Washington, D.C., December 13, 2002 - The ongoing debate over the application of U.S. patent law in genetic research is the focus of this month's Academic Medicine, the journal of the Association of American Medical Colleges (AAMC). This special theme issue, funded in part by the Alfred P. Sloan Foundation, sheds light on this highly complex topic through a series of articles and commentaries that range from a strong defense of the current patent system to thoughtful criticism of patent practices and proposals for reform.

Gene Patents: Legal and Economic Issues Related News: The AAMC has filed an amicus brief with the U.S. Supreme Court in Duke University v. Madey, a patent dispute case involving the "research exemption" in U.S. patent law that was thought to protect institutions engaged in entirely non-commercial research from charges of patent infringement. Amicus Brief (PDF, 285KB)

AAMC Senior Vice President of the Division of Biomedical and Health Sciences Research, David Korn, M.D., and Stephen Heinig, senior staff associate with the division, serve as guest editors for this special edition. In their introduction, "Patents, Genomics and Academic Medicine," Korn and Heinig provide readers with background and an overview of the controversy surrounding patents and biomedical research and its potential effect on the future of scientific discovery and medical practice.

"At the heart of the matter is the patent system's treatment of human gene sequences as simply 'chemical compositions of matter,' concerning which both patent law and practice are well settled," said Dr. Korn. "But it can be argued that genetic sequences are not properly managed by this approach because in fact their biological and medical importance rests far more in the wealth of information they contain than in simply describing their structure. The depth, complexity, and physiological ramifications of that information are not obvious from the simple description of the sequence, but can only be determined by future experimentation. This fundamental fact is not dealt with adequately in current patent law or practice."

The December issue contains several articles exploring the legal and economic rationales supporting and opposing patents on human gene sequences, including:

• Human Gene Patents," by authors Jorge Goldstein, Ph.D., J.D., of Sterne, Kessler, Goldstein and Fox, and Elina Golod, J.D.
  Goldstein and Golod argue that patents and licenses on gene-based diagnostic tests are properly enforceable and do not permit academic or other clinical practitioners to perform such tests without license or other authorizations from the patent holder. They note the different commercial uses of isolated human gene sequences and contend that it is impossible "to create an effective legal system that distinguishes between the different classes of human genes or the different institutions of discovery."

• Patents, Genomic Research and Diagnostics," by John Barton, J.D., George E. Osborne Professor of Law at Stanford University
  Barton, in contrast, contends that several of the underlying legal doctrines in patent law "could be changed or be interpreted in ways more favorable to the conduct of research." He offers two plausible courses for reform. The first is to seek either a narrow statutory exemption permitting patented genomic information to be used freely "when the research purpose is substantial compared with the diagnostic purpose," or a statutory exemption, or compulsory licensing, for use of genomic information for all diagnostic purposes. He offers language that would accomplish the statutory amendment.

This special Academic Medicine also provides the views of several commentators on the front lines of the gene patenting issue, including Lee Bendekgey, J.D., and Diana Hamelt-Cox, Ph.D., J.D., of Incyte Genomics Inc., Rebecca Eisenberg, J.D., of the University of Michigan, and others.

"We hope the well reasoned, divergent views expressed in this issue will help promote a public awareness of this topic, and an informed public conversation, that are long overdue," notes Dr. Korn. "We also hope they will better position academic medicine to engage in a necessary dialogue with the legal and business communities about possible solutions to the challenges posed by patent law and practice to contemporary biomedical research and medical practice."

Please visit www.academicmedicine.org to access this and other issues of Academic Medicine.

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The Association of American Medical Colleges represents the 125 accredited U.S. medical schools; the 16 accredited Canadian medical schools; some 400 major teaching hospitals, including Veterans Administration medical centers; more than 105,000 faculty in 98 academic and scientific societies; and the nation's 66,000 medical students and 97,000 residents.

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The Association of American Medical Colleges is a not-for-profit association representing all 129 accredited U.S. and 17 accredited Canadian medical schools; nearly 400 major teaching hospitals and health systems, including 68 Department of Veterans Affairs medical centers; and 94 academic and scientific societies. Through these institutions and organizations, the AAMC represents 109,000 faculty members, 67,000 medical students, and 104,000 resident physicians. Additional information about the AAMC and U.S. medical schools and teaching hospitals is available at www.aamc.org/newsroom.

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