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Patenting In The Biotech Industry 21 Sep10

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  • 1. Patenting in the Biotechnology Industry: 30 Years After Diamond v. Chakrabarty “Anything under the sun that is made by man . . .” Science Day Lecture Patent Day Symposium September 21, 2010, 4:00 pm September 22, 2010, 8:00 am This landmark Supreme Court decision helped This program includes leading academic and private launch the biotechnology industry, providing sector scientists, lawyers, judges and investors. The assurance to researchers and biotech compa- importance and implications of this Supreme Court nies that subject matter derived from nature Case to their respective fields will be discussed. is eligible for patenting if it is modified by man into something new, useful and nonobvious. Location I Hotel and Conference Center Speaker 1900 South First Street, Champaign, Illinois Dr. Ananda Chakrabarty Distinguished University Professor www.law.illinois.edu/chakrabarty University of Illinois College of Medicine at Chicago Location NCSA Auditorium - 1205 West Clark Street - Urbana Public Reception immediately following talk Page 1
  • 2. Symposium Celebrating the 30th Anniversary of the U.S. Supreme Court decision in Diamond v. Chakrabarty The Diamond v. Chakrabarty decision (holding that “living, man-made micro-organism is patentable subject matter as a “manufacture” or “composition of matter” within the meaning of the Patent Act of 1952) by the U.S. Supreme Court is recognized as a pivotal point for the development of the global biotechnology industry. This decision coupled with the Bayh-Dole Act (also passed thirty years ago in 1980) that permitted universities to develop intellectual property resulting from research supported by the federal government, led to the spawning of new biotechnology companies based on genetically defined life forms. This included new bacteria used to “eat” oil or produce drugs, new plants with new traits and attributes and new animals used for the production of drugs or used as biomedical models of human diseases. Interestingly, the “new life form” being patented by Professor Chakrabarty was a bacterium that could digest oil and would have utility for oil spills. This decision in 1980 provided patent protection to genetically altered life and led to the emergence of the biotechnology industry. Re- gardless of one’s political point of view, everyone acknowledges that this decision represents a historical milestone with respect to technol- ogy and its implications to manipulating life. This is also the year of debates about patentable subject matter. From the Association for Molecular Pathology (AMP) v. Myriad Genetics decision in the Southern District of New York to the U.S. Supreme Court decision in Bilski v. Kappos, the scope and content of eligible subject matter in patent law is rapidly being re-shaped. It is thus appropriate and timely that we revisit and take stock of the impact of patenting in the biotechnology industry. Professor Ananda (Al) M. Chakrabarty is a noted international scientist who received his post-doctoral training in the Department of Biochemistry under Professor Irwin Gunsalus at the University of Illinois at Urbana-Champaign. Professor Chakrabarty is now Distin- guished University Professor at the University of Illinois College of Medicine at Chicago. This special event celebrating the historical decision will be convened on the Illinois campus on Tuesday, September 21 and Wednesday, September 22, 2010. The events are separated into two days of activities. The first day provides an opportunity for students, faculty and staff focused in the life sciences, engineering and technology development and transfer. A public lecture will be given by Dr. Chakrabarty followed by a public reception. On that evening, a dinner with campus administration, faculty and community leaders will be held. The second day features a Symposium focusing on the legal and business aspects of the Chakrabarty decision. This program includes leading academics, private sector scientists, lawyers, judges, and investors. The importance and implications of this Supreme Court Case to their respective fields will be discussed. Organizers: Dr. Jay P. Kesan, College of Law, University of Illinois at Urbana-Champaign (UIUC) Gary M. Myles, Schwabe, Williamson & Wyatt Attorneys at Law Dr. Lawrence B. Schook, Director, Division of Biomedical Sciences, UIUC AGENDA – SCIENCE DAY LECTURE – September 21, 2010 Public Lecture Ananda Chakrabarty, Ph.D., Distinguished University Professor 4:00–5:00 pm University of Illinois College of Medicine, Chicago, Illinois Looking Back: 30 Years After the Supreme Court Decided Diamond v. Chakrabarty National Center for Supercomputing Applications (NCSA) 1205 W. Clark Street, Urbana Reception NCSA Lobby 5:00–6:00 pm Dinner 6:30 pm I Hotel and Conference Center – Chancellor Ballroom – 1900 S. First Street – Champaign (by invitation only) Private Lecture Steve Burrill, Chief Executive Officer, Burrill & Company, San Francisco, California 8:00 pm Biotech 2011: Looking Back to see Ahead (by invitation only) Page 2
  • 3. AGENDA – PATENT DAY SYMPOSIUM – September 22, 2010 7:00 - 8:00 am CONTINENTAL BREAKFAST – Chancellor Ballroom at I Hotel 8:15 - 8:25 am Opening Remarks – Bruce Smith, Ph.D. Dean, College of Law, University of Illinois at Urbana-Champaign 8:25 - 8:30 am Welcome – Jay Kesan, Ph.D. Professor, College of Law, University of Illinois at Urbana-Champaign 8:30 - 9:15 am PANEL I – The Role of Patents in Ensuring Innovation: A View from Industry Morning Keynote Robert Armitage, Senior Vice President and General Counsel, Eli Lilly, Indianapolis, Indiana A Fresh Start of Limiting Patent Eligibility: Barring Patents Where Information or the Exercise of Human Intellect Is An Element of a Purported Invention 9:15 - 10:15 am PANEL II – University Technology Transfer: Bridging the Gap from Innovation to Commercialization Howard Bremer, Emeritus Patent Counsel, Wisconsin Alumni Research Foundation, Madison, Wisconsin Chakrabarty and the Bayh-Dole Act: Science and Law in Evolution James Chiapetta, D.V.M., Sr. Patent Counsel, Boston Scientific, Natick, Massachusetts Toward the Advancement of University-Corporate Collaborations: Open Innovation in Transitional Research 10:15 - 10:30 am BREAK 10:30 - 11:30 am PANEL III – Diamond v. Chakrabarty: An Historical Perspective Edmund Sease, Founding Partner, McKee, Voorhees & Sease, Des Moines, Iowa Thirty Years: From Dr. Chakrabarty’s Oil-Eating Microbes to the Myriad Mess Andrew Torrance, Ph.D., Associate Professor of Law, University of Kansas School of Law, Lawrence, KS Everything Under the Sun Except Man 11:30 - 12:30 pm PANEL IV – Patentable Subject Matter After the Supreme Court Decided Bilski v. Kappos: What is an “Abstract Idea?” Kevin Collins, Professor of Law, Washington University, St. Louis, Missouri Prometheus Laboratories, Association of Molecular Pathology, and Other Claims to Methods of Deductive Reasoning Christopher Holman, Ph.D. Associate Professor ofLaw, UMKC School of Law, Kansas City, Missouri How Will Bilski Impact the Patenting of Personalized Medicine? 