in dispute, which adversely affect the discloser’s own case or support its opponent’s case. However, even these, apparently very wide, requirements have been reduced in recent years with the Court having a wide discretion to limit the scope of disclosure (or even to dispense with it entirely)4 where this is necessary in order to comply with the overriding objective5.

The new pilot scheme – general principles As from 1 January 2019, the disclosure regime has been changed, for at least two years, under a pilot scheme set out in Practice Direction 51U6. IPEC and Shorter Trial List cases are not affected7. The underlying principle is that disclosure should continue to be directed to the issues in dispute, but that it should be no wider than is “reasonable and proportionate….in order fairly to resolve those issues…”8 and that parties to litigation and those representing them should “cooperate with each other and …assist the court so that the scope of disclosure, if any, that is required www.cipa.org.uk

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LITIGATION

in proceedings can be agreed or determined by the court in the most efficient way possible.” The parties are also required to “… act honestly in relation to the process…”9 and to “…undertake any search for documents in a responsible and conscientious manner to fulfil the stated purpose of the search…”10. Equivalent obligations are imposed on parties’ representatives11. There is, in effect, no change to the existing obligations to preserve documents12 and to disclose relevant material that is found or created after exchange of document lists but before the conclusion of proceedings13. To my mind those provisions simply encapsulate the requirements that were already imposed on those representing litigants under existing procedures and the overriding objective. Will reiterating them in slightly different terms really change behaviours?

Detailed procedure The most significant change is that disclosure must now be given in two stages, “initial disclosure” when serving a statement of case and “extended disclosure” under direction from the court at the case management conference. I deal with each of these processes in turn:

Initial disclosure The rules are set out in paragraph 5 of the Practice Direction. They require the particulars of claim, defence or any other statement of case to be accompanied by an “initial disclosure list of documents”, which lists:

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DISCLOSURE

1. the key documents on which [the relevant party] has relied (expressly or otherwise) in support of the claims or defences advanced in its statement of case (and including the documents referred to in that statement of case); and 2. the key documents that are necessary to enable the other parties to understand the claim or defence they have to meet.14 The list may be dispensed with if it would involve more than 1000 pages or 200 documents15 and is only required to include material which the disclosing party had already located for the purpose of the proceedings16. It is not therefore necessary to undertake a separate search just for the purpose of the disclosure exercise, although the list should include a short description of any searches that were undertaken17. Copies of all listed documents should be provided at the same time as the statement of case is served,18 in electronic form19, although the requirement is delayed, in the case of particulars of claim served abroad, until after the defendant has submitted to the jurisdiction20.

Extended disclosure As in the Shorter Trials Scheme, any party seeking disclosure beyond that provided under initial disclosure must ask for it in advance of the case management conference. The procedure for doing so is complicated. The requesting party must, within 28 days of the final statement of case having been served, state in writing whether it requires:

JANUARY 2019

CIPA JOURNAL

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CPD & EDUCATION

INSTITUTE EVENTS

Life Sciences Conference Report of CIPA seminar, Bristol 1 November 2018

he CIPA Life Science Conference 2018 was held in rural Tortworth at De Vere Torthworth Court, located near to Bristol. Here, we saw a large number of delegates attend and were brought up to speed with the latest patent updates in the life sciences field. The delegates were also grateful to our two headline sponsors, Patent Seekers and Dartsip, who helped again to host a great Life Science Conference.

Day 1 Simon Wright (J.A.Kemp) warmly welcomed us all to the conference. New Opposition Procedure at the EPO Suzanne Herrera (EPO) gave the first talk of the day on the new opposition procedure at the EPO. Suzanne provided us with a brief and very informative introduction to the streamlined opposition period, which was introduced in July 2016. The main reason for the new streamlined opposition procedure is for “early certainty”, as the standard length for a standard opposition is now 15 months. Suzanne kindly provided slides on user satisfaction levels with the new procedure at the EPO. While approximately 70% of users are satisfied and satisfaction has increased compared to 2017, there is still room for improvement. A second main point discussed is the new centralised opposition procedure introduced in 2018. The aim of this new procedure is to improve quality, efficiency and timeliness at the EPO. How the EPO aims to accomplish this is through the creation of a pool of specialised examiners who work up to 30% of their time on oppositions, there will also be a specialised formalities dealing only with oppositions. The Opposition Division will be composed of three members, the chairperson is an examiner with technical expertise in the field under discussion and the second member is from the operational directorate, with the third member having an optional background. The talk ended with a look at how the EPO oppositions can be improved upon and suggestions going forward. Recent Changes at the EPO: An Attorney’s View Dr Gareth Probert (HGF) provided a talk on the most recent changes at the EPO from a patent attorney’s perspective. He outlined the streamlined opposition timeline, and the current

Reporters Needed – CIPA is looking for volunteers to report on CIPA events. If you are interested, please contact cpd@cipa.org.uk.

