CIPA JOURNAL Incorporating the transactions of the Chartered Institute of Patent Attorneys
October 2016 / Volume 45 / Number 10
US update USPTO: streamlined patent prosecution for cancer therapies; and new patent eligibility guidelines for examiners and applicants
No challenge too small: working with SMEs Mike Street
The term of a European patent revisited Derk Visser
Amendments to Indonesian patent law Spruson & Ferguson
Optional features under the EPC Yann Robin
Legal opinion on the UK’s participation in the UPC
CIPA JOURNAL
CIPA CONTACTS
Editor Editorial Panel
Alasdair Poore David Barron, Paul Cole, Kristina Cornish, Tibor Gold, Alan White Publications Committee William Jones (Chairman) Production Iain Ross, 020 3289 6445 and advertising (iain@ross-limbe.co.uk) Design Neil Lampert Contact 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. 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. 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.
Tony Rollins President
Stephen Jones Vice-President
Andrea Brewster Immediate Past-President
Chris Mercer Honorary Secretary
Committee Chairs Administrators Vicky Maynard; Business Practice (joint with ITMA) Matt Dixon; Computer Technology Simon Davies; Congress Steering John Brown; Constitutional Alasdair Poore; Designs and Copyright David Musker; Education and Professional Standards Simone Ferrara; Exploitation Catriona Hammer; Informals Ben Charig; Internal Governance Bobby Mukherjee; International Liaison Richard Mair; Life Sciences Simon Wright; Litigation Vicki Salmon; PEB Rob Taylor; Patents Tim Jackson; Protected Titles Lee Davies; Media and Public Relations Jerry Bridge-Butler; Regulatory Affairs Chris Mercer; Textbooks & publications Bill Jones; Trade Marks Keith Howick. Chief Executive Lee Davies Head of Media and Public Affairs Neil Lampert Head of Education Georgina Sear Finance Manager Spurgeon Manuel Finance Administrator Andrew Hewitt Policy Officer Rebecca Gulbul Executive Assistant Gary McFly Communications Officer Isabelle Wilton Education Projects Co-ordinator: Angelina Smith Membership team: Dwaine Hamilton; Frances Bleach; Kirsty Burls; Johanna Lynch, Charlotte Russell. General enquiries: 020 7405 9450; mail@cipa.org.uk; www.cipa.org.uk
© The Chartered Institute of Patent Attorneys 2016 ISSN: 0306-0314
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Contents 40 49 56-70 UP FRONT
ARTICLES
DECISIONS
2
32
The term of a European patent revisited
71
Derk Visser
75
Beyond Brexit
Alasdair Poore 3
Chief Executive Report
Lee Davies 4
40
Council Minutes
Lee Davies 46
7 9 14
IP Pro Bono Initiative The impact of Brexit on IP UK's participation in the UPC
28
Recording of an assignment at the EPO
28
Overseas report
29 29
Changes to the Patents Rules Patentscope extended
60
Lyndon Davies
66
30
Ministerial visit to China
49 52
81
Trade marks and other IP
An Ambiguous Relationship?
EDUCATION
Bristows Bird & Bird LLP
90
Privilege – webinar report
Alexis Harper
Indonesian Patent Law
92
Institute events
The not-so-secret diary Six things we hate (and love) about exams
Ed Lobb, Greg Dykes 56
Amanda R. Gladwin
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Review of SPCs Carpmaels & Ransford
Andrea Brewster 54
Matthew Spencer, David Wortley
Volume 45, number 10
EPO decisions
Adolf Panggabean, Jonathan Loh
Richard Gordon QC, Tom Pascoe
CIPA China team
78
Navigating rocky waters
Optional Features – Article 84 EPC and Rule 137(5) EPC Yann Robin
NEWS
IPO decisions
Barker Brettell LLP
No challenge too small
Mike Street
Interesting Times
Lord Justice Kitchin 6
37
Patent decisions
Beck Greener
US update: patent prosecution
Finnegan
PERSONAL 31 91 94
Law Support Obituary Going Remote
US update: Supreme Court
Finnegan US update: §101 guidance
THE PINKS
Finnegan 95 123 124 126
Recruitment Support International Courses and training OCTOBER 2016
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Beyond Brexit
I
ndonesia features in this issue. Yes, there is a world outside the European Union. So too does a small country like Cyprus. Why do I mention these? Because they are a reflection of the importance of IP to a global economy – and global politics; and the importance of a global economy, and global politics, to IP. Brexit is a symptom, in the UK, of the pressures arising from internationalisation, from flows of people, services and goods across borders, and also the impact that those have on individuals, especially individuals who perceive that the economy, and therefore the politicians, and establishment, have let them down. Cyprus is a small illustration of the impact of the global economy – with a report on the success only eventually in the Cyprus Supreme Court (after 11 years) of McDonald’s: establishing their Mc[food] credentials in successfully opposing another global Singapore-based enterprise seeking to protect the trade mark MacCoffee. The report of the same dispute in the EU General Court draws out the importance of the widespread reputation of McDonald’s name in the provision of restaurant services (see pages 84 and 89). We should not forget, in that context then, that IP is part of the establishment. In relation to Brexit this issue reports on steps to keep the Unified Patent Court Project on the rails. While the UPC is new, it is a reflection both of the efforts to increase harmonisation in that well established institution, intellectual property. To many less well off – individuals, and countries – IP remains contentious. This issue includes a copy of the substance of Counsels’ (more than one of them) Opinion commissioned by CIPA, the IP Federation and the Intellectual Property Lawyers’ Association, on whether it is constitutionally possible to keep the UPC going with the UK as a member, if the UK leaves the European Union (page 14). 2
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Counsels’ instructions observed that they were not being asked to comment on the politics. Counsels’ opinion was that it was constitutionally possible, but repeatedly drew on those instructions, emphasising that they were not saying that it would be politically possible. And behind the scenes one can see politics at work, both in favour of a UPC (with the UK), in favour of a UPC (without the UK), and in favour of pushing the UPC into the long grass. An effect of Brexit – but reflecting also the world economic pressures which have been an influence behind it – is that individual national self interest is raising its profile, and we can expect to see more of that in the years to come. One flavour of that – pharmaceutical related, rather than food related – comes in developments in Indonesia as well as in the United Nations. Readers interested in the pharma sector may have spotted the report from the United Nations Secretary General’s High Level Panel on Access to Medicines Promoting innovation and access to health technologies [see www.ip-watch.org/weblog/ wp-content/uploads/2016/09/HLP-Accessto-Medicines-Final-Report-Sept-2016.pdf] published on 14 September (to be reviewed in due course in this Journal). This report specifically has a section on intellectual property, the impact of some aspects of intellectual property on access to medicines in developing countries, and TRIPS and “TRIPS plus” agreements (agreements that do not rely on some of the provisions in TRIPS that were designed to benefit consumers of health products in developing countries). It also highlights some of the concerns about implementation of, what were intended to be safeguards. For example, the summary observes: “TRIPS flexibilities – for example, the freedom to determine patentability criteria and further define concepts
Alasdair Poore
such as ‘novelty’, ‘inventive step’ and ‘industrial applicability’ – can ensure that patents are only awarded for genuine innovations. Similarly, the ability to determine the terms upon which compulsory licences are issued allows governments to fulfil their human rights obligations by securing the availability and affordability of health technologies. Many governments have not used the flexibilities available under the TRIPS Agreement for various reasons ranging from capacity constraint to undue political and economic pressure from states and corporation, both express and implied.” [Emphasis added; see page 9 of the above URL.] We can perhaps expect, in the light of this report, and the economic and health pressures across the world, that there will be more attention paid to the TRIPS flexibilities. That is already evident in a number of Asian countries, and one can see some aspects of these flexibilities in Indonesia’s latest reforms, including reduced protection for second medical use innovations. Indonesia, it appears, has gone one step further: the report on page 49 draws attention to a reform which will permit what might be described as “super exhaustion” – if a drug is legitimately on the market in any country in the world (whether or not with the consent of the patent holder in Indonesia) it may be imported into Indonesia without infringing any patent protection in Indonesia. It will be interesting to see how this develops, but it is perhaps a reflection again of the increasing tensions in the current world economy driving individual political agendas more and more – and there will be more to come in relation to IP, perhaps from the US following the Presidential election, as well as other countries. www.cipa.org.uk
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NEWS
COUNCIL
Chief Executive’s report
I
t has been a somewhat hectic few months since waking up on Friday 24 June to find that the UK was set on a path to leave the European Union. Given the imminence of the Unitary Patent and the UPC, the focus of attention was always going to be on the status of IP rights in a postBrexit world. CIPA’s message has been a steadying one: don’t panic! We still do not know when Article 50 will be triggered and we are expecting at least two years of business as usual. Our job now is to use the time available to us wisely; to craft our position on the raft of IP rights and lobby government to ensure that the resulting system is in the best interest of rights holders. On patents CIPA’s position is clear. We would like to see the Unitary Patent and the UPC continue with the UK playing a full part in a pan-European system post-Brexit. We recognise, as reinforced by the recent opinion from Counsel on the legal case, that this will require the political will to make it happen and that the UP/UPC will form a small but incredibly important part of the UK’s negotiations. Until we have certainty, we are pressing ahead with a number of initiatives to help our members prepare for the new court system, such as the mock trial in partnership with the European Patent Litigators’ Association, EPLIT [see page 22]. We are not working in isolation. In developing our position on the Unitary Patent and UPC and in securing Counsel’s opinion on the legal issues surrounding Brexit [see page 14], we have been working closely with our colleagues in the IP Federation and the Intellectual Property Lawyers Association (IPLA). On trade marks, copyright and designs, we have liaised closely with the Institute of Trade Mark Attorneys (ITMA) to craft
