Biotech Intellectual Property & Licensing (Spring 2008)
Biopharmaceutical companies typically incur extraordinary research and development costs. Without intellectual property (patent) protection, and the resulting right to prohibit potential
competitors from unfairly competing (creating price competition) prior to patent expiration, the biopharmaceutical industry could not exist. Despite the longstanding importance of intellectual property to the biotechnology industry, biotech patent law and practice continues to evolve. For some critics, this evolution is too late, or misdirected. Biotech companies frequently are criticized for their acquisition and deployment of certain intellectual property protections: that patents on genetic sequences somehow usurp our common human legacy; that patent term “manipulation” and extensions unfairly prolong monopoly pricing; and that biotech intellectual property reduces access to, and affordability of, desperately-needed therapies, particularly in developing countries.
This half-semester course aims to provide high-level but practical information for KGI students who soon will join the ranks of biotechnology inventors, entrepreneurs, businesspeople and policy-makers. The course covers established principles of biotechnology patent law, but emphasizes current developments in this rapidly-changing area of the law. Beginning with a fictional scientist-colleague’s important (but imperfect) entry in a hypothetical laboratory notebook, students will steer their colleague’s “eureka” moment through the creation of intellectual property protection, and beyond - is the invention patentable subject matter? May the invention freely be practiced? What “prior art” stands between the presumed inventor and a government grant of a patent monopoly? What is required to in-license blocking patents, cross-license mutually-competing patents, or out-license the patented invention entirely, perhaps to a better-resourced pharmaceutical company? Should attempts to out-license fail, what are the risks (and costs) associated with patent litigation? What are the factors which companies should consider when entering a know-how collaboration? Finally, is patent protection a moral “good,” to be valued over all other competing interests? Is it ethical to patent “the natural and the human?”
A stellar group of biotech’s leading intellectual property lawyers, transactional attorneys and businesspeople have helped design the course and will present several of the semester’s lectures.
Introduction and Foundation: Biotech IP Basics (PowerPoint Slides and Introduction)
Scott A. Brown
Scott A. Brown is Vice President, General Counsel and Head of Patents at the Novartis Institutes for Biomedical Research in Cambridge, Massachusetts. Previously, Scott was Vice President and Deputy General Counsel at Millennium Pharmaceuticals, Inc., where he oversaw development and implementation of Millennium’s intellectual property and licensing strategy, including procurement of patents, review of intellectual property aspects of company transactions and analysis of intellectual property issues relating to Millennium’s activities.
Staking a Claim: Patenting Biotech Discoveries (PowerPoint Slides and Introduction)
Anita Meiklejohn
Anita Meiklejohn is a Principal in the Boston office of Fish & Richardson P.C. Her practice emphasizes patent prosecution, validity and infringement opinions, and litigation in the area of biotechnology. She previously worked an associate and technology specialist with Fish & Richardson. She also has technical experience as a Post-doctoral Fellow, Harvard University, Department of Biochemistry and Molecular Biology.
Elbow Room: Freedom to Operate & Infringement Analysis (PowerPoint Slides and Introduction)
Jayshree Gerken
Jayshree A. Gerken is an Associate in the San Diego office of Fish & Richardson P.C. Her practice emphasizes patent prosecution in the area of biochemistry. Dr. Gerken has significant technical experience as a research scientist in genomics with Chugai Biopharmaceuticals (1995-1998) and a research scientist in nucleic acid chemistry with Gen-Probe (1993-1995). She also worked as a postdoctoral associate in chemistry at Yale University (1990-1993), research assistant, Ph.D. program in biochemistry, Dartmouth College (1984-1990), and research assistant, Master's program in organic chemistry, Indian Institute of Technology (1982-1984).
In and Out: Licensing Your Rights (PowerPoint Slides and Introduction)
David Kleinsmith
David Kleinsmith is a Principal in Fish & Richardson's San Diego office, where he is a member of the Corporate and Securities group. His practice emphasizes complex technology licensing transactions, intellectual property (IP) due diligence, and patent prosecution across a wide range of technologies. Mr. Kleinsmith’s representative complex technology licensing projects include: negotiating and drafting agreement sets, each directed to forming and/or financing a viable business around IP-protected technology in the pharmaceutical, biotechnology, medical device or nanotechnology areas; and counseling and assisting businesses in the structuring of their rights under early-priority-date patent portfolios for emerging technologies to provide exclusivity in each business’ core operating field while enabling significant ROI opportunities via licensing outside the core operating field. Mr. Kleinsmith brings substantial technical patenting experience to his licensing practice, having prepared over 44 patent applications, and prosecuted numerous others, for inventions in the following technology areas: pharmaceuticals, biotechnology, medical devices, nanotechnology, chemical, mechanical and fuel cells. He has prior professional experience forming his own IP-oriented law firm, working as the first in-house attorney for two venture-backed, 50+ employee startups, and working as an associate for two large law firms in San Diego, where his practice was servicing the transactional IP needs of a mostly start-up clientele. Mr. Kleinsmith has technological experience from Research Assistant roles at Lawrence Berkeley Laboratory in the Cholesterol Research Center (1989-1990), and in the Chemical Biodynamics Division (1985, 1988-1989).