12:30 - 1:00 pm LUNCH – Technology Room, I Hotel 1:00 pm Introduction to Keynote Speaker – Gary Myles, Ph.D., Shareholder, Schwabe, Williamson & Wyatt Lunch Keynote Todd Dickinson, Executive Director, American Intellectual Property Law Association, Arlington, Virginia 1:00 - 1:50 pm Patent Reform and Biotechnology: Congress and the Courts. 1:50 - 2:00 pm BREAK 2:00 - 3:30 pm PANEL V –The Patentability of Biotechnology Inventions after Myriad v. ACLU Chancellor Ballroom Kevin Noonan, Ph.D., Partner, McDonnell Boehnen Hulbert & Berghoff, Chicago, Illinois Myriad v. ACLU: A View from the Inside Cathryn Campbell, Ph.D., General Counsel, Institute for Systems Biology, Seattle, Washington Products of Nature and The Hand of Man: Thirty years after Chakrabarty Jorge Goldstein, Ph.D., Director, Sterne, Kessler, Goldstein & Fox, Washington, DC Human Gene Patents: History, Controversies and Taxonomies 3:30-3:40 pm BREAK 3:40 - 4:40 pm PANEL VI – Policy Issues and the Economics of Patent Protection Alice Martin, Ph.D., Partner, Barnes & Thornburg, Chicago, Illinois What Factors are Generating the Strong Public Opposition Against Gene Patents? Richard Rozek, Ph.D., Senior Vice President, NERA Economic Consulting, Washington, DC The Economic Perspective on Small and Large Molecule Pharmaceutical Technologies 4:40 - 4:50 pm Closing Remarks – Gary Myles, Ph.D., Shareholder, Schwabe, Williamson & Wyatt Attorneys at Law 5:15 - 6:30 pm RECEPTION – Technology Room, I Hotel Page 3 6:30 - 8:30 pm DINNER WITH PANELISTS – Technology Room, I Hotel
  • 4. SCIENCE DAY LECTURE – September 21, 2010 National Center for Supercomputing Applications (NCSA) Public Lecture Ananda Chakrabarty, Ph.D. Distinguished University Professor University of Illinois College of Medicine at Chicago 4:00 – 5:00 pm Ananda Chakrabarty Looking Back: 30 Years After the Supreme Court Decided Diamond v. Chakrabarty Professor Ananda (Al) M. Chakrabarty is a noted international scientist who received his post-doctoral training in the Department of Biochemistry under Professor Irwin Gunsalus at the University of Illinois at Urbana-Champaign. Professor Chakrabarty is now Distinguished University Professor at the University of Illinois College of Medicine at Chicago. Dr. Chakrabarty’s battle for patent protection paved the way for future patenting of biotechnological discov- ery. This landmark decision created the start of the biotechnology industry, that a live, human-engineered micro-organism is patentable subject matter. The Supreme Court ruled that patents could be issued for “any- thing under the sun that is made by man.” Its decision provided assurance to researchers and biotech compa- nies that subject matter derived from nature is eligible for patenting if it is modified by man into something new, useful and nonobvious. Private Lecture G. Steven Burrill, Ph.D., Chief Executive Officer, Burrill & Co. 8:00 pm Biotech 2011: Looking Back to See Ahead G. Steven Burrill has been involved in the growth and prosperity of the biotechnology industry for over G. Steven Burrill 40 years. An early pioneer, Mr. Burrill is one of the original architects of the industry and one of its most avid and sustained developers. He currently serves as Chairman of the Boards of Pharmasset (NASDAQ: VRUS), Abunda Corporation and BioImagene, and is a member of the Boards of Directors of Catalyst Biosciences, DepoMed (NASDAQ: DEPO), Ikano Therapeutics, NewBridge, Proteogenix, Proventys,Targacept (NASDAQ: TRGT) and XDx. Prior to founding Burrill & Company in 1994, he spent 28 years with Ernst & Young, directing and coordinating the firm’s services to clients in the biotechnology/life sciences/high tech- nology/manufacturing industries worldwide. In 2002, Mr. Burrill was recognized as the biotech investment visionary by the prestigious Scientific American magazine (The Scientific American 50), and in 2008, he received the BayBio Pantheon 2008 DiNA lifetime achievement award for his worldwide biotech leadership. In addition to his work with leading life science companies, Mr. Burrill is a founder and currently serves as the Chairman of the Board of the Foundation for the National Medals of Science and Technology. Additionally, he serves as Chairman of the San Francisco Mayor’s Biotech Advisory Committee (MAYBAC). Mr. Burrill also chaired the National Research Council study on linkages in biotechnology between Japan and the United States. He was also involved with the US-Japan Science and Technology Agreement Study of Technology Transfer Mechanisms between the US and Japan. Other not-for-profit ac- tivities include serving on the Boards of Directors of the Bay Area Science Infrastructure Consortium, BayBio (Emeritus), California Healthcare Institute (Emeritus), The Exploratorium (Emeritus), The Kellogg Center for Biotechnology, the MIT Center for Biomedical Innovation, and the National Health Museum (Vice Chairman), BioAg Gateway, City of Madison Vilas County Economic Development Group, the World Council of Ethics, University of Wisconsin Extension, Scientific American Board of Advisors. He also serves on the Purdue Discovery Park External Advisory Committee as well as the editorial board of the Journal of Commercial Biotechnology and is on the advisory board of the Center for Policy on Emerging Technologies (C-PET). He is an advisor to University of Illinois Institute for Genomic Biology, University of Wisconsin Page 4 College of Agriculture and Life Sciences, University of Minnesota College of Biological Sciences, and Duke University, and is an adjunct professor at University of California, San Francisco.
