This year marks 30 years since the inception of C5 Group. C5 It is time to match our brand with the dynamic strides we have made. Business Information in a Global Context See inside for details…
a C5 Group Company
14th & 15th March 2016 | The Wyndham Apollo Hotel | Amsterdam, Netherlands
C5’s 8th Conference on PHARMA & BIOTECH PATENT LITIGATION
Invaluable insight from members of the Kevin Mooney Pierre Veron Alan Johnson Up to 14.5 key Unitary Patent Chair Member Chair Advisory Committees UPC Drafting Committee UPC Drafting Committee AIPPI’s UPC Committee CPD
Get ready for the new Unitary Juergen Dressel Arturo Lucas Practical guidance from senior Head of Patents Litigation Senior Counsel Patent Regime Novartis Pharma AG (Switzerland) Chemo Group (Spain) in house counsel of Pharma with a first-hand and Biotech Corporations: James Horgan perspective from Assistant Managing Counsel, renowned experts Merck Sharpe & Dohme (UK) in the patent litigation field. KEY AREAS OF FOCUS Ask the questions you want AND DISCUSSION: answered from members of the Unitary Patent 1 The landmark Lyrica case, the ripple effect throughout different jurisdictions and consideration Preparatory and Drafting of how all players in the industry will react. Committee and listen to The very latest position on the practical implementation of the Unified Patent Court directly from patent judges from across 2 those who are devising the rules. Europe debate the key considerations for devising Crucial debate around how to plan your patent portfolio opt in/opt out strategy and manage 3 your risk once the new regime begins. effective patent litigation strategies in this changing Understand how Supplementary Patent Protection Certificates will work in practise within the environment. 4 new unitary patent regime.
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a C5 Group Company +44 (0) 20 7878 6888 | C5-Online.com/PatentLitigation Business Information in a Global Context THE WORLD OF PHARMACEUTICAL AND BIOTECH PATENT LITIGATION IS MOVING INTO UNCHARTERED TERRITORY AND THERE IS MUCH TO CLARIFY.
The imminent commencement of the Unified Patent Court continues to dominate the thoughts and concerns of every IP and Pharma expert. It goes without saying, devising an effective patent litigation strategy in an unknown and untested regime does not come without risk. There also remain many unanswered questions surrounding the transition period, the dilemma and transparency of opting out and the implementation of SPC’s within the new regime amongst others, and such uncertainty creates a challenging patent litigation environment.
Case law developments over the past year on Biosimilars, Supplementary Protection Certificates and PLUS, ENHANCE YOUR Second Medical Use Patents have been significant and EXPERIENCE BY ATTENDING have impacted heavily on the patent litigation landscape. THE IN-DEPTH PRE-CONFERENCE Most notably, the repercussions of the landmark Lyrica WORKSHOP ON decision on industry players and stakeholders alike SUNDAY 13TH MARCH 2016: continue to be felt. From a Practical Perspective, How to th C5’s 8 Pharma & Biotech Patent Litigation conference Devise Your Patent Litigation Strategy in will provide an invaluable focus for analysis of all the Conjunction With the New Unitary Patent fundamental changes affecting pharma and biotech Regime: Prior to Commencement, During patents across Europe and the US and consider the Transition and Beyond…. impact of judicial decisions in the national courts on your litigation strategies. The UPC is arguably the to consider and discuss biggest single change to in depth, in an interactive affect the patent litigation environment, the real Receive an in-depth understanding of the hottest environment ever. This challenges and the practical topics, equipping you to alter and strengthen your workshop will guide you on solutions when devising litigation strategies and tailor your techniques to the what you really need to be patent litigation strategy under thinking about right now. How the new unitary patent regime. latest challenges in today’s constantly changing patent and what to opt out of, fees landscape. and costs – all of these issues Our experts will share their and many more, will impact expertise, critical insight and Don’t miss this outstanding opportunity to learn from upon strategy. This workshop suggestions for best practice. industry leaders and network with those at the forefront will provide an opportunity of this field.
