Wednesday, December 17, 2014

Myriad is Finished


Last year, following their loss in the Supreme Court, Myriad sought to block competition in a last ditch effort by suing Ambry and others who would offer BRCA testing. They lost a motion for a preliminary injunction, which would have prevented their competitors from offering tests while the suit was pending, then they appealed that to the CAFC, who today rejected their claims on appeal. This fight is done.

Echoing reasoning I have advocated, the court held:

"Contrary to Myriad’s argument, it makes no difference
that the identified gene sequences are synthetically
replicated. 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.

Myriad has lost all the way, and the BRCA genes and technologies and methods associated with their detection are where they belong: in the commons.

UPDATE: it's particularly good timing as the second edition of Who Owns You is in production and due out in May, including a section about the Myriad case which started after my book was first published. For a recent presentation regarding my theory of the commons and how it relates to the current status of the case law, you might want to scroll through this.

Friday, March 14, 2014

More Stuff Happens with the BRCA genes

So there's still activity in the Myriad case, and also a second edition of my book Who Owns You is now under contract with Wiley. My draft is due in August so I'll be writing this summer to update and revise in light of the significantly different legal landscape since the first edition was published. That landscape is active, but so far stable since the Supreme Court case. When Myriad lost in the Supreme Court, as I indicated they would, they sought to vigorously defend what remained of their patents, including by suing those who used the decision as an argument to compete in the BRCA testing arena. Myriad used the aggressive move of asking for a preliminary injunction in a lawsuit against one of those competitors, which turned out to be a big mistake. To win an injunction like that, before the merits of a case are reached, you need, among other things, to demonstrate a likelihood of success on the merits. In a 100+ page opinion, the court in Myriad v. Ambry denied the injunction, using the opportunity to expound on the merits and concluding that Myriad has no such likelihood. This is an early blow that won't help their stock price, and moreover, gives a pretty good early clue as to how the case will go. With the opinion's clear language, other companies are now entering the testing market and competing with Myriad, taking their chances and betting on the likelihood that in fact Myriad cannot monopolize the isolated DNA segments that the Supreme Court already said they cannot monopolize.