The US Patent Reform for Life Science Companies - C5

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16.10 Thinking Ahead: How Will your Strategies Need to Change in Light of the New Initiatives and Reforms of EU and US Patent Laws 6Panel Session Javier Vera, Deputy Director of Patent Department, Oficina Española de Patentes y Marcas (the Spanish Patents and Trademarks Office) Francesco Macchetta, Director IP, Bracco Group (Italy) Dr. Frank Burkert, European Patent Attorney, Bayer Healthcare (Germany) Prof. Dr. Li Westerlund, Vice President, Global IP, Bavarian Nordic Group (US) • Latest discussion on an “EU patent” and “unitary court system” • Evaluating the potential impact of an EU patent system on the internal practices of biotech companies • Distinguishing the two systems: European Patent Convention and EU Law • Update on the new US Patent Reform - Key developments of the America Invests Act: transition to “first-investor-to –file”, post-grant review proceedings and its impact on U.S. litigation - What impact will it have for the biotech industry How will the industry deal with increased work load and costs 17.20 Chairman’s Closing Remarks and End of Day One Main Conference Day Two: 15 March 2012 9.00 Chair’s Opening Remarks Allen Norris, Vice President, Head Group IP, UCB Pharma (Belgium) 9.05 Patentability of Gene Sequence Patents in Europe and the US Tim Powell, Partner, Powell Gilbert LLP (UK) European Developments • Outcome of Lilly v HGS in the UK Supreme Court and EPO • Relationship between enablement, industrial applicability and obviousness • Examining underlying policy concerns • Addressing the enforceability of gene sequence patents - implications of the CJEU decision in Monsanto v Cefetra US Developments Jennifer Gordon, Ph.D., Partner, Baker Botts (US) The United States Court of Appeals for the Federal Circuit has recently rendered decisions in the Myriad, Prometheus and Classen cases that impact the patent eligibility of DNA sequences (and other biomarkers). These decisions further impact the patent eligibility of diagnostic and therapeutic methodologies that are based on a correlation between a biomarker and an important piece of medical information. This session will explore: • The standards set by the Federal Circuit and the U. S. Supreme Court under 35 USC 101 - for patenting biological compositions of matter - for patenting processes or methods that involve a law of nature, a physical phenomenon or an abstract idea • Whether the U. S. Supreme Court will agree with the Federal Circuit’s analysis in Prometheus, which was based on the transformation prong of the “machine or transformation test” articulated in Bilski • Whether the U. S. Supreme Court will likely hear an appeal in the Myriad case and what the likely outcome may be • What the impact on the U. S. biotechnology and pharmaceutical industries may be, particularly with respect to the area of personalized medicine, if biomarkers and/or methods based thereon are deemed unpatentable by the U. S. Supreme Court • Whether the controversies in this area of law ultimately boil down to claim language and claim interpretation, and how best to draft claims that will pass the patent eligibility hurdle of 35 USC 101 and stand up in litigation 10.10 Examining Case Law Developments in Double Patenting EU Perspective: Dr. Christoph Rehfuess, European Patent Attorney, Director Intellectual Property, MagForce (Germany) • Addressing double patenting at the EPO • Clarifying the legal framework for filing divisional applications • Analysing recent case law of the Enlarged Board of Appeals relating to double patenting (G 1/05 and G 1/06) • Implementation by the Technical Boards starting from T 307/03 and T 1423/07 • Procedural consequences for the practice and open questions US Perspective: Marian Flattery, Of Counsel, Finnegan (US) • Clarifying double patenting and obviousness following the the refusal of grant certiorari in Eli Lilly & Co. v. Sun Pharmaceutical Industries Ltd. - utilizing obvious-type double patenting claims as a litigation tool - investigating the policy implications of patents whose terms are extended well-past twenty years and are vulnerable to invalidation by a double patenting finding - what are the issues that may influence an obviousness rejection • Discussing double patenting standards - understanding the implications of disclosures in the specification for double patenting - considering the public policy implications of double patenting following Amgen v. Roche - dissecting the dichotomy between strict statutory interpretation and policy considerations following Lilly v. Sun 11.10 Refreshment Break 11.30 To Divide, or Not to Divide, That is the Question. Unity of Invention and Divisional Applications Dr. Miranda van Heusden, Examiner in Biotechnology, European Patent Office • Examining recent practice on the evaluation of unity of invention in biotechnology • Addressing implications for applications covering more than one invention • Filing of divisional applications: - recent rule changes and their practical