Myriad Sues 2 Competitors Offering Cheaper BRCA Testing

2 Universities Join in the Suit

Nick Mulcahy

July 12, 2013

Myriad Genetics (Salt Lake City, Utah) is suing 2 companies that offer less expensive testing for the BRCA1 and BRCA2 genes, according to multiple news reports this week. The genes are associated with an increased risk of developing breast, ovarian, and other cancers. The suit alleges that the competitors — Ambry Genetics (Aliso Viejo, California) and Gene by Gene, Ltd. (Houston, Texas) — are infringing on specific Myriad patents that are distinct from those invalidated by the US Supreme Court in June.

DNATraits, a division of Gene By Gene, offers testing for the BRCA1 and BRCA2 genes in the United States for $995, according to the company. Ambry's testing reportedly costs $2280. Both prices compare favorably to Myriad's testing, which costs $4000.

According to documents filed this week in US District Court in Utah, Myriad is not contesting the Supreme Court's rejection of their patents on naturally occurring DNA for the BRCA genes. In fact, the company's lawyers state that their new lawsuit "involves none of those 5 rejected claims."

Instead, the suit relates to patent claims on "synthetic DNA," which Myriad asserts "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 the new lawsuit involve gene-specific probes, primers, and arrays that are part of the Myriad BRCA testing process and employ cDNA synthesized in a laboratory, according to the documents.

Even after the Supreme Court decision, Myriad reports having 24 patents and 515 patent claims that involve BRCA1 and BRCA2 testing.

Ambry, in turn, announced this week that it intends to "vigorously defend itself" against the patent infringement suit.

Myriad is 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.

When the Supreme Court invalidated 5 Myriad patents in June, patient advocates hailed the ruling as opening the door to less expensive testing. However, at the same time, Myriad immediately set the stage for more legal action.

"We believe the Court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward," Peter D. Meldrum, president and CEO of Myriad, said in June.

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