Major ruling overturned as gene patents are declared valid

The final decision about whether isolated genes are patentable probably will come from the U.S. Supreme Court, experts say.

By Alicia Gallegos — Posted Aug. 8, 2011

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A federal appeals court has upheld patents on a pair of genes linked to two cancers, the latest development in a closely watched case for the health care and biomedical research industries.

The 2-1 decision reverses a groundbreaking ruling by a lower court finding isolated genes to be unpatentable. The U.S. Supreme Court is expected to have the last word on the matter, experts said.

The Assn. for Molecular Pathology and others sued Myriad Genetics in 2009, challenging the validity of Myriad's patents on two genes -- BRCA1 and BRCA2 -- linked to breast and ovarian cancer. Myriad's sole rights to the genes and its diagnostic analysis of them leaves women unable to confirm their test results elsewhere, and many cannot afford Myriad's $3,000 screening, the suit alleges.

On March 29, 2010, the U.S. District Court for the Southern District of New York invalidated the patents, ruling that they were barred by laws preventing the patentability of natural phenomena. The court also overturned another patent held by Myriad on a testing method that determines a patient's risk for the two cancers. Myriad appealed to the U.S. Court of Appeals for the Federal Circuit, the appellate court that oversees patent issues.

In that court panel's July 29 opinion overturning the lower court ruling, Judge Alan Lourie said isolated DNA has a "markedly different chemical nature" from its native DNA, making it patentable. The judge countered the "magic microscope" theory, which argues if a microscope could focus in on the claimed DNA molecule as it exists in the human body, the material should not be patentable.

"The ability to visualize a DNA molecule through a microscope, or by any other means, when it is bonded to other genetic material, is worlds apart from possessing an isolated DNA molecule that is in hand and usable. It is the difference between knowledge of nature and reducing a portion of nature to concrete form, the latter activity being what the patent laws seek to encourage and protect," Lourie wrote in the majority opinion. "Visualization does not cleave and isolate the particular DNA; that is the act of human invention."

In a statement, Peter Meldrum, Myriad's president and CEO, praised the court's ruling.

"We believe this decision is in the best interests of the agriculture, biotechnology and pharmaceutical industries, as well as the hundreds of millions of people whose lives are bettered by the products these industries develop based on the promise of strong patent protection," he said.

The American Civil Liberties Union, which represents the plaintiffs, called the ruling a "blow to the idea that patent law cannot impede the free flow of ideas in scientific research."

"Human DNA is not a manufactured invention, but a natural entity like air or water. To claim ownership of genetic information is to unnecessarily block the free exchange of ideas," said Chris Hansen, an ACLU staff attorney.

The appeals panel, however, issued split decisions on whether tests on the genes were subject to patents. At least one Myriad test comparing two gene sequences falls outside the scope of patentable material because it relates to abstract mental processes, the panel found. But another method that screens potential cancer therapeutics through changes in cell growth rates is patentable, the panel said.

Myriad still has 237 method claims related to its BRCA analysis that are not affected by the ruling, Meldrum said in his statement.

The Litigation Center of the American Medical Association and the State Medical Societies previously filed a brief in the appellate court, urging it to uphold the lower court's decision invalidating the gene patents. Myriad's exclusive control over the gene sequences precludes improved genetic tests and prevents patients from obtaining second opinions on screening results, the brief said. The U.S. Justice Dept. also submitted a brief to the court arguing against Myriad's patents.

Wide-reaching impact

The appellate decision on gene patentability is "reassuring to a certain degree to the biotech industry," said James Crowne, director of legal affairs for the American Intellectual Property Law Assn., which represents lawyers who practice patent and trademark law. The AIPLA filed a friend-of-the-court brief in the case, arguing that gene patents promote innovation and lead to more scientific discoveries.

However, Crowne and others acknowledged that the case is far from over. The plaintiffs have the option of asking the panel for reconsideration, requesting a review by the entire appeals court or appealing the case to the U.S. Supreme Court.

The appeals ruling "is just another step in the process. I don't think the party's over yet," said Michael S. Watson, executive director of the American College of Medical Genetics, a plaintiff in the case.

He noted that gene patents across the country already are inhibiting the ability to help patients and are interfering with the transmission of important information. In some cases, doctors and others are unable to tell patients about their significant genetic markers because the information infringes on patents, he said.

"For patents that last forever when science is moving so fast, it's just out of whack," he said.

Plaintiffs in the case planned to meet in early August to discuss the case's next step.

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External links

Assn. for Molecular Pathology et al. v. U.S. Patent and Trademark Office et al., U.S. Court of Appeals for the Federal Circuit, July 29 (link)

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