  • 5. PATENT DAY SYMPOSIUM - September 22, 2010 Opening Remarks Bruce Smith, Dean, College of Law University of Illinois at Urbana-Champaign 8:15 – 8:25 am Bruce Smith is dean of the University of Illinois College of Law and the Guy Raymond Jones Faculty Scholar. He became the 12th dean of the College in February 2009, having previously served as the College’s associate dean for Academic Affairs and, since 2001, as a member of its faculty. An accomplished legal historian who Bruce Smith specializes in Anglo-American criminal procedure in the 18th and 19th centuries, Dean Smith is the author, most recently, of History of the Common Law: The Development of Anglo-American Legal Institutions (2009) (with John Langbein and Renée Lettow Lerner). He is currently completing a second book manu- script, entitled Summary Justice: Magistrates, Theft, and the Law in London and the Urban Atlantic World, 1760-1860. Before entering law teaching, Dean Smith practiced law for five years at Covington & Burling in Washington, D.C., working primarily in the area of intellectual property litigation and sports law – in the latter capacity, representing the National Football League, National Basketball Association, and National Hockey League. He has taught as a visiting professor of law at the University of Michigan Law School and The George Wash- ington University Law School, as an instructor at the University of Oxford and the University of Victoria, and as an invited lecturer at the University of Palermo in Buenos Aires, Argentina. In 2008, he was one of two recipients of the University of Illinois at Urbana-Champaign’s Campus Award for Graduate and Profes- sional Teaching, which recognizes excellence in the classroom, innovative approaches to teaching, and other contributions to improved instruction. Dean Smith received his bachelor of arts summa cum laude with highest honors in history from Williams College and bacherlor’s and master’s degrees in history from the University of Cambridge, which he attended as a Herchel Smith Fellow. He earned his J.D. from Yale Law School, where he served as a senior editor on the Yale Law Journal, and his Ph.D. in history from the Yale Graduate School of Arts & Sciences, where he was a Mellon Fellow in the Humanities.   Page 5
  • 6. Welcome Jay P. Kesan, College of Law University of Illinois at Urbana-Champaign 8:25 – 8:30 am Professor Jay Kesan’s academic interests are in the areas of technology, law, and business. Specifically, his work focuses on patent law, intellectual property, entrepreneurship, internet law/regulation, digital government (e-gov), agricultural biotechnology law, and biofuels regulation (recent publications are on SSRN). He directs the Program in Intellectual Jay Kesan Property & Technology Law at the College of Law. At the Institute of Genomic Biology (IGB), he is group leader of the Business, Economics & Law of Genomic Biology (BioBEL) theme and is program leader of the Biofuel Law & Regula- tion Program at the Energy Biosciences Institute (EBI). In fall of 2009, he was named a faculty fellow in the Office of the Vice President for Technology and Economic Development (OVPTED) for the 2009-2010 academic year. In his role as a faculty fellow, Professor Kesan will be working closely with OVPTED and the Offices of Technology Management (OTM) in furthering the University’s technology commercialization efforts, especially in further refining the University’s intellectual property protection strategy.     At the University of Illinois, Professor Kesan is appointed in the College of Law, the Institute of Genomic Biology, the Information Trust Institute, the Coordinated Science Laboratory, the Department of Electrical & Computer Engineer- ing, the Department of Agricultural & Consumer Economics, and the College of Business. His recent awards include:  IBM Faculty Award in 2006; Best Paper Award for “An Empirical Examination of Open Standards Development” (with R. Shah), 41st Hawaii International Conference on System Sciences (HICSS), 2008; Best Paper Award for “An Empirical Study of Open Standards” (with R. Shah) published in the Proceedings of the 8th Annual International Conference on Digital Government Research, 2007. He has received numerous, multi-year research grants for his work in the areas of intellectual property and technology reg- ulation from the National Science Foundation, the U.S. Department of Agriculture, the Energy Biosciences Institute, the Federal Judicial Center, the Net Institute, the Coleman Foundation, and the University of Illinois Campus Research Board. Professor Kesan continues to be professionally active in the areas of patent litigation and technology entrepreneurship. He was appointed by federal judges to serve as a special master in patent litigations, and has served as a technical and legal expert and counsel in patent matters.  He also serves on the boards of directors/advisors of start-up technology compa- nies. He participated twice in panels at the Federal Trade Commission and the Department of Justice Hearings on the Implications of Competition and Patent Law and Policy. He has also worked with the U.S. Department of Commerce and the U.S. Civilian Research & Development Foundation on their intellectual property protection and technology commercialization activities in the former Soviet Union countries.  Professor Kesan was a JSPS Invited Fellow and visiting associate professor at the University of Tokyo, Japan and has also served as a foreign research fellow at the Institute of Intellectual Property (IIP) in Tokyo, Japan.  He has also served as a visiting assistant professor at Georgetown University Law Center, and as the Jerold Hosier Distinguished Visiting Profes- sor in Intellectual Property at DePaul University. He serves as faculty editor-in-chief of the University of Illinois Journal of Law, Technology & Policy, which published its inaugural issue in spring 2001. He has also developed an online course on “Legal Issues in Technology Entrepreneur- ship,” supported by a grant from the Coleman Foundation. Professor Kesan received his J.D. summa cum laude from Georgetown University, where he received several awards in- cluding Order of the Coif and served as associate editor of the Georgetown Law Journal. After graduation, he clerked for Judge Patrick E. Higginbotham of the U.S. Court of Appeals for the 5th Circuit. Prior to attending law school, Jay Kesan – who also holds a Ph.D. in electrical and computer engineering – worked as a research scientist at the IBM T.J. Watson Research Center in New York. He is a registered patent attorney and practiced at the former firm of Pennie & Edmonds LLP in the areas of patent litigation and patent prosecution. In addition, he has published numerous scientific papers and obtained several patents in the U.S. and abroad. Professor Kesan was born in Mumbai, India, he is an avid cricket fan, and he continues to be active in professional activities in India. Page 6
  • 7. PANEL I – The Role of Patents in Ensuring Innovation: A View from Industry 8:30 – 9:15 am Start on Limiting Patent Eligibility:  Barring Patents Where Information or the Exercise of Human Intellect Is An Element of a Purported Invention The Supreme Court has been closely divided over the reach of the patent system in seminal decisions addressing patent eligibility in Chakrabarty and Bilski.  A recent opinion at the Federal Circuit raised continuing questions over patent-eligibility of isolated human genes.  The persistent controversies over patent-eligibility stand seemingly Robert Armitage at odds with the statutory framework under which patent-eligibility is determined.  In this respect, the patent statute itself is largely unchanged since 1793.  Moreover, the statutory language could hardly be simpler English-language prose.   Given the persistent complexity and confusion in articulating and applying a simple standard for patent eligibility, has the time come for crafting a new and clearer analytical framework for deciding what is excepted from patenting.  Indeed, does the most recent Supreme Court laundry list of exceptions, “laws of nature, physical phe- nomena, and abstract ideas,” make any sense whatsoever?  