Clinical Innovation: Fair and Effective Incentives for New Uses of Established Drugs
8:30 am, 08 February 2018 to 5:30 pm, 09 February 2018
A conference organised by Professor Sir Robin Jacob at UCL and Professor Jay Thomas at Georgetown University Law Center.
Georgetown Law Center, 600 New Jersey Ave NW, Washington DC
BY INVITATION ONLY
About the conference - Our Mission Statement
New medicines have to go through a very risky, expensive and time consuming testing process before can get “regulatory approval” as it is called. The key questions for getting such approval are two: Does the medicine actually work? What are its side effects? If a new medicine can pass these tests, then it will get regulatory approval – but only for the condition or disease for which it has been tested. And the risk does not end here: many drugs prove to be commercial failures, and sometimes drugs have to be withdrawn from the market because of later discovered side effects leading to costly product liabilities.
The immense expense and risk of getting regulatory approval for a new medicine is supported by the patent system. Patent laws allow the patenting of new medicines. A patent monopoly justifies the expense and risk undertaken by pharma companies. To give an idea of that expense and the time involved we are talking of well over $1billion and a period of 12 to 15 years or more.
So far so good. But what about potential new applications – for different diseases – of medicines which have already got regulatory approval for a particular disease and are on the market for that? Here things are not good. There is a mass of evidence showing that, if the necessary development work were undertaken, many existing medicines could well be used for treating diseases or conditions in addition to those for which they initially got approval. Sometimes for instance a doctor reports that he is using medicine A to treat disease X and has noticed that some patients who also have disease Y seem to respond well to the treatment as regards Y. Or a major pharma company which has a medicine A which has regulatory approval for a cancer type X might want to investigate whether it works for cancer type B.
The amount of work and time involved in investigating a new use for an established medicine is quite a lot less than investigating a wholly new medicine. But it is not trivial – maybe $½ billion and 5 years. By and large pharma companies cannot justify the expense and risk of this. So the work is not done – and we never know or find out whether medicine A will really work on disease Y.
The law of most countries simply does not provide either any or a sufficient incentive to carry out research into new uses for existing medicines. If a company decided to investigate and get approval for a new use for an existing medicine, what would happen? The medicine is already on the market and may well be out of patent or nearly so. The medicine is open to generic competition (rightly so) and prices fall. It no longer commands a price which justifies the investment into researching the new use. So no one does it.
It is true that some countries provide some sort of patent protection for novel and inventive second medical uses, but that is not good enough for several reasons
- because in many cases the second use is not novel or inventive,
- there are obvious practical difficulties in having the medicine on the market at a low price for the old, patent expired, use and at the same time at a higher price for the new use, and
- the cheaper generic product may be used for the patent-protected indication.
This conference will explore:
- How big is the problem? How many opportunities for potential new uses are not being followed up?
- How can a way be devised for incentivising research into new uses for known medicines which fairly allows cheap generic medicines for the old use and yet rewards the result of successful research into a new use.
The problem, if solved, would be a huge benefit to mankind. New and better treatments for a wide range of diseases and conditions at a much cheaper price than the cost of a wholly new medicine – and with much less regulatory delay.
- The Programme and Slides
Thursday 8 February 2018 08:30 Welcome and Introduction
Professor Jay Thomas Georgetown University
Professor Sir Robin Jacob UCL
Second Medical Use: Missed opportunities, clinical successes & what the data tells us about missed opportunities
Moderator: Marsha Rose Gillentine Sterne Kessler
Prof. Mondher Toumi University of Marseille
- Prof. Graham Russell NDORMS, University of Oxford
- Dr David Cavalla Numedicus
- Dr Amitava Banerjee UCL Farr Institute of Health Informatics
The Regulators' Perspective
Moderator: Brian Cordery Bristows LLP
- Sir Alasdair Breckenridge Former Chair of MHRA, UK
- Stefano Marino Head of Legal, European Medicines Agency
- Daniel Kracov Arnold & Porter Kaye Scholer LLP
10:10 Break 10:30
A critical review of the current landscape - Presentations
- Gareth Morgan CMS Cameron McKenna Nabarro Olswang LLP
- Daniel Kracov Arnold & Porter Kaye Scholer LLP
- Elaine Herrmann Blais Goodwin Proctor LLP
- Christoph de Coster Taylor Wessing LLP
Examples of Success – The Lyrica Story in Denmark
Moderator: Dr. Thomas Hirse CMS Hasche Sigle
Sture Rygaard Partner, Plesner
- Dr Jane M Love Gibson Dunn
- Dr Trey Powers Sterne Kessler
- Dr Ute Kilger Boehmert & Boehmert
A Critical Review of The Current Landscape - Discussion
Moderator: Dr Ute Kilger Boehmert & Boehmert
- Arti Rai Professor of Law, Duke University
- Rebecca Eisenberg Professor of Law, Michigan University
- Ben Roin Fred Kayne (1960) Career Development Professor of Entrepreneurship, MIT Sloan School of Management
- Todd Volyn Patent Attorney, Johnson & Johnson
- David Kappos Partner, Cravath, Swaine & Moore LLP
- James Horgan Head of European Patents, Merck Sharp & Dohme
13:25 Lunch 14:25
Moderator: Christina Schwarz Partner, Fitzpatrick Cella Harper and Scinto
Presenters and Panellists:
- Henry Grabowski Professor Emeritus of Economics, Duke University
- Margaret Kyle Professor of Cconomics, Center for Industrial Economics (CERNA)
- Alex Brill American Enterprise Institute
The Physician & Pharmacist
Moderator: Laetitia Benard Allen & Overy LLP
Presenters and Panellists:
- Janis Shute Professor of Pharmacology, University of Portsmouth
- Graham Russell Emeritus Professor of Musculoskeletal Pharmacology, NDORMS, University of Oxford
- Jayne Lawrence Head of the Division of Pharmacy and Optometry at Manchester University
16:10 Break 16:30
The Payor’s Perspective: Regulating to incentivise value creation and repair a failed market
Moderator: Nancy E. Taylor Greenberg Traurig LLP
Dr David Cavalla Numedicus
- Peter Neumann Professor of Medicine, Tufts University School of Medicine
- Sergio Napolitano Director, Legal & External Relations, Medicines for Europe
- Erik Komendant VP, Federal Affairs, Association for Affordable Medicines; formerly Head of Policy, AHIIP
17:30 Reception Friday 9 February 2018 08:30 Introduction to Day Two
Professor Sir Robin Jacob UCL
Jürgen Dressel Head of Global Patent Litigation Strategy, Novartis Pharma
Alternative incentives to patents
Moderator: Robert Trenchard Gibson, Dunn & Crutcher LLP
- Constance Bagley Senior Research Scholar, Yale School of Management, and CEO and Founder, Bagley Strategic Consulting Group LLC.
- Prof. David Ridley Faculty Director, Duke University Health Sector Management Program
- Dr Bruce Bloom CEO, Cures within Reach
- Otto Licks Licks Legal
What does the “ideal system” look like?
