Gene patents rejected by federal judge

The ruling, believed to be the first of its kind, is likely to affect genetic testing and research. An appeal is expected.

By Amy Lynn Sorrel — Posted April 12, 2010

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In a groundbreaking decision that could have far-reaching implications for health care and biomedical research, a federal judge invalidated patents on a pair of genes linked to breast and ovarian cancer.

The U.S. District Court for the Southern District of New York found that the patents violated long-standing precedents barring the patentability of natural phenomena, saying the DNA over which Myriad Genetics Inc. claimed a monopoly represented "the physical embodiment of laws of nature."

The court also rejected Myriad's patent claims on a testing method in which it compared gene mutations to determine a patient's predisposition for breast or ovarian cancer.

Myriad plans to appeal to the U.S. Court of Appeals for the Federal Circuit, which oversees patent cases. The U.S. Patent and Trademark Office was dismissed from the case.

The March 29 ruling -- which casts doubt on existing patents covering 20% of the human genome -- is believed to be the first of its kind and has fueled debate about whether such monopolies help or hinder medical innovation.

Organized medicine declared the decision a victory that will pave the way for broader research and more accessible treatments for patients.

"Looking at genetic reports was like looking at a CIA document, where areas were blacked out because somebody owned them, and doctors couldn't report the medical significance," said Bruce R. Korf, MD, PhD. He is president of the American College of Medical Genetics, a plaintiff in the case. "Now we're not going to be bumping into those areas claimed as property by someone else, and the innovation we are looking for could further more efficient ways of doing genetic testing."

On the other side of the debate, patent lawyers and biotechnology firms contend that the decision could hinder such developments if the patent system isn't available to help attract the investment needed for new research.

Past precedents have recognized that a gene or other natural substance that is isolated and purified from its natural state is patent eligible because it is distinct from the way it exists in nature, said Kenneth Chahine, PhD, a visiting professor at the University of Utah's S.J. Quinney College of Law. He filed a friend-of-the-court brief in the case supporting Myriad, which made similar arguments.

"If you look at it from a high level, at some point you can say everything is a product of nature. The challenge is trying to find out where the right balance is," Chahine said. As more companies look to develop tests aimed at tailoring treatments to patients' risk factors, "that's where this ruling starts to infringe and could negatively impact the future of personalized medicine."

Physicians agree that patents can be useful in spurring medical inventions, such as new drugs. But overly broad patents, like those held by Myriad, created a monopoly "that hampered scientific discovery and medical care," said American Medical Association President J. James Rohack, MD. The Litigation Center of the AMA and State Medical Societies joined a group of other medical organizations in filing a court brief contesting the gene patents.

Drawing boundaries

According to the lawsuit, because Myriad had exclusive rights to the use of the BRCA1 and BRCA2 genes and related diagnostic testing, some women were unable to confirm their cancer test results elsewhere, while others could not afford the $3,000 test. In addition, several researchers already engaged in similar testing were forced to stop their work once Myriad began enforcing its patent.

Myriad declined to comment for this article. In a statement, company President and CEO Peter D. Meldrum said the decision conflicted with prior case law requiring broad application of federal patent statutes. He said Myriad's efforts have promoted women's health in the area of hereditary breast and ovarian cancer and "countless lives have been saved as a result."

Myriad argued in court documents that it did break new ground, and the genes it isolated were different from those occurring naturally in the human body.

District Court Judge Robert W. Sweet was not persuaded, however, calling the argument "a lawyer's trick that circumvents the prohibitions on the direct patenting of the DNA in our bodies."

The genes were the same whether inside or outside the body, the court said. Nor did it find anything novel in Myriad's comparative testing methods.

"The judge said correctly that's just a mental process; there's nothing involved there but thinking. And you can't patent thinking," said Chris Hansen, senior staff attorney with the American Civil Liberties Union, which helped bring the case.

But Chahine pointed to a recent decision that could form the basis of a reversal in the gene case. In 2009, the Federal Circuit Court of Appeals ruled in Prometheus v. Mayo that a diagnostic test using patients' metabolite levels to determine drug dosages was patentable. The AMA Litigation Center filed a brief in the case contending that the test covered natural body processes.

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Case at a glance

Are genes and related testing methods patentable?

A federal judge said no, finding that a biomedical firm's gene patents covered fundamental laws of nature.

Impact: Physicians say the ruling allows basic medical information to be shared, removing barriers to new research in and access to genetic testing. Biomedical firms and patent lawyers say the decision could deter critical investment in such developments.

Assn. for Molecular Pathology et al. v. U.S. Patent and Trademark Office et al., U.S. District Court for the Southern District of New York

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