Myriad sues Ambry over BRCA Testing

According to Genome Web, Myriad, and the other relevant patent-holders, have filed suit in the U.S. District Court for the District of Utah against Ambry Genetics on the ground that Ambry’s announced BRCA1 and BRCA2 testing infringes the patents held by Myriad and others. (And here’s a newer, longer, very good Genome Web story.)

Myriad took an aggressive posture immediately after the Supreme Court decision, claiming that their more than 500 valid patent claims still provided get intellectual property protection for their  BRCA testing business.  Given that

1.  The Supreme Court has invalidated its composition of matter claims for BRCA,

2. The Court of Appeals for the Federal Circuit, following the Supreme Court’s decision in Mayo v Prometheus, earlier invalidated its process claims for the method of comparing its patent sequences with a patient’s sequences to make risk predictions, and

3.  Ambry’s tests use a sequencing method that does not seem to require that it make cDNA of the BRCA genes, as to which the Supreme Court upheld the patent claims,

it will be really interesting to see Myriad’s arguments on this infringement case.

I suppose that after their aggressive response to the Court decision, failure to sue might have opened them up to securities law violations.  And, of course, I have not seen the complaint or studied the (so far non-existent) details of this suit.  And I’m not a patent lawyer. So maybe they’ve got some good arguments.  It would surprise me. (But I’ve been surprised before.)

Hank Greely

2 Responses to Myriad sues Ambry over BRCA Testing
  1. They’re suing mostly on dependent method claims of other invalidated claims. (Such as claim 6 on their ‘999 patent, which is dependent on now invalid claim 1.) While it’s true that lack of novelty and obviousness to an independent claim does not necessarily render the dependent claims invalid, I had always thought that declaring an independent claim as falling outside of patentable subject matter made its dependent claims invalid as well.

    After some research today, it seems more nuanced than that. The Federal Circuit hinted at that outcome in a case called In re Comiskey, but in truth, the accused infringer still has the burden to prove the dependent claim is invalid. (And by clear and convincing evidence, no less.) I still think, for this case, this will prove damned easy–hopefully at the motion to dismiss stage–but it’s not as horrifically sanctionable as I first thought. It will be, however, an absolutely ludicrous waste of money–and terrible PR.

    I simply don’t understand why Myriad is going this route. They’re in the doghouse of public opinion, this case is *beyond* a stinker, and they’re going to need all the cash on hand they have to weather the immediate storm of competition. Is this just bad, spiteful management? Have they simply been drinking their own Kool-Aid? Do they know something we don’t about patent law? I don’t know. But Ambry got some free, front page advertising thanks to Myriad. After the dust settles, they may want to thank them.


  2. Although I am not a lawyer, I do think it is not appropriate to patent a gene or a certain genetic testing. Science research and medical diagnosis are supposed to be free to the public. We do research to advance the medicine, not for profitable reasons.


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