Moderator: David Barr Arnold Porter Kaye Scholer
Bob Armitage IP Strategy and Policy Consultant; Formerly General Counsel, Eli Lilly
- David Korn VP IP & Law, Pharmaceutical Research and Manufacturers of America (PhRMA)
- Toni Santamaria Head of IP (Europe), Accord Healthcare
- Mark Steward Assistant General Patent Counsel, Eli Lilly
- Ben Roin Fred Kayne (1960) Career Development Professor of Entrepreneurship, MIT Sloan School of Management
10:35 Break 10:55
Plausibility and Second Medical Use Patents
Moderator: Jane M. Love Gibson, Dunn & Crutcher LLP
- Frits Gerritzen Allen & Overy
- Charlotte Jacobsen Fitzpatrick Cella Harper Scinto
- Barry Schindler Greenberg Traurig
- Michael Eder DF-MP
The politics of incentivising SMUs – Presentation & Discussion
Moderator: Sarah Frederick Goodwin Proctor LLP
Prof. David Ridley Faculty Director, Duke University Health Sector Management Program
- Francois Houyez Director of Treatment Information and Access, Policy Advisor, EURORDIS
- Suzanne Munck Chief Counsel for Intellectual Property for the United States Federal Trade Commission (FTC), and Deputy Director of its Office of Policy Planning
- Tim Molino Peck Madigan Jones
12:40 Lunch 13:40
Examples of clinical success
Moderator: Brian Cordery Bristows
- Francois Houyez Director of Treatment Info & Access Policy Advisor at EURORDIS and patient activist
- Prof. Michelle Petri Director, Hopkins Lupus Cohort
- Dr Bruce Bloom CEO, Cures within Reach
Should the US system be changed
Moderator: Paul Ainsworth Sterne Kessler
Prof. Erika Lietzan University of Missouri Law
- Hans Sauer Vice President for Intellectual Property, Biotechnology Innovation Organization
- Kurt Karst Director, Hyman Phelps & McNamara PC
- Brian Hirsch Vice President Global IP and Legal Head North America at Glenmark Pharmaceuticals
- Dolly Judge Vice President, U.S. Government Affairs, Teva Pharmaceuticals
15:20 Break 15:40
The impact of technology and large databases on the development of new medicines from existing drugs
Moderator: Felix Frueh OpusThree
- Dr Tony Altar Chief Scientific Officer and Senior Vice-president, at Verge Genomics, Inc
- Dr Iris Grossman VP, Head of Early Stage Development, CMO organization, R&D, Teva Pharmaceuticals
Moderator: Karl-Heinz Metten Boehmert & Boehmert
- Prof. Sir Robin Jacob UCL
- Judge Rian Kalden Senior Judge, Court of Appeal, The Hague
- The Hon Arthur Gajarsa former United States Circuit Judge of the United States Court of Appeals for the Federal Circuit
- The Hon Roger Hughes QC
17:30 Closing Remarks
- The Speakers
Tony Altar brings 35 years of experience in CNS drug discovery and development to Verge. He has published over 135 papers in journals including Science and Nature. As Global Head of Neuroscience at Otsuka, he led the team that discovered Abilify, the highest grossing drug worldwide in 2014, and elucidated its mechanism of action, enabling first-in class, FDA-approved uses in bipolar disease, depression, and schizophrenia. As Chief Scientific Officer at Assurex Health, he created pharmacogenomic products for ADHD and pain, and commercial successes yielded an acquisition by Myriad Genetics in 2016. As CSO and President of Psychiatric Genomics, his teams pioneered genomic-based drug discovery to find validated targets for schizophrenia. Dr. Altar led the Biomarkers Consortium for the foundation for NIH, and held positions at Regeneron where he co-founded their vision program, and Genentech. He obtained his bachelors at UCLA, PhD in Psychology at UC Santa Barbara, and held a post-doctoral position in Psychobiology at UC Irvine.
Robert A. Armitage is a consultant, IP Strategy & Policy, based in Marco Island, Florida. Bob consults on patent strategy and policy issues. He is a past chair of the IPL Section of the American Bar Association and past president of the American Intellectual Property Law Section. He earned a J.D. degree from the University of Michigan Law School, an M.S. in physics from the University of Michigan and a B.A. in physics and mathematics from Albion College
Constance E. Bagley is a Senior Research Fellow at Yale School of Management where she was previously Professor in the Practice of Law and Management and a Senior Research Scholar at Yale Law School. Prior to that she was an Associate Professor of Business Administration at Harvard Business School, Senior Lecturer in Law and Management at Stanford Graduate School of Business, and a Partner at Bingham McCutchen LLP. She received her A.B. with Honors and Distinction from Stanford University, her J.D., magna cum laude, from Harvard Law School, and an honorary doctorate in economics from Lund University. Her recent articles include (with Christina D. Tvarnø) “Pharmaceutical Public-Private Partnerships: Moving from the Bench to the Bedside,” Harvard Business Law Review, and “Promoting ‘Academic Entrepreneurship’ in Europe and the United States: Creating an Intellectual Property Regime to Facilitate the Efficient Transfer of Knowledge from the Lab to the Patient,” Duke Journal of Comparative and International Law. She is also CEO of the Bagley Strategic Consulting Group LLC.
After qualifying from Oxford Medical School, Ami trained as a junior doctor in Oxford, Newcastle, Hull and London. His interest in preventive cardiology and evidence-based medicine led to a Masters in Public Health at Harvard(2004/05), an internship at the World Health Organisation(2005) and DPhil in epidemiology from Oxford(2010). He was Clinical Lecturer in Cardiovascular Medicine at the University of Birmingham, before taking up the position of Senior Lecturer in Clinical Data Science and Honorary Consultant in Cardiology at the UCL Farr Institute of Health Informatics in August 2015. In addition to training in all aspects of general cardiology, he has sub-specialised in heart failure. He is Clinical Lead for Education at the Health Informatics Unit, Royal College of Physicians of London. He has a long-standing research and policy interest in access to medicines and has particular expertise in cardiovascular drugs in the Indian context.
Elaine Herrmann Blais
Elaine Blais, head of the Litigation Department in Goodwin’s Boston office, focuses her practice on intellectual property litigation, particularly with respect to patent litigation in the pharmaceutical industry. Ms. Blais has extensive experience representing pharmaceutical companies in infringement lawsuits in federal courts nationwide. Ms. Blais is the co-founder and editor of the firm’s publication Biosimilars: A Guide to Regulatory and Intellectual Property Issues and of www.bigmoleculewatch.com, the blog dedicated to covering developments in the biosimilars space.
Dr. Bruce Bloom is CEO of Cures Within Reach, a non-profit saving lives by repurposing human approved drugs, devices, diagnostics and nutraceuticals to quickly deliver safe and affordable treatments and cures for diseases that have no currently effective therapy. Dr. Bloom is an Ashoka Social Entrepreneur Fellow, the Patient Advisory Board Chair for the Institute for Translational Medicine, board member of the Drug Discovery Center at the University of Illinois, member of the Vanderbilt Institute for Clinical and Translational Research External Advisory Board, the Director of Scientific Affairs for Vision for Tomorrow, and is on the Science Advisory Boards of Rediscovery Life Sciences, the GARROD AKU Consortium, the Dr. Ralph and Marian Falk Medical Research Trust Awards Programs, the Findacure Fundamental Disease Charity, and Healx, LTD, and a member of the editorial board of ASSAY and Drug Development Technologies
Sir Alastair Breckenridge
Sir Alasdair Breckenridge was Chairman of the Medicines and Healthcare products Regulatory Agency which was formed in April 2003 by the merger of the Medicines Control Agency and the Medical Devices Agency. Previously he was Chairman of the Committee on Safety of Medicines and Professor of Clinical Pharmacology in the University of Liverpool. He is now Chairman of the Advisory Board of the Centre of Regulatory Excellence of Duke/NUS in Singapore. He was knighted in 2004.
Alex Brill is a resident fellow at the American Enterprise Institute and the founder and CEO of Matrix Global Advisors, an economic policy consulting firm in Washington, DC. Previously, Alex was the policy director and chief economist for the House Committee on Ways and Means, where he worked from 2002 to 2007. At Ways and Means, Alex directed policy development and led negotiations on a variety of tax, health, pension, and trade matters. He has also served on the staff of the White House Council of Economic Advisers.
