Association for Molecular Pathology v. Myriad Genetics, Inc. (2013)

By Kevin E. Noonan --

The Supreme Court rendered its opinion in Association for Molecular Pathology v. Myriad Genetics, Inc. ("the Myriad case"), and in many ways it was anticlimactic:  the Court adopted the Department of Justice's position (thankfully, sans "magic microscope") by deciding that cDNA was patent eligible but genomic DNA (and fragments thereof including oligonucleotides) was not.  While the biotechnology industry avoided a categorical ban on patenting DNA (which was the goal of the ACLU) or, worse, on "products of nature" no matter how altered, the Court's carefully focused opinion contains enough worrisome dicta to permit plaintiffs to declare victory even though the Court expressly disclaimed any decision on genetic diagnostic methods (which, after all, was the purported basis for the litigation in the first place).

The claims at issue are the following (remembering that claims, not inventions, are the basis for determining compliance with the patent statute):

1.  An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.

5.  An isolated DNA having at least 15 nucleotides of the DNA of claim 1.

6.  An isolated DNA having at least 15 nucleotides of the DNA of claim 2.

7.  An isolated DNA selected from the group consisting of:
    (a)  a DNA having the nucleotide sequence set forth in SEQ ID NO:1 having T at nucleotide position 4056;
    (b)  a DNA having the nucleotide sequence set forth in SEQ ID NO:1 having an extra C at nucleotide position 5385;
    (c)  a DNA having the nucleotide sequence set forth in SEQ ID NO: 1 having G at nucleotide position 5443; and, (d) a DNA having the nucleotide sequence set forth in SEQ ID NO:1 having 11 base pairs at nucleotide positions 189-199 deleted.

U.S. Patent No. 5,747,282;

1.  An isolated DNA molecule coding for a BRCA2 polypeptide, said DNA molecule comprising a nucleic acid sequence encoding the amino acid sequence set forth in SEQ ID NO:2.

6.  An isolated DNA molecule coding for a mutated form of the BRCA2 polypeptide set forth in SEQ ID NO:2, wherein said mutated form of the BRCA2 polypeptide is associated with susceptibility to cancer.

7.  The isolated DNA molecule of claim 6, wherein the DNA molecule comprises a mutated nucleotide sequence set forth in SEQ ID NO:1.

U.S. Patent No. 5,837,492 (recombinant vector and transformed recombinant cell claims are not named);

1.  An isolated DNA comprising an altered BRCA1 DNA having at least one of the alterations set forth in Tables 12A, 14, 18 or 19 with the proviso that the alteration is not a deletion of four nucleotides corresponding to base numbers 4184-4187 in SEQ. ID. NO:1.

U.S. Patent No. 5,693,473 (nucleic acid probe claims are not recited in the complaint).

The Court's unanimous opinion by Justice Thomas, with a concurring opinion by Justice Scalia, began with a recitation of the "facts" as established below; while important this portion of the opinion raises as many issues as it purports to resolve and will be addressed below.  More important to the issue before the Court (and the answer to the Question Presented, "Are human genes patentable?") is the legal rationale Justice Thomas sets forth based on these facts.  The Court in a footnote also puts the standing issue to bed, stating that the only plaintiff found by the Federal Circuit to have standing, Dr. Harry Ostrer, "has alleged sufficient facts 'under all the circumstances, [to] show that there is a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment'" under the Court's MedImmune v. Genentech decision.

The opinion begins in the canonical way, reciting the Constitutional basis of the patent grant, Congress' decision to define patent eligibility broadly, and the Court's imposition of limitations on this breadth (wherein laws of nature, natural phenomena and abstract ideas are excluded).  The opinion then provides the rationale for these exceptions, relying heavily on its recent opinion in Mayo v. Prometheus.  These include that such "basic tools of scientific and technological work" should "lie beyond the domain of patent protection" because if they did not, "there would be considerable danger that the grant of patents would 'tie up' the use of such tools and thereby 'inhibit future innovation premised upon them.'"  In so basing its decision on this principle in this case, the Court ignores the extensive evidence that, with regard to the BRCA genes and Myriad's patents, there has not been such a tying up of isolated BRCA DNA (including evidence of more than 10,000 scientific research reports in peer-reviewed journals regarding research on BRCA).  The Court's apprehension of a "tying up" problem does not exist in this case, regardless of whether it is ever a realistic deleterious outcome of patenting.