Since ideas themselves cannot be patented anyway, what purpose is served by excepting abstract ones?  Since “laws of nature” are at best man-made approximations for un- derstanding how the physical world operates, when old “laws of nature” (Newton’s Laws of Motion) are superseded by more nuanced understandings (e.g., quantum mechanics), does their patent eligibility disqualification change?   Finally, what are the “physical phenomena” that are patent-ineligible other than man-made concepts for understand- ing the manner in which the physical world operates—e.g., gravitation and electric charge?  Is a brighter, clearer, and more durable line to be drawn by regarding mere information—however manifest—as being patent-ineligible, and in the case of processes, disqualifying from patenting claims that are drawn so broadly as to encompass human thought.  In other words, is eligibility for patenting best understood as things and processes that are not dependent upon information or human intellect as one of the elements of a purported invention. Robert Armitage Bio Robert A. Armitage became senior vice president and general counsel for Eli Lilly and Company in January 2003, and is a member of the company’s executive and operations committees. He joined the company as vice president and general patent counsel in October 1999. Armitage was born in Port Huron, Michigan, and received a bachelor of arts degree in physics and mathematics in 1970 from Albion College. He received a master’s degree in physics from the University of Michigan in 1971 and a juris doctor from the University of Michigan Law School in 1973.  Prior to joining Lilly, Armitage was chief intel- lectual property counsel for The Upjohn Company from 1983 to 1993.  He also was a partner in the Washington, D.C. office of Vinson & Elkins LLP from 1993 to 1999. Armitage is a member and a past president of the American Intellectual Property Law Association (AIPLA) and the Association of Corporate Patent Counsel (APC).  He is also a past chair of the Patent Committee of the Pharmaceutical Research and Manufacturers of America (PhRMA), the National Council of Intellectual Property Law Associations (NCIPLA), the Intellectual Property Committee of the National Association of Manufacturers (NAM), the Fellows of the American Intellectual Property Law Association, and the Intellectual Property Law Section of the State Bar of Michigan. He has served as an adjunct professor of law at George Washington University, a member of the board of directors of Human Genome Sciences, Inc., and president of the board of directors of the Hospice of Southwest Michigan, Inc. He has also served as a member of the board of directors of both Intellectual Property Owners (IPO) and the National Inventors Hall of Fame Foundation (NIHFF).  Mr. Armitage served as a member of council for the Intellectual Property Law Section of the American Bar Association (ABA IPL Section) and has been nominated to serve as vice chair beginning in August of 2009. Mr. Armitage currently serves as a member of the Advisory Board for the Patent, Trademark & Copyright Journal of the Bureau of National Affairs, Inc., as a member of the Executive Committee of the Association of General Council (AGC), and is a trustee on the Albion College Board of Trustees. Page 7
  • 8. PANEL II – University Technology Transfer: Bridging the Gap from Innovation to Commercialization 9:15 – 10:15 am Topic 1: Chakrabarty and the Bayh-Dole Act Science and Law in Evolution The confluence of the decision of the Supreme Court in the Chakrabarty case and the passage of the Bayh-Dole Act both occurring in 1980 have engendered a profound effect on our society. That judicial decision, embracing recognition of Howard Bremer evolving science as patentable subject matter and that piece of legislation that established a position for universities, and other non-profit entities as well as small businesses in the disposition of rights to inventions made with federal monies, have been complementary in their contribution to societal benefit. Together they represent the two most potent forces – science and law – which, through their evolution from primitive religion and superstition have shaped society as we know it today. Howard Bremer Bio Howard Bremer holds degrees in Chemical Engineering and Law from the University of Wisconsin-Madison. He has been admitted to membership in the bars of the United States Supreme Court, the Court of Appeals for the Federal Circuit, the District Court for the Southern District of Ohio, and the State of Wisconsin. He has been active in the Patent Law Section of the State Bar of Wisconsin, serving as its Chairman on two separate occasions, The Associa- tion of University Technology Managers (AUTM), serving both as its President and several times as a Trustee of the Association, and has been the President of the Wisconsin Intellectual Property Law Association – Section on Intellectual Property Law and the American Intellectual Property Law Association. He has engaged in legislative activities involving intellectual property matters, offering testimony in hearings before numerous Congressional committees and Federal agencies and served on the National Advisory Commission on Patent Law Reform. He served as a member of the Patent Division of the Procter and Gamble Company for 12 years and then as Patent Counsel for the Wisconsin Alumni Research Foundation for 28 years. He is a recipient of the Jefferson Medal awarded by the New Jersey Intellectual Property Law Association. He currently functions as a consultant in patent, licensing and technology transfer matters. PANEL II – University Technology Transfer: Bridging the Gap from Innovation to Commercialization 9:15 – 10:15 am Topic 2: Toward the Advancement of University-Corporate Collaborations: Open Innovation in Translational Research Open innovation has become an essential reality for corporate entities in many industrial sectors. Reduced R&D Jim Chiapetta budgets, ailing stock prices and the need for multi-disciplinary expertise motivate corporations to reduce in- ternal spend and look to outside sources. As such, universities are a prime source for feeding cutting edge tech- nology into corporate product portfolios. In addition, universities are motivated to form relationships with cor- porations to ensure translation of early stage technology from the bench to practical application. However, while both corporations and universities may have ample motivation to enter into synergistic relationships, differ- ent cultures, misaligned infrastructures, and conflicting priorities can make such relationships a challenge to manage. Identifying common ground, instituting communication processes, and establishing realistic expecta- tions at the outset can help foster successful relationships to promote movement of new technologies into society. Jim Chiapetta Bio Jim Chiapetta D.V.M., J.D. is Senior Patent Counsel at Boston Scientific Corporation. Boston Scientific is an $8 Billion dollar medical device company that develops and markets minimally invasive medical products. At BSC he manages a $1.5 billion intellectual property portfolio in the area of cardiac and peripheral biopharmaceuticals, biomaterials, drug deliv- ery and cell technology. Dr. Chiapetta’s responsibilities include managing all aspects of the IP portfolio including patent procurement, patent litigation, technology acquisition and out licensing worldwide. He is also responsible for evaluating and implementing strategic innovation methods for creating, identifying and harvesting new technologies and managing third party technology relationships. Prior to BSC Dr. Chiapetta practiced as an IP attorney at the law firm of Merchant & Gould, P.A., in Minneapolis where he provided legal counsel for start-up and early stage financed to fortune 100 com- panies including 3M, Cargill, Abbott Labs and EcoLab. He serves on the board of directors or as an advisor for several start-up and early round financing companies in the areas of animal health, biotechnology, artificial intelligence systems Page 8 and homeland security. Prior to his legal career, Dr. Chiapetta practiced equine medicine and surgery for eight years.
