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Nov 27, 2013

Myriad Sues Fifth Rival on Patent-Infringement Grounds

  • Invitae has become the fifth genetic diagnostic test developer since July to be sued on patent-infringement grounds by Myriad Genetics.

    Myriad has asked the U.S. District Court for the District of Utah for temporary and permanent injunctions against Invitae from selling or using products it says infringe on 11 patents held by Myriad and other assignees; as well as damages, and the delivery to Myriad of all products it believes infringe the patents.

    The 11 patents – which cover tests for BRCA and MUTYH – are held by Myriad with other assignees, including the University of Utah Research Foundation, the Trustees of the University of Pennsylvania, an entity affiliated with Toronto’s Hospital for Sick Children, and Canadian company Endorecherche.

    Invitae responded yesterday with a statement in which it promised to “vigorously defend itself against the lawsuit, which it believes has no merit.”

    “The issue of DNA patents goes far beyond BRCA testing,” Randy Scott, Invitae’s co-founder, said in a statement. “Our company was founded around the core belief that every individual has the right to self-knowledge (meaning they have a right to know their own DNA sequence information).”

    Invitae says it charges $1,500 for full gene sequencing for both BRCA1 and BRCA2 with deletion and duplication analysis to physicians with the ability to upgrade to a larger hereditary cancer syndromes panel of 27 genes.

    “Invitae’s mission is to reinvent genetic testing by making it more affordable and accessible than ever before. The company’s goal is to bring multi-use genetic testing into routine medical practice,” Scott said.

    Scott also said Invitae believes “that no company can claim ownership over naturally occurring genetic information.” He cited the U.S. Supreme Court’s June 13 decision in Association for Molecular Pathology (AMP) v. Myriad Genetics, in which the high court unanimously overturned seven of Myriad Genetics’ 24 patents related to its discovery of the precise location and sequence of breast cancer susceptibility genes BRCA 1 and 2; and the court’s decision last year in Prometheus Laboratories v. Mayo Collaborative Services, when Nestle’s Prometheus Laboratories subsidiary suffered a stinging legal defeat as a unanimous Supreme Court held as ineligible for patenting the company’s methods of dosage calibration for thiopurine drugs for gastrointestinal and nongastrointestinal autoimmune diseases.

    But in the AMP v. Myriad ruling, the justices also held that companies can patent composite DNA and other synthetic genetic material not meeting the “product of nature” exemption from patentability under 35 U.S.C. § 101.

    And as Myriad has pointed out in the weeks since the decision, the Supreme Court did not overturn all of its genetic testing patents, leaving the remaining ones in its view to be valid and enforceable. Myriad’s first patent infringement suits came within weeks of the Supreme Court decision; the company has gone to court against Ambry, Gene by Gene, GeneDx, and Quest Diagnostics.

    At issue are U.S. patents No. 5,747,282; No. 5,753,441; No. 6,033,857; No. 6,051.379; No. 6.951,721; No. 7,250,497; No. 7,470,510; No. 7,622,258; No. 7,838,237; No. 7,670,776; and No. 7,563,571.



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