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« Court Report | Main | Docs at BIO: IP Challenges to Personalized Medicine & Diagnostics »

June 17, 2012

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Kevin,

Do get a link to Chris Holman's supplemental amicus brief, and pray that the Federal Circuit panel listens to what he says. Chris points out quite a few "misunderstandings" by the judges on that panel (especially Bryson) about what Myriads' "isolated" genetic sequence claims cover and how, in reality, those "isolated" genetic sequences are made.

EG:

The three broken links in the post -- to the AARP, Kane, and Holman briefs -- have been fixed.

Thanks for the comment,

Don

First, a provisio: this is not my area of technical expertise.

I am not sure I think Bryson was all that misunderstanding in that any actions taken to isolate the particular natural item is somethign that has to be done anyway (and is directly relatable to the Supreme Court verbiage in Mayo about merely directing something to the relevant audiance.

In fact, if the gist of the invention is no different than what that small element does in its native state, there has been no change in kind, even with any actual physical changes completed by the step of isolation.

I think that anti-patent argument in this instance is far stronger than what appears at first glance.

OK, Skeptical, one more time (and you're in luck - this IS my area of expertise).

If we make it the standard that there must be a change in the natural product, and by that mean a structural change rather than a change in purity, to render product of nature patent eligible, then there are many things other than genes for which we must decide patents are unavailable. That has never been the law nor should it be, because that would mean that antibiotics and many other naturally occurring chemicals would be unpatentable (including for example a new lubricant isolated from petroleum). Such a ban would even bar ultra purified silicon used to produce high quality computer chips (NOT my area of expertise).

Gene patents will become irrelevant (for human genes, at least) in about 7.5 years (because most were filed before the turn of the century). A broad ban based on the flawed logic espoused by the ACLU and their friends is much more pernicious than their false rhetoric that gene patents constitute ownership of an individual's DNA.

Thanks for the comment

Dr. Noonan,

Respectfully, you misquote the issue.

You state in part "and by that mean a structural change rather than a change in purity, to render product of nature patent eligible".

The problem is that structural changes are not ENOUGH.

Just as in Prometheus, where a transformation is acknowledged, but STILL is dismissed as not enough, structural changes for a patent in the composition category are not enough.

The Court has clearly enunciated a revived "gist of the invention" and an admittedly highly subjective "moreness" is required. The Court has clearly drawn a line that the plain words of the Patent Act do not and cannot overcome their judicial exceptions, that their judicial exceptions will not be dead letters.

And the Court CAN trace this line of doctine to a necessary "change in kind, not in degree" that has been in the law.

I do agree with you that this places many inventions in jeopardy. But this is NOT the same as saying that "this has never been the law nor should it be." The law has always been that the item culled from nature must be different in kind. What is happening is a tightening of what "different in kind" really means.

The premise behind the ACLU stance, and the stance of those preaching the "DNA as information content" is that the snippets of genes [and I would add even those snippets of genes that have been structurally altered], are NOT different in kind from the naturally occuring genes (or gene segments).

Unfortunately, Skeptical, we must part company here. If the Court does enunciate this standard in Myriad (which is has not yet done), then it will seriously damage the ability to protect much more than genes. I see no reasoned basis for such an outcome.

With regard to the "different in kind" argument, the Court has also said that the invention must evince the "hand of man" and have different uses, for example. All satisfied by isolated DNA.

As for "change in kind, not degree," reread the Wood Pulp Paper cases - the Court expressly declined to address the issue.

And while you may think that the Court has the last word, even the Court recognizes that Congress will. It did so in Deepsouth Packing, and it will do so here for the same reason that the AIA was passed - jobs.

Thanks for the comment

Dr. Noonan,

Let's not part company just yet.

I will grant that the court has not yet enunciated a standard in Myriad. My posts are only meant to draw attention to the possibility (and in some regards, the probability) that the court will draw a standard that will be in opposition to your view, AND that standard will have a legitimate basis in law. If it helps any, you can think of these differently structured claimed inventions as the clay doorknobs of the 21st century.

