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COURT RULINGS

Myriad Appeal Is DeJa Vu All Over Again

Court upholds gene patents, but says methods of comparing those genes are not patentable.

DANIEL S. LEVINE

The Burrill Report

“The United States Court of Appeals for the Federal Circuit found that Myriad Genetics’ isolated DNA for two genes associated with certain forms of breast and ovarian cancer are patentable.”
A federal appeals court that had previously ruled on the Myriad Genetics case, litigation which raised fundamental questions about the patentability of genes, has ruled again. The U.S. Supreme Court instructed the appeals court to revisit its decision in light of a subsequent ruling in a related case. After weighing the court’s instructions, the judges delivered a 2-1 ruling that found the company could patent isolated DNA, but not the methods for comparing those gene sequences.

The United States Court of Appeals for the Federal Circuit found that Myriad Genetics’ isolated DNA for two genes associated with certain forms of breast and ovarian cancer are patentable. The decision overturns a district court’s ruling that found that isolated DNA was not patent eligible as a product of nature. The appeals court, though, said each of the molecules claimed in the Myriad patents represent “non-naturally occurring composition of matter.”

“It’s certainly the best result for Myriad,” says Courtenay Brinckerhoff, partner with Foley & Lardner. “Because I don’t think it was a very unexpected result, I think ‘victory’ is a bit strong. There would have definitely been much stronger reaction if it didn’t come out this way.”

Brinckerhoff says the ruling maintains the status quo as everyone for the industry waits to see whether the plaintiffs in the case once again appeal to the Supreme Court and whether the case will be heard if they do.

The American Civil Liberties Union and the Public Patent Foundation originally filed suit in 2009 charging that the patents were unconstitutional, stifle research, and have a detrimental effect on women getting access to more affordable alternatives by giving Myriad a monopoly on the BRCA genes. Those points, Myriad refuted in a press release announcing the ruling. It pointed to the work of 18,000 scientists who have published more than 9,000 research papers on the BRCA genes and noted about 95 percent of appropriate patients have access to its tests.

Myriad said it was pleased by the favorable decision. “Importantly, the Court agreed with Myriad that isolated DNA is a new chemical matter with important utilities which can only exist as the product of human ingenuity,” says Peter Meldrum, president and CEO of Myriad.

Attorneys for the ACLU expressed disappointment and said the appeals court failed to fully reconsider the facts in the case. “This ruling prevents doctors and scientists from exchanging their ideas and research freely,” says Chris Hansen, a staff attorney with the ACLU Speech, Privacy and Technology Project. Human DNA is a natural entity like air or water. It does not belong to any one company.”

The case has been closely watched among investors and the life sciences industry because of the potential that a ruling invalidating Myriad’s patents could have consequences that extend well beyond the company’s products as life sciences companies rely on nearly 2,000 gene-related patents.


August 17, 2012
http://www.burrillreport.com/article-myriad_appeal_is_deja_vu_all_over_again.html

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