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board of appeal timeline along with the Board of Appeal’s fiveyear plan. Interestingly, the Board of Appeal aims to settle all cases within 30 months, the current average is 35 months. The Rules of Procedure of the Board of Appeal will be revised to increase efficiency by reducing the number of issues to be treated, increase predictability for the parties and increase harmonisation between the 28 Technical Boards. In addition, the Rules of Procedure could potentially encounter radical changes to the procedure and the Boards’ power, for example greater powers not the admit “facts, objections, evidence and requests” and it will become mandatory for the Board of Appeal to issue a Preliminary Opinion. Gareth ended with a list of sound advice for preparing for oppositions at the EPO including: prepare your opposition thoroughly; present a complete case before the Opposition Division and act promptly before the Oppoisition Division. How Early Certainty Changes to Oppositions Have Affected Day- to-Day Work The topic of oppositions continued, Dr Jen Le Miere (Kymab) explained that from the perspective of the opponent the process is similar in that they still have the life of the patent to build their case, plus the nine-month opposition period. If you are the patentee, realistically you only have four months to prepare your defence, as extensions are proving more difficult to come by. In addition, there is pressure on the patentee to file new auxiliary requests as soon as possible after the preliminary opinion to minimise the risk of not being allowed to file, as they may be considered “late filed”. Finally, Jen gave a list of useful reasons that may help you increase chances of successfully receiving an extension such as: the need to obtain/verify experimental data, coordinating instructions over multiple time zones, presence of multiple opponents, large number of documents and a particularly complex case. Current Litigation Trends in Europe: Injunctions After a short coffee break, we moved to the topic of litigation where Marjan Noor and Rafi Allos (Allen & Overy) discussed injunctions. Marjan and Rafi covered the basics of what is needed to request a preliminary injunction in the UK. The recent proportion of granted preliminary injunctions in the UK with regards to pharmaceutical cases is 80%. A final injunction is not a given and will depend on the case being tried, as public policy considerations will be taken into account. Marjan and Rafi provided an interesting overview of the requirements and recent case law trends for preliminary and final injunctions in France, Germany and the Netherlands. www.cipa.org.uk

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CPD & EDUCATION

INSTITUTE EVENTS

and Europe, with the overall message that patenting of computerimplemented inventions is restricted, achieving granted patents can take a long time and, overall, we will have to live with a certain amount of legal uncertainty for the foreseeable future.

Richard Summersell (Vectura): Do device patents assist in protecting a product market?

Hot Topics in Pharmaceutical IP The morning session ended with an interactive panel session on Hot Topics in Pharmaceutical IP. The panel session was moderated by Marion Rees (Adiga Life Sciences). Two panellists David Rosenberg (GSK) and James Hogan (MSD) discussed the effects of Brexti on the pharmaceutical industry, with David Rosenberg stating his belief that Brexit will have an overall negative impact on Pharmaceuticals in the UK. Diagnostics and IP: The Landscape and Challenges The afternoon session began with a talk from Dr Sarah Boxall (Boxall IPM Ltd) on the challenges that exist in obtaining intellectual property for diagnostics. Diagnostics included devices, markers, methods and databases. The talk given by Sarah started with outlining that diagnostic devices per se are all patent eligible subject-matter around the world. The talk than got into regional specifics on patent eligibility. Most notably proteomic tissue markers, metabolites, antigens are not patentable subject-matter in the US following Mayo v Prometheus, whereas proteomic antibodies are patentable in the US provided they are specifically claimed. Another issue in the US is isolated genomic sequences and primers as markers are not patentable as they are considered indistinguishable from that found in nature, whereas cDNA lacking non-coding sequences is patentable subject-matter as cDNA does not occur in nature. Sarah went through the specifics of diagnostic patentability in Europe, US, Japan, China, Australia and New Zealand. Finally, the talk ended with some interesting insight into database protection available in the US and UK. Digital Health and Medical Apps Niklas Mattson (AWA) provided an interesting talk on digital health and medical apps. According to the US FDA the broad scope of digital health includes categories such as mobile health, health information technology, wearable devices, telehealth and telemedicine and personalized medicine. Niklas outlined the challenges faced to obtain IP protection in this area in both the US Volume 48, number 1