David Cavalla has 31 years experience in various senior scientific and commercial roles within the pharmaceutical industry. He is one of the first advocates of drug repurposing, and has used this strategy to create three first-in-class developmental products to have successfully passed human proof of concept clinical stages.
He is author of Modern Strategy for Pharmaceutical R&D — Towards the Virtual Research Centre, and Off-Label Prescribing: Justifying Unapproved Medicine. He frequently contributes articles on pharmaceutical strategy and is on the editorial board of Drug Discovery Today. Formerly he was Chairman of the Society for Medicines Research. He obtained a first degree and PhD at Cambridge University and spent two years as a visiting Fellow at the NIMH, Washington, DC. He is author/inventor of over 70 published papers and patents.
Christoph de Coster
Christoph de Coster is a member of Taylor Wessing’s Patent group. He specializes in advising national and international clients in the life sciences and healthcare sector on cross border patent litigation and IP-related transactions. Recent successes include the representation of a pharmaceutical company before the Supreme Court; the defense of a medical device company against three infringement actions before the Düsseldorf and Mannheim District Courts; the enforcement of a printing plate patent before the Düsseldorf Appellate Court and the German Supreme Court.
Christoph studied Law in Munich, Paris and at the University of California (Davis) where he obtained an LL.M. in Intellectual Property. He passed the New York bar exam in 1998. Christoph is a member of German Association for IP & Copyright; VPP (Association of Intellectual Property Experts); and Licensing Executives Society. He frequently lectures on patent-related topics in the life sciences area.
Jürgen Dressel is responsible for the global litigation strategy at Novartis Pharma IP with focus on patents. He started his chemistry studies in Germany, got a PhD in organic chemistry from the Ohio State University in Columbus, Ohio, USA, and did a postdoc in bioorganic chemistry at the ETH Zurich. He worked as a medicinal chemist at Bayer Pharma Research for nine years until 1997 before he moved to the patents department and qualified as a European Patent Attorney. In 2002 he joined the Generics group in the Novartis patents department, in 2004 returned to the originator business and became responsible for Patents Primary Care which included the cardiovascular, metabolic, respiratory, dermatological, arthritis, gastro-intestinal and neuroscience disease areas. From 2007 to 2014 he headed the patent litigation outside the US, and in 2014 he switched to his current role. Jürgen’s main experience is preparing for and executing patent litigation between originators and generics.
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Dr. Michael Eder is a partner of the boutique IP law firm df-mp in Munich, Germany. He is a German and European Patent Attorney and heads the Chemistry practice group. Dr. Eder advises clients in all aspects of intellectual property, with an emphasis in the areas of pharmaceuticals, industrial chemistry and protein biochemistry. His scientific background includes the fields of biophysical, organic und inorganic chemistry, as well as molecular biology. An important part of his practice relates to rendering patent validity and non-infringement opinions in connection with due diligence and freedom-to-operate projects in multiple jurisdictions. He has been involved in a number of national and multinational patent litigation cases in the pharmaceutical area and is responsible for a number of opposition proceedings before the EPO.
Dr. Eder has been an invited speaker at several legal conferences and has organized workshops with EPO Examiners on topics of interest, particularly in the area of pharmaceuticals.
Rebecca S. Eisenberg, the Robert and Barbara Luciano Professor of Law, specializes in patent law and the regulation of biopharmaceutical innovation. She teaches courses about patent law, trademark law, international intellectual property law, and FDA law. She has written and lectured extensively about the role of intellectual property in biopharmaceutical research, publishing in leading law reviews and scientific journals. Professor Eisenberg has played an active role in public policy debates concerning the role of intellectual property in biopharmaceutical research, advising the National Institutes of Health and the National Academies of Science. She is a graduate of Stanford University and Boalt Hall School of Law at the University of California, Berkeley, where she was articles editor of the California Law Review. Following law school she served as law clerk for the Hon. Robert F. Peckham of the U.S. District Court for the Northern District of California and then practiced law as a litigator in San Francisco. She joined the Michigan Law faculty in 1984.
Sarah Frederick represents clients at Goodwin Proctor in complex product liability mass torts, antitrust multi-district litigation and putative class actions, and challenges to agency actions at the trial and appellate levels. She devotes much of her practice to representing pharmaceutical clients in complex products liability mass torts and antitrust putative class actions, particularly those that require specialized knowledge of the regulatory framework for the pharmaceutical industry. Ms. Frederick also advises pharmaceutical companies on litigation avoidance, including assisting companies with clinical trial preparation, informed consent documentation and labeling. She has been recognized by The Legal 500 as a Next Generation Lawyer for Product Liability: Pharmaceuticals & Medical Devices and by Benchmark Litigation’s Under 40 Hotlist for the most promising emerging talent in litigation. She also serves on the ABA’s Mass Torts Subcommittee on Multi-District Litigation and Class Procedures. Sarah has a J.D. from North Carolina School of Law and a B.A. from Duke University.
Judge Arthur Gajarsa
Arthur J. Gajarsa joined WilmerHale as Senior Counsel in 2013. Judge Gajarsa was appointed to the U.S. Court of Appeals for the Federal Circuit by President William J. Clinton in 1997. Prior to his appointment, he was a partner in the Washington, DC law firm of Joseph, Gajarsa, McDermott and Reiner, P.C. from 1987 to 1997. From 2003 to 2012, Judge Gajarsa was an Adjunct Professor of Law at the Georgetown University Law Center. In June 2012, he was appointed the Jurist in Residence at the University of New Hampshire School of Law. He served as Law Clerk to Honorable Joseph McGarraghy, United States District Court for the District of Columbia from 1967 to 1968. Judge Gajarsa received a B.S.E.E. from Rensselaer Polytechnic Institute in 1962, an M.A. from Catholic University of America in 1968, and a J.D. from Georgetown University Law Center in 1967. Judge Gajarsa retired from the U.S.
Court of Appeals for the Federal Circuit on July 31, 2012.
Frits heads Allen & Overy Amsterdam’s Intellectual Property team. He is an experienced IP litigator, handling cases concerning the enforcement and validity of intellectual property rights. He focuses in particular on patents in the life sciences sector. Frits has broad experience in handling cross border patent cases involving medical equipment and pharmaceuticals. One of his cases set an important precedent in the Netherlands on the issue of protection of pharmaceutical inventions near the end of the patent’s life time. He also provides strategic advice on cross border IP & Tech disputes, and IP heavy transactions. Frits is one of the chief editors of the main Dutch website on IP news (IE-forum.nl).
Henry Grabowski is Professor Emeritus and Director of the Program in Pharmaceuticals and Health Economics at Duke University. He has studied the economics of the pharmaceutical industry over much of his career and has published numerous articles and books on the industry. His publications address the economics of drug innovation, R&D costs and returns, industry competition, and government regulatory policies. He has testified on several issues before Congressional committees including effective patent life and generic competition, biosimilar regulations, the Clinton Administration’s health reform legislation, and the Children’s Vaccine Program. He has been advisor and consultant to the National Academy of Sciences, the Institute of Medicine, the Federal trade Commission and the General Accounting Office. He has held visiting scholar appointments at the International Institute of Management in Berlin, Germany, the Health Care Financing Administration in Washington, DC and the Office of Health Economics in London, England.
Dr. Iris Grossman, VP, Global Head of the Early Stage Clinical Development unit in Teva Global R&D, has dedicated her research career to the advancement of the field of personalized medicine. In her current position she leads a novel model of patient-centric R&D, integrating active physician and patient involvement, as well as collaborative pharmacometric, bio- and digital-marker methodologies into early discovery phases through to enhanced probability of success for proof-of-concept assets.