C5 It is time for a brand, logo and language in keeping with the Business Information in a Global Context dynamic strides we have made as a company. It is time for a brand that will take us forward for the next 30 years. This year marks 30 years since the inception of C5 Group. C5 Group, comprising of C5 in Europe, American Conference Institute and The Canadian Institute, will unite under one central 30 years 30 years 30 years brand image, appropriately a globe. See how bringing together the hosting more building a expanding power of people and the power of information can accelerate your than 6,000 network of across growth and success. conferences industry leaders the globe Our new brand look and language will be fully revealed soon. Stay tuned for more exciting changes
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by calling faxing your registration form to sending an email to registering at +44 (0) 20 7878 6888 +44 (0) 20 878 6885 [email protected] C5-Online.com/patentlitigation
Join the Conversation @C5Live #C5LifeSciences DAY ONE – MONDAY 14 MARCH 2016
8:00 / 12:30 / Registration and Welcome Coffee Networking lunch
Opening Remarks from the Chair Litigating Biosimilars – Round Up of Case Developments across the World 8:45 Paul Inman, Partner, Wragge Lawrence Graham 14:00 & Co LLP (UK) Multi-jurisdictional panel discussion to compare and contrast the position in the US and North American markets compared Second Medical Use Patents: Consequences of to other regimes across the world. 9:00 Lyrica and the Ramifications Throughout Europe Sheldon Hamilton, Partner, Smart & Biggar (Canada) Christoph de Costa, Partner, Taylor Wessing (Germany) Claudia Milbrandt, Partner, Clifford Chance (Germany) Matthew Royle, Partner, Taylor Wessing (UK) John D. Murnane, Partner, Fitzpatrick, Cella, Harper & Scinto Mark Van Gardingen, Partner, Brinkhof (Netherlands) (United States) • Case summary and status Hari Subramaniam, Partner, Subramaniam & Associates (India) • How will the Lyrica decision impact differently across the • Protection of Biosimilars and Enforcing Patent Rights separate jurisdictions? against them • An analysis of Lyrica across a number of different countries • Amgen v. Sandoz (U.S) with consideration of: »» How it may affect Biosimilars litigation in the United States »» The different routes to market • Amgen v Apotex (Canada) »» Contrasting reimbursement systems »» The first wave of the patent dance »» How will the infringement issues arise in each country? »» Approaches by the different courts to the construing Biosimilars – What’s Feeding the Biosimilars Trend? of claims 15:00 »» What will be the ultimate impact on the end user? • Where are we going with Biosimilars? • When will the litigation start? Lyrica– What Will The Generic Companies Do Now? • Technological advances in the bio-manufacturing platforms 10:15 Interactive panel discussion with industry leaders who will • Considerations for marketing? discuss the case of the year. 15:35 / Juergen Dressel, Head of Global Patent Litigation Strategy, Coffee Break Novartis (Switzerland) How Does the Commercial Restructuring of a Pharma Judge Tochtermann, Judge of the Patent Division Business Impact on its Patent Litigation Strategy? of the Mannheim District Court (Germany) 16:00 Arturo Lucas, Senior Legal Counsel, Chemo Group (Spain) Gavin Lawson, Senior Litigation Counsel, GILEAD (UK) Ulrich Reese, Partner, Clifford Chance (Germany) • External and internal impact of large scale mergers and acquisitions in the industry Miquel Montana, Partner, Clifford Chance (Spain) • What happens to litigation strategy when a company buys or • What is the message to generic companies? sells parts of its portfolio? • How can they avoid unwanted attention in the future? • How to manage patent strategy when you have branded and • Will patentees now unjustly profit from a new culture generic businesses under one roof of caution? • Consideration and insight? • Is increased infringement action inevitable as a matter of course? 16:35 Raising the Bar: Are Sufficiency Requirements • How can we start to think about a sensible generic code Changing? of conduct going forward? Paul Inman, Partner, Wragge Lawrence Graham & Co LLP • Perspective of the wider stakeholders – how will the payers react? • What is the current bar for sufficiency and is it getting higher? • How have recent cases impacted on the current standard? 11:15 / • What is the current position of the EPO on sufficiency? Coffee Break • How much data do you really need to support the breadth of your claim? The 101 Issue: Patent Eligibility in the United States – 11:45 Should Europe Fear the US System? 17:10 Chair’s Closing Remarks and Conference Adjourns • Review of recent US case law • Current guidelines for patent eligibility • Where do the challenges lie? • Is the current mood in the US changing? »» Obiter comments in Ariosa v Sequenom • What sort of claims will be allowed in the US? • Attitude towards biotech ventures going forward? • Best practises for patent drafting
