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« NCI Researchers Generate Largest Database of Cancer-specific Genetic Variations | Main | NIH Implements New Policy on HeLa Genomic Data »

August 07, 2013

Comments

Kevin,

The antitrust counterclaims by Ambry aren't surprising, fairly standard fair in such litigation. Your comment about the first alleged "sharp" practice was very astute as Utah has no choice under Bayh-Dole but to pursue patent protection or lose its rights.

It is likely that part of the anti-patent sentiment that seems to run through society comes from references by defendants, judges and others comes from the incessant references to patent "monopolies". When someone is unhappy with a patent, they call it a monopoly. Obviously, that ignores (or implicitly denies) the fact that whoever invented whatever is claimed gave the world whatever it was that was disclosed and claimed.

Also often overlooked is the fact that the patent owner's grip is, for some industries, e.g., drugs, and consumer products with 6- to 12-month life cycles, short-lived. In other cases, the patent owner is dominated by another patent and not free to practice without a license. Any license would make the licensor an evil monopolist? Definitions of monopoly don't exactly capture the subject matter ownership situation with patents.

One can reasonably wonder what Ambry might do if someone else comes along and blatantly infringes Ambry's patent (U.S. 7,741,028) by selling subject matter within the scope of the evil monopoly that Ambry owns. One can easily imagine what both Ambry and the poor stalwart defendant of widows and orphans in that lawsuit might argue. Ambry would probably call its property "valid claims" and defendant would call it a horribly misused "monopoly".

Yes, this looks like a counterclaim anti-trust suit and not the official response to Myriad's lawsuit. I believe the primer/probe defense Ambry puts forth here is right on the money. Same sequence used as found in genomic DNA then can't be patented.

A little confused as to why the author thinks that Myriads method patents have any merit. Although from reading this article seems like he's beginning to seriously doubt them as well. The method claims look very weak. Even though the judge said Myriad was in a position to apply its knowledge, I don't think he was talking about the claims Myriad is asserting. Myriad as a ton of claims and patents covering BRCA, but only a few deal with sequencing. I'm sure they have valid claims that deal with drug discovery, etc. but definitely not these ones.

Supreme court pointed this out the DNA isolation. If Myriad would have used a novel technique to isolate the BRCA genes/DNA then they could patent that method. However the techniques they were using were obvious and used by everyone. This is the same argument with the claims Myriad is now suing for. To sequence a gene, everyone knew you had to use primers and PCR amplify. This was obvious.

Dear DNA:

While I understand that the Court hasn't helped by conflating many of the sections of the patent statute into some undefined "inventive concept" standard, here is the answer to your question. Obviousness is determined by the claims as a whole, which require that the skilled worker would have appreciated with reasonable certainty that the invention would be expected to work. You are correct that amplifying and sequencing were known, but that isn't enough to make Myriad's claims obvious, because the genes themselves were not in the prior art.

Thanks for the comment.

Right but the fact that the genes the methods are based aren't patented material has to come into play. Straight from the Supreme Court:

First, there are no method claims before this Court. Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent. But the processes used by Myriad to isolate DNA were well understood by geneticists at the time of Myriad’s patents "were well understood, widely used, and fairly uniform insofar as any scientist engaged in the search for a gene would likely have utilized a similar approach"

To me, this also holds true for the sequencing claim. Any scientist would have done the same approach as the methods used were all conventional methods.

Nonetheless, these claims all read on cDNA which I'm pretty sure Ambry nor Gene by Gene use in their diagnostic methods so they shouldn't even be infringing those patents.

DNA,

Do you think methods read on products?

Dear DNA:

Your comment illustrates the consequences of the Court's sloppy language. First, how the BRCA genes were isolated is irrelevant to their patent eligibility, which is a categorical judgment. Even if something totally new and otherwise patentable (like the BRCA genes) are insufficientky different from how they occur in nature, and even if they are made using patentable methods, the Court would hold them patent ineligible.

Looking the the methods, the precedent would be Mayo, and I made that distinction in the post. The claims are novel and non-obvious because the BRCA genes were unknown in the prior art.

Thanks for the comment

Dr. Noonan,

It appears that you believe that a method must be both novel and non-obvious if an item created with the method was unknown in the prior art.

I do not believe such a generalization can be sustained.

In one instance, the inputs to a method may be left open ended, thus leaving open ended the final output.

In another instance, the result of a method may be completely unrelated to a finding that the method itself is obvious in view of existing methods.

I am, well, skeptical, that a one-to-one relationship exists. After all, the converse is true: methods that do yield a known result can still be novel and non-obvious.

At best, the result of a method is merely a clue.

Dear Skeptical:

I don't think I was saying that. I was merely commenting that Myriad's method claims can be distinguished from Mayo. I'll have to think more about your hypo of my position

Thanks for the comment

I think the methods Myriad is laying claim to were obvious as there were numerous labs that were already doing PCR and sequencing looking for BRCA at the same time. You have to remember that Myriad's claims have no specific primer or probe sequences listed, just "any" primer or probe that aligns to BRCA cDNA. If this isn't obvious that you would need a primer or probe to amplify BRCA then don't know what is.

Dear DNA:

You may be right, but the counter argument is that you cannot be legally obvious if the BRCA gene was unknown.

Thanks for the comment.

The counter argument is not valid, Dr. Noonan - as I pointed out, a method can have variable inputs and thus variable (and unknown) outputs. Just because a particular output was unknown has no correlation to the method being legally non-obvious.

I think I would much rather be arguing on the side that PCR and sequencing were commonly used methods and Myriad's claims are way too broad. If Myriad loses the preliminary injunction I think we will see a lot of other companies launch BRCA diagnostics as well. If I were Myriad, I'd save my money suing everyone and start to approach companies about licensing out their database. That way, they make money even if they don't run the test. Charge a certain fee per sample analyzed or something like that.

Well, DNA, the licensing approach sounds like Plan B. I wouldn't doubt that we could see Myriad adopt that strategy if they don't prevail.

Sorry, Skeptical - we'll have to agree to disagree. Fortunately, the Federal Circuit and/or the Supreme Court will perhaps decide the issue eventually.

Dr. Noonan, I wish I could see why you are disagreeing with me (I respect your judgement and wish to understand why we are not on the same page here). My logic is sound and it appears only that you want a particular result. I don't see the logic in getting to the result you want.

Dear Skeptical and DNA, I second your observations and really appreciate your commentary here. Myriad’s case just keeps looking weaker, especially after the defense filed their various documents on August 14, 2013, including their well argued opposition to Myriad’s motion for a preliminary injunction.

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