14 October 2013Americas

Myriad hit with gene testing suit

US biotech company Myriad Genetics is facing claims that 14 of its patents covering tests for breast and ovarian cancer are invalid and non-infringed by Quest Diagnostics.

Quest, which provides diagnostic information services, filed for declaratory judgement at the US District Court for the Central District of California on October 10.

The company says it is planning to introduce a test (the BRCA Assay) that detects for hereditary alterations in two human genes, BRCA1 and BRCA2, which can correlate with an increased risk of breast and ovarian cancers.

The types of alterations include changes in DNA copy number, deletions, duplications or rearrangements in BRCA1 and BRCA2. After launch, the test will be made available to doctors and patients.

Until this year only Myriad has been able to test the genes, but other companies have begun offering similar tests since the US Supreme Court ruled in June that isolated human DNA is not patent eligible.

The ruling wiped out some of Myriad’s DNA composition claims, though the company still holds other patents covering the tests and has sued new entrants into the market – namely Ambry Genetics and Gene by Gene.

A third company, Pathway Genomics, has delayed plans to introduce a test because of Myriad’s suits against Ambry and Gene by Gene, according to Quest’s court filing.

Quest claims that “Myriad’s conduct demonstrates that it intends to continue aggressively enforcing its patent portfolio. Myriad has explained that it will vigorously defend method claims that cover its BRACAnalysis testing against competitors who launch competing tests”.

It adds: “Even after the prior court decisions invalidating claims from several of Myriad’s patents, Myriad has emphasised the alleged strength of its patent portfolio and claimed that its BRACAnalysis testing is covered by 24 valid and enforceable patents.”

Quest says it has “specific reason to believe” that it will be sued by Myriad, noting that representatives from both companies held a meeting in which the Myriad employee said Quest’s plans to enter the market “scared” Myriad.

According to Quest, the Myriad representative said in the July meeting that Quest would receive a letter objecting to the use of its tests.

Ten of the 14 patents listed in the suit all feature in the complaints against Ambry and Gene by Gene.

A Myriad spokesman said “we have not received the Quest complaint and it would be premature to comment.

“However, we continue to believe that patent claims related to BRCA1 and BRCA2 gene testing are valid and enforceable. Myriad’s BRCAnalysis is the gold standard diagnostic test for hereditary breast and ovarian cancer and has been used by more than one million patients. BRACAnalysis is widely accessible to patients and is reimbursed by nearly all private and public insurance plans.”

The “big question”, said Kevin Noonan, partner at McDonnell, Boehnen, Hulbert & Berghoff LLP, is whether or not Quest’s technology has developed so much that, as the company says, ‘we don’t practice the technology protected by Myriad’s patents’.

“The technology dates to about 15 years ago, so Quest could be right that – and I can’t answer this as don’t know exact details of the test – the technology has advanced significantly.”

Most of the original patents protecting Myriad’s test expire in about two or three years, Noonan said, so Myriad “must have been planning” on challenges to its market share.

When the patents expire, the shape of the market will “depend on whether the incessant urge to reduce costs gets so bad that Myriad could lose significant market share”.

But, he said, Myriad has such established tests and lots of statistical information on gene mutations that its test could remain popular.

He added: “Overall, there has been a lot in the press about the Supreme Court ruling being a great victory for the ACLU [American Civil Liberties Union] and for women, but most of that is smoke – the court made a very narrow decision.”

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