Join the Conversation @C5Live #C5LifeSciences DAY TWO – TUESDAY 15 MARCH 2016
8:30 / 12:30 / Welcome Coffee Networking lunch
Litigating Biosimilars – Round Up of Case 9:00 Opening Remarks from the Chair The UPC: Is It Really An Improvement On What We 14:00 Developments across the World 14:00 Already Have? Multi-jurisdictional panel discussion to compare and contrast Case Law Round Up On Supplementary Protection Alan Johnson, Bristows, Chair of AIPPI’s UPC Committee (UK) the position in the US and North American markets compared to other regimes across the world. 9:15 Certificates Judge Tochtermann, Judge of the Patent Division of the Mannheim An essential update on the key cases over the last year that are District Court (Germany) Sheldon Hamilton, Partner, Smart & Biggar (Canada) impacting on SPC’s. Richard Ebbink, Partner, Brinkhof (Netherlands) Claudia Milbrandt, Partner, Clifford Chance (Germany) • The “UK Torpedo” Debate and Panel Discussion John D. Murnane, Partner, Fitzpatrick, Cella, Harper & Scinto »» Actavis UK Ltd & Others v Eli Lilly • Is the new system as attractive as we once thought? (United States) • The question of scope • How are you going to plan your portfolio opt in/opt out »» Pharmaq v Intervet International BV Hari Subramaniam, Partner, Subramaniam & Associates (India) strategy around an unknown and untested procedure? • The Seattle Genetics Case • Protection of Biosimilars and Enforcing Patent Rights • What are the drawbacks and the risks attached to each decision? against them Supplementary Protection Certificates under the • How to plan strategy throughout the “sunrise period” – • Amgen v. Sandoz (U.S) 10:00 Unitary Patent Regime – How will they Work Together Are the risks the same? »» How it may affect Biosimilars litigation in the United States in Practice? • Amgen v Apotex (Canada) • How the UPC will impact on multiple ownership »» The first wave of the patent dance James Horgan, Assistant Managing Counsel, • To what extent will fees and costs under the new system Merck Sharpe & Dohme (UK) determine patent strategy? Biosimilars – What’s Feeding the Biosimilars Trend? Daniel Wise, Partner, Carpmaels and Ransford LLP (UK) 15:00 Inter Partes Reviews: Increasingly Significant • Where are we going with Biosimilars? • “New” and “old” SPC’s – is there going to be 14:45 in a Wider Litigation Strategy? • When will the litigation start? a contradiction between the two systems? Karen Mangasarian, Partner, Ropes & Gray (US) • Technological advances in the bio-manufacturing platforms • What will be the different rules in the different jurisdictions? • Considerations for marketing? • Is it possible to lose your SPC rights under the • Are the increasing use of IPR’s a strong indication of good new regime? procedure? 15:35 / • Will SPC’s still be reliable and enforceable under the new • Will greater use of IPR’s lead to cheaper litigation? Coffee Break system? • What are the challenges of using them? • How the documentation requirements will work under the • Exclusivity periods How Does the Commercial Restructuring of a Pharma new regime Business Impact on its Patent Litigation Strategy? 16:00 • Will there be potential to transfer SPC’s within 15:30 / Arturo Lucas, Senior Legal Counsel, Chemo Group (Spain) a company group? Coffee Break • The Seattle Genetics Case • External and internal impact of large scale mergers and The Competition Authorities and Patent Litigation – acquisitions in the industry 10:45 / 15:45 What Exactly Are They Looking For? • What happens to litigation strategy when a company buys or Coffee Break sells parts of its portfolio? • How are the activities of the Competition authorities • How to manage patent strategy when you have branded and The Practicalities of the UPC: The Facts – What We impacting on day to day settlements in the field? generic businesses under one roof 11:15 Know and What We Don’t • Recent competition activity in the market • Consideration and insight? »» Published