Believe me, a more firm believer in patents you will not find (notwithstanding my chosen moniker). I am playing the devil's advocate because the devil is in the details and the details do not look good for Myriad.

As for your asking me to read a([n] old) case inwhich the court of that time expressly declined to address the issue is rather a red herring. THIS court in THIS time MAY address the issue.

And I will also grant you that Congress does have the last word. No argument from me on that point. However, your insuation that jobs will swing the court opinion is expressly, and in my mind, deftly, handled by the Government's Amicus Brief. To borrow a phrase, jobs will not make the Court's judicial exceptions a dead letter.

Thanks for the dialogue.

Dear Skeptical:

If you, or anyone, thinks the government's brief deftly handles anything I beg to differ - a more clueless document would be hard to find (except, perhaps, the last government brief on the issue). It is hard to be so wrong on both the facts and the law.

I agree that the Court will not be swayed by the jobs argument, but Congress will. The only basis for the Court overturing an express provision in the law contrary to your position (excepting spite) would be that such a provision does not promote the progress - a hard thing to establish (which, of course, the Court would have to establish before striking down the law). Any such action would invalidate not only gene patents but thousands of patents routinely granted throughout the history of the Republic; while I don't doubt that this Court could do so in the first instance I think it would be harder if Congress spoke affirmatively.

The Court's judicial exceptions are not "a dead letter" (which, to place the phrase in context, was merely how the Court characterized what would happen to Section 101 should they defer to the expertise of the Patent Office and permit the Prometheus claims to be invalidated on Section 102 or 103 grounds). There is nothing wrong with excepting natural laws, natural phenomena or abstract ideas from the scope of patent protection, but defining isolated and purified molecules from nature as being within the scope of that prohibition is both unnecessary and unwise.

Without meaning to argue ad hominem, your comments reflect the risk in permitted generalists who do not understand the technology to opine on fundamental questions like patent eligibility. I do not take a position here that on balance there are no advantages to this scheme, just pointing out the disadvantages.

(You will be interested to know that former Acting S.G. Katyal spoke at BIO, and said that he determined that genomic DNA should not be patent eligible, and that such a ban would not have the effects we have been discussing, after spending much time at the NIH. The problem, of course, is that I don't think a scientist's view on what is patent eligible is the appropriate standard.)

We will be posting on all the briefs, and welcome further discussions as that process proceeds. Thanks for the discussion here.

Skeptical,

I'm with Kevin on this issue. And I strongly suggest you read Professor Holman's supplemental brief which exposes not only the scientific and patent law "fallacies) of the ACLU and PubPat about what Myriad's isolated DNA sequence claims cover, but also those of Judge Moore and Judge Bryson who are on this Federal Circuit panel. (You can read my article posted on IPWatchdog today to get an understanding of what Professor Holman's supplemental brief says about the correct "science" and patent law in this case.)

What really irks me about this case is how much the ACLU and PubPat have manipulated both the "science," as well as the patent law. They are trying to take over the issue of the patent-eligibility of isolated genetic material by using hyperbole and disingenuous, inapt analogies like “plucking a leaf.” The ACLU and PubPat frankly can’t win on the real “science.” Instead, they resort to the bio equivalent of astrology.

If I were a Federal Circuit judge on this panel I would directly ask the ACLU and PubPat to define what they mean by “gene”: that would likely expose that their definition of “gene” is not only unscientific but also false. While I’m not a molecular biologist like Kevin, I’ve got two books on molecular biology with glossaries which define many biological terms, including “genes.” In molecular terms, a “gene” is defined as the “entire DNA sequence, including exons, introns, and non-coding transcription-control regions, necessary for production of a functional protein or RNA."As Professor Holman’s supplemental brief carefully points out, Myriad’s isolated DNA sequence claims don’t cover “genes,” not even close.