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our respective positions on matters relating to rights processed through the European Union Intellectual Property Office (EUIPO). CIPA’s position is set out in its statement ‘the impact of Brexit on intellectual property’, see page 9. The mantra ‘business as usual’ means attending to those things that were scheduled in long before Brexit loomed on the horizon, such as CIPA Congress. By the time this edition of the Journal goes to press, we will have held CIPA Congress 2016 at the Royal Institute of British Architects. With close to 200 delegates registered, double the attendance at recent Congresses, the new one-day format has proved to be attractive to members. A big thank you to the voluntary members of the Congress Steering Committee, led by John Brown, for putting together a brilliant programme packed full of valuable CPD. Another big thank you to the CIPA Administrators Committee for organising its annual conference to run alongside Congress, bringing the combined number of delegates on the day to over 300. On 14 October 2016, we will see the launch of IP Pro Bono [see page 7], a cross-sector initiative aiming to make legal support and advocacy available to individuals and small businesses who find themselves in the process of litigation but without the means or resources for the action. CIPA has been very much at the forefront of this initiative, with our Vice-President Stephen Jones taking over as Chair of the steering committee from our President, Tony Rollins. IP Pro Bono has the full backing of the Intellectual Property Enterprise Court (IPEC), with His Honour Judge Hacon the driving force behind the project. A team of expert case officers will vet applications for pro bono support and distribute
deserving cases across a panel of firms and individual attorneys who sign up to the scheme. It was great to welcome 26 chief executives from some of the UK’s leading professional bodies and trade associations to CIPA Hall in September for an evening entitled ‘the Minister will see you now’. The event came about following a survey of members of the Institute of Association Management’s CEO Forum, where managing the relationship between a membership association and government and, in particular, lobbying civil servants and ministers, rated highly on the radar of chief executives. In conversations with many of my colleagues, it is clear that membership associations work hard to break free from the stereotype of ‘pressure group’ or ‘special interest group’ and enjoy a successful collaboration with parliamentarians. It was my great pleasure to introduce the speaker for the evening, Bill Rammell. Mr Rammell, now Vice Chancellor at the University of Bedfordshire, served in a number of ministerial positions when in government with the Labour Party, including Minister of State at the Foreign & Commonwealth Office, Minister of State for the Armed Forces and Minister of State for Further and Higher Education. We conduct meetings of the CEO Forum under strict Chatham House Rules, meaning that I cannot share many of his highly personal insights into the workings of government, save to say that Mr Rammell was insightful in his description of the life of a minister and all those present left with useful tips and hints on how to manage the relationship with government much more effectively. Needless to say, we talked a lot about Brexit! Lee Davies, Chief Executive OCTOBER 2016
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Interesting times
Lord Justice Kitchin
Lord Justice Kitchin’s speech from the Gala Dinner to celebrate the 125th anniversary of the granting of CIPA’s Charter, Thursday 14 July 2016.
M
r President, Ladies and Gentlemen. It was on the evening of the annual Hugh Laddie lecture that your President invited me to say a few words at the start of this dinner to celebrate the 125th anniversary of the incorporation of the Chartered Institute by Royal Charter. I was delighted to accept that invitation. I thought I would be painting for you a rosy picture of the future. Just two days later the result of the referendum was announced. As I think Jeremy Thorpe said, two weeks can seem like a lifetime; but sometimes a lifetime happens in two weeks. How it will affect us and the UPC project is a subject to which I will return in a moment. But first I would like to say something about the history and values of this great Institute and the important role it has played and I have no doubt will continue to play in the months and years to come. The Institute was founded as the Chartered Institute of Patent Agents in 1882 and nine years later, in 1891, it was granted its Royal Charter. That was a significant step for it gave the Institute all the powers of a natural person and meant that important aspects of the control of its internal affairs became vested in the Privy Council. It was also a mark of the status it had already acquired. I am told that Bristows (Bristows, Cooke and Carpmael as it was) drafted the Charter – but sensibly the Institute said it could not pay their bill and negotiated a lower price. They were interesting times. Britain was technically pre-eminent and the inventions made here were enjoying considerable commercial success.
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Many of them were showcased in the Great Exhibition of 1851. With patent agents in the vanguard, this industrial power house also drove significant improvements in the patent system. 1883 saw the new Patent’s Designs and Trade Marks Act, the founding of the Patent Office, the introduction of a requirement that patents must include at least one claim and the exclusion of juries from trials of infringement actions. Further changes came in 1905 with the introduction of searches for novelty purposes. With all these changes afoot, the need for an association of the practising patent agents was all too apparent. And so the Institute was born. Its objects were to form a representative body to promote further improvements in patent laws and regulations; to establish rules that all practising patent agents must observe and, importantly, to facilitate the discussion and exchange of ideas and knowledge concerning the profession. The Institute has pursued these objects ever since, together with a concern to protect and promote the interests of the public the patent profession it serves. It has done a magnificent job and I have no doubt it will continue to do so. I joined the world of patents in the late 1970s when I started a pupillage in the chambers of Thomas Blanco White which in those days were in Francis Taylor Building in the Temple. That was nearly 40 years ago, a significant part of the life of this Institute. It was also another time of rapid development, in fact more radical than our patent world had seen before. The 1977 Act had just come into force and it brought with it
the machinery for the EPC, the PCT and the CPC. The need for this third system was well understood at that time. It was clear then that the EPC had advantages but also serious inherent deficiencies. Patentees end up with a bundle of national patents which they have to enforce in the national courts of different member states. And as I discovered in practice and even more as a judge, this can be very costly and lead to unpredictable results and inconsistent decisions. Unfortunately, a unitary patent system became notoriously difficult to implement. The participating countries could not agree. The Commission made a proposal to create a Community Patent in 2000; attempts to reach a final agreement failed in 2003; negotiations were launched once again in 2007. All ran into the sand. But then, urged on by the judges, the EPLA and supported by this Institute, 12 member states wrote to the Commission in December 2010 indicating they wished to establish enhanced cooperation and asking the Commission to submit a proposal to the Council for that purpose. The Council’s response was swift. It authorised enhanced cooperation in March 2011, paving the way for what the Commission called the Unitary Patent Package with its two regulations and the UPC Agreement. I must confess that at the start I had a degree of scepticism about this package – and in particular its proposal for the UPC. It differs from the one conceived by the judges. It will only be available in those territories which ratify the www.cipa.org.uk
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GALA DINNER
agreement; and it will not be available in other EU member states or other EPC contracting states. Further, in those countries that do ratify the agreement, the unitary patent will sit alongside other existing systems. In other words it provides an alternative. Yet further, for at least seven years, patentees may opt to keep their European patents outside of the scope of the UPC system where they will remain unless opted back in. But my most serious concerns related to the structure of the court, its propensity for bifurcation, the
LORD JUSTICE KITCHIN
litigation around Europe have met frequently to road test the system and talk through the difficult questions it raises. There has been a tremendous convergence of approach and strategies to make sure the potential benefits of the system are realised. Of course some problems remain. But there is every reason to hope that the system is now as good as a system of this kind can be. And of course we fought for and secured a significant part of it in this country – the life sciences part of the central division and our local division.