Prior to joining Teva, Dr. Grossman was CEO and president of the pharmacogenetics management consultancy IsraGene Ltd., providing services to both the pharma and biotech sectors. In academia, Dr. Grossman was a key member of Professor David Goldstein’s team at the Center for Population Genomics and Pharmacogenetics, Institute for Genome Sciences and Policy, at Duke University.
Brian Hirsch is Vice President, Global IP and Legal Head North America for Glenmark Pharmaceuticals. Brian leads Glenmarks’ Global IP team and is responsible for developing and implementing Glenmark’s IP strategy and associated Patent and Trademark Office activities, including its US Hatch-Waxman and rest-of-world patent litigation. Brian also leads Glenmark’s North American commercial legal activities. Prior to joining Glenmark, Brian worked at Sandoz Inc., where he was the Head of U.S. Patent Litigation. Prior to that, Brian worked for Teva Pharmaceuticals (via its acquisition of Cephalon), where he served most recently as Associate General Counsel. Earlier in his career, he worked in the Philadelphia offices of Dechert LLP. He has also clerked for the Honorable Walter K. Stapleton of the United States Court of Appeals for the Third Circuit.
James Horgan is Assistant Managing Counsel at Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. He heads the European Patent Department based in the United Kingdom. He has a degree in chemistry and has practiced extensively in the pharmaceutical, vaccine and biotechnological fields for over 20 years supporting research sites in England and Italy. He has wide experience of prosecuting applications before the EPO where he appears in ex parte and inter partes Oral Proceedings. He has filed and prosecuted a large number of SPCs. He has been involved in major multi-jurisdictional litigation for Merck in cases in the UK, Sweden, Belgium Germany, The Netherlands, Spain, France and Malaysia. He sits on the Board Sponsored Committee for Innovation of EFPIA and is President of the IP Federation. He was has been included in the IAM list of the World’s 300 Leading IP Strategists employed in industry since its inception in 2015, and is also one of Managing Intellectual Property’s Corporate IP Stars.
François Houÿez is working at the European Organisation for Rare Diseases EURORDIS where he is Director of Treatment Information and Access, and Policy Advisor (since 2003).
Francois has always worked as a patient advocate since the early 90s, joining Aids advocacy groups in France, Europe and internationally, as he was studying medicine. He represents EURORDIS at the Patients’ and Consumers’ Working Party at the European Medicines Agency (EMA) and in the European Network of Health Technology Assessment Agencies (EUnetHTA). He participated in the first meeting between patients and the European Medicines Agency in April 1996. François is also a patient
The Hon Roger Hughes
Roger Hughes joined JAMS after over a decade of experience as a judge on the Federal Court (Canada). He is a recognized expert in intellectual property matters and brings the perspective of a longtime federal practitioner—as advocate, judge and neutral—to each of his matters. As one of Canada’s foremost experts in IP law and, in particular, patent matters, Justice Hughes is also a registered patent agent.
Roger T. Hughes, Q.C., obtained his LL.B. at the University of Toronto in 1966 and is called to the Bar in both Ontario and Alberta. Prior to his appointment to the Federal Court of Canada in June 2005, Justice Hughes practised law in Toronto as an Associate and Partner at Sim, Hughes, Ashton & McKay and Sim & McBurney. He served as past President of the Patent and Trademark Institute of Canada and Director of The Advocates’ Society, and authors a variety of intellectual property treatises.
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Charlotte practices complex patent litigation concerning biotechnology, pharmaceuticals, and the chemicals arts, with an emphasis on litigation under the Hatch-Waxman Act. She has litigated cases concerning anti-cancer drugs, oral contraceptives, immunosuppressants, and drugs for treating high cholesterol, chronic kidney disease, Alzheimer’s disease, and Parkinson’s disease, including as lead trial counsel. Additionally, she has experience arguing before the United States Court of Appeals for the Federal Circuit and in inter partes review proceedings before the Patent Trial and Appeal Board, as well as in litigation pertaining to patent inventorship and arbitration before the ICC International Court of Arbitration.
Dolly A. Judge serves as Vice President, U.S. Government Affairs for Teva Pharmaceuticals, with responsibility for local, state and federal government relations for the company. Ms. Judge oversees the company’s interactions with government officials on legislative and regulatory matters and works to ensure access to Teva’s branded and generic medicines. Ms. Judge joined Teva in May of 2017, from Quest Diagnostics, where she served as the head of Government Affairs for the largest innovator in the clinical laboratory sector. While at Quest, Ms. Judge represented the company in negotiations in Congress over the reform of the Medicare Clinical Laboratory Fee Schedule, a market-based overhaul of the payment system for laboratory testing.
Prior to her four years with Quest Diagnostics, Ms. Judge headed Cigna's Washington, D.C. office, where she a led the company’s government relations activities following the passage of major health care reform, the Affordable Care Act. Ms. Judge spent ten years at Pfizer, with increasing roles and responsibilities for government affairs at the federal level, culminating in serving as Vice President of Government Relations. Ms. Judge was delighted to return to the biopharmaceutical sector and enjoys representing a company like Teva with such a broad portfolio of medicines. In the United States, one in every six prescriptions filled is a Teva medicine. Prior to joining the private sector, Ms. Judge served as a legislative assistant for U. S. Senator and a Member of the U.S. House of Representatives. She is a graduate of Southern Methodist University (Dallas, Texas) with a B.A. in English and History and a minor is Political Science. Ms. Judge is active on several charitable boards and volunteers in her community in McLean, Virginia.
Judge Rian Kalden
Rian is a judge in The Court of Appeal of The Hague in September 2013 where she now heads the Division that, among other areas, also covers all IP cases, including patent cases. Kalden graduated from Leiden University and has a Masters (including Intellectual and Industrial Property law at LSE) from Londen University in. In 1991 she joining the Amsterdam Bar with the law firm Stibbe, where she practised for almost 11 years in both the intellectual property and the company law departments. In 2002 she became a judge at the District Court of The Hague where she joined the Patent Chamber. From 2005 to mid 2008 she was a judge – in 2007 appointed vice president – at the District Court of Haarlem, where she joined the Criminal Division. Mid 2008 she returned to the Intellectual Property Division of the District Court of The Hague, from January 2009 as head of the Division. She speaks at national and international conferences on Patent law and related issues. She also acts as an arbitrator in NAI (Netherlands Arbitration Institute) arbitrations.
David Kappos is a partner at Cravath and a leader in the field of intellectual property. From 2009 to 2013, he served as Under Secretary of Commerce and Director of the U.S. Patent and Trademark Office. In that role, Mr. Kappos advised the President, Secretary of Commerce and the Administration on IP policy matters. Prior to the USPTO, he served as IBM’s Vice President and Assistant General Counsel for Intellectual Property from 2003 to 2009. Mr. Kappos has received numerous accolades for his contributions to the field, including being named one of the Top 25 Icons of IP by Law360.
Kurt R. Karst
Kurt R. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, paediatric testing, and orphan drugs. He helps clients develop strategies for product lifecycle management, obtaining approval, managing post-marketing issues, and defining periods of exclusivity. Mr. Karst’s knowledge of FDA precedents and timely analysis of developments helps clarify and shape the industry’s understanding of Hatch-Waxman, in particular. He is a prolific writer, contributing to the blog and publishing articles in major legal journals. Mr. Karst clerked for Hyman Phelps & McNamara while attending law school and served as articles editor for the American University Law Review. Before joining the firm, Mr. Karst lobbied for F. Hoffmann-La Roche Inc. In 1995, he was awarded a Fulbright Scholarship for post-graduate studies in Germany.