  • 9. PANEL III – Diamond v. Chakrabarty: An Historical Perspective 10:30 – 11:30 am Topic 1: Thirty Years: From Dr. Chakrabarty’s Oil-Eating Microbes to the Myriad Mess An outline of the dramatic changes in patent eligible subject matter (35 U.S.C. § 101) from the 1980 Chakrabarty decision to the 2010 Myriad case. Edmund Sease Edmund Sease Bio Ed holds a degree in chemistry and graduated Order of the Coif from Drake University Law School in 1967, where today he is an adjunct professor. He has taught copyright, trademark and patent law as well as courses in intellectual property litigation. Ed also teaches at the University of Iowa College of Law. Ed is a trial lawyer with more than 30 years of experience litigating intellectual property cases before judges and juries throughout the country. Ed has argued before the Supreme Court of the United States in a precedent-setting case shap- ing the law of utility patents for plants. PANEL III – Diamond v. Chakrabarty: An Historical Perspective 10:30 – 11:30 am Topic 2: Everything Under the Sun Except Man Patent law has been accused of treating human beings, and aspects thereof, as property by allowing inventions related to the human body to constitute patentable subject matter.  The threat of such patent servitude may be exaggerated. Although patent law contains few explicit subject matter limitations, patents claiming human bodily structures or func- tions have often been limited, or even eliminated, by the courts. In addition to prohibiting the patenting of human Andrew Torrance beings per se, there has been a trend in patent law against the patentability of human genes, human embryonic stem cells, metabolic products of human in vivo conversion, and human thought. Thus, despite anxieties to the contrary, patent law provides little support for the patenting of humans. Andrew Torrance Bio Andrew W. Torrance joined the University of Kansas School of Law faculty in 2005. In 2009, he was named a Docking Faculty Scholar at KU, and a 2009/2010 Fellow in Law, Innovation, and Growth at the Searle Center at Northwestern Law School. Torrance received his PhD in biology from Harvard University in 1997 and is a 2000 graduate of Harvard Law School. He earned his Bachelor of Science from Queen’s University in Canada. In 2003, Torrance was named the Hrdy Visiting Professor of Conservation Biology at Harvard University. He taught Biodiversity: Science, Policy, and Law; at Harvard University from 1999, until his arrival at KU. Torrance practiced biotechnology patent law at Fish and Richardson LLC and then served as in-house patent counsel at Inverness Medical Innovations. Torrance has presented his research in the United States, Canada, Finland, Scotland, England, France (at the Organisation for Economic Coop- eration and Development), and Germany. His articles have been published in journals such as the Berkeley Technology Law Journal, the Columbia Science and Technology Law Review, and the Minnesota Journal of Law, Science & Tech- nology. Since 2007, Torrance has run Biolaw: Law at the Frontiers of Biology, an annual conference that gathers leading scholars at KU Law to present their insights on the latest developments in biolaw. Torrance’s research interests include intellectual property, patent law, innovation law, biotechnology, biolaw, food and drug law, biodiversity law, climate change law, and international environmental law. Page 9
  • 10. PANEL IV– Patentable Subject Matter After the Supreme Court Decided Biliski v. Kappos: “What is an “Abstract Idea?” 11:30 – 12:30 pm Topic 1: Prometheus Laboratories, Association of Molecular Pathology, and Other Claims to Methods of Deductive Reasoning Kevin Collins Prometheus Laboratories v. Mayo Collaborative Services and Association of Molecular Pathology v. USPTO both draw attention to the patent eligibility of “correlation” claims. Although they vary considerably in their details, correlation claims at their core describe a two-step method. First, they describe the act of “measuring” or “determining” a first fact with a prior- art method. Second, they describe the act of “inferring” a second fact from the first fact or “correlating” the first fact with a second fact. The patent eligibility of correlation claims is conventionally framed as a policy question with ramifications that are specific to the medical, biotechnology, and pharmaceutical sectors. This frame is unquestionably an important one, as correlation claims, if valid, allow companies that discover previously unknown correlations to internalize a larger share of the social welfare generated by technological advances in the overlapping fields of pharamacogenomics, biomarkers, and diagnostic testing in general. However, if framed in this fashion, then the debate over the patent eligibility of correlation claims will be misleadingly narrow. A broader frame is needed. If nonobvious correlation claims are categorically valid, in theory mean that anyone who discovers a previously unknown fact about the world to propertize any mental act of deductive reasoning in which the newly discovered fact operates as a premise. Whether and under what conditions correlation claims should be patent eligible remains a difficult policy question, but viewing the question as specific to the medical, biotechnological, and pharmaceutical industries provides a misleading narrow frame that may overestimate the net social value of correlation claims. Kevin Collins Bio Professor Collins joined the faculty at the Washington University School of Law in St. Louis in 2010. His research focuses primarily on intellectual property and, most recently, on two specific topics in patent law: the optimal reach of patent rights into after-arising technologies and the patentability of newly discovered acts of human thought. A licensed architect who spent five years as a project architect and lead designer with Bernard Tschumi Architects, Professor Collins is also interested in the intersection of law and architecture. Professor Collins earned his BA in Molecular Biophysics and Biochemistry from Yale in 1990, his M Arch from Columbia in 1994, and his JD from Stanford in 2002. He clerked for the Honorable Judge Sonia Sotomayor on the Second Circuit Court of Appeals and the Honorable Judge Raymond Clevenger III on the Federal Circuit Court of Appeals. He taught at the Indiana University Maurer School of Law in Bloomington from 2004 to 2010. Professor of Law, Washington University School of Law in St. Louis. Page 10
