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Court Denies Motion to Dismiss BRCA Patent Suit Against Myriad, Others

NEW YORK (GenomeWeb News) – A US district court has denied a motion by the US Patent and Trademark Office, Myriad Genetics, and the University of Utah Research Foundation to dismiss a lawsuit brought against them challenging the legality and constitutionality of BRCA gene patents owned by the University of Utah and exclusively licensed to Myriad.

In a decision handed down this week, the US District Court for the Southern District of New York determined that the plaintiffs, led by the Association for Molecular Pathology, "possess the necessary standing to bring their claims against the defendants," and that the facts alleged in the case "are plausible, specific, and form a sufficient basis for [the] plaintiff's legal arguments."

The court also denied motions by the defendants to dismiss the case based on jurisdictional and other issues.

The plaintiffs, who also include the American Civil Liberties Union and Public Patent Foundation at the Benjamin N. Cardozo School of Law, among others, originally filed suit against the USPTO, Myriad, and the UURF in May, claiming that the BRCA gene patents "stifle research that could lead to cures and limit women's options regarding their medical care."

UURF has exclusively licensed the rights to perform diagnostic tests on the genes to Myriad, which provides genetic testing for ovarian and breast cancer. Myriad also is co-owner of several patents challenged in the suit. In total, the plaintiffs are challenging the legality and constitutionality of four categories of claims in seven US patents.

In July, the USPTO filed a motion to dismiss the case, arguing that the "plaintiffs lack standing to sue the USPTO, the Court lacks subject matter jurisdiction, and the action is barred by the sovereign immunity. Moreover, plaintiffs' unsupported legal conclusions fail to state a claim for a constitutional violation and therefore should be dismissed."

Myriad and the directors of UURF also filed their own memorandum supporting dismissal of the suit.

The lawsuit has essentially been viewed as a challenge to the entire practice of gene patenting, and the outcome of the case could have far-reaching effects for the research and genetic diagnostics fields.

The district court has ruled that the defendants' motion for summary judgment in the case will be due Dec. 2; the plaintiffs' reply due Dec. 9; and hearings will be held on Dec. 11.

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