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Biotech Intellectual Property & Licensing (Fall 2006)

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
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
Ramon K. Tabtiang

Ramon K. Tabtiang is an Associate in the Boston office of Fish & Richardson, a national intellectual property law firm with over 350 lawyers. Ramon has extensive experience with patent prosecution, portfolio management, and counseling on product development for biotechnology clients.

Elbow Room: Freedom to Operate & Infringement Analysis
Cathy McCarty

Cathy McCarty is an Associate in the Boston office of Fish & Richardson. Her practice emphasizes patent prosecution and litigation in the area of chemistry. Cathy previously worked as a Summer Associate (2001), and a Law Clerk (2000-2001) for Fish & Richardson. Her technical experience includes work as a Chemist for Vertex Pharmaceuticals (1998-1999), and as a Chemist for Abbott Laboratories, Pharmaceutical Products Research (1996-1998). Her research experience includes work as a Research fellow at Yale University, Department of Chemistry (1996), Undergraduate Research Fellow at Indiana University, Department of Chemistry (1993-1994). Cathy's other experience includes Organic Lab Teaching Assistant for Yale University, Department of Chemistry (1995-1996).

In and Out: Licensing Your Rights
Joseph L. Faber and Gregory J. Ikonen

Joseph L. Faber is a Co-Founder and Principal of Faber Daeufer & Rosenberg, a boutique business law firm for companies, research institutions and investors in the life sciences, with offices in Boston and New York. Joe is a seasoned corporate lawyer, with substantial experience in corporate strategic planning, public and private finance, M&A transactions and product-focused biopharmaceutical licensing.

Gregory J. Ikonen is Of Counsel to of Faber Daeufer & Rosenberg. Greg formerly was General Counsel to Arriva Pharmaceuticals (Alameda, California), and earlier was a partner in the Intellectual Property Transactions Practice Group and a member of the Life Sciences Practice Group at the Heller Ehrman law firm. Greg has extensive experience in structuring and negotiating corporate partnering and technology transfer deals; in intellectual property law and litigation; and general corporate matters. Prior to joining Heller Ehrman, he was a director at Venture Law Group.

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. Frank joined the firm in 1971. An experienced biotech IP attorney, his practice emphasizes patent and trade secret litigation and appellate work. Like most great biotech lawyers, Frank was an undergraduate English Literature major.

Working Together: Collaborations and IP
Joseph L. Faber and Gregory J. Ikonen

Joseph L. Faber is a Co-Founder and Principal of Faber Daeufer & Rosenberg, a boutique business law firm for companies, research institutions and investors in the life sciences, with offices in Boston and New York. Joe is a seasoned corporate lawyer, with substantial experience in corporate strategic planning, public and private finance, M&A transactions and product-focused biopharmaceutical licensing.

Gregory J. Ikonen is Of Counsel to of Faber Daeufer & Rosenberg. Greg formerly was General Counsel to Arriva Pharmaceuticals (Alameda, California), and earlier was a partner in the Intellectual Property Transactions Practice Group and a member of the Life Sciences Practice Group at the Heller Ehrman law firm. Greg has extensive experience in structuring and negotiating corporate partnering and technology transfer deals; in intellectual property law and litigation; and general corporate matters. Prior to joining Heller Ehrman, he was a director at Venture Law Group.

Patenting and Owning: The Natural and The Human
Steven H. Holtzman

Steven H. Holtzman is founder and Chief Executive Officer of Infinity Pharmaceuticals, Inc., in Cambridge, Massachusetts. From early 1994 through mid 2001, Mr. Holtzman served as the Chief Business Officer of Millennium Pharmaceuticals. In this role, at various times he had management responsibility for the Company’s business development, M&A, licensing, bioethics, intellectual property and corporate law functions.

Wrapping Up
Professor Cohen

Gary A. Cohen, the Joe and Vi Jacobs Visiting Professor of Biotechnology Law and Ethics at the Keck Graduate Institute of Applied Life Sciences, 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. Prior to joining Millennium, Professor Cohen was vice president and general counsel at Genzyme Transgenics (now GTC Biotherapeutics), and senior counsel at Genetics Institute, Inc. He also practiced law with Palmer and Dodge in Boston, and served as a foreign legal advisor with Yuasa and Hara in Tokyo.