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Drug/device Combinations – Is Device IP Useful? Richard Summersell (Vectura) continued with the topic of drug device intellectual property. Device patents assist in protecting a marketed product, with infringement being possible depending on claim scope. One aspect covered was the listing of the device patent in the Orange Book, which can be very useful to the patent holder in the US. If a patent infringement lawsuit is filed for a patent listed in the Orange Book, there will be an automatic 30-month stay of FDA approval. This provides valuable market exclusivity time for the patent holder. The following are specifically prohibited from being listed in the Orange Book: process patents, patents claiming packaging, metabolites and intermediates. Devices can be added to the Orange Book, the regulation around listing is not very clear but there are plenty of examples of device only patents that are listed. Finally, Richard ended on discussing the usefulness of trade mark protection for shape and colour of a device. Patent Term Extensions for Combinations and Devices After a short tea break, Andy Cook (AstraZeneca) provided an insight into the world of patent-term extensions for combinations and devices. SPCs are available for fixed dose combinations but the product must be protected by a basic patent in force according to article 3(a) of the SPC regulation. What exactly is covered by a patent was discussed along with the CJEU requirements and the impact of Teva v Gilead, with an overall outcome that it is now tougher to get SPCs to fixeddose combinations. Andy discussed what is available in terms of patent term extensions for countries other than the UK. Finally, Andy touched on what SPC and patent-term extensions are available for medical devices in the UK and elsewhere, where many issues remain outstanding.

Andy Cook (AstraZeneca) provided an insight into the world of patentterm extensions for combinations and devices. JANUARY 2019

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CPD & EDUCATION

INSTITUTE EVENTS

CIPA events in 2019 For a complete list of CIPA events please see the website – www.cipa.org.uk/whats-on/events. Also see Informals events on pages 42-43.

A look at the rules on money laundering and advice on the best approach to compliance and conflicts.

• Patent invalid since it was not entitled to priority – common general knowledge cannot be relied upon to add to contents of priority document • Patentee’s defence that it did not know, or have reason, to suspect that its patent was invalid was rejected • Hence the threats could not be justified and the appeal was dismissed.

Speaker: James Tumbridge, Venner Shipley CPD: 1; Prices: £72 (£48 CIPA members)

CPD: 1 Prices: £96 (£72 members). The seminar is followed by refreshments

Tuesday 29 January 2019 Webinar

CONFLICTS AND MONEY LAUNDERING Time: 12.30–13.30

Thursday 24 January 2019 Regional Meeting

MERSEYSIDE MEETING 2019 Time: from 12.30 Location: Hard Days Night Hotel, 41 North John Street, Liverpool, L2 6RR Join CIPA for the first Regional Meeting of the year! Topics include: • Second medical use patents - is there a cure for their ills? • EP changes • EU TM Directive – UK’s implementation • Intellectual Property strategies for blockchain software development

Thursday 31 January 2019 Seminar

THE INFRINGEMENT THAT CAME IN FROM THE COLD

DESIGNS – UKIPO & EUIPO from a Formalities Perspective

Time: 17.00–19.30 Location: CIPA, Halton House, 20-23 Holborn, London, EC1N 2JD

Time: 12.30–13.30

Douglas Campbell QC (3 New Square) will discuss the ‘Icescape’ case. Details of the case include:

See the full programme online. Speakers include: Julia Florence (CIPA President); Julia Gwilt (Appleyard Lees); Dr Alicia Instone (Cleveland Scott York); Kevin Fournier (IBM); Christopher Rennie-Smith CPD: 3.5 Prices: £234 (£156 members). Monday 28 January 2019 Webinar

PATENTING STEM CELLS Time: 12.30–13.30 An introduction to issues concerning the patentability of stem cells in Europe and further afield. This webinar will address technical considerations, as well as the various specific legal considerations, based on practical advice gained over years of working in this area Speaker: Iain Armstong, HGF CPD: 1; Prices: £72 (£48 CIPA members) 40 CIPA JOURNAL

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JANUARY 2019

Wednesday 13 February 2019 Webinar

• First IP trial in the Shorter Trial Scheme to reach the Court of Appeal – a threats action with counterclaim for infringement • First in-depth discussion by the Court of Appeal of the change to the law of infringement made by the Supreme Court in Actavis v Eli Lilly • Purposive construction is now “but the first stage in the determination of the scope of protection conferred” by patent claims • First example of a party losing on purposive construction but winning on doctrine of equivalents – even though Improver was not argued at first instance • First practical guidance as to how the doctrine of equivalents is to be applied • Court of Appeal rejects attempt to rely on contents of the EPO prosecution file in relation to doctrine of equivalents

