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Date: Nov. 17, 2005
Contacts: Vanee Vines, Senior Media Relations Officer
Megan Petty, Media Relations Assistant
Office of News and Public Information
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Intellectual Property Rights Must Be Balanced With Research Needs
To Realize Full Potential of Biomedical Research

WASHINGTON -- Intellectual property (IP) restrictions rarely impose significant burdens on biomedical research, but there are reasons to be apprehensive about their future impact on scientific advances in this area, says a new report from the National Academies' National Research Council. The nation's policy-makers, courts, and health and patent officials should take appropriate steps to prevent the increasingly complex web of IP protections from getting in the way of potential breakthroughs in genomic and proteomic research. For example, Congress should consider legislation that would allow scientists to conduct research on patented inventions in order to discover novel uses or improvements without fear of liability for patent infringement. And should the rare case arise in which restricted access works against the interests of public health, courts should follow legal precedents and allow the provision of products or services that the public needs, while awarding compensation to particular inventors for the use of patented material.

Genomics, the study of an organism's genome and the functions of genes, is a rapidly growing field that may uncover new ways to diagnose and treat disease. Proteomics – the large-scale study of protein structures and functions – may also lead to advances in health care. Over the past decade, universities and industries have aggressively sought and defended IP protection for discoveries in these fields, often long before commercial application. The U.S. Patent and Trademark Office (USPTO) has been inundated with requests for patents on genes, gene fragments, proteins, and methods to study or produce them. Because thousands of genes or proteins can now be examined simultaneously, there is a real possibility that a thicket of restrictions could impede scientific progress by blocking access to previous findings.

Furthermore, a federal appellate court recently rejected the claim that the so-called "experimental use" legal defense shields academic research from patent infringement liability. In the future, academic and other nonprofit research institutions may feel compelled to protect themselves and their scientific investigators from liability by trying to regulate investigators' behavior, the report says. This move could not only hinder research but also fail to prevent legal problems because researchers are often ill-equipped to determine how existing patents apply to their work. It is also possible that patent holders, knowing that universities do not currently have legal protection from such liability, could increase demands for patent-licensing fees or dictate other terms that would burden the research enterprise. The situation could worsen over time as licensing restrictions imposed by patent holders, including universities and private research institutions, begin to accumulate.

"The goal is to ensure that public investments in genomics and proteomics bring about the greatest public good," said committee co-chair Shirley Tilghman, president, Princeton University, Princeton, N.J. "In aiming for that goal, researchers, policy-makers, and other stakeholders must recognize that achieving an appropriate balance between protecting research discoveries and granting access to them is critically important to fostering scientific progress and enhancing human health."

The committee reviewed the science base in these areas, gathered insights from personnel in academia and industry, and sponsored a survey of biomedical researchers who work for the government, private industries, and universities. It is rare for research to be stopped, significantly delayed, or redirected because of intellectual property mandates, the survey found. On the other hand, failure to comply with requests for the exchange of biomedical research material, patented or not, is common in both the public and private sectors.

In general, problems can be minimized or avoided if scientists and their institutions follow norms and best practices for sharing research data and licensing patented technology, the committee concluded. The National Institutes of Health should continue to encourage the free exchange of material and data among its grantees and contractors. Additionally, NIH should require these individuals to comply with the agency's guidelines for obtaining and disseminating biomedical research resources and for licensing genomic inventions. Industries and nonprofit institutions should standardize and streamline their processes for exchanging biological material or data.

NIH also should adapt and extend the "Bermuda Rules," which were created in 1996 by scientists involved in the publicly funded human genome project. The rules instruct genomics researchers to share their data in a free public database called GenBank. They should be extended to include protein-structure data that NIH-funded centers generate for large projects in genomics, the report says. Researchers in both the public and private sectors should make this information freely available in the Worldwide Protein Data Bank, a project overseen by a consortium of international research groups.

Patents on new, useful inventions -- and copyrights on works of art, literature, and other forms of expression -- are issued on the assumption that although firms and individuals have many incentives to create, some innovations are more likely to be forthcoming and attract investment if the creators are granted exclusive ownership rights. By temporarily impeding imitators, these rights give creators opportunities to recoup initial investments. In exchange for periods of exclusivity, creators must disclose the knowledge they developed, which may, in turn, spur further innovation.