decision on the “perindopril fines” Kevin Mooney, Partner of Simmons & Simmons and Chair of the • Best practice to ensure ongoing cooperation and compliance UPC Drafting Committee (UK) with the authorities 16:35 Raising the Bar: Are Sufficiency Requirements Changing? Pierre Véron, Partner of Véron & Associés, UPC Drafting Committee (France) The Nagoya Protocol – A “Patent-Like” Legal Paul Inman, Partner, Wragge Lawrence Graham & Co LLP 16:15 framework and its Impact on FTO strategy • Status report on the courts - when will they actually go live? • What is the current bar for sufficiency and is it getting higher? • When will the local and regional divisions be established? • How might the Nagoya Protocol change the patenting • How have recent cases impacted on the current standard? • Training and education of the judges process? • What is the current position of the EPO on sufficiency? • When can you start making applications for the unitary patent • How could it result in more litigation? • How much data do you really need to support the breadth • How and where exactly to opt out – who manages the process? • What are the sanctions for non-compliance? of your claim? • Transparency of opt outs – will there be a register? • Who will police it and how likely are sanctions to be enforced? • How can we resolve anticipated disputes over who owns and Chair’s Closing Remarks and Conference Adjourns 17:10 Reconciling the UPC and the European Patent Office profits from an invention? • What are the implications for non US ratification on products 12:00 Dr Pierre Treichel, International Legal Affairs, researched in the US but later marketed worldwide? European Patent Office
• How will the EPO and the Unitary Patent Regime work 16:50 Chair’s Closing Remarks and End of Conference together? • The role of the EPO and new tasks • State of play of implementation: work of the Select Committee • How will we reconcile and relate unitary patent court decisions to decisions made by the EPO?
Join the Conversation @C5Live #C5LifeSciences WEBCAST WHO SHOULD ATTEND? Can’t take time out of the office? Attend the conference C5’s 8th Conference on Biotech & Pharmaceutical Patent Litigation from the convenience of is an Unmissable Event for: your home or office. Save Pharmaceutical and Biotech • Patent Counsel/Attorneys and Managers money on travel and view the Companies: • Patent Managers conference according to your • In-House General Counsel • Head of R&D own schedule. This interactive • Heads/Directors of IP, Patents and live webcast allows you to Legal Affairs Private Practice Lawyers and Patent Attorneys specialising in: participate in the sessions • VP/SCP of Patents • IP and Patent Litigation as they occur, download • IP Counsel and IP Managers hand-outs, and ask speakers • Life Sciences/Pharma and Biotech questions. If you can’t watch the live Sponsored by: Executive Sponsors: Brinkhof (Amsterdam) has a strong focus on feed, the recorded archives of innovation, technology and market regulation. The firm is particularly strong in coordinating parallel European the presentations will also be Associate Sponsors: litigation and has the biggest litigation team in the Dutch market. Brinkhof is actively involved in shaping the future of European patent litigation under available for you to view for the UPC; the firm’s lawyers are frequently consulted by EU and national Taylor Wessing is a leading (Dutch) legislators on this subject, speak at international conferences, and 45 days after the conference international law firm. We think are active in the EPO’s training program for UPC candidate judges. In Pharma creatively about business issues and are constantly looking for new and & Biotech, Brinkhof works both for originators and generics. is over, so you can re-watch better ways to add value with truly innovative solutions that help to grow our clients’ businesses. Our Patents group is one of the largest and best At Fitzpatrick, IP is not just a practice area – it is our sessions, or view any sessions known in Europe. Highly experienced in both contentious and noncontentious sole focus. We have one of the premier patent litigation patent matters, we help our clients, based in Europe and internationally, and prosecution practices and consistently appear in you may have missed. exploit, protect, manage and defend their IP rights. We serve knowledge- the list of top litigation and patent prosecution firms. based and technology rich businesses operating across a variety of industry