On the threshold of a new world of patent litigation in Europe, after 40 years of work, and this country votes for Brexit. Is this the end? possibility of forum shopping and strategic litigation and the burdens this could place upon defendants of modest means. It seemed to me that the focus was all upon the patentees and the new opportunities for enforcement the system would give them. As Thomas Blanco White would say, a weak patent in strong hands is worth more than a strong patent in weak hands. This new package seemed to me to give those strong hands another weapon. Yet over the last three years an enormous amount of work has been done, again supported by this Institute. The rules have been developed, including costing structures; the fees have been carefully worked out; a battle has been fought and won concerning the terms upon which judges will be engaged and those terms are now such that we can hope that the very best have applied; and the judges and other professionals involved in patent Volume 45, number 10
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So here we are, on the threshold of a new world of patent litigation in Europe, after 40 years of work, and this country votes for Brexit. Is this the end? Many commentators have said that it is. They say that we cannot participate in the UPC scheme if we are no longer members of the EU. They say that such has been decided by the Court of Justice. And they say that the unitary patent will become less attractive and that the fees for the patent and the court may need review to reflect the lower values involved. I am not so pessimistic. Indeed I think there are grounds for real optimism. Let me tell you why. First, there has been a massive investment of time and resources in this project, it is one to which we are committed and it is ready to go. No one wants to see it founder again. Secondly, I believe our departure would be met with dismay by those developing the UPC system and by
those involved in the project in other participating countries. They really want us to stay a part of it. Thirdly, mechanisms are now being developed and discussed which may allow our continued participation – provided the political will is there. It is of course true that the UP regulations would cease to apply to the UK if we left the EU, but it has been suggested that there may be another way by which the unitary patent could still have effect here, namely through an amendment to the UP agreement to give effect to Article 142 of the EPC. It is also true that Article 84 of the UP agreement says that it may only be ratified by member states, but we are a member state and are likely to remain so for a number of years. Furthermore, it may be possible to devise a scheme whereby we continue to give effect to Article 21 of the UP agreement concerning Union law and ensure it is endorsed by the EU in the exit agreement. These are early days and there may be delays. But this is a great project. It is one to which we are committed, and I believe rightly so. I know members of this Institute will be working with Government and other interested parties to find a solution. Now is the time to deploy all of our ingenuity and determination to make sure we are successful.
Correction – PEB On page 32 of the July issue, at the end of the article on “Advocacy – A Beginners Guide”, the description of the writer suggested that there is only one Principal Examiner at the PEB when in fact there are 13. The description should have read: “Dr Sean Curley is a Principal Examiner for the Litigation Skills Examinations…”. Many thanks to Dr Sarah Boxall (Chief Examiner for the PEB Final Diploma exams and the Principal Examiner for FD2) for pointing out the error.
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NEWS
UPC
UK's participation in the UPC after Brexit CIPA, the Intellectual Property Lawyers' Association (IPLA) and the IP Federation asked Richard Gordon QC and Tom Pascoe to provide an opinion on the constitutional possibility of the UK remaining in the UPC after Brexit. A slightly shortened version of their opinion (omitting the sections reciting the legal background) is reproduced below. The full opinion can be viewed at www.cipa.org. uk/policy-and-news/latest-news/. This opinion is of course addressed to the legal issues – is it possible – and does not touch on the potentially difficult political issues.
… 4. In outline, our opinion on each of the six questions is as follows: a. Question 1a: Can the UK continue to be part of the Unitary Patent? The UK may only continue to participate in the unitary patent by entering into a new international agreement with the participating EU Member States. The permissibility of such an agreement under EU law would turn upon essentially the same matters as the legality of the UK’s continuing participation in the UPCA. b. Question 1b: Can the UK continue to participate in the UPCA? It is legally possible for the UK to continue to participate in the UPCA after ‘Brexit’ (although the CJEU’s reasoning in Opinion 1/09 is opaque and there is therefore a risk that the CJEU would find otherwise). c. Question 1c: Can the UK continue to host the Life Sciences/Chemistry section of the central division? Provided that it is legally possible for the UK to continue to participate in the UPCA, there is no reason why it cannot continue to host a section of the central division. d. Question 2: What changes would have to be made to the UPCA? A number of amendments would have to be 14
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made to the Agreement, which we set out in detail below. e. Question 3: What would the UK have to sign up to? The UK’s continued participation in the UPCA would require it to submit to EU law in its entirety as regards proceedings before the Court. It would also need to sign up to an appropriate jurisdiction and enforcement regime (such as the Lugano Convention). f. Question 4: Does it matter whether the UK joins the EEA? Our advice does not depend upon whether the UK joins the EEA. g. Question 5: Is it possible or desirable to obtain an opinion from the CJEU? It would only be possible to obtain a preemptive opinion from the CJEU on the legality of the UPCA if the Union became a party to the Agreement. h. Question 6: What would be the consequences of ‘Brexit’ if the UK ratifies the UPCA without amendment? If the UK ratified the UPCA, without amendment, and subsequently left the EU, any divisions of the UPC in the UK would have to cease operating. The transitional consequences of this are matters of detail to be negotiated as part of the UK’s exit negotiations.
5. We make clear that our advice is confined to the six questions above, which all relate to the threshold issue of whether it is possible for the UK to participate in the UPCA. [Counsel then set out some of the background legal provisions, see full opinion for details.] ...
ii. CJEU Opinion 1/09 14. In July 2009, the Commission requested the CJEU to give an opinion on the compatibility of the draft UPC Agreement with EU law.7 At that stage, the parties to the Agreement were a mixture of Member and non-Member States. The CJEU found that the Agreement was incompatible with EU law. In summary, its reasons were as follows: a. The founding treaties of the EU created a legal order whose essential characteristics are primacy and direct effect ([65]). b. Member States’ duty of sincere cooperation under Article 4(3) of the TEU includes a duty to ensure the application of, and respect for, Union law within their territories ([68]). c. The envisaged UPC was outside the institutional and judicial framework www.cipa.org.uk
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NEWS
of the EU. The UPC had distinct legal personality under international law ([71]).
international court which is outside the institutional and judicial framework of the European Union an exclusive jurisdiction to hear a significant number of actions brought by individuals in the field of the Community patent and to interpret and apply European Union law in that field, would deprive courts of Member States of their powers in relation to the interpretation and application of European Union law and the Court of its powers to reply, by preliminary ruling, to questions referred by those courts and, consequently, would alter the essential character of the powers which the Treaties confer on the institutions of the European Union and on the Member States and which are indispensable to the preservation of the very nature of European Union law” ([189]).
d. The proposed Agreement vested the UPC with exclusive jurisdiction over certain types of dispute, and thereby divested national courts of their jurisdiction over such disputes ([72]). e. It is legally possible for the EU to submit itself to the jurisdiction of a court other than the CJEU. However, in all previous cases the jurisdiction of the international court has been limited to interpreting and applying the international instrument which brought it into existence, not EU law ([74]-[77]). f. By contrast, the UPCA requires the UPC to apply and interpret EU law ([78]). g. Member States cannot, by way of international agreement, deprive their own national courts of (i) the task of interpreting and applying EU law; and (ii) the power (or in some cases the obligation) of making preliminary references to the CJEU pursuant to Article 267 TFEU ([80]). h. Article 267 requires national courts and the CJEU to co-operate with each other to ensure the uniform application of EU law. It follows that the tasks entrusted to the national courts and CJEU are “indispensable to the preservation of the very nature of the law established by the Treaties” ([83]-[85]). i. Furthermore, a Member State is required to provide compensation where a national court misapplies EU law. The Agreement did not permit a litigant to bring infringement proceedings, or obtain compensation, if the UPC breached EU law ([87]-[88]). j. The CJEU summed up its reasoning in the following terms: “Consequently, the envisaged agreement, by conferring on an Volume 45 number 10
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UPC
...
B. The legal consequences of ‘Brexit’ 32. The process of exiting the EU is governed by Article 50 TEU, which provides: “Article 50 1. Any Member State may decide to withdraw from the Union in accordance with its own constitutional requirements. 2. A Member State which decides to withdraw shall notify the European Council of its intention. In the light of the guidelines provided by the European Council, the Union shall negotiate and conclude an agreement with that State, setting out the arrangements for its withdrawal, taking account of the framework for its future relationship with the Union. That agreement shall be negotiated in accordance with Article 218(3) of the Treaty on the Functioning of the European Union.16 It shall be concluded on behalf of the Union by the Council, acting by a qualified majority, after obtaining the consent of the European Parliament.
