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Circuit Court Re-hears Myriad Case in Wake of Prometheus Ruling

NEW YORK (GenomeWeb News) – In a case that could have wide implications for US gene patenting laws, a US Federal court today heard oral arguments focused on whether a recent Supreme Court decision that invalidated certain biotech patents will affect Myriad Genetics' patent claims related to breast cancer risk genes.

The Court of Appeals for the Federal Circuit heard arguments for the second time in a lawsuit between Myriad Genetics and the University of Utah Research Foundation and plaintiffs including the Association for Molecular Pathology, the American Civil Liberties Union, and the Public Patent Foundation.

The lawsuit, which AMP, PubPat, and the ACLU filed in 2009, centers on the claim that Myriad's patents related to its BRCA1- and BRCA2-based test for assessing individual breast and ovarian cancer risk, and other similar gene patents, should not be valid because as genes they are products of nature and cannot be patented.

The CAFC today heard the case for a second time in a year. The Supreme Court had remanded the case back to the CAFC for review in light of its recent decision in another major patent case, Mayo Collaborative Services v. Prometheus Laboratories.

In that opinion, the Supreme Court decided that certain Prometheus patents were unpatentable because they merely describe laws of nature, and add nothing specific to those laws of nature.

Last August, however, before the Myriad case went to the Supreme Court, the CAFC had decided that Myriad's patents covering isolated DNA are patentable under section 101 of US Patent Act.

The Supreme Court in late March sent the Myriad case back to the CAFC for a review that would take into account the Prometheus ruling.

The plaintiffs in the Myriad case have suggested that the Prometheus decision should impact the way the three-judge CAFC views at the Myriad case in its second go-around, and have said that Prometheus affirms their core argument that genes have a special status in the natural world.

“Genes are not ‘invented,’ so they cannot be said to be owned by anyone,” Daniel Ravicher, executive director of PUBPAT, said in a statement from the ACLU today, asserting the plaintiffs' central argument.

“This is a case about whether a company own genes that occur naturally in our bodies simply because they removed them from the body. This is a genetic marker that occurs naturally in the human body. That should never be patented," Ravicher said.

In earlier phases, this case has involved other issues, such as the ACLU and AMP's claim that Myriad holds a monopoly on BRCA1 and BRCA2 testing and that the company is keeping researchers from studying these genes and patients from having choices in the genetic testing market.

Those issues have been set aside now, with the sole focus on the Prometheus ruling's effect on the CAFC's earlier decision, which was a mixed decision among the three-judge panel that upheld Myriad's claims that its methods and technologies are not products of nature, even if the Supreme Court has decided that the genes involved are.

The oral arguments today centered on how Prometheus might apply to Myriad's claims for methods that would be used in screening for potential therapeutic agents, as well as whether and how that ruling could apply to Myriad's claims that its process for isolating DNA is eligible for patenting because it is a process and not a law of nature, Jennifer Camacho, an attorney and shareholder with law firm Greenberg Traurig, told GenomeWeb Daily News today.

Also, because the Prometheus ruling dealt with how patenting could inhibit public access to fundamental laws of nature, the plaintiffs argued that Prometheus does apply to the Myriad case, which involves a question of public access to genetic information, Camacho said.

Robert Sachs, an attorney with Fenwick and West, told GWDN that in amicus briefs filed with the CAFC Myriad's opponents took the approach that the BRCA1 and BRCA2 technologies are laws of nature, and some of the arguments centered on whether chemicals are products of nature, and likely not patentable, or if they can be viewed as information, which could be patentable.

Sachs explained that this case is happening within a larger context of confusion about the patentability of natural products that even the Prometheus ruling has not cleared up.

"There is no way to say that the law will be clear. Confusion will still reign," Sachs said. "[That is] because the jurisprudence in this area is fundamentally flawed. That is because the court has never thought very hard about what it is talking about when it talks about 'laws of nature.' What is it talking about when it talks about 'abstract ideas.' The court has not spent any time thinking about those questions at a hard level."