Our practice is dedicated exclusively to intellectual property (“IP”), and we cover the spectrum of intellectual property services, including applying sectors including pharmaceuticals, technology and telecoms, biotechnology, for patent and trademark protection, litigation, appeals, interferences, chemicals, medical devices & equipment, electronics & software, automotive post-grant challenges (e.g., IPRs), alternative dispute resolution, licensing, GLOBAL SPONSORSHIP and the energy sector. opinions, corporate transactions and due diligence. OPPORTUNITIES Ropes & Gray is one of the world’s premier law firms, Wragge Lawrence Graham and Co is a UK — with approximately 1,100 lawyers serving clients in C5 works closely with headquartered UNPARALLELED IP®. international law major centers of business, finance, technology and government. The firm firm providing a full range of legal services to clients has offices in New York, Washington, D.C., Boston, Chicago, San Francisco, Silicon Valley, London, Hong Kong, Shanghai, Seoul and Tokyo. sponsors to create the worldwide. The partner-led firm delivers top-quality legal advice and with experts across the world, it has perfect business development the resource, relationships and expertise to handle Session Sponsors: solution catered exclusively the largest instructions. A trusted adviser to FTSE 100 and 250 companies, Carpmaels & Ransford has one of the multi-national corporations, financial institutions, and UK and overseas largest and highly regarded Life Sciences IP to the needs of any practice government departments, Wragge Lawrence Graham & Co’s experts deal teams in Europe, consistently topping industry rankings, and handling the full with day-today issues and complex, strategic matters. spectrum for Life Sciences patents (including patent drafting, prosecution, opposition and litigation, and SPCs). Our quality pedigree traces back to group, business line or On 8 July 2015 Wragge Lawrence Graham & Co. LLP announced it will be the inception of the biotechnology industry, and our enviable experience of merging with Canadian firm, Gowlings, on 1 January 2016, to form a new handling the most complex work achieves great results for our clients. corporation. With over 300 firm called Gowling WLG. SMART & BIGGAR/FETHERSTONHAUGHis conferences held in Europe, Canada’s largest and highest-ranked firm practising exclusively in intellectual property and Russia and the CIS, China, Clifford Chance is one of the world’s technology law. Our experience is unmatched and our goal is unwavering: to pre-eminent law firms with significant provide our clients with UNPARALLELED IP®. India, the US and Canada, depth and range of resources across five continents. As a single, fully integrated, global partnership, we pride Sponsor: C5 provides a diverse ourselves on our approachable, collegiate and team based way of working. We believe in a relationship-oriented trusted advisor’s approach and on The firm, Subramaniam & Associates (SNA) portfolio of first-class events specialising in industry sectors to provide the highest level of client service founded by highly qualified and experienced available. Our Healthcare & Life Sciences Sector group advises leading professionals, commenced its practice tailored to the senior level multinational companies on the full range of industry matters, from M&A and on April 01, 1998. The firm specialises in intellectual property laws, viz., joint ventures to litigation and regulatory compliance. For more information, patents, trademarks, designs, copyright and domain name related issues. executive. visit www.cliffordchance.com It is equipped to provide complete and highly cost effective services from drafting, filing and prosecution of applications to searches, oppositions To find out how to position and enforcement. The total staff strength of the Firm is 50 of which 19 are highly qualified attorneys. It has an excellent network of associates and your firm as an industry correspondent counsels world-wide. leader by sponsoring this Media Partners: event, please contact Chris Murphy on +44 (0)20 7878 6955 or email [email protected]
©C5, 2015 a C5 Group Company +44 (0) 20 7878 6888 | C5-Online.com/PatentLitigation Business Information in a Global Context 14th & 15th March 2016 C5 The Wyndham Apollo Hotel Business Information in a Global Context Amsterdam, Netherlands a C5 Group Company
C5’s 8th Conference on PHARMA & BIOTECH PATENT LITIGATION
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