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. Associate Sponsors: Executive Sponsors: Session Sponsors: Sponsor: 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 CONFIRM YOUR PLACE TODAY 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