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November 05, 2013

Comments

Welcome back in time to the "only good patent is one that has not yet appeared before us" era.

"This case illustrates the uncertainty that comes from enunciating a standard that raises a court's subjective opinion on patent eligibility to be dispositive.

Kevin,

You are spot on. With all due respect, the opinion by this district court judge is utter rhetorical nonsense, and painfully illustrates the chaos created by the illogical reasoning of SCOTUS in Mayo on determining the patent-eligibility of diagnostic method claims under 35 USC 101. If the diagnostic method claims in this case can't pass muster under 35 USC 101, it's hard to see how any commercially significant diagnostic method claims can.

Is there a conflation here, between separating a discovery, from an invention based on the discovery, and issues related to the breadth of the claim?

It certainly appears, from the EP perspective, that, at least in biotech, the difference between a discovery and an invention is easy to discern. A discovery is the identification of a phenomenon, here the realisation that paternal sequences are present in the pregnant maternal blood, whilst the use of that phenomenon to achieve a useful end (a diagnostic), could be an invention (assuming the usual hurdles are overcome).

The hurdle is quite low as it should be. After all 101 is a gate-keeper to the real meat of patentability - novelty, inventive step and support/disclosure

The claim is, in fact quite broad, essentially monopolising the detection of paternal DNA in maternal blood following amplification, but this is quite a separate issue.

Kevin,

You've persuaded your friends, it looks like. And I suspect this is the line of logic that CAFC will use to reverse. But if/when it goes to S Ct, then the claims language drafted to clearly preclude any alternative way of measuring cffDNA will be troublesome and the pre-emption problem will raise its head. I believe that part of Judge Illston's argument will have appeal (so to speak).

The very reason for this business squabble is to establish a service monopoly for cffDNA testing, v four companies in more or less the same space. That means the claims do preclude alternatives. If so, let's argue on merits of that, but not dance on heads of pins about extent of pre-emption. This case clearly pits "invention" v "discovery" (and the premption problem) against a novel use of sequencing. Does not seem like a simple case for either side, and the "right" answer is all that clear. The conventional wisdom in patent law yields the answer you reached; but that is the very thing being changed by recent S Ct jurisprudence. The difference, however, is not intellectual coherence but where the line of patent-eligibility lies.

Excellent post--thank you.

"It is a statistical certainty that somewhere there is a universe where this logic makes sense, but it isn't this one." LOL. I nominate that for quote of the year.

Unfortunately, that's the only humorous thing going on here. As was to be expected after Myriad, we're off to races, conflating patent eligibility with novelty and inventiveness. Thanks, SCOTUS. And the pre-emption question could be dealt with through the written description and enablement requirements. But why use a fine chisel when you can use a sledgehammer, right?

"The conventional wisdom in patent law yields the answer you reached; but that is the very thing being changed by recent S Ct jurisprudence."

Bob,

That is exactly what SCOTUS has unfortunately done, including completing ignoring/disregarding it's own precedent, especially Diamond v. Diehr, that correctly shows why the subjective standard expressed in Mayo creates utter chaos under 35 USC 101. The decision in Mayo is completely driven by Breyer's desire for a specific a result untethered to any reasoning (or precedent) that I can accept/agree with as being rational. It's also why I've got minimal, if any, respect for SCOTUS, especially in the area patent law jurisprudence.

The only thing that seems at all even potentially amiss in this decision is the part where they state what sequenom argues:

"Sequenom argues that its use of cffDNA is inventive because prior to the invention, no one had started with the mother's plasma or serum to detect paternally inherited fetal DNA"

I just don't know if we can make the determination as cavalierly if they're arguing that. But on the other hand, I don't understand the facts well enough to say either way in this case. Sequenom should have been very insistent that the judge understand the facts behind what it is arguing if they expect to prevail.

"It's also why I've got minimal, if any, respect for SCOTUS, especially in the area patent law jurisprudence."

A lawyer that doesn't respect the courts which he is supposedly an officer of? One would think at the least you'd resign, but in the best case scenario that would seem to be ample grounds for dismissal, in this case disbarment.

The comedic relief of 6 has worn through.

Hey 6, hate to "burst" your "bubble," but I'm not a member of the SCOTUS bar (and probably never will be), so SCOTUS has no authority (or control) over me. Anyway what I'm critical off and have no respect for is the "reasoning" of SCOTUS in its decisions, especially those related to patent law. You do recall that we have a 1st Amendment "free speech" right, correct?

Thanks for the write-up Kevin. You may recall from your earlier posting regarding this case (http://www.patentdocs.org/2013/08/aria-diagnostics-inc-v-sequenom-inc-fed-cir-2013.html) that we came to an agreement about the key fact that would determine eligibility in view of the Prometheus rule.

As you put it: "I agree that the patent eligibility of the claim will depend on whether detecting fetal DNA in maternal blood was "new" when the patent application was filed."

Was that fact elucidated? Had detecting fetal DNA in maternal blood been done by others before the priority date of this patent (March 4, 1997)? The opinion seems to suggest that the answer is "no" based on testimony from Evans, cited by the judge on page 2:

"Prior non-invasive DNA research had focused on detecting fetal cells in a mother’s bloodstream, because the presence of cell-free fetal DNA was not known"

But that seems strange given the following publications:

PRENATAL SEX DETERMINATION BY DNA AMPLIFICATION FROM MATERNAL PERIPHERAL BLOOD

That's fetal DNA detection in maternal blood, by one of the inventors, published in Lancet in 1989, 7 years before the patent at issue here was filed. This paper is mentioned in the background section of specification. Also this publication from the inventors in 1993:

http://link.springer.com/article/10.1007/BF00217445 "Prenatal sex determination from maternal peripheral blood using the polymerase chain reaction"

At the time of publication of those papers, it was already known that PCR would and could detect minute amounts of DNA. I haven't read these two papers to read all the details but at least one Ph.D. student wrote the following: "Lo et al. (1989) have demonstrated by PCR the existence of fetal cell-free DNA in maternal plasma ..." Perhaps that student misread the paper ...

Regardless, it boggles the mind that nobody in the field suggested checking whether some of that fetal DNA was cell-free around the time that those earlier papers were published. I would expect such an analysis would show up as a control in those papers circa 1989-1993. Very odd.

Eg I never said you are or they did. Though I will note that the supreme court of Ohio has power over you, and I will say that you are a registered attorney there. You may want to brush up on the part about respecting the legal system and all those in it buried way down deep on page 1 of the Ohio rules of professional conduct.

http://www.supremecourt.ohio.gov/LegalResources/Rules/ProfConduct/profConductRules.pdf

Here is a snippet to refresh your memory.

Lawyers play a vital role in the preservation of society. A lawyer’s conduct should conform to the requirements of the law, both in professional service to clients and in the lawyer’s business and personal affairs. A lawyer should use the law’s procedures only for legitimate purposes and not to harass or intimidate others. A lawyer should demonstrate respect for the legal system and for those who serve it, including judges, other lawyers, and public officials. Adjudicatory officials, not being wholly free to defend themselves, are entitled to receive the support of the bar against unjustified criticism. Although a lawyer, as a citizen, has a right to criticize such officials, the lawyer should do so with restraint and avoid intemperate statements that tend to lessen public confidence in the legal system. While it is a lawyer’s duty, when necessary, to challenge the rectitude of official action, it is also a lawyer’s duty to uphold legal process.


DEMONSTRATE DAT RESPECT BRO.

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