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Appeals Court Rules Gene Patents Eligible under US Law

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – A US Federal Circuit Court of Appeals in Washington, DC, today ruled that US patent law allows for the patenting of human genes when it overturned an earlier district court decision that tests using isolated human DNA were invalid because genes were natural products.

"Today's ruling is a blow to the idea that patent law cannot impede the free flow of ideas in scientific research," said Chris Hansen, a staff attorney with the American Civil Liberties Union Speech, Privacy and Technology Project. "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."

The ACLU noted that although the court ruled companies can obtain patents on genes, it also ruled against patent methods to compare those gene sequences.

The ACLU, the Association for Molecular Pathology, and other plaintiffs filed suit two years ago against Myriad Genetics and the University of Utah Research Foundation alleging that the BRCA gene patents held by the defendants "stifle research that could lead to cures and limit women's options regarding their medical care."

The lawsuit claimed that Myriad's BRCA gene-related patents are invalid because genes are natural products that cannot be patented, and last year that position won over a US District Court judge in New York.

In its appeal of that ruling, Myriad argued in April that its patent claims on BRCA genes, which it uses in its BRACAnalysis test for predicting individual breast and ovarian cancer risk, are in accord with US patent law.

As GenomeWeb Daily News reported at the time, Myriad presented the view that isolated DNA is "a chemical composition which is not found in the human body, and which has important diagnostic and therapeutic uses that cannot be accomplished with a human's natural or native DNA as found in the body," according to a company spokesperson.

In its ruling issued today, the US Court of Appeals said that it considered several issues that were brought forth in oral arguments and in amicus briefs, including one from the US Patent and Trademark Office, concerning whether isolated DNA was similar to naturally occurring elements such as lithium, or if it was something in part engineered by human development. The court also considered whether or not the plaintiffs in the suit had shown that Myriad's patents have caused any harms or hindered research on these gene variants.

After reviewing a number of arguments, the three-judge circuit court stated that its decision that "isolated DNA molecules are patent-eligible comports with the longstanding practice of the PTO.

"The Supreme Court has repeatedly stated that changes to longstanding practice should come from Congress, not the courts," it added in the ruling.

The appellate court's ruling was welcomed by Myriad.

"We strongly support the Court's decision that isolated DNA and cDNA are patent-eligible material as both are new chemical matter with important utilities which can only exist as the product of human ingenuity," Peter Meldrum, President and CEO of Myriad Genetics, said in a statement. "Furthermore, 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."