Ute is a partner at Boehmert & Boehmert. She is a member of the German Association for the Protection of Intellectual Property, the Association of Intellectual Property Experts (VPP), and the Licensing Executive Society. Additionally, she is the co-chair of the Global Series Committee of the Federal Circuit Bar Association. Furthermore, she has a seat on the Supervisory Board of the Deutschen Biotech Innovativ AG.
Ute Kilger assists pharmaceutical, biotechnology companies and academic institutes in all kinds of patent related issues concerning the obtaining and enforcement of property rights, due diligence, mergers and acquisitions, contract negotiations, and licensing agreements. She manages large patent portfolios in view of the business strategies as well as the cost-benefit analysis.
Ute Kilger is a lecturer for the MBA BioMed course “Intellectual Property” at the University of Potsdam, and for the SPARK educational program of the Charité-Universitätsmedizin Berlin.
Currently the Vice President of Federal Affairs at the Association for Accessible Medicines, Erik is the senior strategist and lobbyist for the national trade association representing the generic pharmaceutical industry. He is the point person for the industry with Congressional Democrats, including House and Senate leadership and the principle health care committees in Congress. Erik is responsible for shaping the industry’s advocacy agenda. Prior to this role, Erik was head of Federal Affairs and Public Affairs, at America’s Health Insurance Plans (AHIP), the national trade association representing the health insurance industry. For over five and a half years, he led efforts to effectively position the industry during implementation of the Affordable Care Act (ACA). Prior to AHIP, Erik worked on Capitol Hill for more than seven years, including as Policy Director for the Blue Dog Coalition.
David Korn is Vice President, Intellectual Property (IP) and Law, for the Pharmaceutical Research and Manufacturers of America (PhRMA). He focuses on IP and related issues in Congress, the Patent and Trademark Office and the Food and Drug Administration, as well as in amicus briefs in cases of interest to PhRMA. He has degrees in biomedical engineering from Duke and Northwestern and a J.D. from Harvard Law School. Prior to joining PhRMA, he worked in private practice and clerked in the U.S. District Court for the District of Delaware.
Daniel Kracov is a partner and co-chair of the Arnold & Porter Kaye Scholer Life Sciences and Healthcare Regulatory practice. For decades, he has been one of the foremost Food and Drug Administration lawyers in the country, and his expertise in critical regulatory matters has been widely recognized by Chambers, the Legal Times, Best Lawyers in America, and other publications. A particular focus of his practice is assisting pharmaceutical, biotechnology, medical device and diagnostic companies negotiate challenges relating to the development, clearance/approval, and marketing of FDA-regulated products. He also has extensive experience in government investigations and enforcement, internal investigations, and compliance matters.
Margaret Kyle currently holds the Chair in Intellectual Property and Markets for Technology at MINES ParisTech. Her research concerns innovation, productivity and competition. She has a number of papers examining R&D productivity in the pharmaceutical industry, specifically the role of geographic and academic spillovers; the firm-specific and policy determinants of the diffusion of new products; generic competition; and the use of markets for technology. Recent work examines the effect of trade and IP policies on the level, location and direction of R&D investment and competition. She also works on issues of innovation and access to therapies in developing countries. Her papers have been published in various journals of economics, strategy, and health policy, including the RAND Journal of Economics, Journal of Public Economics, Review of Economics and Statistics, Journal of Public Economics, Journal of Law and Economics, Antitrust Law Journal, Management Science, and Health Affairs.
Jayne is currently Head of the Division of Pharmacy and Optometry at Manchester University, a position she took up in the summer of 2017. Prior to that Jayne was Professor and Head of the Pharmaceutical Biophysics Group in the Pharmacy Department at King’s College London. Until the spring of 2017 Jayne was on a half time secondment as the Chief Scientist at the Royal Pharmaceutical Society where she commented in the National media on a number of pharmaceutical science issues including antimicrobial resistance, biologicals and biosimilars and patient safety. Jayne is a pharmacist by training who, in addition to working in academia, has also spent time working in community, hospital and industrial pharmacy. Her research is focussed on improving the delivery of drugs and genes, with special interest in increasing drug solubility. In addition to presenting her work at national and international conferences, she on a number of national and international committees and grant awarding bodies.
Erika Lietzan is an associate professor at the University of Missouri School of Law. She researches, writes, and teaches primarily in the areas of drug and device regulation, intellectual property, and administrative law. Some of her recent scholarship has focused on the incentives to study approved drugs for new uses, on the relationship between incentives for drug innovation and the length of premarket testing programs for new drugs, on competition and innovation in the market for biological medicines, and on data exclusivity for new molecular entities. Professor Lietzan brings to her scholarship and teaching eighteen years of private practice experience, eight of them as a partner at Covington & Burling in Washington, DC. She is an elected member of the American Law Institute, serves in the leadership of the Food & Drug Law Institute, and is an active member of the American Health Lawyers Association, the American Intellectual Property Law Association, and the American Society of Law, Medicine, and Ethics.
Otto Licks is a partner at Licks Attorneys, a Brazilian law firm with over 150 people in Rio de Janeiro, São Paulo, Brasília (2018), Tokyo and Silicon Valley (2019). Otto is an expert on complex litigation and policy making, with over 23 years of experience representing international clients in life sciences (small molecules, biologicals, agrochemicals and medical devices), telecom, electronics and internet. He has established a reputation as a trial and appellate practice specialist, focusing on preliminary and permanent injunctions and monetarization (damages and licensing), advising clients primarily on patent, trade secrets, unfair competition and regulatory data exclusivity, government procurement, food and drug and regulatory of telecom and internet. He was the first chair in over 100 cases, from TROs and ex-parte injunctions up to leading cases before the Brazilian Supreme Court. Otto has been recognized by some of the most important international rankings. He is an accomplished speaker in the United States, Europe, Asia and Latin America, and has published extensively in his areas of expertise.
Jane M. Love
Jane M. Love, Ph.D., a partner in the New York office of Gibson Dunn, is a member of the Intellectual Property and Life Sciences practices. Jane is a first-chair patent litigator in district court and before the PTAB. She also advises on strategic prosecution issues and carries out IP due diligence for transactions. Jane has extensive experience in pharmaceutical and biologics patent issues, including Hatch-Waxman and BPCIA litigation. Often, she coordinates global litigation of corresponding patents. She has handled cases concerning pharmaceuticals, biologics, biosimilars, antibodies, gene editing, vaccines, RNA therapies, medical devices and other technologies.
Stefano Marino joined the European Medicines Agency in June 2013 as Head of the Legal Service, after a long career as in-house counsel in pharmaceutical and petrochemical industries as well as a legal expert in industry associations’ working groups.
In his first years at the Agency he was very busy with heavily debated topics such as the “access to documents” submitted to EMA by marketing authorisation applicants and EMA’s policy on the “proactive publication” of clinical study reports. At present he is particularly engaged in tackling all legal and regulatory issues stemming from Brexit and the upcoming relocation of EMA to Amsterdam.
Tim Molino is a political consultant specializing in intellectual property issues. Tim began his political career in the United States Senate Judiciary Committee’s Antitrust, Competition Policy and Consumer Rights Subcommittee under Senator Herb Kohl (D-WI) before working for Senator Amy Klobuchar (D-MN), where he served as her Chief Counsel. Tim advised Senator Klobuchar on a variety of issues, including intellectual property and antitrust, including the navigating the passage of the America Invents Act. Prior to entering politics, Tim practiced patent law for eight years at two national law firms. He currently works for Peck Madigan Jones, a small lobbying boutique firm in Washington, DC. He holds a biology degree from the University of Mary Washington and received law degree from Washington & Lee University.