  • 11. PANEL IV– Patentable Subject Matter After the Supreme Court Decided Biliski v. Kappos: “What is an “Abstract Idea?” (continued) 11:30 – 12:30 pm Topic 2: How Will Bilski Impact the Patenting of Personalized Medicine? Personalized medicine is predicted to play an increasingly important role in healthcare.  Innovation in personalized medicine will typically involve the identification of some correlation between a biomarker and optimal drug regimen Chris Holman in individual. For example, in the case of the breast cancer drug Herceptin, genetic markers were identified that pre- dict whether a patient will respond positively to treatment with the drug. Personalized medicine will often comprise diagnostic testing (often genetic testing) and subsequent use of the resulting information to inform the choice of drug, or the amount and timing of drug administration, etc. Thus, personalized medicine inventions will often consist of the discovery of biological information, e.g., a correlation between a genetic marker and likely efficacy of a particular drug. This could raise issues of patentability, particularly in view of recent developments in the jurisprudence of the pat- ent eligibility doctrine, and challenges that have been raised to inventions based on biological discoveries. In my talk, I will outline some of the challenges facing inventors of personalized medicine, and discuss some recent and ongoing cases of particular relevance, including LabCorp v. Metabolite, Bilski v. Kappos, Prometheus v. Mayo, and AMP v. USPTO. Chris Holman Bio Chris Holman is an associate professor of law at the University of Missouri-Kansas City School of Law. He teaches and writes primarily in the areas of intellectual property, biotechnology and antitrust law, with a focus on the interface between patents and biotechnology. Prior to becoming a law professor, he served as vice-president of intellectual property and pat- ent counsel at several Silicon Valley biotechnology companies. He was also an associate at a major intellectual property law firm. A native of California, Professor Holman received a Ph.D. in biochemistry and molecular biology from the University of California at Davis, and engaged in post-doctoral drug discovery research at Roche Biosciences in Palo Alto, California. He attended law school at UC Berkeley’s Boalt Hall. Introduction of Lunch Keynote Speaker Gary Myles Ph.D., Shareholder, Schwabe, Williamson & Wyatt Attorneys at Law 1:00 pm Gary Myles focuses his practice on the protection of life science, biotechnology, pharmaceutical (small molecule), and medical device inventions, with special emphasis on patent counseling, patent application drafting and prosecution, and related licensing, evaluation, and dispute resolution. He has extensive  experience in the formulation of freedom-to-operate, non-infringement, and invalidity opinions, and performs intellectual property due diligence reviews in the context of business transactions including M&A and venture financing. Dr. Myles has deep knowledge in the areas of science and technology including molecular and cell biology, biochemistry, Gary Myles organic chemistry, physical chemistry, and immunology. He obtained his Ph.D in the laboratory of Aziz Sancar from the University of North Carolina, Department of Biochemistry and Biophysics where he studied the molecular mechanisms of nucleotide excision repair of damaged DNA.  He spent six years as a post-doctoral and senior research fellow at the Fred Hutchinson Cancer Research Center where he researched the molecular mechanisms of signal transduction through structure function studies on the c-fms receptor tyrosine kinase and studied the effect of receptor mutants on the processes of cellular differentiation, proliferation, and transformation. Dr. Myles has been recognized as a Washington Super Lawyer, which is an annual listing of outstanding lawyers who have attained a high degree of peer recognition and professional achievement. Dr. Myles is an adjunct professor at the Seattle University School of Law where he teaches “Biotechnology and the Law” and is an adjunct professor and law, technology and arts fellow at the University of Washington School of Law, where he teaches the Advanced Patent Law Seminar to JD and LLM students. Dr. Myles is active with the American Cancer Society Cancer Action Network, the  Washington State Bar, Washington Biotechnology and Biomedical Association, American Bar Association, Washington State Patent Law Association, American Intellectual Property Law Association, American As- sociation for the Advancement of Science, Licensing Executives Society, Greater Seattle Chamber of Commerce, and the Association of University Technology Managers. Page 11
  • 12. Lunch Keynote Presentation Todd Dickinson, Executive Director Intellectual Property Law Association 1:00 – 1: 50 pm Patent Reform and Biotechnology: Congress and the Courts Todd Dickinson Congress has been pursuing legislative reform aggressively over the last several years. Many of the most controversial issues directly implicate biotechnological research and commercialization. These remarks will address the reform ef- fort generally, with special emphasis on the impact on biotechnology. Meanwhile, many aspects of the reform agenda are being addressed in the Courts. The remarks will also address those with the same biotech focus. Todd Dickinson Bio Todd Dickinson is the Executive Director of the American Intellectual Property Law Association, a bar association of over 16,000 members and one of the world’s leading policy and advocacy organizations in the field of intellectual property. He has over 30 years of experience in all aspects of intellectual property, having previously served as both Vice President and Chief Intellectual Property Counsel for the General Electric Company, where he had corporate-wide responsibility for intellectual property matters, and Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office under President Clinton. He was also a partner in the Howrey law firm, where he co-chaired its intellectual property practice. Mr. Dickinson has written and spoken extensively around the world on intellectual property issues, and in the U.S. has testified before Congress, the Federal Trade Commission and the National Academy of Sciences on intellectual property administration and policy. Mr. Dickinson was previously on the Executive Committee of the Intellectual Property Owners Association, Vice-Chair of the Intellectual Property Law Section of the American Bar Association, and has been named four times one of the “50 Most Influential People in Intellectual Property” by Managing Intellectual Property magazine. He earned his B.S. from Allegheny College in 1974, and his J.D. in 1977 from the University of Pittsburgh. He is admitted to the bars of the District of Columbia, Pennsylvania, Illinois, California, the United States Patent and Trademark Office, and the Court of Appeals for the Federal Circuit. Page 12