The Court is careful to ensure that its decision is not interpreted as being a categorical ban on "naturally occurring things," reminding us that "all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas," and "too broad an interpretation of this exclusionary principle could eviscerate patent law," a concept also taken from its Mayo decision.  The decision solidifies the Court's precept that patenting must achieve a "balance" between too little patenting or too much patenting, either of which the Court believes can harm innovation and thus not "promote the Progress . . . of the useful Arts."

Turning to Myriad's claims, the Court terms its Diamond v. Chakrabarty decision as being "central" to the inquiry of whether claims to isolated DNA are patent-eligible.  Comparing Myriad's claims to this standard the Court opines that "Myriad did not create anything" (the limitations of this statement are discussed below).  The Court then announces that "[g]roundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry"; the only saving grace in this statement is the qualifier "by itself," which prevents the sentence from being interpreted to mean that "[g]roundbreaking, innovative, or even brilliant discovery" per se would categorically be outside the scope of patenting (an interpretation that, inter alia, would be contrary to the express language of the statute).  Support for this statement is, not surprisingly, Funk Bros. Seed Co. v. Kalo Inoculant Co., which the opinion describes as a case involving claims to a "mixture of naturally occurring strains of bacteria that helped leguminous plants take nitrogen from the air and fix it in the soil."  The basis for the Court's decision that these claims were unpatentable is that "the composition was not patent eligible because the patent holder did not alter the bacteria in any way," and the Court analogizes the "discovery" that certain bacteria could be combined with Myriad's "discovery" of the "location of the BRCA1 and BRCA2 genes in the chromosomes."  This analysis ignores several distinctions between these inventions, including (as set forth in the opinion) that the existence of the bacteria in Funk Bros. was known, and that the bacteria had been isolated and used by farmers to "inoculate" their crops to improve the level of nitrogen fixation in the soil.  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."

Part of the problem, however, is the specification of the '282 patent and the way it can be (and has been) misinterpreted; the Court calls out portions of the specification that it 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.  The Court interprets this disclosure as "simply detail[ing] the 'iterative process' of discovery by which Myriad narrowed the possible locations for the gene sequences that it sought," and then ascribes to Myriad an attempt to "import these extensive research efforts into the §101 patent-eligibility inquiry" (finding these efforts to be unavailing).  The Court also does not credit isolation of the BRCA genes as being anything more than cleaving chemical bonds of the BRCA gene from the other portions of the chromosome.  In a portion of the opinion that seemingly fails to recognize how the chemical compound that is an isolated DNA molecule is claimed in English words, the opinion states that "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 genes."  It is unlikely that the Court is implying that the claim should have used chemical structures to identify the isolated DNA or that such a representation would have satisfied the 101 inquiry.  But by the plain meaning of the language in this sentence of the opinion, the Court ignores the well-recognized convention that a claim to "an isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2" is understood to be a representation of the chemical composition that depends on the chemical changes that differentiate the isolated DNA from the DNA as it exists in the chromosome.  The opinion also prompts the conclusion that the ACLU's position that "DNA is information" was successful, despite the fact that DNA sequence information is not patented.  This conclusion is reinforced by the next sentence in the opinion, that:

If the patents depended upon the creation of a unique molecule, then a would-be infringer could arguably avoid at least Myriad's patent claims on entire genes (such as claims 1 and 2 of the '282 patent) by isolating a DNA sequence that included both the BRCA1 or BRCA2 gene and one additional nucleotide pair.  Such a molecule would not be chemically identical to the molecule "invented" by Myriad.  But Myriad obviously would resist that outcome because its claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule.

The Justices have passed through the looking glass to have come to these conclusions based on the evidence presented by Myriad and its amici.

The Court dealt easily and summarily with the policy question of whether calling into question thousands of patents granted by the U.S. Patent and Trademark Office would deny the Executive the deference it deserves as a co-equal branch of the Federal government.  While this is not surprising from a Court where one Justice believes the PTO is "patent-happy," the position taken by the Obama administration's Justice Department "weigh[ed] against deferring to the PTO's determination" that isolated DNA claims encompassing genomic DNA were eligible for patenting.  Insofar as reliance interests are relevant, the Court directs Myriad to Congress in a footnote.

