More thoughts on Myriad Genetics’ new BRCA patent lawsuits

Myriad

Last Friday, I very briefly touched on the fact Myriad Genetics had filed two new lawsuits against Ambry Genetics and Gene by Gene, alleging infringement on patents related to BRCA gene testing held by Myriad. I was somewhat surprised by this, because I seemed to recall the US Supreme Court had just unanimously struck down Myriad’s BRCA gene patents about a month ago. But as with many things, there is more to the story.

Literally the same day as the Supreme Court decision was announced, Ambry and Gene by Gene announced they would begin offering BRCA testing. These entries into the BRCA testing market seemed to be the logical result of the Court’s decision, which effectively ended Myriad’s monopoly on BRCA testing.

So how is it Myriad is able to bring these suits if it no longer has the patents on the BRCA genes? The answer is Myriad is suing the companies for infringing on patents that utilize conventional laboratory techniques to sequence the BRCA gene and assess it for mutations, not for infringing on the BRCA gene patents themselves, which were invalidated.

It is important to note the claims Myriad is endeavoring to protect were not the claims at issue in the AMP v. Myriad case the Supreme Court just decided. Therefore, these new suits are novel cases.

Will Myriad’s bid succeed? We won’t know for a while, but I wonder if Myriad’s primary goal isn’t to win (which will likely be difficult in light of the Mayo v. Prometheus decision), but merely to run the clock out on its patents, the first of which I believe expires in 2015.

Along those lines, one of the things Myriad asks for in its complaint is an injunction that would prevent the companies from offering BRCA testing until the matter is resolved. And it can take a long time to do that in the United States.

Including all the procedural wrangling, trials, appeals, etc, the AMP v. Myriad case took four years to run its course. If Myriad’s requested injunction is granted and these cases take just as long to weave their way through the court system, then Myriad will have achieved BRCA testing monopolization throughout the entire lifespan of its original patents in spite of the Supreme Court decision. That would be quite an accomplishment.

Another interesting part to this is that Quest Diagnostics (and several other labs) also announced it would begin offering BRCA testing. But Myriad has yet to file a lawsuit against Quest.

At first I wondered if the reason for this is that Myriad is purposely targeting smaller labs with limited ability to put up a strong defense. I may not have been far off.

In an article about these suits over at GenomeWeb, Dan Burk, a patent lawyer at the University of California-Irvine, was quoted as saying:

It is very common to choose a defendant against whom you can quickly obtain a court order, and then use that success to convince other potential defendants to take a license or to cease their activity,” he added. “Presumably, Myriad and the other plaintiffs took all this into account in deciding to begin with Ambry.

He later went on to say:

Often the real goal in these suits is to get a preliminary injunction, which can happen very quickly and very early,” Burk said. “That alone sometimes puts the alleged infringer out of business, or induces them to negotiate for a license.

So in the end, Myriad is still simply just fighting to protect its business. After all, BRCA testing accounts for approximately 80% of Myriad’s revenue.

It literally cannot afford to have competitors.

Myriad’s complaint against Ambry Genetics is here, and its complaint against Gene by Gene is here. Note-They are nearly identical.

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