  • 13. Panel V – The Patentability of Biotechnology Inventions after Myriad v. ACLU 2:00 – 3:30 pm Topic 1: Myriad v. ACLU: A View From the Inside Biotechnology has revolutionized almost all aspects of human existence over the past 30 years, nowhere more so than in biomedicine. Monoclonal antibody therapies, genetic diagnostic testing, forensics, biologic drugs, disease-, pest- and Kevin Noonan pesticide-resistant crops and biofuels are just a few examples. By and large these advances have been the result of an unprecedented and fertile collaboration between academia, start-up companies and large pharmaceutical and other concerns. These efforts have been facilitated by the patent system, promoting the disclosure that scientific advances and the scientists that make them require, while protecting technological applications of these advances that investors demand. But like any successful enterprise, biotechnology has its critics, and their most recent criticisms are directed at the patent system. While not perfect, the alternative to patenting would discourage disclosure, weaken if not destroy the ties between industry and academia, and slow the pace with which scientific advances are translated into new medicines and other technologies. Kevin Noonan Bio Kevin E. Noonan is a U.S. patent attorney with almost 20 years experience representing biotechnology and pharmaceutical clients. Dr. Noonan brings more than 10 years of experience as a molecular biologist working on high-technology problems to his legal work. He has wide experience in all aspects of patent prosecution, interference, litigation, and client counseling on validity, infringement, and patenting strategy matters. He represents biotechnology and pharmaceutical clients both large and small, as well as several universities in their technology-transfer and licensing efforts. In addition to an extensive schedule of writing and speaking, Dr. Noonan is a founding author of the biotech and pharma patent law and news weblog, Patent Docs (www.patentdocs.org.) Panel V – The Patentability of Biotechnology Inventions after Myriad v. ACLU 2:00 – 3:30 pm Topic 2: Products of Nature and The Hand of Man: Thirty years after Chakrabarty In its precedent-setting case of Diamond v. Chakrabarty, the Supreme Court adopted a broad interpretation of the patentability of innovations emerging from the then-nascent biotechnology industry.  In the decades since, judges, juries, advocates and attorneys--as well as Patent and  Offices and tribunals in this and other countries--have wrestled with the issue of how and when the “hand of man” could turn “anything under the sun” into a patentable invention. Claims to biochemical Cathryn Campbell products in an isolated or purified form, such as antibiotics, have long been held to  possess the requisite novelty to avoid prohibitions against the patenting of products of nature.  But can the same logic be applied to permit the patenting of genes? of Proteins? of living animals or chimeras?  Cathryn Campbell Bio Cathryn Campbell is General Counsel for the Institute for Systems Biology, a not-for-profit medical research foundation in Seattle, Washington.  She received her PhD in population genetics from the University of California, Davis, and her JD from the UCLA School of law, after which she clerked for the US Court of Appeals for the Ninth Circuit.  She was in the private practice of  law for over 25 years  with several firms, most notably as a founding partner of Campbell & Flores, LLP, a law firm specializing in biotechnology intellectual property in San Diego.  While her practice focused primarily on patent and transactional matters, she worked with the Firm’s litigation team which handled Integra LifeSciences v. Merck KGaA,  from the trial court up through the Supreme Court; the case related to the safe harbor exemption from infringement for medical research. Cathryn has published and lectured widely in both science and law.   She has been active and held offices and board seats in a number of professional societies, including Vice President for the Western Region of the Licensing Executives Society.  Among other honors and awards she was named one of California’s top patent attorneys by the California Lawyer and was recipient of  the Athena Pinnacle Award.  But she is perhaps most proud to have been named one of San Diego’s Page 13 Ten Cool Women by the Girl Scouts of San Diego County.
  • 14. Panel V – The Patentability of Biotechnology Inventions after Myriad v. ACLU (continued) 2:00 – 3:30 pm Topic 3: Human Gene Patents: History, Controversies and Taxonomies Almost thirty-five years after human somatostatin was first cloned and a patent application filed on its DNA in 1977 by Arthur Riggs (it issued in 1982), we are still in the midst of a vigorous debate as to whether claims to isolated human genes Jorge Goldstein are or not statutory, proper or wise. This has had less to do with any dramatic developments in the law than with inexo- rable developments in the science (we went from heroically seeking needles in haystacks to routinely sequencing multi- tudes of DNAs of unkown function), with the commercial choices and taxonomy of genes that were patented (we went from protein drugs to research tools, and from single gene to multigene diagnostics), and with the effects that these devel- opments had on the distinct constituencies involved. We will discuss how we got here and where we are likely to go next. Jorge Goldstein Bio Jorge Goldstein is a founding director of Sterne Kessler Goldstein and Fox, PLLC, a 290 person IP law firm in Wash- ington DC. He founded its Biotech/Chem Practice in 1982 and, after serving as Managing Director of the firm for many years, is now Practice Chair and active in Patent Office Litigation and licensing. Dr. Goldstein has more than 30 years of experience in preparing, prosecuting, licensing, enforcing and litigating biotech patents. Noteworthy among several of his appellate cases, in 1988 Goldstein was lead counsel in In re Wands et al. 8 USPQ2d 1400 (Fed. Cir.), a pivotal decision on biotechnology enablement. Born in Buenos Aires, Argentina, he received a B.S. in Chemistry from RPI in 1971, a PhD in Chemistry from Harvard in 1976 and a JD from the George Washington University in 1982. The Legal Times of Washington, Chambers USA, and Legal 500 have repeatedly named him a Leading Lawyer and he was, again for 2011, named in Best Lawyers in America. Panel VI – Policy Issues and the Economics of Patent Protection 3:40 – 4:40 pm Topic 1: What Factors are Generating the Strong Public Opinion Against “Gene Patents”? Is there such a thing as a “gene patent”? The term certainly enkindles strong negative emotions in many individuals and recently stimulated organized opposition in the courts and the legislature to what are perceived as “gene patents,” but what Alice Martin really is under attack? This opposition appears to be an indicator of underlying diverse philosophical positions in our society which - if not considered, respected and resolved, will have adverse consequences on healthcare. Among those opposed to “gene patents,” the “Frankenstein” fear factor may be what inflames the scientifically unsophisticated; religious groups may consider anything involving “life” to be the province of a deity; patient