Thursday, October 24, 2013

Myriad Sues Quest Over BRCA1/2 Patents

Original post on GenomeWeb, 10/24/13

Myriad Genetics yesterday filed a suit against Quest Diagnostics alleging patent infringement, the fourth lawsuit Myriad has filed against a competitor following a US Supreme Court ruling on patents covering BRCA1 and BRCA2 gene testing.

The lawsuit was filed in US District Court for the District of Utah, Central Division, and in addition to Myriad, the plaintiffs include the Trustees of the University of Pennsylvania, the Hospital for Sick Children in Toronto, and Canadian firm Endorecherche.

The plaintiffs allege Quest infringes eight patents covering BRCA1/2 genes — US Patent No. 5,709,999; No. 5,747,282; No. 5,753,441; No. 5,837,492; No. 6,033,857; No. 6,051,379; No. 6,951,721; and No. 7,250,497.

This week's development follows Quest's lawsuit filed almost two weeks ago seeking a declaration that its test, called BRCAvantage and launched last week, does not infringe Myriad's patents. Myriad similarly sued GeneDx last week, claiming that that firm infringes 14 patents held by Myriad and the other plaintiffs covering BRCA1/2 testing.

During the summer, the Salt Lake City company took Ambry Genetics and Gene by Gene to court after those firms commercialized BRCA1/2 gene tests that Myriad claimed infringes its patents. The two companies have fired back with their own lawsuit accusing Myriad of antitrust violations.

Another firm, Counsyl, also sued Myriad in September and asked a California federal district court to preemptively declare it does not infringe Myriad's patents.

The impetus for the legal free-for-all is a June ruling from SCOTUS that Myriad's competitors have interpreted as a green light to enter the BRCA1/2 gene testing space, a market that Myriad had owned almost exclusively in the US.

In its decision, SCOTUS ruled that human genes cannot be patented. However, synthetic DNA, or cDNA, can be patented.

Myriad has maintained that in spite of the ruling, it still has 500 valid and enforceable claims in 24 patents underlying its test called BRACAnalysis.

In its action against Quest, Myriad seeks a jury trial, damages, a preliminary injunction against Quest from selling or marketing products that allegedly infringe Myriad's patents, and an order that Quest deliver to Myriad products that it believes infringes the patents for possible destruction.

In an e-mail to GenomeWeb Daily News a Quest spokesperson said that the firm expected Myriad's lawsuit and called it "merely the latest in a pattern of behavior toward any test provider that introduces a new option in BRCA testing that can benefit patients.

"We are confident that our offering does not violate any Myriad claims," she added. "We will vigorously defend, and continue to provide, BRCAvantage to the many patients who seek options in BRCA testing."

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Tuesday, October 15, 2013

Who Can Challenge Myriad's Monopoly In Breast Cancer Gene Tests?

Original post on by Mathhew Herper, 10/15/13

Four months after a Supreme Court decision that invalidated some patents on Myriad Genetics’ tests for breast and ovarian cancer risk, the Salt Lake City biotechnology firm is facing a new, and very big, competitor: Quest Diagnostics, the $7 billion (sales) maker of laboratory tests.

Quest will offer the most comprehensive version of the tests, which look at variation in the DNA in the BRCA1 and BRCA2 genes, for $2,500, about 40% less than Myriad charges. Simpler tests, which can look for particular spelling variation because of a patient’s family history or ethnicity, will cost $500.

“We’re certainly starting to see the classic race to the bottom I’ll be astonished if the price isn’t under $500 for the whole thing pretty soon,” says George Sledge, Chief of the Division of Oncology at Stanford University. “The actual analysis if you’re not using 1995 technology the prices should be super-cheap because the price of sequencing is following a super-Moore’s law track. It doesn’t make much sense from a technology standpoint that it should be this expensive.”

Not everyone agrees that a race to the bottom is in the works. Myriad has several advantages over other players: it has other patents that were not touched by the Supreme Court decision; it controls a proprietary database of which variants in the BRCA1 and BRCA2 genes increase the risk of breast and ovarian cancer, and by how much; and it has developed a good reputation among cancer doctors and gynecologists, who have no reason to switch to a new test just because it is cheaper so long as insurers pay for the old one. Myriad has reason to fight, because it gets much of its $613 million in annual sales from sales of the BRCA tests.

The first two challengers, Ambry Genetics and Gene-By-Gene, are already embroiled in a legal battle with Myriad. And Myriad isn’t showing any signs of backing down for Quest. When Quest sued it ahead of its product launch, a Myriad spokesman told GenomeWeb that it would be “premature to comment” but that the patents around the tests are “valid and enforceable.”

Sue Friedman, the executive director of Facing Our Risk of Cancer, a patient group that advocates for people with hereditary cancer risk, says she still hopes Quest’s entry is a move toward healthy competition. “We’re hoping that having another laboratory that has a reputation for high quality lab tasting to offer testing to patients will drive the cost down,” she says.

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Thursday, October 3, 2013

The Angelina Jolie Effect: What Every Woman Should Know About Her Genetics

The JCC of Woodbridge will be hosting "The Angelina Jolie Effect: What Every Woman Should Know About Her Genetics", tonight from 7:00 - 9:00pm. This talk will include a panel of medical experts from Yale, including genetic counselor Ellen T. Matloff.

Jewish Community Center,
360 Amity Road,
Woodbridge, CT, 06525,
Phone: 203-387-2424,
Fax: 203-387-1818,

Enid Groves,
Phone: 203-387-2424
Fax: 203-387-1818

JCC - The Angelina Effect

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Wednesday, October 2, 2013

Mammography techs ordering their own genetic testing? It appears our suspicion was correct.

A concerned referring physician of ours recently called to report that her confused and somewhat panicked patient just returned from her mammography appointment to say that the tech ordered genetic testing. Based on the patient’s questions and concerns it appeared she had received no genetic counseling and had no informed consent discussion. Additionally, she did not know what test had been ordered and she had no follow-up plan to discuss her test results. The physician was upset and asked, "Is this something that is happening now? Is it common for mammo techs to order this testing? I’m not really sure what to tell the patient or where to go from here if she tests positive. Isn’t this what a genetic counselor is for? Is it just me or does this seem like it could go really bad…?"

No, it isn't just you. This could be a disaster in the making for not only the patients, but also the well-meaning professionals, likely with no education in genetics, who are being subjected to great liability by offering services far outside their professional scope. Read more!