3. The Treaties shall cease to apply to the State in question from the date of entry into force of the withdrawal agreement or, failing that, two years after the notification referred to in paragraph 2, unless the European Council, in agreement with the Member State concerned, unanimously decides to extend this period. 4. For the purposes of paragraphs 2 and 3, the member of the European Council or of the Council representing the withdrawing Member State shall not participate in the discussions of the European Council or Council or in decisions concerning it. A qualified majority shall be defined in accordance with Article 238(3)(b) of the Treaty on the Functioning of the European Union. 5. If a State which has withdrawn from the Union asks to rejoin, its request shall be subject to the procedure referred to in Article 49.” 33. The obvious starting point is that the referendum result to leave the EU has no immediate legal consequences. Until the Article 50 process is triggered by a notification of intention to withdraw, and a period of two years elapses (unless extended by agreement), the UK remains a member of the EU and the Treaties will continue to apply.17 As a matter of domestic and EU law, the UK could therefore ratify the UPCA without complication at any time until the Treaties cease to apply in accordance with Article 50(3). 34. Under Article 50(4), the UK will be excluded from decisions regarding the exit agreement. The balance of negotiating power is therefore placed in the hands of the EU and the Member States, not the UK. 35. When the Treaties cease to apply pursuant to Article 50(3), UK primary and secondary legislation which incorporates EU law will remain in force.18 However, EU OCTOBER 2016
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The term of a European patent revisited Derk Visser (Associate) provides a perspective from the EPC on the term of a European patent.
T
he article ‘What is the term of a European patent?’ by Mike Snodin and Jim Boff1 describes the divergence amongst EPC contracting states in the interpretation of the 20-year patent term for a European patent. It proposes a specific interpretation of the patent term and makes an urgent appeal to the affected national patent offices to amend their laws and practice, in particular the UK IPO and other contracting states that have ratified or will ratify the Unified Patent Court Agreement (UPCA). Since the unitary patent must have unitary effect, it should have the same date of lapse in all contracting states of the UPCA. This article looks at the patent term from the point of view of the EPC and investigates the origin of the divergence. It proposes a practical way towards harmonisation of the patent term.
Post-grant harmonisation in the EPC The European patent application and patent have a unitary character during proceedings before the EPO2. The grant of the patent does not result in a bundle of national patents that follow national law. Instead, it results in a bundle of European patents that follow certain standard rules laid down in the EPC for the main aspects and national law for other aspects. The Preamble of the EPC mentions the establishment of certain standard rules governing European patents as a desideratum. The effect of a European patent is laid down in Rule 2(2) EPC: “The European patent shall, in each of the Contracting States for which it is granted, have the effect of and be subject to the same conditions as a national patent granted by that State, unless this Convention provides otherwise.” The “unless” relates to the standard rules laid down in the EPC. The subordinate clause at the end of Article 2(2) EPC is actually the main rule. The standard rules are the basis of the European character of the European patent3. 32 CIPA JOURNAL
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The harmonisation of the bundle of European patents by the standard rules was regarded necessary in view of the Community Patent Convention, envisaged in 19734. The standard rules for European patents in the EPC govern the main aspects of the patent, such as the term of the patent, exhaustive grounds for national revocation, and the extent of protection. When the standard rules have no direct effect in a contracting state, they must be incorporated in its national law. National courts must apply these standard rules, not the corresponding national provisions, when deciding on a European patent5. One of the standard rules, Article 63(1) EPC, defines the harmonised patent term for European patents as: “20 years from the date of filing of the application”, independent from national law6. The provision intends to result in a uniform patent term in all contracting states.
Effect of Article 63(1) EPC on the patent term The effect of Article 63(1) EPC on the patent term can be seen to some extent in the European Patent Register. The EPC obliges the EPO to record the date of lapse of a European patent in a contracting state only during the opposition period and any opposition procedure, i.e. only when the patent can become or is the subject of opposition proceedings before the EPO7. Nevertheless, the EPO does record each date of lapse of a European patent that a contracting state communicates to the EPO. The dates are recorded in a special section of the Register called Legal Status. The EPO does not accept any responsibility for the accuracy of the data in the section. As an example, the dates of lapse of European patent EP0700437 in the validated contracting states have been checked8. The date of filing of the patent application was 25.05.1994. The patent application designated 16 of the then 17 contracting states of the EPC; MC is not designated. The following dates of lapse are given in the Register. Behind each www.cipa.org.uk
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date the contracting states are given that have communicated the particular date. • • • • • • •
24.05.2014: GB 25.05.2014: DE, DK, BE, PT, NL, IE, AT 26.05.2014: ES, GR 27.05.2014: DE9 30.05.2014: CH10 03.06.2014: PT11 01.07.2014: SE12
A few contracting states, DE and PT, have given two dates of lapse with otherwise identical or similar wording in the entries. The date of lapse for LI is the same as for CH and is not separately mentioned in the Register13. Some contracting states, FR, IT and LU, have not communicated a date of lapse to the EPO. The above dates 27.05.2014 to 01.07.2014 are apparently not dates of lapse but could be dates relating to entry of data into a register. Hence, CH and SE have not communicated a proper date of lapse.
EUROPEAN PATENT
dt. The date of filing is the day of the relevant event. The filing date of 25.05.1994 will result in the last day of the patent term being 25.05.2014. dtt. The first day of the patent term is the day of the relevant event. GB and NL use option c, GR uses dtt. The third issue is which date is taken as the date of lapse to be entered into the Register. e. The date of lapse is the last day of validity of the patent. f. The date of lapse is the first day of invalidity of the patent. GB and GR use interpretation e, NL interpretation f17. Since each patent office has to make a choice for each of the three issues, it can select from 12 different ways of calculating the patent term and recording the date of lapse: • GB uses a + c + e18, resulting in a date of lapse of 24.05.2014. • NL uses a + c + f19, giving a date of lapse of 25.05.2014. • GR uses b + dtt + e20, giving a date of lapse of 26.05.2014.
Different ways of determining the date of lapse The different dates of lapse in the Register can partly be attributed to different ways the contracting states have determined the date of lapse. One can distinguish three issues that determine the date of lapse: status of the filing date, calculation of the 20 years, and definition of the term “date of lapse”. The EPC has not provided rules for these issues and, consequently, each contracting state has made its own choice of the different options for each issue. The following overview sets out different options for each issue. The choices made by GB, GR and NL have been investigated and are indicated. The first issue is the status of the filing date. a. The date of filing is included in the 20-year period. Hence, the first day of the patent term is 25.05.1994. b. The date of filing is not included in the 20-year period. Hence, the first day of the patent term is 26.05.1994. GB14 and NL15 use option a, GR16 option b. The second issue is how the last day of the 20th year is calculated. There are three options. c. The 20 years are calculated in full years. When the first day of a year is 25.05.1994, the last day of that year is 24.05.1995. Hence, the last day of the patent term is 24.05.2014. d. The 20 years are calculated using Rule 131(3) EPC for calculating periods expressed as one or more years. The calculation depends on the day on which the relevant event occurred. There are two possibilities for the relevant event: Volume 45, number 10
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Note, that the patent is still valid on the date of lapse in GB and GR but not in NL. Each of the above options a to f can be argued to have a basis in the EPC and other international treaties. The arguments in favour of each option are given in the Annex to this article (page 34). Although Article 63(1) EPC has achieved a harmonisation of the patent term used by the contracting states for a European patent on the level of years21, its definition is insufficient to harmonise the patent term on the level of days. Not providing a precise definition of the patent term can be regarded as a lapse of the legislator, causing a disharmony in one of the standard rules governing the European patent.
Legal uncertainty The lack of definition of the patent term causes legal uncertainty for the patentee and third parties. The data provided in the European Patent Register are not useful for determining the expiry of a patent term of a European patent in a contracting state. Reliable information must be gathered from the national patent register together with knowledge of the national interpretation of the terms used in the register. One day of difference in the date of lapse can be very important for parties, in particular the pharmaceutical industry22. After entry into force of the UPCA, the EPO will enter the date of lapse into its Register for each unitary patent23. That date of lapse applies to all member states in which the unitary effect exists. The unitary effect causes harmonisation of the patent term of the unitary patent. However, it does not provide the desired legal certainty, because the way OCTOBER 2016
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the Judge, Arnold J has made a reference to the CJEU – illustrates just how valuable those last days could be. An application for an SPC has to be made before the expiry of the relevant patent (“the product is protected by a basic patent in force”: Article 3(1)(a) Regulation (EC) 469/2009), based on the grant of a Marketing Authorisation for the relevant pharmaceutical product. In this case, Merck applied for the SPC just one day before the patent expired. The issue here, and the question referred to the CJEU, was whether at that time the Marketing Authorisation had in fact been granted or additional time could be permitted. However, in other cases that one day might make the difference between obtaining an extremely valuable SPC and not doing so. Merck Sharp & Dohme v The Comptroller of Patents [2016] EWHC 1896 (Pat) (www.bailii.org/ew/cases/EWHC/ Patents/2016/1896.html), also discussed at page 42.
