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« USPTO Issues Memo on AMP v. Myriad to Examining Corps | Main | NAPP Annual Meeting »

June 13, 2013

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Kevin,

As was expected and it could have been far, far worse. At least Thomas wrote it in a way that kept the patent-ineligible part of the holding pretty much cabined, more so than you might think. Let's definitely not get lost in the media and ACLU hyperbole about this case being about "patenting human genes" which it was not. I've frankly seen too much "doom and gloom" from the patent law world, including once such statement from the AIPLA.

Also, besides saying that Myriad's cDNA was patent-eligible (versus “isolated” DNA that wasn’t), I actually take solace from are sentences at pages 14-15 of the slip opinion: “Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2.” In other words, Myriad’s claimed “isolated” DNA sequences didn’t look enough like a chemical molecule divorced from the native DNA, i.e., were not a "difference in kind rather than degree" which comes straight out of the "product of nature" doctrine cases. Those sentences are also somewhat of a backhand “jab” at Breyer’s derogatory comment in Mayo about not letting patent-eligibility under 35 USC 101 depend on the “draftsman’s art.” I realize that what Thomas' opinion requires in terms of defining that "chemical molecule" is odd for the molecular biology world, but we can cope and have done so in the past.

Further, as I, likely you, and others know, the Myriad opinion is essentially applicable only to that 2% of the human genome that follows the pre-ENCODE approach to genetics. That means that the Myriad opinion is really inapplicable (i.e., not on point) as to 98% of the human genome that doesn’t follow the pre-ENCODE approach to genetics. So keep your chin up, the “game” isn’t over yet by a long shot.


I've also seen comments about Thomas’ statement (which is dicta) about, while Myriad's claimed cDNA being patent-eligible, “very short series of DNA which may have no intervening introns to remove in creating the cDNA” might not be. Unless I'm missing something, by definition, cDNA is a DNA molecule which is created from mRNA, and therefore must be lacking in the introns in the DNA of the genome. Thomas (or more likely his clerks) may not have realized that what they were talking about isn’t what would be defined as cDNA.

As much as I'd like to agree/believe your conclusion that "does not establish a categorical "product of nature" preclusion and thus should not be interpreted as mandating that other products of nature (such as those identified by Judge Moore in her concurring opinion) are categorically unpatentable," I'm not understanding how you can read the opinion that narrowly.

"In this case, by contrast, Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention."

I do not understand how this statement does not support an argument that NO isolated/purified naturally occurring compounds are patent-eligible. Not genomic DNA, not probes or primers that correspond to sequences within one exon (or to ANY viral, bacterial, some plant genes); naturally occurring proteins or fragments thereof, including antibodies (how about antibodies made in mice which have human genes in their genomes); chemical compositions such as adrenaline and strawberry flavor?

A request - can you please post (1) the claims Myriad has lost or ceded, including any method claims lost based on Mayo v. Prometheus; and (2) the claims Myriad still has that protect its business, in particular its genetic testing business. It is hard to tell what is pending, since many of their cases do not have their file history posted, and we can't see what has been corrected by certificate of correction, or what has been lost in litigation or by disclaimer.

It would be interesting to hear your opinion about the patent eligibility under Mayo v. Prometheus of Myriad's remaining method claims.

Finally, do you think that the USPTO is about to be inundated in reissue applications, as gene patent holders (ALL genes, not just human genes, of course) rush to get claims specifically to labeled probes and primers, and to tweak their methods claims as well?

"That was not the case when the patents were filed and was even less the case after Myriad disclosed the positions of the diagnostic mutations in its patent specification."

Breaking new ground. Could only come from the trained minds of patent practitioners.

Kind of like saying, I never hit my wife and I hit her even less since then.

EG "In other words, Myriad’s claimed “isolated” DNA sequences didn’t look enough like a chemical molecule divorced from the native DNA, i.e., were not a "difference in kind rather than degree" which comes straight out of the "product of nature" doctrine cases."

As Dr. Noonan noted, it does not matter if you claim a naturally-occuring polynucleotide by reciting the letters in chemical form. If the DNA sequence of that polynucleotide occurs naturally in a genome, the claimed "isolated" polynucleotide is ineligible. That's the rule.