As Professor Holman's brief points out and as Kevin has also said, the "name of the game is the claim." The ACLU, PubPat and Judge Sweet try to avoid this inconvenient "truth" by likening Myriad’s isolated DNA sequence claims to a "lawyer's trick." That's like saying the terms of a contract are a "lawyer's trick." The patent claim terminology does matter in this case. Only by disingenuously mischaracterizing what Myriad’s isolated DNA sequence claims cover does the ACLU, PubPat and others argue that this case is about "patenting human genes." Unfortunately for them, Professor Holman's brief exposes that argument as utter "mythology."

That the ACLU, PubPat (and others) refer to this case as an effort to “patent human genes” is simply a brazen PR campaign to generate in the public hysteria and emotion for their agendas. In fact, the “real plaintiffs” in this case are not those that the ACLU and PubPat frankly fabricated to get this case launched (and to try to avoid the obvious “standing” issue), but the ACLU and PubPat themselves. That the Federal Circuit has knocked out all but one of the plaintiffs on the “standing” issue alone exposes how much the ACLU and PubPat have manipulated this case, including what Myriad’s isolated DNA sequence claims actually cover.

As you might gather, I’ve got nothing but contempt for the ACLU and PubPat for manipulating our court system and patent law in this manner.

I think we are in understanding how each of the other feels.

Thank you.


But to pick a nit, the dead letter comment in context was NOT to 101; but rather, it was to the judicial exception related to 101.

"This approach, however, would make the 'law of nature' exception to §101 patentability a dead letter." 566 U. S. ____ (2012) at 21.

The only reason I pick the nit is that the emphasis by the Court is not on the legislative law, but rather on the judicial law. The context reveals what I consider a very telling emphasis of how the Court views its role in the issue.

I'm just amused to learn that claims are not meant to be read "literally" according to Holman.

Skeptical "structural changes for a patent in the composition category are not enough"

This is ridiculous on its face and demonstrates it's exactly why Myriad will win. As demonstrated in Prometheus, the Justices are not so short-sighted.

The reason that conventional and old transformations are not sufficient to turn an ineligible mental step into eligible subject matter is because the inclusion of such steps still leaves practitioners of the prior art in jeopardy of being hauled into court as infringers merely because they've learned a new fact and thought about it. This is why the Supreme Court noted that Prometheus' claims were effectively claims to the "natural law" (actually a simple correlation) itself.

But this logic in Prometheus is simply not to composition claims that describe novel compositions. If the positively recited structure of the claimed composition is different from that found in nature, then there is no ineligible subject matter at stake, i.e., nobody is "effectively" precluded from thinking about, studying or using the composition in its "natural" state -- unless you want to re-define "effectively" to mean "sort of impacting the field". That would be a radical change in the law with radical consequences, as Kevin correctly observes here.

By the way, Kevin, congrats on articulating the issues at play here. You dropped the ball on Prometheus, probably because your friends were too deeply invested in the wrong result. Now is your chance to get it right.

On the contrary, Keep It Real, your statement is anything but real:

"This is ridiculous on its face and demonstrates it's exactly why Myriad will win. As demonstrated in Prometheus, the Justices are not so short-sighted."

It is the very demonstration in Prometheus that fuels the "not enough" of a change, even though there is structural change.

The analogy to the method claim is in fact crystal clear: transformative steps, normally enough to get by 101 were held not too. Likewise, structural changes, normally enough to get by 101 are also quite possibly not enough.

As far as your "mental step" portion of the post, the tone indicates that you would be more at home at Patently-O. Your position sounds like that board's "MM," a contributor of such dubious nature, that I hesitate to even respond to your post on this respected blog.

As it were, I see nothing in your post other than bold and empty proclamation and there is not anything to say in reply except that you are clearly mistaken.

Skeptical: "The analogy to the method claim is in fact crystal clear: transformative steps, normally enough to get by 101 were held not too. Likewise, structural changes, normally enough to get by 101 are also quite possibly not enough."