Notes and references 1. July [2016] CIPA 17 2. Article 118 EPC 3. Stauder in Singer/Stauder, EPÜ, 5. Auflage, Art 2 Rdn 4 4. The granting of European patents, M. van Empel, section 57 - 58 and Beier/Ohly in Münchner Gemeinschaftskommentar, 22. Lieferung Art 2 Rdn 9 5. Singer/Stauder (see footnote 3) Art 2 Rdn 6 6. Münchner Gemeinschaftskommentar (see footnote 4), Art 2 Rdn 8 7. Rule 143(1)(p) EPC. The rule does not take into account limitation proceedings under Article 105b EPC. 8. Link to the EPO Register: https://register.epo.org/ application?number=EP94916860&lng=en&tab=legal 9. This date is not mentioned in the German patent Register.
23.
Rule 16(1)(m) of the Rules relating to Unitary Patent Protection. Published in OJ EPO 2016 A39.
24.
The Rules relating to Unitary Patent Protection (see footnote 22) do not refer to the EPC for the definition of the patent term, but instead provide their own definition in Rule 14(1), using wording different from Article 63(1) EPC (“after” instead of “from”), which will increase the chance of a different interpretation.
10.
The Swiss patent register does not mention the date 30.05.2014 entered into the European Patent Register; it does mention “Cancellation date 24.05.2014”.
11.
The Portuguese patent register gives 03.06.2014 as the “status start date” of the “legal status: patent lapsed”. It also mentions: “Expected Validity End 25-05-2014”.
25.
epi Information 2|16, “Report of the European Patent Practice Committee (EPPC)” by F. Leyder, point 4
12.
According to the Swedish patent register the patent lapsed on 10.06.2014.
26.
Rule 16(1)(m) of the Rules relating to Unitary Patent Protection (see footnote 22)
13.
The date of lapse for LI is the same as for CH because they form a group of contracting states in the sense of Article 142(1) EPC. The European Patent Register should state CH/LI instead of only CH.
27.
Decision of the Dutch Patent Office (see footnote 15)
28.
Oxford English Dictionary, 2nd edition. However, the entry adds between brackets “(The date from which one reckons may be either inclusive or exclusive).”
29.
Regulation 1182/71 (EEC, Euratom), http://eurlex.europa.eu/ LexUriServ/LexUriServ.do?uri=CELEX:31971R1182:EN:HTML
30.
The EPC violates the principle in using inconsistent terminology just in regard of periods. Article 120 EPC relates to “time limits”, whereas the implementation (Rule 131-134 EPC) relates to “periods”, although the chapter containing these rules is titled “Time limits”. The EPO uses “time limit” and “period” for the same notion. However, in plain language a time limit is a limit in time, i.e. the expiry of a period. The EEC regulation 1182/71 (see footnote 28) uses “time limit” only in the sense of expiry of a period. See also The Annotated European Patent Convention, D. Visser, 23rd edition, Article 120 note 2.
31.
Article 5 of the European Convention on the Calculation of TimeLimits, concluded in Basle in 1972 limits the application of extensions on account of non-working days to periods in which an act has to be performed. See www.coe.int/nl/web/conventions/full-list/-/conventions/ treaty/076. The convention should not be used for defining the patent term, because it has been signed by ten contracting states only.
14.
UK patent law Section 25(1) of the 1977 ACT states, that a patent “shall continue in force until the end of the period of 20 years beginning with the date of filing the application for the patent”.
15.
Decision of the Dutch Patent Office of 22.06.2000 on the patent term of a European patent (in Dutch), www.rvo.nl/sites/default/ files/octrooiportal/2013/11/2000_nr10_%252881-91%2529.pdf, Jurisprudentie, page 373, section nr. 91.
16.
GR patent law 1733, art 11(1) states: “The duration of the validity of the patent shall be twenty years starting the day following the date of the filing of the patent application.”
17.
The Dutch patent register has recorded for the patent: “Expiration date: 24/05/2014; Lapsed By Expiration Date: 25/05/2014”. The corresponding entry in the European Patent Register for NL is: “lapsed because of reaching the maximum lifetime of a patent; Effective DATE: 20140525”. It suggests a different meaning of the terms expiration date and date of lapse.
18.
Article by Snodin and Boff (see footnote 1)
19.
Personal call with the legal department of the Dutch patent office.
20.
Personal call with the legal department of the Greek patent office.
32.
Basle Convention (see footnote 30), in particular Articles 3-5.
21.
The number of years of the national patent term varied between 15 and 20 at the time the EPC 1973 was drafted. See Münchner Gemeinschaftskommentar (see footnote 4), Art. 2 Rdn 8.
33.
22.
Editor: One day is not just important because one day’s revenue in the Pharma industry can be a large amount. A recent case – in which
The first patent year starts on the date of filing and ends on the same date of the following year; it has a duration of one year plus one day. For the second and subsequent years, the patent year starts one day after the anniversary of the date of filing and ends on the same day as the date of filing of the following year.
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No challenge too small Most experienced attorneys have worked with SMEs – small and medium sized enterprises. Some are still drawn to the big ticket clients; some take it in their stride; and others relish the chance to contribute to smaller businesses. Mike Street (Marks & Clerk) explores, especially (but not exclusively) for fresher patent attorneys, some of the challenges and opportunities, watch points and excitement of working with SMEs.
B
efore training as a patent attorney, I worked in a hightechnology industry for a medium-sized business and jointly founded a start-up company, so I have always felt a great deal of empathy and admiration for my SME clients. I am constantly intrigued by the challenges that my clients face in different industries and different fields of technology. And I am impressed by the solutions they find to those problems. On a more human level, I really enjoy interacting with interesting people with clever ideas; but most of all, as a patent attorney, it can be very rewarding to help a client transform an initial concept into revenue and growth. Working with SMEs over the last decade has provided me with plenty of experiences to share. Many of the issues discussed here will be familiar to patent attorneys working with SMEs either in private practice or in-house; but everyone’s individual experience of working with SMEs is unique and depends on their clients (or their employer). For those attorneys with less experience of SMEs, this article will hopefully provide an introduction and whet your appetite for this kind of work. In my experience, SMEs often ask a patent attorneys in private practice (like myself) to work directly with their inventors and other staff, rather than employing an in-house attorney – possibly because it would not be as cost-effective for an SME to employ an in-house attorney as it would be for a larger organisation. This means I can learn about my client’s technology first-hand and also requires me to work with them to identify the commercially important features of the technology as well as those that distinguish it over the prior art. For simplicity’s sake, I have categorised SMEs according to whether they are pre-revenue (that is, before they start earning money from selling something) or post-revenue (when they have “grown-up”, and reached the revenue making threshold). Each type of SME client having different IP requirements.
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Pre-revenue SMEs Considering IPRs and identifying and applying for registered IPRs, where appropriate, is likely to be important for any prerevenue business undertaking product development regardless of the business model being pursued. This may be particularly important when seeking investment. A pre-revenue business is often aware of the general importance of IP without necessarily having any detailed knowledge of the procedures, strategies and costs involved. Consequently, the education of management and staff can play an important role. When discussing the importance of IP to early stage businesses, I often use the analogy of house insurance. An individual’s home is often their most precious possession; many people feel that they simply cannot afford not to insure their homes. By analogy, a significant proportion of the value of an early-stage business may be associated with its IP. Can an early stage business really afford not to insure their most precious possession by identifying and applying for registered IPRs? Regarding patents, I often find myself explaining the basic requirements for patentability to start-up clients. I also clearly and repeatedly state, in correspondence, the importance of the client avoiding any public or non-confidential disclosures of an invention before filing their patent application. Some SME clients find it difficult to resist the temptation to disclose details of their latest idea, so it can be frustrating for them when a patent attorney explains that the requirement for novelty applies not only to third party publications but also to their earlier public or non-confidential disclosure of the invention. Spotting inventions can also be difficult for engineers and scientists. They often mistakenly believe that everything they do is obvious; that for their invention to be patentable, it must OCTOBER 2016
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SPCs – navigating rocky waters In the second of a two-part review, the team at Carpmaels & Ransford report on an eventful 12 months for supplementary protection certificates. See part one of the SPC review at August-September [2016] CIPA 14. The scope of protection of an SPC SPCs for biologics – guidance on product definitions, scope and validity from the EFTA Court and Norway in Pharmaq AS v Intervet International BV1 The scope of protection provided by a supplementary protection certificates (SPC) and the significance of the definition of the “product” in an SPC application has not yet been the subject of detailed analysis by the Court of Justice of the European Union (CJEU). The uncertainty is particularly acute for biologics, which are complex macromolecules that can be defined in various levels of specificity. Although not legally binding, the Court of Justice of the European Free Trade Association States (EFTA Court) has provided guidance regarding the scope and validity of SPCs for biologics, and the language it has used may concern some innovators. A subsequent split decision from the Oslo District Court following the EFTA Court judgment offers little further clarification. It remains to be seen whether the CJEU and national EU courts will approach these issues in a similar manner.
