Another Defeat for Myriad in BRCA Gene Patent War

Roxanne Nelson

December 29, 2014

Myriad Genetics has chalked up yet another defeat as the company continues to try and defend its patents for the BRCA1 and BRCA2 genes.

Another appeal by Myriad Genetics to block its competitor Ambry Genetics from offering competing tests to determine BRCA gene mutation status has been resolutely denied. A US Court of Appeals for the Federal Circuit, ruling in favor of Ambry, said that claims from three of the patents covering DNA-based BRCA1 and BRCA2 tests that Myriad is asserting against Ambry do not contain subject matter that is eligible for patent protection.

The ruling affirms an earlier decision made this year to allow competing products to remain on the market.

"Myriad did not create or alter any of the genetic information encoded in the BRCA1 or BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them," the US Court of Appeals for the Federal Circuit stated in their opinion.

The Court of Appeals also pointed to last year's Supreme Court opinion, which found other of Myriad's claims patent-ineligible. "As the Supreme Court made clear, neither naturally occurring compositions of matter, nor synthetically created compositions that are structurally identical to the naturally occurring compositions, are patent eligible," they wrote.

This ruling is just the latest in a multiyear series of legal battles that Myriad Genetics has been fighting to maintain its patent claims and monopoly over BRCA1 and BRCA2 genetic testing.

As previously reported by Medscape Medical News, last year Myriad filed lawsuits against two companies that planned to offer less-expensive testing for the BRCA1 and BRCA2 genes. The lawsuits came within a month of a US Supreme Court ruling that effectively invalidated the patents held by Myriad for the genes and ended its monopoly on testing.

However, Myriad's lawsuit alleged that its competitors, Ambry Genetics (Aliso Viejo, California) and Gene by Gene Ltd (Houston, Texas), were infringing on specific Myriad patents that are distinct from those invalidated by the US Supreme Court.

The Supreme Court had unanimously ruled that although naturally isolated DNA is not patentable, synthetically created exon-only strands of nucleotides, known as complementary DNA, is patentable. So although the ruling invalidated five of Myriad's claims covering isolated DNA, the company stated that they held more than "500 valid and enforceable claims in 24 different patents conferring strong patent protection for its BRACAnalysis test."

In its lawsuit against competitors, Myriad stated that was related to patent claims on "synthetic DNA," which Myriad asserted "were not affected by the Court's decision and remain valid and enforceable." Synthetic DNA, also known as cDNA, is patentable, according to Myriad's interpretation of the Supreme Court's ruling in June, because it involves "physical, transformative steps" in the laboratory.

A number of the patent claims in their new lawsuit involved gene-specific probes, primers, and arrays that are part of the Myriad BRCA testing process and employ cDNA synthesized in a laboratory.

Myriad was joined in the new suit by a group of coplaintiffs: the University of Utah Research Foundation, the University of Pennsylvania, HSC Research and Development LP, and Endorecherche, Inc.

Ambry Fights Back

The plot thickened as Ambry Genetics geared up for battle and announced its intention of "vigorously" defending itself against the patent infringement suit. Within days of Myriad's action against them, Ambry reported it had filed an antitrust counterclaim against Myriad in response to the patent infringement lawsuit Myriad and other plaintiffs filed on July 9, 2013.

Ambry's antitrust counterclaim alleged that Myriad's lawsuit was in violation of the Sherman Antitrust Act because the "asserted claims against Ambry are invalid under two Supreme Court decisions and Federal Circuit authority." By bringing this patent infringement lawsuit, Myriad was thus continuing to use "overreaching practices to wrongfully monopolize" the diagnostic testing of BRCA1 and BRCA2 genes in the United States and attempting to injure any competitors who challenged their monopoly on testing.

"Being sued for patent infringement a month after the Supreme Court ruled 9-0 unanimously against Myriad is just wrong," said Ambry Chief Executive Officer Charles Dunlop at the time the company announced its countersuit. "As alleged in our counterclaim, Myriad Genetics is also wrongfully depicting Ambry's variants of unknown significance statistic to be as high as 30%, when it actually is approximately 5% for BRCA1/2 diagnostic testing. Tactics like this have no place in the medical field, especially cancer, as it will take a collaborative, industry-wide effort to further understand the disease and find cures."

The Gene War Continues

This past March, Myriad suffered another setback when a US federal district court denied the company's request for a preliminary injunction that would have stopped Ambry from offering BRCA testing. That ruling effectively allowed Ambry to continue offering the test, which Myriad once again tried to stop with its current appeal.

The battle for supremacy in the world of genetic testing appears to be far from over: Myriad has also taken legal action against a number of other companies who are now performing BRCA testing, including LabCorp, Quest Diagnostics, GeneDx, and InVitae. However, Myriad has not sought a preliminary injunction against any of them, aside from Ambry.

Myriad and Gene by Gene also have settled their dispute out of court, in what could be considered a major victory for Myriad. Under the terms of the agreement, Gene-by-Gene had to immediately stop "selling or marketing" BRCA gene tests, either as standalone tests or as part of a wider panel, in the United States. However, they will be able to offer "whole genome" testing and exome testing, as well as "custom" array products for Mendelian-inherited disease and disorders (which may include the BRCA genes).

At least for now, Ambry Genetics is pleased with the current court decision. "As a geneticist, I am thrilled," commented Elizabeth Chao, MD, chief medical offer at Ambry, in a statement. "This decision echoes what the Supreme Court unanimously stated 18 months ago. It's a win for patients, for practicing clinicians trying to access genetic testing for their patients, and for the industry overall."

"It's great not to have these patent claims holding back important research and progress in genetics," she said. "At Ambry, we will continue to offer our high-quality testing that has been very beneficial for families."

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