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« Follow-on Biologics Data Exclusivity Debate Scorecard - Part III | Main | 12 Senators Write in Support of 12-Year Data Exclusivity Period »

November 02, 2009



I won't address the standing and jurisdictional issues which this judge spent a mind-boggling 80 pages addressing in this opinion. But I remain of the opinion that these constitutional challenges to these gene patents are absolutely unsupportable and frivolous no matter what facts might be presented

And with all due respect to the judge here, he’s turning this case into a farce to continue to allow these constitutional challenges to these gene patents to proceed forward. Since Chakrabarty v. Diamond, SCOTUS has said that life forms may be patentable subject matter. That implies that the genetic material or testing procedures based on that genetic material may also be patentable subject matter. SCOTUS in Chakarabarty saw no “constittuional Issue” in patenting life forms or its genetic material, nor do I. That the judge’s opinion spends a mere 4 pages on the constitutional challenge issue (after spending 80 pages on the standing and jurisdictional issues) just highlights the absurdity of allowing this issue to proceed forward.

Interestingly, there is absolutely no mention of the suffiiciency of this Complaint under 35 USC 101 as to whether these patents cover merely a “product of nature.” That’s the only issue that might have any merit to go forward, at least to a motion for summary judgment. But as I said before this opinion came out, these constitutional challenges have absolutely no merit to go forward.

Beautiful summary of a long and detailed (84-page) decision that kept me up until 1 a.m.

Diamond v Chakrabarty does not seem terribly germane here, since the claims are not on a life form, but on DNA sequences and methods of use. Judge Sweet's document tells us nothing of what he thinks about the issues of patent eligibility and patentabiity that will be crucial in this case.

When you said "This case will not go to trial" did you mean "now" or "not yet?" I see Myriad et al. have until Dec 2 to file further motions, ACLU, Pubpat et al. until Dec 9 to respond, and then oral arguments Dec 11. Can you tell us what would typically happen next, and on approx. what time frame? ACLU clearly wants to take this as high as it can in the federal court system, and presumably Myriad will have to do so also. What are the likely steps in that process?

Dear Bob:

I can see no reason why the parties would go to trial in this case - it will be decided on the briefs by summary judgment. Each party will make their arguments, and there are few material facts that in serious dispute. This is a little like the Rochester case, also decided by summary judgment. In addition, the Federal Circuit encourages summary judgment in appropriate cases, and this one (which is really a policy argument) is ripe for being decided on that basis.

So the parties will file briefs, the court will hear argument (probably by the end of the year) and then decide sometime early next year. No matter what happens, an appeal goes to the CAFC, which will most likely invite amici to file briefs and may even hear the case en banc (why waste time on a panel decision and then go en banc?). Which puts the cert petition sometime by the end of 2010, with the Supreme Court argument coming no earlier than the spring session of the Court (with the fall 2011 session being more likely).

What I think this will do to investment in the biotech sector, just when the US economy is coming out of the recession, should be evident to anyone who reads this blog regularly. The only hope (and it is a faint one) is that the Supreme Court denies cert, which may happen only if the Solicitor General files a strong brief on behalf of gene patenting. The Solicitor's Bilski brief sheds little light on the administration's views in this area; that may become more evident if the Solicitor files a brief regarding the Mayo cert petition. And remember that there only need to be 4 votes on the Court to grant cert, Justices Breyer and Stevens remain on the court, and no one knows the views of the Chief Justice or Justice Sotomayor.

All in all, a fine mess.

Thanks for the comment.

"Interestingly, there is absolutely no mention of the suffiiciency of this Complaint under 35 USC 101 as to whether these patents cover merely a “product of nature.” That’s the only issue that might have any merit to go forward, at least to a motion for summary judgment'


Having now reviewed the patents involved, let me correct this statement I made earlier: there is no basis under 35 USC 101 for challenging these patents either. The claims are to isolated genetic material or methods for identifying/screening/detecting. In other words, the patentee isn't simply claiming a "product of nature" (the claimed isolated genetic material doesn't exist in nature).

To put it bluntly, the plaintiff's allegations that these patents cover "products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought" are utterly groundless and complete rhetorical nonsense. As far as I'm concerned,this suit is a complete waste of judicial resources. I can only hope that the Federal Cirucit will trounce this opinino when it gets the appeal.

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