Background The EFTA Court fulfils a role similar to the CJEU for Norway, Iceland and Liechtenstein. These states are not members of the EU, but they are members of the European Economic Area (EEA), and the EEA Agreement incorporates the SPC Regulation. Judgments of the EFTA Court are not binding on the CJEU or courts in non-EFTA states, but in the absence of guidance from the CJEU on the particular issues considered by the EFTA Court in this case, its judgment may turn out to be persuasive in these states. Notably, the European Commission took the time to make submissions in this case, which emphasises its potential significance across Europe. Pharmaq and Intervet had developed vaccines against viral pancreatic disease in salmon using different inactivated virus strains. Pharmaq sought a declaration before the Oslo District Court that a Norwegian SPC held by Intervet does 40 CIPA JOURNAL
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not cover the virus strain in the Pharmaq vaccine, or that the SPC is invalid. The SPC in question is based on a marketing authorisation for the specific strain used by Intervet, but the SPC was granted with a broader product definition that encompasses the Pharmaq strain. The Oslo District Court asked the EFTA Court to consider whether the scope of protection for an SPC can cover not only the specific strain included in the relevant medicinal product, but also other strains covered by the basic patent and the SPC product definition, and whether an SPC is valid if it is granted with a product definition that is not limited to the authorised strain. The EFTA Court also considered the validity of the SPC in light of earlier marketing of the Intervet vaccine under special approval exemptions, prior to the full MA used for the SPC application. The exemptions are used in rare circumstances to allow provisional supply of products in the event of serious diseases, and this aspect of the judgments is not discussed here.
Context The questions addressed by the EFTA Court are significant because practice regarding how a product should be defined in an SPC application and the resulting scope of a granted SPC is not settled. Article 4 states that: “the protection conferred by a certificate shall extend only to the product covered by the
Editor’s summary Supplementary Protection Certificates (SPCs) are a creature of EU law. A straightforward concept and a few simple words. In the second of a two-part review, attorneys from Carpmaels & Ransford provide a straightforward explanation of some of the tangled issues about SPCs in a way which provides insights for non-pharma practitioners on how simple words can tax the courts.
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authorisation to place the corresponding medicinal product on the market”, but as in the present case, many SPCs are granted with product definitions that encompass other products in addition to the authorised product. Also, the scope of protection provided by SPCs, in particular in relation to biologics, has not been clearly defined in case law. Currently, the entry of biosimilars to the market generally respects innovators’ SPCs covering reference products, but it has not been confirmed that an SPC for a reference product will necessarily always cover a biosimilar. The CJEU held a number of years ago in Farmitalia2 that an SPC “is capable of covering the product, as a medicinal product, in any of the forms enjoying the protection of the basic patent”, which suggests that a broad interpretation of Article 4 is appropriate. However, Farmitalia related to a small chemical entity and there is doubt whether the reasoning in Farmitalia can be transposed to complex biologics.
The EFTA Court judgment In its judgment, the EFTA Court apparently approved the reasoning in Farmitalia as relevant to complex biologic products, such as the vaccine compositions at issue, and the Court repeated the observation in Farmitalia that an excessively narrow interpretation of Article 4 would allow medicinal products that are “therapeutically equivalent” to the product protected by the SPC to enter the market. The Court felt this approach would frustrate the purpose of the SPC Regulation. These comments should be reassuring for biologics innovators because they suggest that biosimilars, which generally must be “therapeutically equivalent” to a reference product, will be covered by an SPC. However, the Court then turned to Article 4 itself and provided a final answer to the questions using more narrow language: “the scope of protection conferred by a supplementary protection certificate extends to a specific strain of a virus covered by the basic patent, but not referred to in the marketing authorisation… only if the specific strain constitutes the same active ingredient as the authorised medicinal product and has therapeutic effects falling within the therapeutic indications for which the marketing authorisation was granted”. This answer appears to suggest that the Court considered an SPC to cover products not referred to in the MA only if the products constitute the same active ingredient, without any reference to products that are “therapeutically equivalent”. It is unclear what variation or modification might cause a biologic to no longer be considered “the same active ingredient”. Nevertheless, despite the relatively narrow language used, it does appear that the Court intended to imply that useful scope around the authorised product should be acknowledged, because the Court asserted that: Volume 45, number 10
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“It is not relevant whether a medicinal product based on such other strain would require a separate marketing authorisation.” This is significant, because it suggests that follow-on products cannot be distanced from an SPC merely by obtaining a new MA. This was a suggestion made by Pharmaq and in observations by the EFTA Surveillance Authority. The Court went on to use strongly negative language in its comments regarding the validity of SPCs granted with product definitions that are broader than the MA. The Court concluded that: “A supplementary protection certificate is invalid to the extent it is granted a wider scope than that set out in the relevant marketing authorisation.” Taken out of context, this conclusion could be a concern to SPC proprietors who have been granted SPCs with apparently broad product definitions. However, this aspect of the judgment does not include detailed reasoning and it may not have been the Court’s intention to suggest that SPCs with broad product definitions are invalid, rather than merely partially unenforceable. Indeed, the Court’s comment regarding SPC validity is possibly inconsistent with its comments regarding SPC scope.
The subsequent Oslo District Court judgment The EFTA Court judgment seems to mirror judgments of its sister court the CJEU, in that it is not entirely clear what was intended. Indeed, when applying the EFTA Court judgment to the technical facts of the case, the Oslo District Court failed to reach a unanimous decision. A majority of two judges concluded that the SPC is valid and that its scope of protection encompasses the Pharmaq vaccine, whilst the remaining judge concluded that the SPC is invalid because the product definition extends beyond the specific strain indicated in the MA, contrary to Article 4. The majority judges reviewed the technical evidence and concluded that the differences between the virus strains in the two vaccines were so insignificant that they should be considered the same active ingredient. In contrast, the dissenting minority judge focused on the narrower statements in the EFTA Court’s judgment, in particular its reference to “the same active ingredient”, and concluded that the strains in the two vaccines are from different subtypes and are “therefore not the same (identical)”. An appeal hearing to determine whether the judges’ overall conclusions were correct is scheduled for late 2016. The judgments of the two courts are, of course, focused on the issues as they relate to the specific virus vaccine products that were under dispute, and the conclusions reached by the judges of the Oslo District Court could have been different if OCTOBER 2016
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Six things we hate (and love) about exams Ed Lobb (Kilburn & Strode LLP) and Greg Dykes (A.A. Thornton & Co.) highlight what they hate (and love) about the qualifying exams.
1
Social Life
You can’t beat that feeling of excitement when you and your friends start to organise that long-awaited trip to Oktoberfest, or ten days in Chamonix carving through the white stuff. However, you quickly realise that this is nothing but a pipe dream. Add to that dream the birthday parties, concerts, cinema trips and even the hallowed Friday night drinks because in the lead up to exams your social life is, to all intents and purposes, non-existent. The best you can hope for in terms of downtime is perhaps a quick Game of Thrones break between studying reinstatement and groundless threats. Even then, the trauma of the Red Wedding is enough to put you off your after-dinner Section 60 session. Once you finally come to terms with the fact that you will not be seeing the light of day, or dark of night, for at least a few months, the whole ordeal is made worse by your friends constantly inviting you to the pub, or sending pictures of their various japes over WhatsApp, chipping away at the last of your resolve. The only consolation is that, as a patent attorney famous for your raucous and jam-packed social calendar, you can’t lose what you never had.
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2
Revision courses
Your arrival is full of hope and wonder; this is when you finally learn the magic method to pass P6 and WOW, there’s an on-site gym! The charm quickly wears off when you realise that everyone else has done twice as much revision as you. You can’t learn anything because it takes every ounce of your concentration to avoid sounding like an idiot in front of your peers for fear they’ll scupper your next career move: “Greg Dykes? Rings a bell – wasn’t he the one who thought the priority year lasted 18 months?” You numb the pain by propping up the bar in the evenings, but this coping mechanism bites you in the backside the next day. The tutors barely stifle their laughter while watching you try to justify your slightly avant-garde construction of “frangible rotatable member” to 15 strangers while you’re sweating out six pints of cheap lager. Worse still, you’re sat in Milton Keynes eating an under-cooked jacket potato for lunch when you learn that your QM-UL mates from Big Bucks LLP are going on a residential course in France for a winefuelled jolly. Gits.
