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« Mitsubishi Chemical Corp. v. Barr Laboratories, Inc. (Fed. Cir. 2011) | Main | Biotech/Pharma Docket »

August 03, 2011

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Kevin,

Nice "dissection" of Judge Bryson's nonsensical dissenting opinion. Judge Bryson is apparently in Judge Dyk's (see Invert v. Merial) camp on the isolated gene sequence issue. Their views mystify and annoy me from the standpoint of ignoring the science, chemistry, molecular biology, and more significantly, the reality here. You would expect such rhetorical nonsense from a disctrict court judge (e.g., Judge Sweet) or perhaps from the Supreme Court. But not the Federal Circuit.

Kevin,

Thank you for tackling a topic that most fear to touch with the proverbial ten foot pole: Judicial incompetence in areas (i.e. biochemistry) where they know not how incompetent they truly are.

What to do about it?

This is a big problem because judges yield extraordinary power and oft suffer from hubris as well as self-inflicted blindness due to the brilliance of their own self-adjudged high IQs.

I for one, do not see any simple answers.

Maybe a first step is for all judges to exercise some form of transparent humility by admitting on record that they did not spend 10 years in graduate school earning a PhD in biotechnology and admitting that perhaps there are some areas of knowledge that are not easily acquirable though a 2 minute tutorial from a biased lawyer. If the latter were true (that anything and everything can be learned via 2 minute tutorial), then we are all foolishly wasting billions of dollars by sending our sons and daughters to college and graduate school.

"Another mischaracterization... The inaccuracy of ..."

- One needs sequencing primers and they potentially fall within the 15-nucleotide claims. So Judge Bryson maybe right for the wrong reason.

Dear DSK:

I might agree if I thought the primer claims were valid - but I don't think they are. But not for the reasons Judge Bryson thinks they are not.

Thanks for the comment.

Dear step:

To be fair, part of the blame lies on the lawyers and the judge's clerks for not assiting the court to understand the issues.

But the problem you mention has a solution, one proposed by Learned Hand in the last century:

"The test laid down [in 35 U.S.C. § 103] is indeed misty enough. It directs us to surmise what was the range of ingenuity of a person "having ordinary skill" in an "art" with which we are totally unfamiliar; and we do not see how such a standard can be applied at all except by recourse to the earlier work in the art, and to the general history of the means available at the time. To judge on our own that this or that new assemblage of old factors was, or was not, "obvious" is to substitute our ignorance for the acquaintance with the subject of those who were familiar with it. Reiner v. I. Leon Co., 285 F.2d 501 (2d Cir. 1960)

"Courts, made up of laymen as they must be, are likely either to underrate, or to overrate, the difficulties in making new and profitable discoveries in fields with which they cannot be familiar; and so far as it is available, they had best appraise the originality involved by the circumstance which preceded, attended and succeeded the appearance of the invention. Safety Car Heat & Light Co. v. General Electric Co., 155 F.2d 937 (2d Cir. 1946)."

Thanks for the comment.

"But the problem you mention has a solution, one proposed by Learned Hand in the last century:"

A rather poor solution, and one which gets worse as arts get more and more complex with each passing day.

But never mind all that, gimme that ol' time religion, I say gimme that ol time patent religion!

Thanks, Kevin. As Sideshow Bob might say, "Euhhhhhhhhh".

I noticed that Judge Bryson was also on the panel that decided Schering v Geneva. In that case, Judge Rader, writing for the panel, noted near the end of the opinion that although the metabolite claimed in claim 1 had existed before, proper claim drafting could still have saved something for the patentee:

"A skilled patent drafter, however, might fashion a claim to cover the metabolite in a way that avoids anticipation. For example, the metabolite may be claimed in its pure and isolated form, as in Kratz and Bergstrom, or as a pharmaceutical composition (e.g., with a pharmaceutically acceptable carrier). The patent drafter could also claim a method of administering the metabolite or the corresponding pharmaceutical composition. The '233 patent would not provide an enabling disclosure to anticipate such claims because, for instance, the '233 patent does not disclose isolation of DCL."

Judge Bryson didn't dissent then, implicitly agreeing with the statement, but the positions he takes in AMP seem to be at odds with the view in Schering. I wonder if the inconsistency is due to a change of heart, or just sloppiness.

Dear Dan:

Sometimes it's context; I think he believed Chris Hansen when he said the composition of matter claims would raise infringement liability for whole-genome sequencing.

Thanks for the comment.

Kevin,

You picked on poor Judge Bryson's ignorance re DNA molecules.

But how about Judge Moore?

Isn't she equally guilty (although to a much lesser degree)?
Moore J. "gets it" about the end bonds of the isolated molecule. But does she mention protein folding, enzyme attachment, etc.?

Mind you, I'm no biochemist and therefore I am well out of my normal woods when it comes to this stuff. But I get a sense that the judges involved are even farther out in the open meadow when it comes to scientifically complex issues such as these.

One shudders to think what will happen when stuff like this moves up into the US Supreme Court!

(...and yes, I do recall you have a past history with one of the justices)

Dear step:

I agree that lay judges have some of the same problems as the rest of the public in understanding technology. But Federal Circuit judges do better than most; I think Judge Bryson simply got caught up in the while genome sequencing argument and was trying to make a "pro-technoloy/pro-innovation" decision.

Thanks for the comment.

Kevin, regarding your comment about the 15mer claim, are you construing the claim to require that the 15 nucleotides be consecutive? That's the only way the claim has any possible validity. Assuming you are reading "consecutive" into the claim, are you saying that there is at least one published sequence out there (published prior to the filing date) that discloses 15 consecutive nucleotides of the cDNA? Have you actually checked into this? 15 is pretty short, but 1994/95 was a long time ago...

Or are you reading "consecutive saying the claim is invalid because the word "consecutive" is omitted, or are you reading "consecutive" into the claim and instead saying that it fails 102 (due to previously disclosed sequences)? The "consecutive" issue is sort of a big issue. If the 15 nucleotides are not consecutive, then what the heck

Ignore last paragraph -- something weird happened with the post.

Dear Gary:

First, the information comes from Bob Cook-Deegan - I wrote about it on March 30, 2010 (see www.patentdocs.org/2010/03/caught-in-a-time-warp-the-invalidity-of-brca1-oligonucleotide-claims.html?cid=6a00d83451ca1469e20133ec6192bb970b). From what I recall, he found several 15-mers that were part of other genes known at that time.

I think (and am writing a post) that one of the problems in this case was the failure to construe the claims - much of the debate has to do with one side or the other working from an interpretation of the claim that goes against the "ordinary and customary" meaning of the terms as they are used in the art (both biotechnology and biotechnology patent law). I do "read into" the claims that the nucleotides are consecutive, because any random series of nucleotides of whatever size can be gleaned from any sequence, taking away all specificity for the BRCA gene.

Thanks for the comment.

Kevin: Forgot about that post. Seems no doubt that the claim is invalid. It's not really important one way or the other since neither this claim nor the full-length claim would be infringed by performance of a sequencing based test (at least the way Myriad does it). The real issue concerns the correlation claims. This panel killed them, and although the panel absolutely reached the correct result, it's reasoning was totally incorrect (it's all going to get hashed out anyway in Prometheus). I saw an article where Dr. Cook-Deegan characterized as disingenuous Myriad's public statements that the decision regarding the correlation claims was immaterial. He's right. These claims are really the whole ballgame. The only problem (which is not insignificant) for competitors is the proprietary mutations. In the course of doing its test, Myriad has discovered and characterized many mutations that the public knows nothing about.

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