The same rule explains Thomas' comment about the possible ineligibility of short cDNAs. It must first be recognized that simply calling a nucleic acid a "cDNA" does not make it eligible, nor is the method by which the polynucleotide was obtained relevant to the question. The issue is: what is the sequence and how does it relate to the universe of naturally-occuring sequences (which presumably also includes any sequence, synthetic or not, in the public domain)? Going back to Thomas' cautionary note about short cDNAs, if one claims a short enough cDNA, it becomes statistically more likely that an identical DNA sequence will be found "in nature." Similarly, if one attempts to claim only a portion of a larger cDNA molecule, the same issue will arise. That's my understanding of what he was driving at. To his credit, at least that part of his analysis is scientifically accurate.

Dr. Noonan (or anyone else who has thought on the subject): as a biotech prosecutor who has handled similar claims as Myriad's, I always advised clients to obtain at least some claims that were bounded at both ends (with respect to length and sequence). For example, at some point in prosecution, claims in the form "polynucleotide consisting of SEQ ID NO:#" would be presented.

Did Myriad ever do this? If not, why not? And if they did do it, what happened to those claims (were they not asserted)? Unless I'm misunderstanding something, it would seem straightforward to individually claim a discreet specific set of novel, non-obvious probes with demonstrated utility for detecting the presence of the mutation. I understand that there would be design-around issues (preventable by well-drafted method claims, perhaps) but there would still seem to be some value in obtaining coverage for those compositions. More importantly, Myriad could have avoided the "pre-emption" issues that dogged them throughout this litigation and ultimately led to the decision (which has to be chalked up as a net loss for them).

Dr. Noonan: "In the words of the Court's Mayo decision, the bacteria were "well-known, established and conventional," in contrast with the BRCA genes isolated by Myriad into a composition of matter "having a distinctive name, character [and] use."

I think it's important to look at the claims in both these cases. When you do that, the distinction you are drawing seems to fall apart. In Funk, the claims were drawn to an (allegedly) new mixture of bacteria, where the mixture was "limited" by the recitation of a property to be possessed by the mixture. That property of certain bacterial mixtures was deemed by the Court to be a "natural principle", hence the 101 result.

Myriad's claims suffer from a problem of extreme breadth in two respects: (1) there is no upper bound to the length, so the claims arguably cover extremely long molecules such as broken pieces of an isolated human chromosome (well-known, as of the filing date); and (2) the broadest claims cover an enormous number molecules comprising much shorter nucleotide sequences, many of which are also in the prior art.

I'm not making any judgment about Funk, or the Court's analysis of Funk, or its reliance on Funk (all questionable, in my opinion). Just pointing out that Myriad's *claims* are at least as flawed (and possibly more so) as Funk's claims when compared to the prior art.

@DCox Myriad doesn't need that may patents to protect its business model, they have a giant proprietary database of genoptype-phenotype correlations that they don't have to disclose to anyone that was going to support them when the BRCA patents expired in a few years anyway.

"[I]ntellectual humility"? -- I would not be so inclined to tip my hat. "[U]nable to affirm those details on my own knowledge or even my own belief[,]" implies that he may not "believe" in genes. Intellectually inert would be closer to the truth.

Are primers and probes now ineligible?

Shrivan,

Please read carefully the full the statement you quoted from my comment: that "isolated" chemical molecule needs to be a "difference in kind, not degree." Merely claiming the "isolate" molecule isn't enough; that "isolated" molecule has to be truly "different in kind" (e.g., properties) which Myriad's claimed "isolated" DNA sequence was deemed not to be.

I did read carefully what you wrote, EG. You wrote:

"I realize that what Thomas' opinion requires in terms of defining that "chemical molecule" is odd for the molecular biology world, but we can cope and have done so in the past."

First, there is nothing "odd" about defining molecules chemically in the "molecular biology world." I do that for my clients routinely, in almost every case. What is a sequence listing if not a listing of chemical structures? Second, you seemed to be suggesting by reference to "Breyer's jab" that Thomas had a problem with the way the claims were drafted and not with the subject matter covered by the claims. If you weren't suggesting that, whatever point you were making is lost on me.

"Myriad’s claimed “isolated” DNA sequences didn’t look enough like a chemical molecule divorced from the native DNA"

That's not true. The Court recognized that Myriad's claimed sequences were "divorced" from the native DNA and they said so. They admitted (rightly or wrongly) that Myriad's claims did not cover natural sequences.

But then the Court simply decided that a DNA composition that *could be made* (regardless of how it was actually made) by taking a naturally occuring DNA and chopping a piece out of it was not an "invention" under 101. More specifically, each of the individual pieces themselves could not be patented ... unless, apparently, a tiny modification is made to a piece. Then suddenly it's okay. Because it's "different in kind"? If that's the Court's reasoning, then I have no idea what "different in kind" means. Does the phrase ever appear in the decision?