3
The law
When you first start attempting practice questions on calculating response deadlines (even including that ever-useful ten-day mailing period kindly provided by the EPO), you may start to think that this whole revision lark is going to be easy. However, it soon becomes apparent that the 10% of the law that you actually use in your day-to-day working life is not going to be good enough to get you through these exams. After the initial confidence-shattering realisation that you have no idea when you are even supposed to pay an appeal fee, let alone how you get it reimbursed, you soon get your head around it only for the futility of the exercise to become all too apparent. Yes, I know how to file an application in Swahili for a Bolivian inventor on Ascension Day at the end of the priority year, but the chances of ever using this in practice are almost as low as getting full marks on a PCT Chapter II exam question. And none of it actually helps to overcome Monsieur Vouillarmet’s repeated clarity objections.
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SIX THINGS…
4
Helpful advice
Your supervising partner has been qualified since before you could read, so he or she must have some sage and practical advice, right? “FD4? Is that what the kids are calling P6 these days? Yes, well that should be easy for you… when I sat it in 1992 it was a four-hour paper, so if you can’t pass it in five then we’ll probably have to reconsider your position.” Senior colleagues also believe that you should know the Black Book cover-tocover to pass FD1 (or P2 for those of you who still refer to “restitutio in integrum”). Woe betide those who dare to suggest that the Green Book is about ten times smaller and does the job just fine. To keep your partner happy, just get the huge CIPA tome out of the office library (consult HR for the appropriate manual handling training when lifting heavy items), stick a few coloured tabs in it, and move it around your desk periodically. If this wasn’t enough, roughly twothirds of your colleagues will be adamant that their FD4 (P6) method will give you a guaranteed pass. You’ll try them all, hate them all, and end up blindly groping about for the construction swing points like Ed Lobb when he drops his spectacles.
5
EXAMS
Resits
At university, if you scored 43% in an exam, the worst that happened was your mates laughed at you for getting a ‘Dame Thora Hird’. Now, if you’re unlucky enough to fail, you have the dubious privilege of being able to try again. For many people, a patent exam will be the first time they’ve ever failed anything so, inevitably, existential crises can ensue. However, it’s a very common occurrence in this profession, so don’t be disheartened. The good news is that everyone around you will help you pick yourself up, dust yourself off, and get back up on that horse. The bad news is that you now have a whole year to wait for your next shot at it, a delay that gives you the exact amount of time needed to both keep the memory of your past failure intact and forget everything you learned in the lead up to your last set of exams. However, if you stick at it, seek some advice on where you went wrong, and maybe even attend some exciting re-sitters’ courses (see point 2), you’ll eventually find yourself in the veritable nirvana of…
Passing
6
After all the toil, blood, sweat, tears and crumpled pages of Hoekstra, or Visser if you are that way inclined, nothing can beat the feeling of finally passing your exams and never having to worry about the stress, boredom and general sense of hopelessness ever again (we will forget about the pesky UK litigation course for now). The feeling of cramming your PCT Applicants’ Guide onto a shelf between your red P6 book and the National Law Relating to the EPC, never to see them again, is unnervingly delightful. The congratulations from your friends, family and, more importantly, colleagues are terribly satisfying, as well as the realisation that your evenings and weekends are yours to squander as you wish. And let’s not forget the pay rise that comes with qualifying – now you can buy as many different coloured highlighters, little glue rollers, and bottles of Lucozade as you would have needed to get through the exams in the first place. All that remains now is a long and distinguished career, beginning with the insistence around the office that you are now the “go-to” person for any intricate points of law, and the look of disappointment on your superiors’ faces when you don’t know the answer. And let’s not forget that strange feeling of foreboding you get when you finally plug your authorised EPO smart card into its reader only to see the little green light of potential negligence burning a hole through your retinas. Enjoy!
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Section 101 guidance New USPTO §101 guidance: blueprints for examiners and applicants. By the Finnegan team.
I
n May 2016, the United States Patent and Trademark Office (USPTO) issued additional §101 guidance for examiners and patent practitioners1. The guidance includes several new examples illustrating patent eligibility, as well as long-awaited examples for diagnostic methods. The USPTO retained its two-step eligibility analysis but emphasizes that an examiner must support a §101 rejection with a reasoned rationale, and must carefully consider the applicant’s rebuttal arguments and evidence. Although certain aspects of this guidance – like the guidance before it – may leave practitioners scratching their heads, the guidance does shed light on what the USPTO deems “well-understood, routine, or conventional” for purposes of determining whether claim elements add “significantly more.”
Guidance for examiners The May guidance affirms the two-step eligibility analysis of the USPTO’s 2014 Interim Guidance2. That analysis asks in Step 1: Is the claim directed to a statutory category? If yes, the examiner must then ask (Step 2(A)): Is the claim directed to a judicial exception? If yes, the examiner moves onto Step 2(B): Does the claim, as a whole, amount to significantly more than the exception? The May guidance provides further instruction on how to apply that rubric in formulating a rejection during prosecution. The examiner should begin by identifying the judicial exception and explaining – “using a reasoned rationale” – why it is considered an exception3. The examiner should then identify any additional elements in the claim beyond the judicial exception and explain why “the additional elements taken individually, and also taken as a combination, do not result in the claim as a whole amounting to significantly more than the judicial exception4.” When considering abstract ideas, examiners are invited to rely on US appellate court decisions for what amounts to an abstract idea. However, the USPTO cautions examiners not to reach beyond concepts that are 66 CIPA JOURNAL
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similar to what the courts have identified as abstract ideas, and points to a chart of court decisions available on the USPTO’s website5. To determine whether claim elements add “significantly more” to a judicial exception, examiners must determine whether the elements are well-understood, routine, conventional activities previously engaged in by those in the relevant field. According to the USPTO, a prior art search “should not be necessary” for this analysis because finding the element in the art does not, by itself, establish that an activity or element is routine or conventional. Even the fact that a particular laboratory technique was discussed in several widely-read scientific journals may not be dispositive. Beyond repeating the phrase, however, the guidance provides little concrete advice on what constitutes “well-understood, routine, conventional activity previously engaged in by those in the relevant field6.” This somewhat circular definition begs the question whether the analysis will become subjective instead of objective – based entirely on a given examiner’s perception of what is and is not well-known, routine, or conventional. Examiners are reminded that an additional claim element may qualify as significantly more if it meaningfully limits the judicial exception, improves another technology or technical field, improves the functioning of a computer itself, or adds a specific limitation that is unconventional and confines the claims to a particular useful application7. Several of the new examples address such limitations. The guidance also clarifies that “preemption is not a standalone test” for patent eligibility8. Thus, an applicant’s argument that a claim does not preempt all applications of the judicial exception, without more, may not overcome a §101 rejection. “While a preemptive claim may be ineligible, the absence of complete preemption does not demonstrate that a claim is eligible9.” In other words, preemption is a one-way test. The new §101 examples provide insight into how the two-step analysis should be applied in several hypothetical www.cipa.org.uk
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US UPDATE
situations. The examples are intended to be illustrative and are not meant to form the basis for a rejection. Examiners should not require applicants to model their claims or responses after the examples to attain eligibility10. Nonetheless, the examples give applicants tools for crafting patent-eligible claims, especially for diagnostic methods – subject-matter missing from prior USPTO §101 guidance.
