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Invitae been Sued for BRCA1/2 Patent Violation by Myriad Genetics

Reporter: Aviva Lev-Ari, PhD, RN

Myriad Genetics Sues Invitae over BRCA1/2 Gene Patents

November 26, 2013

NEW YORK (GenomeWeb News) – Myriad Genetics has sued a fifth firm alleging infringement of its patents covering BRCA1 and BRCA2 gene testing.

In a lawsuit filed on Monday in US District Court for the District of Utah, Central Division, Myriad claims that Invitae infringes 11 patents held by Myriad, along with other assignees – the University of Utah Research Foundation, the Trustees of the University of Pennsylvania, HSC Research Development Limited Partnership (Hospital for Sick Children in Toronto), and Endorecherche.

Each of the assignees are listed as plaintiffs in the case, the latest volley by Myriad as it tries to fend off competitors following a decision by the US Supreme Court in Junethat invalidated certain claims by Myriad. The court found that human genes cannot be patented, but that synthetic DNA is patentable.

In its complaint, Myriad accuses Invitae – which was formed in the summer of 2012 from a Genomic Health subsidiary, also called InVitae, combined with a genetics firm called Locus Development – of infringing 11 patents. They are US Patent 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.

Myriad asks the court for damages, a temporary and permanent injunction against Invitae from selling or using products it believes infringes on its patents, and the delivery of all products to Myriad that it believes infringes the patents.

Invitae in a statement on Tuesday called the lawsuit meritless and said it would defend itself vigorously, noting the June SCOTUS ruling, as well as an earlier SCOTUS ruling, Mayo Collaborative Services v. Prometheus Labs.

“The breast cancer community will benefit from these decisions with the introduction of multiple new diagnostic tests to analyze BRCA1 and BRCA2 mutations, increasing the availability and options for patients and physicians,” Invitae said.

The company’s Co-founder Randy Scott added, “The issue of DNA patents goes far beyond BRCA testing. 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), and we believe that the Supreme Court rulings validate our view that no company can claim ownership over naturally occurring genetic information.”

Invitae offers full gene sequencing for both BRCA1 and BRCA2 with deletion and duplication analysis for $1,500, it said.

The company is one of several that since the SCOTUS ruling have launched their own BRCA1/2 gene tests, going head to head with Myriad’s BRACAnalysis test, which prior to the ruling had had a monopoly on the US BRCA1/2 test market.

Myriad has responded to those launches by taking its competitors to court. Before this week’s lawsuit, the Salt Lake City-based firm sued Ambry GeneticsGene by Gene,GeneDx, and most recently Quest Diagnostics.

Ambry and Gene by Gene have countersued Myriad alleging it of antitrust violations, while Quest and another firm, Counsyl, separately sued Myriad seeking preemptive declarations that they do not infringe Myriad’s patents.

 

Related Articles were published in this Open Access Online Journal, including the following:

Genomics & Ethics: DNA Fragments are Products of Nature or Patentable Genes?

https://pharmaceuticalintelligence.com/2013/02/27/genomics-ethics-dna-fragments-are-products-of-nature-or-patentable-genes/

Genomic Liberty of Ownership, Genome Medicine and Patenting the Human Genome

https://pharmaceuticalintelligence.com/2013/03/27/genomic-liberty-of-ownership-genome-medicine-and-patenting-the-human-genome/

 

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