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Federal Court Rules that Myriad's BRCA Patents are Invalid; Deems 'Isolated DNA' Unpatentable

NEW YORK (GenomeWeb News) — A US District Court today sided with the American Civil Liberties Union and other plaintiffs in an ongoing anti-gene-patenting lawsuit by declaring Myriad Genetics' BRCA gene patents invalid.

The suit, filed last May by the ACLU and the Public Patent Foundation on behalf of several scientific organizations and women's health groups, charged that the BRCA gene patents held by the University of Utah Research Foundation and exclusively licensed to Myriad "stifle research that could lead to cures and limit women's options regarding their medical care."

The suit, while focused on Myriad's patents, essentially challenged the constitutionality of patenting all genetic sequences on First Amendment grounds.

The ACLU said in a statement today that the ruling "marks the first time a court has found patents on genes unlawful and calls into question the validity of patents now held on approximately 2,000 human genes."

In the ruling, Judge Robert Sweet of the Federal District Court for the Southern District of New York noted that the case hinged on the fact that the patents protect "isolated DNA," which is "premised on the view that DNA should be treated no differently from any other chemical compound and that its purification from the body, using well-known techniques, renders it patentable by transforming it into something distinctly different in character."

However, Sweet noted that because "DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature … [its] existence in an 'isolated' form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes."

Therefore, he concluded, "the patents at issue directed to 'isolated DNA' containing sequences found in nature are deemed unpatentable subject matter."

The court also granted a request by the US Patent and Trademark Office that it be released as a defendant in the lawsuit because it had already ruled in favor of the plaintiffs.

The ACLU said today that the outcome of this case "could have far-reaching effects beyond the patents on the BRCA genes."

Myriad intends to appeal the District Court's decision.

"While we are disappointed that Judge Sweet did not follow prior judicial precedent or Congress's intent that the Patent Act be broadly construed and applied, we are very confident that the Court of Appeals for the Federal Circuit will reverse this decision and uphold the patent claims being challenged in this litigation," Myriad Genetics President and CEO Peter Meldrum said in a statement.

He also said that the firm believes that the outcome of the litigation will not have a material impact on its operations "due to the patent protection afforded Myriad by its remaining patents."