Are you an IP Paralegal? Book now to hear what you need to know if you are a formalities administrator tasked with filing designs. Speakers: Gary Doody and Andrew O’Connor (Keltie LLP) CPD: 1; Prices: £72 (£48 CIPA members)

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Thursday 14 February 2019 Regional Meeting

YORKSHIRE MEETING Time: from 12.30 Location: Radisson Blu, Leeds, The Light, The Headrow, Leeds, LS1 8TL Join CIPA for the annual Yorkshire Meeting. Don’t miss your chance to gain 3.5 hours of CPD. plus excellent networking opportunities – including a drinks reception. Topics include:

www.cipa.org.uk

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CPD & EDUCATION

• Formal Aspects of Priority at the EPC • The Future of Patent Drafting • SPC Update

INSTITUTE EVENTS • IP INCLUSIVE

OUTSIDE YOUR COMFORT ZONE: DESIGNS

See the full programme online.

Time: 12.30–13.30

Speakers include: Britta Kley (EPO); Gwilym Roberts (Kilburn & Strode); Nicole Jadeja (Fieldfisher) CPD: 3.5 Prices: £234 (£156 members).

The webinar will cover some of the key aspects of design law in the UK and Europe, and some of the latest developments in design regulations, practice and case law.

Thursday 28 February 2019 Webinar

OUTSIDE YOUR COMFORT ZONE: SOFTWARE & PATENTING

Thursday 9 May 2019 Webinar

Thursday 4 April 2019 Webinar

Speaker: Alex Brown, Venner Shipley LLP CPD: 1; Prices: £72 (£48 CIPA members)

BLOCKCHAIN: IP CONSIDERATIONS Time: 12.30–13.30 An introduction to blockchain for practitioners across all technical disciplines looking into various IP considerations for blockchain, including patentability, trade secrets, development collaborations and open source software requirements. Speakers: Kevin Fournier (IBM) Philip Horler (Withers & Rogers LLP) CPD: 1; Prices: £72 (£48 CIPA members)

Time: 12.30–13.30 A talk about how the EPO treats patent applications in the software area. The webinar will include some examples and compare the EPO approach with that in the UK and the US. This will be followed by some practice tips. Speaker: Michael Williams, Cleveland Scott York CPD: 1; Prices: £72 (£48 CIPA members)

Thursday 7 March 2019 Regional Meeting

EAST OF ENGLAND MEETING Time: from 12.30 Location: University Arms Hotel, Regent Street, Cambridge, CB2 1AD Don’t miss your chance to gain 3.5 hours of CPD. plus excellent networking opportunities – including a drinks reception. Topics include: • Old Dogs and New Tricks? – changes at the EPO Boards of Appeal • IP strategies for software development in the field of blockchain See the full programme online. Speakers include: Kevin Fournier (IBM); Christopher Rennie-Smith CPD: 3.5 Prices: £234 (£156 members).

Volume 48, number 1

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IP Inclusive events ALLIES, ADVOCATES & SUPPORTERS Thursday 17 January 2019 Time: 17:30 – 22:00 This exciting, first-of-a-kind joint collaboration from the three support groups of IP Inclusive – IP & Me, IP Out, and Women In IP – explores how we can all be allies, advocates, and supporters for each other: a game changing concept to promote Diversity & Inclusion. Join a fantastic panel as they discuss their experiences and share tips, then mingle afterwards with a wide range of IP Inclusive supporters. Like others organised by these groups, this free event will be open to all IP professionals. The event will consist of a panel discussion, starting at 18:00, followed by a drinks reception. Panellists: • Charlotte May QC – 8 New Square • David Cousins – IBM • Daniel Winterfeldt (Reed Smith; Chair InterLaw Diversity Forum • Ros Lynch – Copyright and IP Enforcement Director, IPO. • Chaired by Andrea Brewster – Leader, IP Inclusive & Member of CIPA Council. Values to take away: • How can I show that I support diverse groups in the workplace? • What can I do to help make an atmosphere conducive to everyone’s success? • How can I help my colleagues feel free to be themselves? • How can my organisation signal that it is making a commitment to diversity and inclusion? Kindly hosted by Norton Rose Fulbright at their London offices.

IP INCLUSIVE’S ANNUAL GENERAL MEETING Tuesday 22 January 2019 Time: 10.00-12.00 Everyone is welcome to hear what we’ve been up to over the last 12 months, and to help shape our plans for the future. RSVP to ipinclusiveevents@gmail.com.

JANUARY 2019

CIPA JOURNAL

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We help businesses use IP to imagine, plan, nurture, protect and deliver their innovations to market... Sound exciting? Come join our team

We’re hiring and we want Engineering and Physics Patent Attorneys

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