Gareth is a solicitor qualified in England and Wales, listed on the role in Ireland and a Partner in CMS CMNO in London.
Gareth has acted in many landmark UK IP trials concerning patent entitlement, biotechnology patent validity and infringement, SPCs (including EU Court of Justice references) and the interpretation of IP licences.
Gareth’s regulatory practice extends across medicines, medical devices to cosmetics and food products. Gareth has particular experience advising on the borderline of such product classes and the consequential implications for the regulation of the products.
Suzanne Munck is Chief Counsel for Intellectual Property for the United States Federal Trade Commission (FTC), and Deputy Director of its Office of Policy Planning. Ms. Munck manages all intellectual property issues related to the agency’s policy and advocacy efforts. Recently, she led the FTC’s 2017 modernization of the FTC/DOJ guidelines for licensing intellectual property together with the Antitrust Division and the FTC’s 2016 report on PAE activity. She frequently speaks before expert audiences on cutting-edge intellectual property policy issues.
Ms. Munck also has significant litigation experience managing intellectual property issues that arise during the FTC's enforcement efforts in the ICT and healthcare sectors. She was the lead patent attorney in the FTC’s pay-for-delay action against Cephalon, which resulted in a $1.2B settlement for consumers, and the lead patent attorney in the FTC’s action against Google, Inc. and its subsidiary Motorola Mobility.
In recognition of her work at the intersection of antitrust and intellectual property, Ms. Munck has received the Commission’s Paul Rand Dixon and Janet D. Steiger Awards. Before joining the FTC, Ms. Munck was an antitrust and IP litigator in Los Angeles. She received her BA in mathematics from Bryn Mawr College and her JD from the University of Minnesota Law School, where she was a managing editor of the Minnesota Law Review.
N - V
Sergio Napolitano is Legal Affairs and External Relations Director at Medicines for Europe. Before joining Medicines for Europe, Sergio Napolitano worked in the Directorate General for External Policies of the European Parliament where he was part of the Secretariat of the Committee on International Trade (INTA). In 2012, he authored a Report of the European Parliament on “The Role of the Congress in Shaping the US Trade Policy”. He previously worked in the Trade Policy Department of the Permanent Representation of Italy to the EU on multilateral, plurilateral and bilateral trade negotiations, EU investment policy and IPR. Sergio Napolitano is qualified for mediator certification in most American states. He holds a degree in Law from the University of Naples Suor Orsola Benincasa, an Erasmus Diploma at the Université Paris-Sorbonne, and a LL.M. on EU and European Public Law from the University College of London (UCL).
Peter J. Neumann, Sc.D., is Centre Director for the Evaluation of Value and Risk in Health at Tufts Medical Center, and Professor of Medicine at Tufts University School of Medicine. Prior to joining Tufts, he was on the faculty of the Harvard School of Public Health. His research focuses on the use of comparative effectiveness research and cost-effectiveness analysis in health care decision making. He is the founder and director of the Cost-Effectiveness Registry (www.cearegistry.org), a comprehensive database of cost-effectiveness analyses in health care. Dr. Neumann has written widely on the role of clinical and economic evidence in pharmaceutical decision making and on regulatory and reimbursement issues in health care. He is the author of Using Cost-Effectiveness Analysis to Improve Health Care (Oxford University Press, 2005) and co-editor of Cost-Effectiveness in Health and Medicine, 2nd Edition (Oxford University Press, 2016). Dr. Neumann has served as President of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), and as a trustee of the Society for Medical Decision Making.
Michelle Petri is a Professor of Medicine in the Division of Rheumatology and Director of the Lupus Center at the Johns Hopkins University School of Medicine in Baltimore, Maryland. She earned her medical degree from Harvard Medical School in Boston, Massachusetts, and completed her internship and residency in Internal medicine at Massachusetts General Hospital. Thereafter, Professor Petri completed her Postdoctoral Fellowship in Allergy, Immunology, and Rheumatology at the University of California, San Francisco. She subsequently earned her master’s in Public Health and Epidemiology from Johns Hopkins University Bloomberg School of Public Health. Professor Petri’s research focuses on several aspects of systemic lupus erythematosus (SLE), including atherosclerosis, antiphospholipid syndrome (APS), lupus nephritis, and pregnancy. Professor Petri has authored over 500 papers and chapters on SLE and APS.
Arti Rai is Elvin R. Latty Professor and Founding Director, Center for Innovation Policy, at Duke Law. Rai’s extensive research on innovation law and policy in biotechnology, pharmaceuticals, and software has been funded by NIH, the Kauffman Foundation, and the Woodrow Wilson Center. From 2009-2010, Rai served as Administrator of the Office of External Affairs at the U.S. Patent and Trademark Office (USPTO). As External Affairs Administrator, Rai led policy analysis of the patent reform legislation that ultimately became the America Invents Act and worked to establish the USPTO’s Office of the Chief Economist.
David Ridley is the Dr. and Mrs. Frank A. Riddick Professor of the Practice of Business. He is also the Faculty Director of Duke’s Health Sector Management program. In his research, David examines innovation and pricing in health care. To encourage development of new treatments for neglected diseases, David and his co-authors proposed the priority review voucher program which became law in the United States. David’s research appears in economics journals (Journal of Public Economics), medical journals (Journal of the American Medical Association), and scientific journals (Nature Reviews Drug Discovery). David teaches daytime and executive MBA students. He received a PhD in economics from Duke University in 2001.
Benjamin Roin is the Fred Kayne (1960) Career Development Professor of Entrepreneurship and an Assistant Professor of Technological Innovation, Entrepreneurship, and Strategic Management at the MIT Sloan School of Management. He is also an Associate Member of the Broad Institute. Ben’s work focuses on entrepreneurship, intellectual property, and innovation policy. His primary areas of research are patent law, biopharmaceutical innovation, and government regulation of the pharmaceutical industry. He has written about the market-exclusivity protections available for old and repurposed drugs, the implications of the finite patent term and limited patent-term extensions for drug-development strategy, public and private insurer reimbursement policies, and Hatch-Waxman litigation. In addition to his academic research, he currently works with the Institute of Medicine, National Health Council, and the Multi-Regional Clinical Trial Center on issues related to patent law, FDA law, clinical-trial regulations, and pharmaceutical innovation policy.
Graham Russell (R G G Russell) is Professor of Musculoskeletal Pharmacology at Oxford and Sheffield Universities. He graduated in Biochemistry from Cambridge University and spent his formative years in Leeds, Davos, Bern, Boston and Oxford, where he completed medical studies. He was Professor of Human Metabolism at Sheffield from 1977-2001. In 2001 he moved back to Oxford University as the first Director of the newly established Botnar Research Centre. His research interests are in skeletal biology and disease, and he is author of over 550 publications. His early work with Herbert Fleisch in Switzerland led to the discovery of the biological effects of bisphosphonates, and to their eventual successful clinical use in the treatment of bone disorders, including Paget’s disease, cancer metastases in bone, and osteoporosis. Bisphosphonates continue to be the major drugs used worldwide to treat these disorders. There are several new potential medical uses for these compounds emerging
Sture Rygaard is partner in Plesner, a Law Firm situated in Copenhagen, Denmark. He is an experienced IP litigator with a main focus on pharma and biotech litigation. He has litigated patent matters for several of the world’s largest pharmaceutical companies and also a number of patents in the biotech, medical device and mechanical field.