implications for the practitioners - time frames for filing divisional applications - the issue of double patenting and the use of disclaimers 12.10 Adopting New Patenting and Marketing Strategies to Overcome the Challenges of Filing your SPC Applications at an Earlier Stage Dr. Thierry, Calame, Partner, Head of Intellectual Property, Lenz & Staehelin (Switzerland) • Recent SPC cases referred to the CJEU and opinions by the Advocate General - Medeva BV - Georgetown University - Yeda Research and Development Company Ltd - Neurim Pharmaceuticals (1991) Ltd - Merck Sharp & Dohme Corp. • Overview of current requirements for SPC applications • Devising effective SPC filing strategies to overcome challenges based on recent case law 12.50 Lunch To register call +44 (0) 20 7878 6888 OR fax +44 (0) 20 7878 6885
13.40 Dosage Regimes: A Therapeutic Method Dr. Marc Markus, Head of Patents Biotherapeutics East, Pfizer (France) • Addressing the exception of patentability of therapeutic methods in Europe • Examining current EPO and EP national case law on dosage regimens • Comparing approaches to dosage regimes in the national Courts • To what degree have EU national courts achieved a common interpretation of the provisions in the EU Patent Convention on dosage regimes • Discussing dosage regimen claims in the context of personalized medicine & biomarkers 14.20 Understanding the “Person Skilled in the Art” Concept when Litigating Patents Isabelle Romet, Partner, Vėron& Associės (France) • General criteria for determining the “person skilled in the art” - what are the deviations in approaches taken by the various EU national courts • Applying the judgment by Kitchen J in Astrazeneca (Esomeprazole) • How can you present the skilled person into evidence • Where you are permitted to have a “person skilled in the art” to give expert evidence, what are the requirements - requirements in UK proceedings - approach by other EU national Courts • How can you use the same expert in more than one jurisdiction 15.00 Reviewing Recent Case Law Developments Regarding Reverse Payment Settlements Andrzej Kmiecik, Partner, Van Bael and Bellis (Belgium) • Review of the recent 2nd monitoring report by the European Commission • Update on the review of Servier by the European Commission • Recent US case law developments on reverse payment settlement agreements • Distinguishing the US approach with developments in Europe 15.40 Refreshment Break 16.00 The Current Stance on Nanotechnology for Medical Devices in Europe Thomas Adocker, Partner, Schwarz Schönherr Rechtsanwälte (Austria) Andreas Wildhack, Partner, Wildhack & Jellinek (Austria) • Introduction to legal problems of nanotechnology and medical devices - protection - regulation - liability • Using nanotechnology for medical devices • What are the approaches to nanotechnology in the various EU national patent offices - review of the recent decisions • EPO approach to patent applications for nanotechnology 16.50 Latest Biotech Patenting Regulatory Changes and Developments in India Hari Subramaniam, Patent & Trademarks Attorney, Subramaniam, Nataraj & Associates (India) • Recent case law developments and their potential impact on other jurisdictions • How to protect and enforce your patents in India - what aspects of the EU and US patentability criteria are followed • Sufficiency of disclosure • Novelty considerations • Defending patent infringements in India 17.30 Chairman’s Closing Remarks and End of Conference “ Level of detail was just right. Very Useful.” M Rees, IP Manager, Podermed (past delegate to Biotech Patenting Munich) “I would highly recommend this conference to colleagues. The presentations and presentation material were very helpful.” Gabriel McCool, Edwards Angell Palmer & Dodge (past delegate to C5’s Biotech Patenting forum in Munich) POST-CONFERENCE WORKSHOP: 16 MARCH 2012 | 9.00am – 12.30pm Strategies for Claiming Commercial Products in your Biotech Patent Applications Workshop leaders: Dr. Leo Polz, Partner, Hoffmann Eitle (Germany) Based on the knowledge gained in the previous two days this practical workshop will address the more complex areas of patent application strategies for commercial biotech products. Areas to be examined will include, but are not limited to: • Determining what biotech products are already on the market • What are the examiners looking for • Identifying what prior art should be cited • Fall-back positions for possible later amendments • How much and what kind of experimental data is needed to support certain types of claims • Structuring your claims with attention to detail - When to file broad and when to file more narrow claims - How to ensure a broad scope of protection • Examples of best practice strategies from recent cases Benefit from interactive delegate participation: The emphasis throughout the workshop will be on practical examples, hands-on exercises and interactive discussions. ©C5, 2011 Fax order form to +44 (0) 20 7878 6885 or register online at www.C5-Online.com/biotechpatenting 7
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