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Federal Circuit to Hear Appeal of Human Gene Patent Decision

By Kristine L. Roberts, Litigation News Associate Editor – July 29, 2010

The U.S. Court of Appeals for the Federal Circuit will review a recent decision [PDF] casting doubt on the validity of human gene patenting. In a thorough 153-page opinion, Judge Robert W. Sweet of the U.S. District Court for Southern District of New York held that two genes associated with cancer are unpatentable “products of nature.” If upheld by the Federal Circuit, the decision would threaten thousands of existing gene patents and lead to major changes in both patent law and the biotechnology industry.

Drawing the Line on Gene Patents
On May 12, 2009, the American Civil Liberties Union and the Public Patent Foundation filed a lawsuit along with a number of physicians, patients, and health care organizations, seeking to invalidate patents relating to the human genes BRCA1 and BRCA2, whose mutations correlate with an increased risk of breast and ovarian cancer.

The defendants are Myriad Genetics and the University of Utah Research Foundation, as well as the U.S. Patent and Trademark Office. As the district court noted, Myriad is the “sole provider of full sequencing of BRCA1 and BRAC2 genes in the United States on a commercial basis.”

The plaintiffs moved for summary judgment, claiming that patents directed at DNA in an isolated form cover products of nature or natural phenomena, which are not patentable under the Patent Act, 35 U.S.C. § 101.

Myriad argued that the isolation of genes from the human body transformed them and rendered them eligible for patenting. According to Myriad, the purified and isolated DNA molecules are “markedly different” from DNA found in nature.

Are Isolated Human Genes Patentable?
The district court rejected Myriad’s position that the purification of a natural product makes it patentable, citing Diamond v. Chakrabarty and other U.S. Supreme Court precedents. The court also discounted the structural and functional differences between the native and isolated DNA claimed in the patents. As Judge Sweet explained, “[b]ecause the claimed isolated DNA is not markedly different from native DNA as it exists in nature, it constitutes unpatentable subject matter under 35 U.S.C. § 101.”

In June, Myriad and the other defendants appealed the decision and the resulting final judgment to the Federal Circuit. “Many who are following the decision believe that it may be reversed on appeal,” says Coke Morgan Stewart, Washington, D.C., cochair of the ABA Section of Litigation’s Intellectual Property Litigation Committee.

The Federal Circuit could instead narrow the decision, for example, by construing the claim more narrowly than Judge Sweet did, says Robert M. Asher, Boston, cochair of the Patent Subcommittee of the Intellectual Property Litigation Committee.

Far Reaching Effects
Yet “if Judge Sweet’s decision stands, the impact will be huge and adverse on privately funded genetic research,” says Rodney K. Adams, Richmond, VA, cochair of the Medical Ethics Subcommittee of the Section’s Health Law Litigation Committee.

“Patents have been responsible for making the biotechnology industry possible and incentivizing it,” adds Asher. “The sequencing of genes is time consuming and expensive, and for that reason, entrepreneurs contend that they should be able to capitalize on their findings in the marketplace,” explains Adams.

The district court acknowledged the “deep disagreement” between the parties regarding the “effects of gene patents on the progression of scientific knowledge.”

“From the patient care perspective, Judge Sweet rightly points out that many individuals will not be able to afford diagnostic tests, and may incur significant costs and even death as a result,” says Adams.

“There is an ever-present tension in patent law between encouraging innovation by providing an exclusive benefit to the innovator and discouraging exclusive rights that may dampen competition or preclude public access to information,” Stewart notes. “Judge Sweet’s decision highlights this tension,” says Stewart.

“The decision is of great interest to those who work and practice law in the biotechnology field,” says Stewart.

According to a declaration cited by Judge Sweet in his opinion, “nearly 20% of human genes” are “explicitly claimed as United States intellectual property.” “Until now, no decision has questioned the patentability of genetic material,” says Asher. Whatever the result, the Federal Circuit’s decision on appeal will have far reaching effects on patient care, patent law, and biotechnology.

Keywords: Litigation, human genes, patents, Federal Circuit

Related Resources

  • » Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office, 2010 U.S. Dist. LEXIS 35418 (S.D.N.Y. Apr. 5, 2010).


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