In our Fourth Annual Patent Law Moot Court here at Mizzou Law, the students are grappling another Myriad lawsuit asserting its BRCA1 gene patents. The question presented is whether the cDNA claims that the Supreme Court suggested are patent eligible could be voided as improperly claiming an abstract idea.
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Order: Presently before the Court is Defendant’s motion to dismiss under Federal Rule of Civil Procedure 12(b)(6). In its oral motion, Defendants’ asserted that Claims 2 and 6 of Myriad’s U.S. Patent No. 5,747,282 are directed toward unpatentable subject matter under 35 U.S.C. § 101 as improperly claiming an abstract idea.[1] Plaintiffs disagreed and further responded that the issue had been foreclosed in its favor by the Supreme Court’s recent decision regarding the claim and patent at issue and that the issue was not the proper subject of a motion to dismiss.
Parties will brief the issue and particularly address the following:
- Whether the asserted claims of the patent-in-suit are directed toward an unpatentable abstract idea in violation of the requirements of 35 U.S.C. § 101.
- The direct impact of Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S.Ct. 2107 (2013) on this motion.
- Whether a challenge to subject matter eligibility is the proper subject of a motion to dismiss.
Briefs will be submitted simultaneously by 5:00 pm on April 6, 2015 and will otherwise follow the requirements set out in Local Rule 4.3. The Court will entertain oral arguments on April 10, 2015 at 3:30 pm. Each party will be given up to 20 minutes to present its case.
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[1] The parties have stipulated that Claim 2 is directed toward a cDNA version of the naturally occurring BRCA gene and that Claim 6 is a fragment of the cDNA sequence defined by Claim 2.
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Should be interesting. How would you argue the case for/against?
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SPONSOR US: I’m looking for a sponsor for the event so that I can give the winner a cash prize. A tax-deductable donation of $5,000 will fund the system for the next four years and get your name mentioned in Patently-O each year!
Dennis
Interesting that Mizzou does this. AIPLA administers a patent-focused moot court competition at the same time. link to aipla.org
Was AIPLA’s moot court considered inferior or insufficient for some reason? Or is there especially high demand for more mooting at Mizzou?
Dennis, I am troubled by the underlying premise of “The question presented is whether the cDNA claims that the Supreme Court suggested are patent eligible could be voided as improperly claiming an abstract idea.” and “Whether the asserted claims of the patent-in-suit are directed toward an unpatentable abstract idea in violation of the requirements of 35 U.S.C. § 101.”
An analogous question would be “Whether claims to a CD (which is nothing but a combination of many different molecules) containing data are patent eligible”.
The incorrect premise is that a single chemical molecule (cDNA or DNA) should be treated differently than the CD containing data. Where does such a premise even come from?
Good intent versus poor content seems to be the main problem with the Court’s decision in Molecular v Myriad. While trying to decide on patentability, they relied upon an incorrect analysis that eradicated the clear boundaries between 101, 102 and 103.
The Court incorrectly concluded that the isolated DNA of claim 1 was subject matter ineligible under 101 rather than being unpatentable under 103. I believe it can be fairly argued that almost any DNA that is merely isolated is obvious over the product of nature but that does not mean that the isolated DNA is subject matter ineligible.
The Court correctly recognized the existence of structural differences between the natural and isolated DNA; however, the Court erroneously concluded that it was “not different enough”. Having admitted that the natural and isolated DNA are structurally different, the Court should have acknowledged subject matter eligibility (the isolated DNA is/was a “manufacture”) and should instead have concluded that the isolated DNA was unpatentable under 103, because although it was not a product of nature (thus it was subject matter eligible under 101) and it was different (thus not anticipated under 102) from the natural product, it was not different enough (obvious under 103) from the natural DNA, because isolated DNA is well known and the isolated BRCA1 gene is merely another isolated DNA. So even though the Court likely correctly concluded that the isolated DNA was unpatentable, it incorrectly concluded that it was subject matter ineligible. Had the Court used this reasoning, it would have followed long-standing precedential case law and would not have obfuscated patent law by improperly relying upon obviousness considerations in a subject matter eligibility analysis.