Enforcing and Challenging: Patent Litigation
Frank P. Porcelli
Frank P. Porcelli is a principal of Fish & Richardson in the firm's Boston and Delaware offices. He joined the firm in 1971. His practice emphasizes patent and trade secret litigation and appellate work. Named in the 2007 International Who's Who of Patent Lawyers. Frank was named to the 2006, 2007, and 2008 editions of The Best Lawyers in America. Named one of the "Best Lawyers in Boston" for Intellectual Property in Boston Magazine (2002). Harvard Law School, John A. Reilly Visiting Professor from Practice in Intellectual Property Law (academic year 1998-99 and 2000-01), Visiting Professor of Law from Practice (academic year 2001-02). Chair, Fish & Richardson Appellate Practice Group (1996 - present). Instructor on Biotechnology Litigation in Patent Resources Group Continuing Legal Education course "Biotechnology: Patents, Licensing & FDA Practice" (2000 to present). President of the Boston Patent Law Association (1990 to 91); Committee Chair, AIPLA Chemical Practice Subcommittee on Legislation (1987 to 89), Committee Chair, AIPLA Chemical Practice Subcommittee on Judicial and Administrative Decisions (1989 to 91), and Committee Chair, AIPLA Chemical Practice Committee (1991 to 92). Presenter and co-author of "Markman Hearings and Claim Construction - A Dialogue On The Sedona Conference Report on the Markman Process," presented at the AIPLA Public Forum (April 2007). Author of numerous articles on patent damages and other patent litigation and patent law topics, and co-author, with fellow principal John Dragseth, of "Patents -- A Historical Perspective," a casebook on patent law (in progress). Listed in Boston Magazine's November 2004 and 2007 issues as one of Massachusetts' "Super Lawyers." Named by Chambers USA as a recommended lawyer in 2005. Named in Euromoney's Expert Guide as one of the "World's Leading Patent Law Experts" (2005).
Working Together: Collaborations and IP (PowerPoint Slides and Introduction)
Bruce Leicher
Bruce A. Leicher has served as the Altus Pharmaceuticals, Inc. Senior Vice President, General Counsel and Secretary since December 2006. Prior to joining Altus, Mr. Leicher served as Vice President, General Counsel, Secretary and Compliance Officer at Antigenics, Inc. where he was responsible for advising the board and management on corporate governance, intellectual property, and corporate finance matters, and representing the Company in partnering negotiations, licensing transactions, regulatory strategy and compliance, and in litigation. Prior to his tenure at Antigenics, Mr. Leicher was Vice President, Chief Pharmaceutical Counsel, and Compliance Officer at Millennium Pharmaceuticals, where he was recruited to build a commercial legal group for the Company’s first product launch. There he provided legal advice involving product development and registration, partnering transactions, FDA clearance of promotional materials, pricing strategy, sales and marketing compliance, and the establishment of safety surveillance, medical affairs, and product distribution functions. Previously in his career, Mr. Leicher also led the Lifesciences practice group at Hill & Barlow and held senior legal positions at Curis, Inc., Ontogeny, Inc., Genetics Institute, Inc. and Bolt Beranek and Newman Inc. after practicing law at Hale and Dorr. Mr. Leicher received his J.D. from the Georgetown University Law Center and holds a B.A. from the University of Rochester.
Wrapping Up (PowerPoint Slides)
Professor Cohen
For the 2006-2007 and 2007-2008 academic years, Gary A. Cohen is the Joe and Vi Jacobs Visiting Professor of Biotechnology Law and Ethics at the Keck Graduate Institute of Applied Life Sciences, where his teaching duties include biotechnology business law and regulation; biotechnology intellectual property and licensing; an introductory course on bioethics and business ethics; and an advanced course on bioindustry ethics.
Gary Cohen has more than 20 years of law and ethics experience, including legal representation of industry-leading biotechnology companies. His most recent industry position was vice president, ethics and corporate responsibility, at Millennium Pharmaceuticals, where he was responsible for coordinating both in-house and external programs in bioethics, business ethics and corporate social responsibility. Earlier in his career at Millennium, Professor Cohen was Vice President and Associate General Counsel; in this role, he organized the company's business law group and helped manage the Legal Department during a period of unprecedented corporate growth and ambitious, record-setting transactions. Prior to joining Millennium, Professor Cohen was vice president and general counsel at Genzyme Transgenics (now GTC Biotherapeutics); and for many years, he served as as senior counsel at Genetics Institute, Inc. Professor Cohen also practiced law with Palmer and Dodge in Boston, and served as a foreign legal advisor with Yuasa and Hara in Tokyo.
Professor Cohen is frequently invited to speak on business and bioethics topics to, and serve on working groups with, national and international organizations, including BIO; PhRMA; The Hastings Center; Public Responsibility in Medicine and Research; American Society for Bioethics and Humanities; Fordham University Center for Ethics Education; American Society of Law, Medicine & Ethics; Harvard Business School; Harvard Law School; Boston Bar Association; Albany Medical College/Graduate College of Union University; the Academy of Management; and Time Magazine’s “Future of Life” conference. Before joining the Keck Graduate Institute, Professor Cohen co-taught Professor Charlie Nesson's 2006 Harvard Law School class on Biotechnology: Academic, Government & Industry Interactions and Tensions.
Cohen received his BA from Washington University in St. Louis; studied at the Beijing Language Institute; and received a law degree at Columbia University, and an MPH degree, with a concentration in health law, bioethics and human rights, from the Boston University School of Public Health.
