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« BIO IP & Diagnostics Symposium | Main | Fresenius USA, Inc. v. Baxter International, Inc. (Fed. Cir. 2013) »

July 09, 2013

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Listed below are links to weblogs that reference Myriad Genetics Files Suit Against Ambry Genetics for Genetic Diagnostic Testing of BRCA Genes:

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Really nice post, Kevin.

The claims are mainly the PCR-based method claims (plus the claims in the GeneLogic and OncorMed patents that include all sorts of methods), although the complaint does include the likely-invalid 15-mer claim 6 of '282.

It is indeed interesting that NIH is not included, as Myriad signed an agreement in Feb 1995 that includes obligatory consultation with NIH and a 90-day "no litigation" clause. I do not know if that agreement is still in effect (it is part of the '282 patent file wrapper: http://duke.edu/~kgm4/Myriad282/utah%20nih%20agreement.pdf). If it is, it is surprising this suit would be filed well before that 90-day no-litigation deadline and before formally notifying Ambry, which appears to be an obligatory initial action under the agreement.

If this goes to trial, perhaps we'll begin to finally learn what some of these claims mean. But for Myriad to prevail, they have to at least mean "if we find a gene, we get exclusive rights to PCR amplify that gene for the term of the patent" (including if segments from that gene are a minority among segments from many other genes being PCR-amplified and sequenced).

And perhaps you can edify us about the legal strategy. They have sued the weakest and smallest of the competitors, which of course they can do. But I'm wondering why, aside from perhaps wanting to shoot across the bow of others. Or is this likely just the first of several suits? And the only effective remedy here would be an injunction, but given the history of this case and in light of eBay v MercExchange, that seems a dicey. Is this perhaps just the opening phase of Myriad out-licensing? I would think this litigation could in fact force Myriad into just that.

We'll see.

Two other points.

First, I know that some of the labs were well aware of the unchallenged claims in AMP v Myriad, so it's not quite true their decision to enter the market is an unwitting risk. I presume their (supremely competent, in at least one case) lawyers have thought through this.

Second, I was surprised that Myriad brought BRCA2 into their infringement allegations. Their BRCA2 patents seem quite vulnerable, given that USPTO never declared a BRCA2 interference, so far as I can tell, and yet Myriad scientists openly acknowledge that they "got wind" of Stratton's work and rushed to do their own patent. If that was because a Nature reviewer shared the information about a pending publication, wouldn't those OncorMed and Myriad/Utah BRCA2 patents be on very thin ice?

"And perhaps you can edify us about the legal strategy. They have sued the weakest and smallest of the competitors, which of course they can do. But I'm wondering why, aside from perhaps wanting to shoot across the bow of others."

Bob,

The strategy is very obvious to me. What Myriad wants to do is get, as quick as possible, is a validity/infringement judgment ruling early, and the best way to do that is against the weaker/smaller competitors. With such a judgment in hand, Myriad can then push against the bigger/stronger competitors, including going for a preliminary injunction (success of which often requires having at least prior validity ruling and possibly prior infringement ruling). I could be wrong on the strategy, but that's what it looks like to me what Myriad is doing.

A similar question was posed with Monsanto - why would they pick on a small-time independent 80+ year old farmer who obviously does not have deep pockets...

Dear Bob:

EG is correct that some litigants will pick a smaller infringer, typically with a view towards licensing as you propose. Myriad could be working on a licensing structure that would require Ambry or other genetics diagnostic test providers to obtain a Myriad test result from any prospective client, which would deal with the "second opinion" issue (and could preclude or at least forestall Congressional action if and when the long-awaited "second opinion" study is released).

And while I have no reason to question the competancy of Ambry's legal counsel, I'm not sure anyone can give advice with any certainty in this area, in view of the "know it when we see it" standard that the Supreme Court has adopted regarding testing.

I suspect the BRCA 2 claims are in the case because Ambry said it would provide this testing, and if it comes to trial I would expect Ambry to assert prior invenetion under 102(g). Because we don't know the facts it is impossible to predict whether Myriad will prevail on priority to the claims at issue directed to BRCA 2.

Thanks for the comments.

Dear Skeptical:

I don't know about Farmer Bowman, but in earlier cases the "small farmer" was producing soybeans from tens of thousands of acres. This may be a remnant of changes from the days of the family farm, where modern technology and the economic downturn on farms in the 1980's permitted small farmers to increase their yields and holdings to levels that would not satisfy most peoples' definitions of "small."

Or maybe Monsanto had other strategic reasons (other than the "pick on the little guy" approach) that were relevant to the decision.

After all, Monsanto also sued DuPont/Pioneer and got a $1 billion judgment against them, so the company is not afriad to take on bigger opponents when need be.

Thanks for the comment.

Next up, Gene by Gene Ltd. - 7/10/2013

Thanks, Paul - see next post

Kevin: "[P]laintiffs challenged claims to isolated DNA (characterized as "genes"), even though such claims are not infringed by the practice of modern genetic diagnostic methods."

Right, but according to Myriad, each of the primers -- in fact, every nucleic acid primer that is not modified in some specific (claimed) manner -- is ineligible in view of Myriad.

Do you really think the courts are going to find that you can turn ineligible subject matter into an eligible claim merely by reciting another ineligible composition? Can I claim a composition consisting of, say, an ineligible probe and an ineligible complementary chromosomal sequence, thereby preventing someone from using that probe to bind to the sequence (which I was the first to discover, of course)? What's the difference?

Dear Huong:

You can certainly take an unpatentably reagent and perform a test that you patent. What's the difference?

I would hazard a guess that a product of nature judicial exception does not rule out the ability to obtain a PROCESS patent for obtaining an end result (the product of nature), that itself is not eligible for patenting.

Come up with a new way to make water? Great - have a patent on the process.

Want a patent on water? Sorry, no.

And yes I used water as a readily identifiable item - I could have used "sdfghala" and postulated that "sdfghala" was a product of nature, though just discovered (and purposefully echoing Chakrabarty at that).

Dear Skeptical:

You don't need to guess - just read the Cochrane v. Badische Anilin Soda Fabrik case

Dr. Noonan,

The 'hazard a guess' was rhetorical.

Sorry, Skeptical - but thanks for helping to enlighten others

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