" reads as being an assertion by Myriad that its invention was the identification of the location of the BRCA genes and the association of mutations with increased breast cancer risk. "

That isn't really a "problem" since they did assert it at oral arguments straight up.

Perhaps, as I have argued, a synthesized natural product is not, in itself, inventive because it is not the product of man's design and intention? This seems to me to be a reasonable ontology of the current state of the law. In order to not fall in the excluded categories, something must be both the product of man's intention and design. Like O2, the morphology is never the product of man's design, as the morphology of synthesized natural molecules is never the product of man's design. There is an ontology (thank you philosophy) at work in this decision.

Shrivan,

Yes, what Thomas' opinion essentially said was that Myriad's "isolated" DNA sequence, as claimed, wasn't "different in kind" in view of the "product of nature" doctrine. First, page 1 of the slip opinion says is that "naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated." That's straight out of the "product of nature" doctrine that "differences in degree" (i.e., simply isolation of the segment from the DNA without) don't count for the purposes of patent-eligibility. (As the slip opinion says, "Myriad did not create anything").

Second, the Chakrabarty and Funk Brothers cases that are cited and relied upon in the main body of Thomas' opinion both deal with "product of nature" doctrine; that's made explicitly clear at page 11 of the slip opinion with regard to Chakrabarty. As page 12 of the slip opinion states, the Chakrabarty bacterium was new “with markedly different characteristics from any found in nature"("markedly different" meaning a "difference in kind"). By contrast, the claimed mixture of naturally occurring strains of bacteria in Funk Brothers wasn't patent-eligible because the patent holder did not alter the bacteria in any way "because the patent holder did not alter the bacteria in any way" ("did not alter" meant that the mixture, at most, was a "difference in degree").

As far as our debate about defining Myriad's as a "chemical molecule," I probably wasn't clear enough in expressing the key point in Thomas' opinion addressing that issue. It's more than simply expressing the isolated DNA sequence as a chemical molecule. As page 14 of the slip opinion says, Myriad's claims do not "rely in any way on the chemical changes that result from the isolation of a particular section of DNA." In other words, how Myriad's "isolated" DNA sequence was different in terms of utility, chemical properties, etc., from simply the snipped segment from the native DNA nowhere appears in that claim. And that quote from page 14 of the slip opinion is also consistent with the "product of nature" doctrine requiring a "difference in kind, rather than degree."

"a synthesized natural product is not, in itself, inventive because it is not the product of man's design and intention."

David K.

"Synthesized natural product"? "Synthesized" and "natural" don't go together. Talk about a curious ontology.

Also how the Supreme Court ruled in this case has nothing to doabout "philosophy," or about "preventing the patenting of human genes," and everything to do about applying the legal "product of nature" doctrine. We in the patent world can deal with that. See my comments upthread to Shrivan.

Also, what Myriad claimed didn't mean they owned you, me or anyone else. Oh by the way, wasn't it interesting that the claimed cDNA was deemed patent-eligible by the Supreme Court.

David,

You are correct when it comes to product of nature being off-limits in spite of the arguments of 'philosophy' - not because of them.

Be aware of the limitations you set for yourself with your desire to delve into metaphysics. You risk being too clever by half.

Shrivan,

By the way, thanks for the helpful dialogue. Based on what you said, I needed to sharpen my thoughts on what the Myriad decision means.

EG,I never claimed that the genes being "human" was ever relevant. All my arguments were founded on the product of nature exception (see, e.g. the actual text of my book), and I never claimed cDNA wasn't eligible in my book, though I later decided it may not be. I'm comfortable with the compromise, actually, and it fits my argument that to be eligible and inventive, a composition of matter should be both the product of man's intention and design. And to claim that there is no "philosophy" at work is to be incredibly ignorant about what philosophy is. Philosophy is the meta-science, according to the philosophers I bear the most affinity to. It as not somehow divorced from everything else.

And finally, I never claimed anyone owned anyone, that was a provocative title, identical to one used in Scientific American a few years prior on the identical topic. I explicitly denied anyone owned anyone as a result of gene patents, again in the text of the actual book. Doubt me, I'll send you a PDF to pore over if you'd like. Or an autographed hardcopy if you prefer. ;)

And one way to reconcile the curious ontology of "synthesized natural products" is to see that what matters in determining whether a product is natural or not is its state as a continuant: its morphology, which is the product of nature, not man's invention. The process of synthesis of that continuant is a man-made occurrent, but a coherent ontology cannot conflate continuants and occurrents. The thing must not be confused with the act of making the thing.

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