Sture is Member of the Board of EPLAW (2017-), Chairman of the AIPPI Standing Committee on Trade Secrets (2017-) and Vice-Chair of the Danish Association for the Protection of Industrial Rights. He is co-author of a book on the UPC rules of procedure and has contributed other books on IP, Life Science and Trade Secrets.
Dr. Toni Santamaria is Head of Intellectual Property – Europe at Accord Healthcare. Dr Santamaria manages IP issues for Accord including pro-active and defensive patent litigations, regulatory exclusivities strategies, patent and trademark prosecution, spanning the Europe and MENA regions. Holding a PhD in Organic Chemistry from the Universitat Autonoma of Barcelona and a degree in Documentation, Dr Santamaria has been a Qualified European Patent Attorney since 2010. Prior to joining Accord in 2010, Dr. Santamaria has previously worked for pharmaceutical companies including Invent Farma and Farmhispania, where he specialised in IP matters and quality assurance.
Hans Sauer is Vice President for Intellectual Property for the Biotechnology Innovation Organization, the main trade association for the biotechnology industry in the United States, representing more than 1,100 member companies, nonprofit research institutions and affiliated entities. At BIO, Dr. Sauer advises the organization’s board of directors, amicus committee, and various staff committees on patent and other intellectual property-related matters. Prior to taking his current position in 2006, Dr. Sauer was Chief Patent Counsel for MGI Pharma, Inc., and Senior Patent Counsel for Guilford Pharmaceuticals Inc. Dr. Sauer has testified in both houses of Congress on patent legislation, and regularly advocates on life sciences patent policy on behalf of the industry. He holds a M.S. degree in biology from the University of Ulm in his native Germany; a Ph.D. in Neuroscience from the University of Lund, Sweden; and a J.D. degree from Georgetown University Law Center where he serves as adjunct professor.
Barry J Schindler
Barry J. Schindler is the Co-Chair of Greenberg Traurig’s Global Patent Prosecution Group. Barry has more than twenty-five years of legal experience in all aspects of pharmaceutical and chemical patent prosecution -- representing numerous major pharmaceutical and chemical companies regarding patents relating to small molecules and synthetic compounds.
Barry has helped companies of all sizes build and manage significant patent portfolios, develop in-house procedures, and formulate intellectual property strategies. Barry positions clients to gain a competitive advantage by identifying patentable subject matter and drafting claims and providing patent opinions in such a way that infringement becomes possible to prove. Barry, an active member of the firm’s Israel Practice also focuses his practice on managing the patent portfolio for numerous innovative Israeli start-ups. Barry is a frequent business visitor to Israel and is very involved with the local tech community.
William B Schultz is a partner in the Washington, D.C. law firm Zuckerman Spaeder. Between 2011 and 2016, he was General Counsel of the Department of Health and Human Services. He is a member of the Committee on Science, Law and Technology, National Academy of Sciences, and for 10 years he taught at Georgetown University Law Center (Litigation; Food and Drug Law). He was also: Deputy Assistant Attorney General, Civil Division, U.S. Department of Justice (1999-200) in charge of appellate litigation nationwide; Deputy Commissioner for Policy, Food and Drug Administration (1994-1999); and Counsel to the Subcommittee on Health and the Environment (Rep. Henry A Waxman, Chairman), Committee on Energy and Commerce, U.S. House of Representatives. From 1976 and 1989, Bill worked as a public interest lawyer at Public Citizen Litigation Group. He began his legal career clerking for Judge William B. Bryant, U.S. District Court, D.C. Bill received his undergraduate degree from Yale College and his law degree from the University of Virginia School of Law.
Janis Shute is Professor of Respiratory Pharmacology at the University of Portsmouth, UK. Jan conducted the pre-clinical research that led to the filing of patents around the novel use and repurposing of heparin for inhalation as a mucolytic in patients with respiratory diseases characterised by mucus obstruction of the airways. Her research led to clinical studies of inhaled heparin in patients with cystic fibrosis and COPD, demonstrating both the safety and efficacy of this approach. She is a founding director and Chief Scientific Officer of Ockham Biotech Ltd who now own the patents and continue to develop heparin for inhalation.
Mark Stewart has for the last 20 years worked as in-house patent counsel for Eli Lilly and Company. He is currently a Senior Director and Assistant General Patent Counsel in the patent litigation department. Mark manages a group of attorneys that work primarily on US and European patent litigation. Mark also currently manages several ongoing U.S. litigation efforts that include IPRs as well as district court litigation. Mark has authored papers and amicus briefs related to the application of the written description requirement in the biotechnology field and has served on the AIPLA Editorial Board. Mark received a B.S. in Chemistry from Butler University, a Ph.D. in Biochemistry from Colorado State University, and a J.D. from Indiana University.
Professor Mondher Toumi is M.D. by training, M.Sc. in Biostatistics, and in Biological Sciences (option pharmacology) and Ph.D. in Economic Sciences. Mondher Toumi is Professor of Public Health at Aix-Marseille University. He is a recognized expert in health economics and an authority on market access and risk management. He has more than 200 scientific publications and oral communications, and has contributed to several books. He recently published a book Introduction to Market Access for Pharmaceuticals (CRC Press). He has worked in both the university and pharmaceutical industry at Lundeck A/S. In 2008, he founded Creativ-Ceutical, an international consulting firm dedicated to support health industries and authorities in strategic decision-making. He also recently created the Market Access Society to promote research and scientific activities around market access, public health and health economic assessment.
Todd Volyn is Associate Patent Counsel at Johnson & Johnson. His practice in the pharmaceuticals business focusses on intellectual property transactions. He has also worked on intellectual property transactions, patent prosecution, intellectual property analysis, and litigation in the medical device sector at Johnson & Johnson. His transactional work includes complex multi-party public-private arrangements, business divestitures, business acquisitions, and collaboration and license agreements. He previously practiced in all areas of intellectual property at Shell Oil Company. Mr. Volyn earned his J.D. and M.I.P. degrees in 1993 from the University of New Hampshire (formerly Franklin Pierce Law Center), where he was a Research Fellow. He also holds a B.S. in Chemistry from the University of Louisville. He is admitted to the bars of Pennsylvania, Texas (non-practicing), New Jersey (in-house only), and the United States Patent and Trademark Office.
- The Moderators
Paul Ainsworth - Sterne, Kessler, Goldstein & Fox PLLC
Paul Ainsworth, a director in the Litigation Group, is an experienced intellectual property trial attorney with a practice focused on patent and trade secret disputes in federal district courts, at the US International Trade Commission, and before the US Court of Appeals for the Federal Circuit. Paul also regularly represents clients in proceedings before the Patent Trial and Appeal Board. Paul’s clients include leading companies in the pharmaceutical, medical devices, chemical manufacturing, consumer products, electronics, and e-commerce industries. Paul is particularly well-known for his work in the firm’s award-winning Hatch-Waxman litigation practice.
David K. Barr - Arnold & Porter, Kaye Scholer LLP
David K. Barr concentrates in the areas of patent, trade secret, and unfair competition litigation and counseling. Mr. Barr’s experience includes litigation in federal and state courts, appeals to the Federal Circuit Court of Appeals and practice before the US Patent and Trademark Office, including contentious inter partes proceedings. Mr. Barr has been lead trial counsel in many complex Hatch-Waxman and biotech patent infringement cases, and has counseled clients on product development and strategic patent planning. He has extensive experience in intellectual property transactions, including licenses and acquisitions. Mr. Barr has also conducted numerous patent due diligence investigations, and has drafted patent license and related agreements. His patent matters have involved a variety of technologies, including biotechnology, pharmaceuticals, industrial chemistry and biomedical and mechanical devices.