Any DNA isolated as a direct result of human effort is necessarily a “manufacture” and not a “product of nature” because it is structurally “different” as acknowledged by the Court. The question of “different enough” is a 103 analysis concerning obviousness and not a 101 analysis concerning eligibility. The isolated DNA is thus subject matter eligible (101) even though it may well be unpatentable (102, 103).
Rick, if the chemical sequence claimed is found identically in nature, is not the claim claiming a product of nature?
And as a corollary, if the claim is not claiming a product of nature, then the claim is not claiming a product of nature.
And, might I add, that if something is claimed functionally, it is construed to cover the “corresponding structure.” See, Westinghouse v. Boyden Power Brake in connection with claim 2.
Apologies in advance for the lengthy response.
Before reading any further, please remember that there are numerous very different independent claims across numerous patents that Myriad held/holds, so the comments below are directed solely to those claims that merely claim the isolated DNA.
The isolated DNA is structurally different than the DNA as it exists in nature. Although they both have the same “primary structure” (the chemical sequence claimed), the isolated DNA is missing additional nucleotides at the front and tail ends. This structural difference was recognized by several of the Federal Circuit judges and even the Sup. Crt. Below is some of the relevant text of the Fed. Circ. opinion as cited in the Sup. Crt. opinion.
In brief, Lourie was correct in his determination of subject matter eligibility as he recognized the isolate DNA as a manufacture that is structurally different in isolated form than in nature.
“Lourie and Moore agreed that Myriad’s claims were patent
eligible under §101 but disagreed on the rationale. Judge
Lourie relied on the fact that the entire DNA molecule is
held together by chemical bonds and that the covalent
bonds at both ends of the segment must be severed in
order to isolate segments of DNA. This process technically
creates new molecules with unique chemical compositions.
See id., at 1328 (“Isolated DNA . . . is a free-standing
portion of a larger, natural DNA molecule. Isolated DNA
has been cleaved (i.e., had covalent bonds in its backbone
chemically severed) or synthesized to consist of just a
fraction of a naturally occurring DNA molecule”). Judge
Lourie found this chemical alteration to be dispositive,
because isolating a particular strand of DNA creates
a nonnaturally occurring molecule, even though the chemical alteration does not change the informationtransmitting
quality of the DNA. See id., at 1330 (“The
claimed isolated DNA molecules are distinct from their
natural existence as portions of larger entities, and their
informational content is irrelevant to that fact. We recognize
that biologists may think of molecules in terms of
their uses, but genes are in fact materials having a chemical
nature”). Accordingly, he rejected petitioners’ argument
that isolated DNA was ineligible for patent protection
as a product of nature.
Moore was partially incorrect in that although she acknowledged the structural differences between the isolated DNA and the DNA in nature, she argued it was not “patentable” subject matter which led the conversation away from “eligible” subject matter.
“Judge Moore concurred in part but did not rely exclusively
on Judge Lourie’s conclusion that chemically breaking
covalent bonds was sufficient to render isolated DNA
patent eligible. Id., at 1341 (“To the extent the majority
rests its conclusion on the chemical differences between
[naturally occurring] and isolated DNA (breaking the
covalent bonds), I cannot agree that this is sufficient to
hold that the claims to human genes are directed to patentable
subject matter”)…
Bryson was completely incorrect in that he regarded structural differences between isolated DNA and natural DNA as insignificant and went so far as to argue ““[T]here is no magic
to a chemical bond that requires us to recognize a new product
when a chemical bond is created or broken.” Id.,
at 1351.” His analysis is the same as saying that a tankful of carbon dioxide and water is the same as a tankful of glucose. Finally, he concluded that “genetic structural similarity dwarfs the significance of the structural differences between isolated DNA and
naturally occurring DNA, especially where the structural
differences are merely ancillary to the breaking of covalent
bonds, a process that is itself not inventive.” His conclusion is the same as saying a CD and magnetic tape containing the same information are the same. Moreover, he has completely stepped away from an eligibility analysis and relied solely upon an obviousness (differences) analysis.