Summary of new examples Example 28: Vaccines Example 28 recites seven hypothetical claims and describes how the two-step analysis was applied to show that six of those seven claims are patent eligible. The first two claims are directed to non-natural structurally altered viruses. Only step 1 of the 2 step analysis was considered because the viruses are not products of nature. The next four claims are directed to compositions comprising a combination of ingredients including a peptide isolated from naturally occurring virus. The broadest claim (claim 3) is directed to a vaccine comprising the peptide and a pharmaceutically acceptable carrier – which the USPTO reads as water by applying Broadest Reasonable Interpretation (BRI). The USPTO determined that although the two components did not occur together in nature, mixing them together did not change the structure or function of either component or add “significantly more”. In contrast, claim 4 is directed to a composition comprising the peptide and a carrier selected from a cream, emulsion, gel, liposome, nanoparticle, or ointment. Focusing on the cream composition, the USPTO determined that although a cream comprises naturally occurring components, such as oil and water, together the components form a semisolid emulsion that is structurally and physically distinct from water and oil. The USPTO concluded that the claimed peptide-cream composition is not considered to be a product of nature and thus the claim is not directed to a judicial exception. No “significantly more” analysis was performed. Interestingly, the USPTO only analyzed the cream component of the Markush group, but concluded that the whole claim is patent eligible. No mention is made of separately analyzing the other members of the group. Presumably, the USPTO considers the cream to be representative of the group. If claiming a natural product in a composition comprising a cream, emulsion, gel, liposome, nanoparticle, or ointment renders the composition patent eligible, we may see more effort to formulate drugs in this fashion in the future. In claims 5 and 6, the components of the claimed vaccine – peptide and AlPO4 plus a carrier in claim 6 (read water) – are naturally occurring and no structural changes result from the mixture. In spite of this, the USPTO says that these claims are patent eligible. The determination is based solely on a functional change (enhanced immunogenicity) that amounted to more than the sum of the components. In other Volume 45, number 10
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words, a synergistic combination of natural components should be considered patent-eligible subject-matter. Again, in these examples, no “significantly more” analysis is performed because the claim is considered not to recite a judicial exception. Claim 7 is directed to microneedle arrays coated with the virus peptide. Because the peptide is considered to be a natural product, the USPTO conducted the “significantly more” analysis. It found that even though microneedle arrays were known to most scientists in the field, this type of needle was not “routinely or conventionally used to administer vaccine.” As a result, the USPTO concluded that a vaccine composition claim reciting “coated microarray needles” is patent eligible because it is directed to a product that amounts to significantly more than the natural product itself. The distinction between the analysis of claims 4 and 7 is interesting. The combinations of elements in the vaccines of claims 4-6 were considered as a whole in the step 2A analysis, with a conclusion that the presence of a non-natural or structurally-altered element, or a synergistic combination is sufficient to make the claim patent eligible. However, the combination of elements in the peptide coated needle of claim 7 – one of which is clearly a non-natural product – are analyzed as separate elements in step 2A and the combination was only considered when applying the step 2B analysis. The USPTO does not provide a rationale for treating these claims differently11.
Example 29: Diagnosing and treating julitis This example illustrates how the “significantly more” analysis is applied to diagnostic and treatment claims. The applicant had found that the presence of a particular protein (JUL-1) in a patient sample is indicative of a particular skin disease (julitis). JUL-1 is not present in persons who do not suffer from julitis. Prior to the invention, julitis was known to be difficult to diagnose. The disease was traditionally treated with anti-TNF antibodies. The applicant discovered that it was possible to treat julitis with topical vitamin D. The first claim is directed to (1) obtaining a patient sample and (2) detecting the JUL-1 in a patient sample using an antibody. This claim is patent eligible because it does not recite or describe any recognized exception. The USPTO indicates that the fact that the protein and the antibody may be natural products is irrelevant because the claim is to a method and not to the products themselves. Claim 2, however, which recites the same two steps as claim 1 and adds a third step to diagnosing julitis based on the detection of JUL-1, is ineligible. The USPTO describes this claim as being directed to a “law of nature, an abstract idea [because the diagnosis step can be performed using basic critical thinking], or both.” According to the USPTO, the “significantly more” analysis shows that the additional elements, i.e., the steps of obtaining a sample and using an OCTOBER 2016
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EVENTS
INSTITUTE EVENTS
Institute Events For more information and to book onto any event please see the CIPA website or email cpd@cipa.org.uk
Thursday, 13 October 2016 Social
Merseyside Happy Hour
Time: 18.00–19.30pm Location: District House, 18 Water Street, Liverpool, L2 8TD Join us for an opportunity to network with other IP professionals over drinks. Please note, booking is mandatory and drinks tokens will be distributed on arrival. FREE for CIPA members, register at www.cipa.org.uk/ whats-on/events/
Friday, 14 October 2016 Mock Trial
Mock Trial before the Local Division of the UPC
Tuesday, 18 October 2016 Webinar
Update on SPCs
Time: 12:30–13:30pm (GMT) This webinar will summarise developments in SPC case law, with discussion of the Merck/montelukast, Seattle Genetics, GSK/active ingredient and Forsgren decisions. The impact of a Brexit on SPC law and practice in the United Kingdom will be considered, as well as some of the issues highlighted in the European Commission’s proposed study on the legal aspects of the SPC regime.
Prices: €495 (€395 EPLIT & CIPA members)
Patent Case Law Scotland
Time: 12:30–17:00pm Location: Radisson Blu Hotel, 301 Argyle St, Glasgow, G2 8DL This seminar will focus on interesting patent decisions to have come from UK and US courts, and the EPO Boards of Appeal in 2016. This seminar will also be held in London, Bristol and Manchester (see below). CPD: 3; Prices: £234 (members £156)
CIPA is looking for volunteers to report on regional CIPA events. If you are interested, please contact cpd@cipa.org.uk.
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Time: 12:30–17:00pm Location: Hilton Manchester Deansgate Hotel, 303 Deansgate, Manchester, M3 4LQ Arrive from 12.30 for a buffet lunch before the seminar starts at 13.30. After the seminar has finished, please join us in the Zeus Lounge, Cloud 23 Bar located at the very top of the hotel for a traditional CIPA Happy Hour (and a half!). Please see www.cipa.org.uk/whats-on/ events for updated information regarding topics, titles and speakers.
Thursday, 10 November 2016 Seminar
The Wales Meeting 2016 Monday, 31 October 2016 Seminar
Reporters Needed!
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Manchester Regional Meeting
CPD: 3.5; Prices: £156 (members only) Speaker: Duncan Curley, Innovate Legal CPD: 1; Prices: £72 (members £48)
Location: London’s UPC Central Division, 2 Leman St, London E1 8FA Following the successful EPLIT event in Munich earlier this year, EPLIT will run another mock trial before the Local Division of the Unified Patent Court in London on 14 October 2016. EPLIT is of the view that the Unified Patent Court system is much more attractive if the UK continues to participate in it. The mock trial is therefore being held in London in order to emphasize the benefits of a harmonization of patent litigation that includes the UK. See page 22 for more information.
Thursday, 3 November 2016 Seminar
Time: 12:30–17:30pm Location: Park Plaza Cardiff, Greyfriars Road, Cardiff, CF10 3AL This seminar will cover some recent and upcoming legislative changes relevant to patent practice, including forthcoming adjustments to Patent Rules, the new "intention to grant" procedure at the IPO, and a run-through of the proposed new unjustified threats regime, currently being considered in a Bill before parliament. Speakers: James Porter, IPO; Victoria Jones, 3PB Barristers; Debbie Slater, UDL Intellectual Property CPD: 3; Prices: £234 (members £156)
14 & 15 November 2016 Two-day Conference
CIPA Life Science Conference See full details on page 124. Location: The Grand, Brighton
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EVENTS
Monday, 21 November 2016 Seminar
Patent Case Law London
INSTITUTE EVENTS
Monday, 28 November 2016 Seminar
Patent Case Law Bristol
Monday, 12 December 2016 Seminar
Patent Case Law Manchester
Time: 12:30–17:00pm Location: CIPA, 95 Chancery Lane, London, WC2A 1DT
Time: 12:30–17:00pm Location: Mercure Brigstow Hotel, 5-7 Welsh Back, Bristol, BS14SP
Time: 12:30–17:00pm Location: DoubleTree by Hilton Hotel Manchester, M1 3DG
This seminar will focus on interesting patent decisions to have come from UK and US courts, and the EPO Boards of Appeal in 2016. This seminar will also be held in Glasgow (see above), Bristol and Manchester.
This seminar will focus on interesting patent decisions to have come from UK and US courts, and the EPO Boards of Appeal in 2016. This seminar will also be held in London, Glasgow and Manchester.
This seminar will focus on interesting patent decisions to have come from UK and US courts, and the EPO Boards of Appeal in 2016. This seminar will also be held in London, Glasgow and Bristol.
CPD: 3; Prices: £234 (members £156)
CPD: 3; Prices: £234 (members £156)
CPD: 3; Prices: £234 (members £156)
The West Midlands Meeting Thursday, 20 October 2016 12:30pm – 17:00pm Radisson Blu Hotel Birmingham, 12 Holloway Circus, Queensway, Birmingham, B1 1BT This CPD meeting will include a range of talks on topical issues from speakers who are experts in their fields. Includes lunch, refreshments and a drinks reception, providing plenty of networking opportunities. Speakers: David Bloom, IP Insurance; Suzanne Gregson, IPO CPD: 3; Prices: £234 (members £156)
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