To qualify for a patent, an invention must be useful and must represent a creative leap; it cannot be obvious to a person of ordinary skill in a given area. When applying the "nonobviousness" standard to genomic and proteomic inventions, the report says, USPTO and the courts should consider whether a scientist of ordinary skill would have been motivated to create a given invention with reasonable expectations of success at the time the invention was actually made. The committee concluded that in the area of biotechnology, that standard has been somewhat weakened by court decisions.

Principal investigators and their institutions should avoid seeking patents for genes or proteins whose functions are unknown, the report says. These include proteins that are useful for research but do not have therapeutic or diagnostic functions, as well as random haplotypes -- stretches of DNA that are inherited together as unbroken blocks and can be identified by just a handful of DNA markers.

The report recommends several approaches to improving public access to patented inventions. Congress should consider legislation that would exempt research on certain aspects of patented technologies or inventions from patent-infringement liability, with the goal of promoting scientific discovery. Likewise, owners of the patented technology behind certain gene-based diagnostic tests should establish procedures that allow other clinicians to validate test results. If these patent holders do not take this step voluntarily, Congress should consider whether work to validate such results should be shielded from liability in the interest of public health.

Genomic and proteomic research depends on rapidly changing technology and complex theory, the report emphasizes. USPTO should create a formal mechanism, such as an advisory board of leading scholars in these fields, to inform examiners of new developments and research directions.

The study was sponsored by the National Institutes of Health. The National Research Council is the principal operating arm of the National Academy of Sciences and the National Academy of Engineering. It is a private, nonprofit institution that provides science and technology advice under a congressional charter. A committee roster follows.

Copies of Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health will be available this fall from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at Reporters may obtain a pre-publication copy from the Office of News and Public Information (contacts listed above).

[ This news release and report are available at ]

Division on Policy and Global Affairs
Board on Science, Technology, and Economic Policy
Committee on Science, Technology, and Law

Committee on Intellectual Property Rights in Genomic and Protein Research and Innovation

Shirley M. Tilghman1,2 (co-chair)
Princeton University
Princeton, N.J.

Roderick R. McKelvie (co-chair)
Covington & Burling
Washington, D.C.

Ashish Arora
Professor of Economics and Public Policy
Heinz School of Public Policy and Management
Carnegie Mellon University

Helen M. Berman
Board of Governors Professor of Chemistry and Chemical Biology
Department of Chemistry and Chemical Biology
Rutgers University
Piscataway, N.J.

Joyce Brinton
Office for Technology and Trademark Licensing
Harvard University (retired)
Cambridge, Mass.

Stephen K. Burley
Chief Scientific Officer
Structural GenomiX Inc.
San Diego

Q. Todd Dickinson
Vice President and Chief IP Counsel
General Electric Co.
Fairfield, Conn.

Rochelle Dreyfuss
Pauline Newman Professor of Law
School of Law
New York University
New York City

Rebecca S. Eisenberg
Robert and Barbara Luciano Professor of Law
School of Law
University of Michigan
Ann Arbor

Charles M. Hartman (deceased)
General Partner
CW Ventures Group
New York City

Daniel J. Kevles
J.O. and Juliette Koepfli Professor of the Humanities Emeritus
California Institute of Technology, and
Stanley Woodward Professor of History
Yale University
New Haven, Conn.

David Korn2
Senior Vice President for Biomedical and Health Sciences Research
Association of American Medical Colleges
Washington, D.C.

George M. Milne Jr.
Senior Vice President and President of Central Research
Pfizer Inc. (retired)
Niantic, Conn.

Richard H. Scheller1
Executive Vice President of Research
Genentech Inc.
San Francisco

Rochelle Seide
Arent Fox PLLC
New York City

Robert H. Waterston1,2
William Gates III Professor and Chair
Department of Genome Sciences
University of Washington

Nancy S. Wexler2
Higgins Professor of Neuropsychology
Departments of Neurology and Psychiatry
Columbia University
New York City

Brian Wright
Department of Agricultural and Resource Economics
University of California


Stephen A. Merrill
Study Co-Director

Anne-Marie Mazza
Study Co-Director

1 Member, National Academy of Sciences
2 Member, Institute of Medicine