The Court came to the same conclusion of patent-ineligibility for claims to oligonucleotides, despite their synthetic nature and based on the identity of the sequence of these (albeit single-stranded) molecules with the corresponding sequence in chromosomal DNA.  On the other hand, the Court found that claims to cDNA "do[] not present the same obstacles to patentability as naturally occurring, isolated DNA segments," based on the "creation" by man of a "non-naturally occurring" DNA molecule.  The Court rejected the sequence-based objections argued by Petitioners, stating that while "[t]he nucleotide sequence of cDNA is dictated by nature, not by the lab technician," "the lab technician unquestionably creates something new when cDNA is made."  The only exception would be for "very short series (sic) of DNA [having] no intervening introns to remove when creating cDNA" which "may be indistinguishable from natural DNA."  In another footnote, the Court rejects the argument that the existence of pseudogenes (reverse transcription copies of genes reintroduced into human chromosomes) requires cDNA to be treated as a natural product like genomic DNA, saying that "[t]he possibility that an unusual and rare phenomenon might randomly create a molecule similar to one created synthetically through human ingenuity does not render a composition of matter nonpatentable" (emphasis in opinion).

The Court in its recent patent decisions has been careful to craft them to the issue at hand and to avoid broad, precedential decisions that could implicate future technology in unpredictable ways.  Justice Thomas's opinion does that here, in the final section of the opinion:

First, there are no method claims before this Court.  Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent.

[Second], this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes.  Judge Bryson aptly noted that, "[a]s the first party with knowledge of the [BRCA1 and BRCA2] sequences, Myriad was in an excellent position to claim applications of that knowledge. Many of its unchallenged claims are limited to such applications."

Nor do we consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.  Scientific alteration of the genetic code presents a different inquiry, and we express no opinion about the application of §101 to such endeavors.

And the Court set forth succinctly its only holding:

We merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material.

There are some troubling aspects to the decision, not the least of which is the failure of the Court to recognize what in fact was claimed.  The Court's opinion begins with the assertion that Myriad "discovered the precise location and sequence of two human genes, mutations of which can substantially increase the risks of breast and ovarian cancer.  Myriad obtained a number of patents based upon its discovery."  The Court also opines that:

It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes.  The location and order of the nucleotides existed in nature before Myriad found them.  Nor did Myriad create or alter the genetic structure of DNA.  Instead, Myriad's principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13.  The question is whether this renders the genes patentable.

Of course, that is not how the claims at issue read nor how those claims would be construed in an infringement action.  This failure is significant because it influences the Court's appreciation of the scope of Myriad's claims and their preclusive effects.  Indeed, the information disclosed by Myriad, including the chromosomal location of the BRCA genes, their genetic sequence, and the residues that when mutated enable an increased risk of developing breast and ovarian cancer do not fall within the scope of the claims and using this information does not infringe the composition of matter claims at issue.  Accordingly, the Court from the outset approaches the question of whether these claims do not promote the progress of the useful arts from a false premise, which colors and distorts the remainder of the decision.

The Court also goes astray in stating that "isolation is necessary to conduct genetic testing" when discussing the preclusive effect vel non of Myriad's isolated DNA claims.  Petitioners labored mightily to conflate the effects of the genetic diagnostic method claims they challenged and the isolated DNA claims, and they were clearly successful in convincing the Court that these claims could be asserted against competitors practicing Myriad's claimed methods.  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.  Once these positions were known, isolation was no longer necessary.

It is important to recognize what this opinion does not do:  it 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.  Those cases are to come (and those inventions will be the subject of future posts).  Despite the glaring scientific and technological weaknesses of the Court's opinion, it does not (fortunately) invalidate thousands of existing patents or sufficiently upset the "settled expectations" of the biotechnology community.  But the opinion is another data point on a trend of the Court imposing its opinion of what is patent eligible on grounds that come perilously close to "we know it when we see it," a standard that works even less well for patenting than it did a generation ago for pornography.

Finally, Justice Scalia's concurrence is remarkable for its intellectual humility and honesty; the Justice refuses to join the portions of the opinion "going into fine details of molecular biology," the Justice stating that he is "unable to affirm those details on my own knowledge or even my own belief."  Would that the remainder of the Court had come to this realization.

Comments

[EG]

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.

[DCox]

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?

[Patent Pallooza]

"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.

[Shrivan]

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.

[Shrivan]

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).

[Shrivan]

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.

[Jonathan]

@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.

[RVC]

"[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.

[ap]

Are primers and probes now ineligible?

[EG]

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.

[Shrivan]

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?

[6]

" 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.

[David Koepsell]

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.

[EG]

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."

[EG]

"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.

[Skeptical]

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.

[EG]

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.

[David Koepsell]

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.

[David Koepsell]

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. ;)

[David Koepsell]

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.