I had to read this five times before I could convince myself that it wasn't a joke. Good luck, Skeptical. With that kind of legal "logic", how can you possibly lose? Too funny.

You must be the poster known as MM.

Your response is rude and pointless. Please stay at Patently-O.

"Such a ban would even bar ultra purified silicon used to produce high quality computer chips (NOT my area of expertise)."

Nah Kev, because the silicon used in compooter chips is not simply "ultra purified silicon". It is an "ultra-purified silicon lattice wafer or boule" neither of which have anything to do with something in nature or are a mere purified version of something in nature.

But you are right that there are situations where this kind of a rule could spill out. It's just that the group of such situations are much smaller than the group of situations you think would be drawn into this as being problematic.

Fact is, your art is dealing with things one step, a purification etc, away from nature. There aren't many other arts that deal with something of that nature. They do exist of course, but it wouldn't be so bad if they were somewhat curtailed as well.

"And while you may think that the Court has the last word, even the Court recognizes that Congress will. It did so in Deepsouth Packing, and it will do so here for the same reason that the AIA was passed - jobs."

How many people like the good Dr. Ostererblah would have a job if not for Myriad's monopoly on that testing?

Do not be so quick do think that the only way jobs are created is by carving out Imaginary Property.

What is funny is that after reading the Holman brief I understand Judge Sweet's reasoning a lot better. Mr. Holman may well be shooting his own side squarely in the face.

"It is true that the process of initially isolating the BRCA genes involved

extracting native chromosomal DNA from human cells, and cleavage of that native

DNA into fragments. But these are merely intermediate steps in the preparation of

the genomic DNA library, from which the genes were actually isolated, and would

not fall within a reasonable construction of the claims."


Yeah, we know Holman, you're attempting to obtain a 20 year monopoly on something which you neglected to claim by claiming something that is required to use that something. This is called effectively pre-empting in USSC language.

"Of course, one might argue that a literal reading of the claims would cover
bulk extracted chromosomal DNA, or fragments of native DNA used in the preparation of a library, since they would inherently include a BRCA gene. But to give the claims such a broad interpretation would render them anticipated by the extraction and cleavage of chromosomal DNA, and the preparation of genomic DNA libraries, activities that were routine and widely described in printed
publications long before the isolation of BRCA1/2. J. Sambrook et al., MOLECULAR CLONING: A LABORATORY MANUAL, Chapter 9 (1989 2nd Edition). To give the claims such a broad construction would not only be inconsistent with the disclosure, and with the general practices of molecular biologists, it would assume that the patent examiner issued claims that are invalid on their face in view of prior art of which the examiner had to be aware."

Why not just throw the case to the ACLU? With friends like Holman who needs adversaries? I guess he was in support of neither party though.


"Not only does the claimed DNA originate outside the body, it has distinct functional and structural characteristics that distinguish it from native genomic
DNA. "

Nobody cares. What we care about is the effect which the claim has in real life applications.

you conveniently omit the amicus brief of James Watson.

How convenient for you.

Dear Observer:

We didn't know Dr. Watson filed an amicus. If you have a copy, send it along and we will include it.

But your implication points out a fallacy common in this debate (by those on the ACLU's side). That fallacy is that the opinion of scientists, even renowned ones like James Watson, are relevant to the question of patent-eligiblity of genomic DNA. Their opinions are neither relevant nor dispositive because the question is a legal one, and in our experience most scientists espousing these views base their beliefs on additional legal fallacies - such as the one that the isolated DNA claims are infringed by sequence-based genetic diagnostic testing, or that they will be infringed by whole genome sequencing. These claims will not be infringed, again based on a legal not a scientific analysis.

But don't feel too bad. Former Acting Solicitor General Katyal told an audience at BIO last week that he understood the patent ineligibility of genomic DNA as the result of spending a "great deal of time" at the NIH.

Thanks for pointing out that Dr. Watson as filed a brief. We will also endeavor to obtain a copy.

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