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BRCA, Lawsuits, and Rhetoric

Nearly a year after the Supreme Court's unanimous decision in the Association for Molecular Pathology et al. v. Myriad Genetics gene patenting case, the long legal soap opera that is the world of BRCA patents just keeps going and going.

PatentDocs' Kevin Noonan offers a highlight reel of the ongoing litigation between Myriad and several genetic testing rivals over BRCA1 and BRCA2 testing in the US District Court for the District of Utah.

Some recent developments have been good for Myriad and some not so good, and the rhetoric is heating up, Noonan notes.

The district court quashed two sets of counterclaims made by defendants: one to dismiss Ambry Genetics' assertion that Myriad's lawsuit against it was itself a violation of antitrust laws and another in which Quest Diagnostics claimed Myriad had asserted its patents broadly against anyone entering the BRCA testing market.

On the flip side, Myriad lost a strong voice in favor of patent rights and enforcement when Chief Judge Randall Rader said recently that he would step down from the bench at the end of June.

"[Rader] consistently applied patent law using traditional concepts … and whatever influence he might have with other members of the Court is now lost," Noonan says.

A couple of recent Supreme Court decisions also may prove thorny for Myriad, as they suggest that the district court might find that bringing several lawsuits against defendants might leave the company liable for all of the defendants' litigation expenses.

But a more significant issue is Pathway Genomics' arrival with testing for the BRCA1, BRCA2, and MUTYH genes. Pathway started offering testing on June 3, and Myriad filed suit 10 days later.

Pathway says it offers a sensitivity of 99.99 percent, and says it will donate up to $10 million in "free" genetic testing through a partnership with eight advocacy organizations.

Noonan says Pathway has "seized the rhetorical high ground (or low, depending on your understanding of the issues)," by claiming that it "defends the rights of all women to receive BRCA testing regardless of socioeconomic status."

As Noonan notes, Pathway's "Fight Back Against Myriad Genetics" slogan was accompanied by a graphic portraying a raised fist — a pink raised fist, that is — and Pathway's CEO Jim Plante followed that up with a message focused on rights.

"We believe that no corporation should have a monopoly over an individual's genes. Every person should have access to vital information about their own body," Plante says.