“Finally, Judge Bryson concurred in part and dissented
in part, concluding that isolated DNA is not patent eligible.
As an initial matter, he emphasized that the breaking
of chemical bonds was not dispositive: “[T]here is no magic
to a chemical bond that requires us to recognize a new product
when a chemical bond is created or broken.” Id.,
at 1351. Instead, he relied on the fact that “[t]he nucleotide
sequences of the claimed molecules are the same as
the nucleotide sequences found in naturally occurring
human genes.” Id., at 1355. Judge Bryson then concluded
that genetic “structural similarity dwarfs the significance of the structural differences between isolated DNA and
naturally occurring DNA, especially where the structural
differences are merely ancillary to the breaking of covalent
bonds, a process that is itself not inventive.” Ibid…
Moving now to the Sup. Crt’s decision, the Court stated and asked:
“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.”
That question simply has nothing to do with subject matter eligibility and everything to do with obviousness.
The Court then correctly characterized Chakrabarty (bacterium as a nonnaturally occurring manufacture or composition of matter) but then stated, “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.”
The Court incorrectly relied upon the obviousness of the act of isolation in determining patentability rather than on the structural differences in determining subject matter eligibility.
The Court then relied upon Funk Brothers (another incorrect 101 decision by the Sup. Crt. regarding a nonnaturally occurring mixture of bacteria) and argued “The Court held that the composition
was not patent eligible because the patent holder did not
alter the bacteria in any way. Id., at 132 (“There is no
way in which we could call [the bacteria mixture a product
of invention] unless we borrowed invention from the discovery
of the natural principle itself ”). His patent claim
thus fell squarely within the law of nature exception. So
do Myriad’s. Myriad found the location of the BRCA1 and
BRCA2 genes, but that discovery, by itself, does not render
the BRCA genes “new . . . composition[s] of matter,” §101,
that are patent eligible.”
There is no reason that Funk Brothers should have been required or even motivated to alter the bacteria because doing so might very well have changed the desired different abilities of nitrogen fixation. The simple fact is that the mixture of bacteria in Funk Brothers did not exist in nature and was the product of human intervention so the Court should have recognized it as subject matter eligible. There simply was no issue regarding a “natural principle”(or law of nature exception) in Funk Brothers until the Court created it.
In the most relevant part of its analysis in Myriad, the Court states, “Nor are Myriad’s claims saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule. 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. 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.”
THIS IS VERY IMPORTANT. The Court correctly acknowledged the structural differences between the isolated and natural DNA and argued the claims were nonetheless problematic as not focusing on those structural differences and instead focusing on the information contained within.
So, had the relevant claims been drafted to specify the structural differences between the isolated and natural product, we would likely not have been left with the problematic decision we now have.
You know, Rick, I thought the Supreme Court was going to come down on the side of eligibility precisely because the structure claimed was different from that found in nature – exactly as Judge Lourie explained in his opinion. But as we know, the portion of the composition that generated the protein was the sequence, and that was found in nature.
Had the claim been to the precise structure of the isolated composition, I think the Supreme Court would have found eligibility. But because Myriad claimed the structure that generated the protein, and that structure was identically found in nature, that was enough.
The bottom line is this, they treated the following claim
1. Isolated DNA structure that generates protein X;
as if it were claiming
2. DNA structure that generates protein X.
Why the equivalence? Because, claims having mixtures of the eligible with the ineligible, the invention must be in the eligible. Since the isolation process was conventional, it could not serve to distinguish the claim to the novel DNA structure.
How lovely. The supreme court says the sky is purple, so now law schools play along and pretend that this is so.