Laëtitia Bénard - Allen & Overy LLP
Partner Laëtitia Bénard leads the Paris Intellectual Property practice and is co-head of Allen & Overy’s Life Sciences Group worldwide. She advises companies in the life sciences field in all intellectual property areas including patents, trademarks, copyright and unfair competition issues, both contentious and non-contentious, having acted in numerous complex patent disputes as well as on patent portfolios, patent validity, and freedom to operate issues. She has specific knowledge of the life sciences field, in which she also advises on various regulatory and contractual matters such as price regulation, advertisement for medicines, transfers of technology and anti-bribery rules.
Brian Cordery - Bristows
Brian was recently appointed joint head of Patent Litigation. He specialises in intellectual property dispute resolution with a focus on patent litigation in the life sciences sector. Brian’s patents practice has involved cases for numerous sectors with most of his experience acquired in the pharmaceutical field. As well as English litigation Brian is engaged in life-cycle management projects for several of the world’s best-selling medicines. This involves the co-ordination of legal teams in more than 40 countries to ensure that optimal strategy is pursued at both global and local levels.
Felix is the Executive Partner at Opus Three and former Chief Scientific Officer at Human Longevity, Inc. He was co-founder and CEO of Intellos Health, Entrepreneur-in-Residence at Third Rock Ventures, and is the former President of the Medco Research Institute. Prior, he was the first Associate Director for Genomics at FDA/CDER and held various positions in biotechnology companies. He serves or served on the Boards of Enterome Biosciences, Ariana Pharma, TcLand Expression and the Personalized Medicine Coalition. Felix is a Fellow of the American College of Clinical Pharmacology and held faculty positions at Georgetown University in Washington, DC and at the University of North Carolina. He was a Research Fellow at Stanford University and holds a PhD in Biochemistry from the University of Basel, Switzerland.
Thomas Hirse - CMS Hasche Sigle
Dr. Thomas Hirse is partner in the Duesseldorf office of CMS Hasche Sigle. He is specialized in patent law, employee inventions law, law relating to technology transfers and licenses and R&D cooperations, trade secret law and data protection law. Thomas provides advice mainly to clients in the pharmaceutical, chemical and biotechnological sector. He represents them in na-tional and multi-jurisdictional patent litigation, complex contract negotiations and IP driven transactions. He has successfully drafted and negotiated numerous complex R&D and license agreements. Thomas is member of LES Germany, GRUR, EPLAW, AIPLA as well as the ad-visory board of the Forschungsverbund Leibniz Gesundheitstechnologien.
Marsha Rose Gillentine - Sterne, Kessler, Goldstein & Fox PLLC
Marsha Gillentine, Ph.D. is a director in the Biotechnology/Chemical Group focused on the pharmaceutical industry. Marsha is intimately familiar with the Hatch-Waxman Act and Biologics Price Competition and Innovation Act, and understands patent litigation strategy in the context of the statutory schemes. She has provided hundreds of patentability, noninfringement, and invalidity opinions. Marsha has rendered opinions in at least the following areas: small molecules, therapeutic antibodies, polymorphs, salts, synthesis, pharmaceutical formulations, and pharmacokinetics. She also assists clients in implementing lifecycle management strategies, including those for personalized medicine patent portfolios.
Christopher Holding - Goodwin Proctor
Mr. Holding’s practice focuses on competition issues in the pharmaceutical industry and the intersection of antitrust and intellectual property. Mr. Holding regularly counsels clients on, and litigates cases about, competition issues relating to patent settlements, life cycle management/product hopping, REMS policies, pricing, and the licensing of IP rights, as well patent damages and regulatory exclusivities. He has litigated cases in federal and state courts throughout the country and defended federal and state investigations.
Karl-Heinz Metten - Boehmert & Boehmert
Karl-Heinz Metten is a parter at Boehmert & Boehmert. His practice includes advising clients, in his capacity as a patent attorney, on all patent law in the field of pharmacy and chemistry. He also advises clients on implementing and optimizing IP strategies and the enforcement of IP rights.
Karl-Heinz studied chemistry at the University of Bochum. He received his Ph.D in organic chemistry focusing on stereoselective synthesis of drug tarts and on the chemistry of saccharides. As a postdoctoral fellow he specialised in organometallic chemistry at Imperial College London and University of Cambridge. Before joining Bohemert & Boehmert in 2002 he worked in the patent department of a major German chemical company.
Trey Powers - Sterne, Kessler, Goldstein & Fox PLLC
Trey Powers, Ph.D. is a director in the Litigation Group, but also has deep roots in the firm’s Biotech Practice Group. He has served as counsel on over 40 inter partes review and post grant review proceedings and has extensive experience litigating before the Patent Trial and Appeal Board. Trey also works with clients on a variety of other matters including district court litigation, intellectual property strategic advice, licensing, International Trade Commission investigations under §337, evaluating patent portfolios, drafting patent applications, and prosecuting interferences. He also manages the preparation of invalidity, non-infringement, and freedom-to-operate opinions.
Wolfgang Rehmann - Taylor Wessing
Dr. Wolfgang Rehmann is head of the international Life Sciences group and partner of the pharmaceutical law group at Taylor Wessing, Munich. Wolfgang offers both advice and forensic services to leading companies of the Life Sciences industry. His forensic work is presented before German courts and also the EU courts in Luxembourg, concentrating on issues of pharmaceutical law, intellectual property, antitrust law and community law. Most recent examples include representing a globally active medical devices manufacturer vis-à-vis both the competent authorities and courts in connection with product problems that occurred, advising a manufacturer of pharmaceutical products on the introduction of an app to improve patient communication and compliance, and representing a biotech enterprise in connection with a strategic cooperation venture with an international partner.
Wolfgang studied law in Würzburg and spent part of his legal training in France.
Christine Schwarz - Fitzpatrick, Cella Harper and Scinto
Christina Schwarz’s practice focuses on complex patent litigation under the Hatch-Waxman Act and contested proceedings before the United States Patent Office, including inter partes review proceedings and patent interference proceedings. She has experience counseling clients, providing opinions, and working on cases involving a range of pharmaceutical and biotechnology products, including drugs or treatments for immunosuppression, cancers, renal disease, HCV, Pompe disease, schizophrenia, modified dosage forms, drug delivery devices and polymers.
Nancy E. Taylor - Greenberg Traurig LLP
Nancy Taylor is Co-Chair of the Health Care & FDA Practice and has advised clients on health and FDA related matters for more than two decades. She has broad experience in areas relating to the Affordable Care Act provisions, CMS reimbursement and policy issues relating to providers and plans, and she has done a significant amount of FDA regulatory work. Prior to joining Greenberg Traurig, Nancy served 10 years as Health Policy Director for the Senate Committee on Labor and Human Resources and worked on a number of significant health and FDA laws, including NLEA, Safe Medical Device Act, Hatch-Waxman, COBRA and ADA. She also served as CEO of a start-up medical device company, where she obtained eight product clearances, including securing reimbursement coverage for each product.
Robert Trenchard - Gibson, Dunn & Crutcher LLP
Robert Trenchard is a litigation partner in the New York office of Gibson, Dunn & Crutcher. Mr. Trenchard has extensive first-chair experience in life-science patent litigation, including in U.S. district court and in multiple trials before the U.S. Patent Trial and Appeal Board. He has litigated cases involving pharmaceuticals, biologics, genetics, siRNA and medical devices. He has maintained a diverse litigation practice in New York for 23 years. He represents corporate and individual clients in complex civil and regulatory matters in federal and state courts through and including trial, and before governmental bodies.
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