Intellectual Property in Genomic and Protein Research and Innovation

A joint project of the Board on Science, Technology and Economic Policy and the Science, Technology and Law Program, the committee will review the patenting and licensing of human genetic material and proteins, which represents an extension of intellectual property rights to naturally occurring biological material and scientific information, much of it well upstream of drugs and other disease therapies. Both the evolution to date of patents on DNA sequences and the emerging direction of patenting protein structures and functions will be evaluated for their implications for the conduct of research, the development of commercial products, and clinical practice to diagnose and treat a variety of human diseases. The study will document the types of patents that have been issued and to whom (or applied for and by whom), differences in the criteria being applied by the U.S. and other major patent offices to the examination of such applications, and, to the extent, possible, the licensing arrangements for different types of patented materials. In view of the substantial evidence that patents play an important role in certain kinds of biomedical innovations, especially the development of therapeutic drugs, the committee will carefully consider the impact of its recommendations on investments in R&D and the commercialization of their results.

Meeting 1: February 27-28, 2004

Agenda
Participants
Transcript (560KB)
Presentations

Charge to the Committee and Points to Consider
Francis Collins, NHGRI, NIH and Jeremy Berg, NIGMS, NIH
Intellectual Property and Genomics: A Rocky Relationship
Francis Collins, NHGRI, NIH
Presentation
Jeremy Berg, NIGMS, NIH
The Research Exemption in Non-profit Research
Mark Rohrbaugh, TTO, NIH
Research Directions in Genomics
Dennis Drayna, NIDCD, NIH
DNA Patent Project: Database and Survey
LeRoy Walters, Georgetown University
Patenting and Licensing of Research Tools and Biomedical Information: Where Do We Go From Here?
John Walsh, University of Tokyo/UIC

Meeting 2: June 4, 2004

Agenda
Participants
Transcript (340KB)
Presentations

Public Intellectual Property Resource for Agriculture
Alan Bennett, University of California
Issues in Patenting
Scott A.M. Chambers, Patton Boggs
Patenting Genomics: IP, the Evolving Structure of the Pharmaceutical Industry, and Its Implications for Research Productivity
Iain Cockburn, Boston University and NBER
What is Being Patented/Licensed
Wes Cohen, Duke University
What is Being Patented/Licensed
Lori Pressman, Consultant
NIH Patenting and Licensing Policies
Richard Rodriguez, NIH
Exploring Patenting and Licensing Policy for Proteomics: A Small Biotech Perspective
Avi Spier, Allon Therapeutics, Inc.
Structural Genomics/Proteomics: What is Being Patented and Who Owns the Rights?
Sara Vinarov, Quarles and Brady

Meeting 3: August 5, 2004

Agenda
Participants
Transcript
Presentations

Academic Experience Post-Madey: Impressions, Digressions, and a Few Facts
Susan Ehringhaus, AAMC
Biotechnology Innovation Report 2004
Arie Michelsohn, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Research Tool Patents: Are their any exceptions to infringement?
Rochelle Seide, Baker Botts, LLP
Patenting, Licensing, and Universities: Trends and Implications
Mark Sobel, Association of Molecular Pathology
The AUTM Data Set
Ashley Stevens, Boston University

Meeting 4: October 1-2, 2004

Agenda
Transcript (Day 1/Day 2)
Presentations

Charles Caruso, Merck & Co.
Merck’s Perspective on International Biotechnology Patent Processes
Jeff Kushan, Sidley, Austin, Brown & Wood LLP
EPO Standards for Genomic Patents
Debra G.B. Leonard, College of American Pathologists & Weill Medical College of Cornell University
Gene Patents: A Physician’s Perspective
John Merz, University of Pennsylvania School of Medicine
Empirical Insights about Gene Patents
Edwin Stone, The University of Iowa, HHMI
A Strategy for Improved Access to Genetic Testing for Rare Inherited Disorders Affecting Vision
Lawrence Sung, University of Maryland School of Law
Challenges of Patenting and Licensing Genomic and Proteomic Inventions

Meeting 5: December 13-17, 2004

Agenda
Transcript (Day 1/Day 2/Day 3/Day 4)
Presentations

Helen Berman, Rutgers University
Data Sharing in Structural Biology and Structural Genomics
Rochelle Dreyfuss, NYU Law School
Shielding Research from Patent Infringement Liability
Hans-Rainer Jaenichen, Vossius & Partners
Patent Standards for Genomic and Protein Inventions: The European Patent Office
Robert Kneller, University of Tokyo
The Impact of Patenting and Licensing on Research – a Japanese university perspective
Tim Leshan, U.S. National Institutes of Health
U.S. National Institutes of Health - Access to & Licensing of Genomic Inventions
Gert Matthijs, Center for Human Genetics, BE
No title
John Norvell, U.S. National Institutes of Health
Protein Structure Initiative
Koichi Sumikura, National Graduate Institute for Policy Studies
Discussion Material on Patent Standards for Genomic and Protein Inventions
Akiteru Tamura, Japan Patent Office
Examination of Biotech-related Applications at the Japan Patent Office
Akiteru Tamura, Japan Patent Office
Shielding Research from Patent Infringement Liability - The JPO’s Position
Akiko Tanaka, RIKEN Genomic Sciences Center
RIKEN Structural Genomics/Proteomics Initiative
Udo Heinemann, Max Delbrueck Centrum fur Molekulare
What is Structural Genomics?

Meeting 6: February 11, 2005

Agenda
Transcript
Presentations

Sadao Nagaoka, Hitotsubashi University
Access problem to research tool patents as seen in Japan
William E. Rusconi, Myriad Genetic Laboratories, Inc.
Patenting and Licensing of the Breast Cancer Susceptibility Genes - BRCA1 and BRCA2