advocacy groups may feel their access to diagnosis and therapy is limited; medical associations may fear independence of their members to practice medicine is compromised; and clinical laboratories may have monetary concerns. On the other hand, the biotech industry and some academic centers are concerned that without patent protection, funding for future medicines, diagnostics and therapeu- tics will be jeopardized and advances in healthcare will cease. Politicians react to pressures from their constituents and are understandably confused. Little hard data supports the adverse effects claimed by the opposition to “gene patents,” yet scientific, legal, and financial arguments for the value of patents to society in promoting medical advances fall on deaf ears. Until the underlying bases for the negative and positive positions are understood including whether “gene patents” are really the issue, no reasonable decisions can be made. Proponents of the various positions on patenting anything that relates to “life,” not just “gene patents” must meet and delve deeper into the real issues, to find mutually beneficial solutions. Page 14
  • 15. Panel VI – Policy Issues and the Economics of Patent Protection 3:40 – 4:40 pm Alice Martin Bio Alice O. Martin is a partner in the Chicago office of Barnes & Thornburg LLP. She is a member of the Intellectual Property Department where she concentrates on patent and trademark litigation and prosecution, opinions and due diligence investigations. Dr. Martin’s practice covers biotechnology, agriculture-plants and animals, stage equipment, medical compositions and devices, laboratory equipment, computer systems, business methods, genetics, treatments and assays for various diseases, surgical techniques, tissue culture methods, and waste management and monitoring. Dr. Martin is a member of the National Institutes of Health Study Sections and has written more than 100 articles for scientific publications and delivered more than 50 presentations nationally and internationally on scientific and legal issues. She was recommended by her peers as a Leading Lawyer in Intellectual Property Law and was selected for inclusion in The Best Lawyers in America® 2010 in the field of biotechnology law. Martin received her M.S. in genetics from the University of Michigan in 1963 and her Ph.D. in biology (genetics) in 1969 from Case Western Reserve University. She received her J.D. from Loyola University School of Law, Chicago in 1989. Panel VI – Policy Issues and the Economics of Patent Protection 3:40 – 4:40 pm Topic 2: The Economic Perspective on Small and Large Molecule Pharmaceutical Technologies Richard Rozek Research-based pharmaceutical companies have made substantial investments in large molecule or biologic technologies through such activities as internal R&D, mergers, and licensing. These investments have generated some scientific and commercial successes. With the growing importance of large molecule technologies in the research pipelines of pharma- ceutical companies, economists have started to compare and contrast the development, manufacture, and sale of products based on small molecule technologies and large molecule technologies. Some of the issues that prompted interest in the industry between 1960 and 1990 such as safety and efficacy, patent protection, data exclusivity, and entry by sellers of generic small molecule products are now being raised with respect to products based on large molecule technologies. The purpose of this research is to assess small and large molecule pharmaceutical technologies from an economic perspective. The three main goals are: to summarize the current state of economic research on small molecule technologies and large molecule technologies; to identify trends in licensing patents for small and large molecule technologies; and to highlight emerging issues for policymakers, investors, and companies. Richard Rozek Bio Dr. Rozek received a B.A. degree in Mathematics with honors from the College of St. Thomas, a M.A. degree in Mathematics from the University of Minnesota, and M.A. and Ph.D. degrees in Economics from the University of Iowa. Dr. Rozek began his professional career as an Assistant Professor at the University of Pittsburgh. Dr. Rozek then worked for over six years in the Bureau of Economics at the Federal Trade Commission in a series of senior staff positions including Deputy Assistant Director for Antitrust. While at the FTC, Dr. Rozek evaluated antitrust and regulatory issues in electric and gas utilities, oil pipelines, soft drinks, forprofit and nonprofit hospitals, motion pictures, pharmaceuticals, and infor- mation industries. For two years, Dr. Rozek worked as the economist at the Pharmaceutical Research and Manufacturers of America. He conducted research on issues such as the cost to develop a new pharmaceutical, pharmaceutical industry profitability, benefits and costs of intellectual property protection, productivity of R&D personnel in the pharmaceutical industry, and reform of the health care reimbursement system. Since joining NERA in 1987, Dr. Rozek has worked on projects in the antitrust/health, intellectual property, energy, and tele- communications practices. He has addressed economic issues in industries such as agricultural chemicals, automobiles, cellular telephone service, convenience food, electric equipment, electric utilities, hospitals, medical devices, newspapers, pharmaceu- ticals, and professional services. He has testified as an expert witness in antitrust, contract dispute, and intellectual property matters. Dr. Rozek has valued intellectual and tangible property for tax and other business purposes. Dr. Rozek’s published research has appeared in journals such as Applied Economics, Contemporary Policy Issues, Energy Journal, Economics Letters, Journal of Economics, Journal of Research in Pharmaceutical Economics, Journal of World Intellectual Property, Mathematical Modelling, Metroeconomica, Research Policy, and Tax Notes International. He has spoken at Page 15 various forums throughout the world on intellectual property issues.
  • 16. Video Presentations will be available at: http://www.law.illinois.edu/chakrabarty Videos provided by: John Tubbs, University of Illinois at Urbana-Champaign Our Sponsors Sponsored by: I Hotel and Conference Center • College of Law, Program in Intellectual Property and Technology Law • Institute for Genomic Biology • Division of Biomedical Sciences • Center for Advanced Study • Office of Corporate Relations • Office of Technology Management, Urbana Campus • Office of Technology Management, Chicago Campus • Office of the Vice President for Technology and Economic Development, University Administration • School of Molecular and Cellular Biology • Department of Biochemistry Special Thanks to Elizabeth Stull - Conference Administrator, University of Illinois at Urbana-Champaign for coordination of this event Page 16