Myriad was premised on several fallacies. Rather than indoctrinating students to perpetuate a myth, law schools would do well to instruct them in the error of the court’s ways and to explain how that error can be corrected: through legislation, or by convincing the court to reconsider and to reverse itself. Admittedly, both are long-shots, and neither is going to occur in the near future. But sometime in the future, nine of today’s law students will be sitting as supreme court judges. They should be trained to correct their predecessors’ mistakes, not to perpetuate them.
The law schools are now teaching new speak. The world is getting stranger and stranger.
How about a moot court that asks the question: what in the world does abstract mean to the SCOTUS? Or, is the SCOTUS qualified to render opinions for any issue that involves science?
Dennis, simple.
The SC in Myriad held DNA was not a “new” composition, where newness was in the 101 sense as opposed to being in the 102/103 sense. 102 asks whether something is known. 103 asks whether something is obvious over something known. 101 newness asks whether something exists in nature regardless of whether it is known or unknown.
In contrast, cDNA was new in the 101 sense. Whether cDNA is obvious over DNA is irrelevant to 101 newness.
Abstract means non statutory: 1) something not within the four classes, or 2) something that is, but is claimed at the level of an idea.
As to 1, the most common examples of stuff not within thee four claims includes information and its processing.
As to 2), stuff claimed at a high level of abstraction includse the oft-cited Rubber Tip pencil case where an old and conventional piece of rubber, known to stick onto objects, was claimed “for use” as the tip of a pencil. No claim to the actual combination was presented, nor was any specific configuration of rubber for the tip. What was claimed was a disembodied concept — an idea.
cNDA is a composition, and, as such, not merely an idea. cDNA is not abstract.
Dennis, I am having a problem even understanding why you are asking the question?
Ned,
Maybe he wants you to realize that your view of Alice is critically flawed in that with both stipulation by both parties that the claim met the statutory category aspect, your IMHO-Ned law as stated here cannot be correct and that you need to realize exactly what the Supreme Court did with its (unlimited) “Gist/Abstract” sword.
To this day, you seem to have been unable to grasp what is actually going on.
Anon, I am not going to disagree that the Supreme Court cases lack clarity.
Steven’s concurrence in Bilski is the closed the Supreme Court ever got to simply following Hotel Security.
You do realize that Stevens was wrong in his dissent dressed as a concurrence and that he lost his slated position to write the majority opinion because of it, right?
You do realize further that this position has lost ground in the Supreme Court (the 3, the new 4, is still not 5 line that you seem to have trouble grasping), right?
Ned, it is points like these that you seem simply unable (or unwilling) to acknowledge that greatly reduces any hope you have for establishing credibility.
Ned. The important feature of DNA is the information carried by the genetic code.
Thanks.
I am not going to argue that point here, but it will be interesting to see how your students address it.
That’s the gist of it….
(literally)
We have a molecule that is not naturally occurring and that is claimed structurally in terms that are sufficiently definite to distinguish it from other molecules. Seems like a straightforward application of Amgen and Fiers with a sprinkle of Myriad (cDNA is patentable).
If I represented the plaintiff, I wouldn’t be overly worried.
“Whether the asserted claims of the patent-in-suit are directed toward an unpatentable abstract idea in violation of the requirements of 35 U.S.C. § 101.
The direct impact of Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S.Ct. 2107 (2013) on this motion.
Whether a challenge to subject matter eligibility is the proper subject of a motion to dismiss.”
1. Nah not that I know of. They’re an actual composition of matter artificially created and specifically set forth iirc.
2. Seems like the supremes pretty much covered 101 as a whole in that case. It wasn’t just the “product of nature” prong of 101 they touched on. Especially since the DC below had ruled based on an abstraction iirc.
3. Idk about all that collateral estoppal or whatevez. But generally it seems like that might apply here if the supremes did claim 2 and 6 (I forget if they did or not).
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