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Posts Tagged ‘Myriad Genetic’


 

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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Genomics in Medicine – Tomorrow’s Promise

Reporter: Larry H Bernstein, MD, FCAP

Genomics in Medicine: Today’s Issues, Tomorrow’s Promise

KM Beima-Sofie, EH Dorfman, JM Kocarnik, MY Laurino
Feb 13, 2013 Medscape Genomic Medicine

What do you think about these issues before reading this piece?

The Broader Implications of Genetic Sciences
The 62nd annual meeting of the American Society of Human Genetics (ASHG), which was held in San Francisco, California, in November 2012, featured a diverse array of research in basic, clinical, and population science contributed by human geneticists across the globe.
Genetic Sequencing Moves Beyond the Laboratory
Several presentations at the meeting focused on the lessons learned from the National Heart, Lung, and Blood Institute (NHLBI) Exome Sequencing Project. The goal of the project was to
  • develop and validate a cost-effective and high-throughput sequencing technology
  • capable of analyzing the DNA sequence in the exome, which
  • consists of all protein-coding regions in the human genome.
At previous ASHG meetings, presentations and discussions largely focused on
  • the development of sequencing technology and on applications of this technology for research.
Now that sequencing is an increasing reality, this year’s conference featured presentations on
  • what to do with the resulting information, in both research and clinical settings.
Issues discussed include the challenges of
  • interpreting sequence data,
  • determining which results should be returned to various parties, and
  • the potential impacts of different testing techniques.
Results from the NHLBI Exome Sequencing Project and other projects are fueling the discussion on
legal issues surrounding gene patenting, a hotly debated topic that is currently under consideration by the US Supreme Court. During a plenary session on gene discovery and patent law,
Of particular focus was the lawsuit brought by the American Civil Liberties Union against Myriad Genetics,
  • contesting the company’s patent of the BRCA1 and BRCA2 genes for hereditary breast and ovarian cancer.
At present, Myriad has exclusive rights to offer clinical genetic testing for these genes; one of the main arguments of the lawsuit is
  • that gene patents hinder the pursuit of confirmatory tests and limit the testing options available to women.
DNAPrint Genomics

DNAPrint Genomics (Photo credit: Wikipedia)

English: Exome sequencing workflow: Part 2. Ta...

English: Exome sequencing workflow: Part 2. Target exons are enriched, eluted and then amplified by ligation-mediated PCR. Amplified target DNA is then ready for high-throughput sequencing. (Photo credit: Wikipedia)

Cost per Megabase of DNA Sequence (Why biologi...

Cost per Megabase of DNA Sequence (Why biologists panic about compute) (Photo credit: dullhunk)

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