By Kevin E. Noonan --
As we reported earlier today, the Federal Circuit, in a decision that substantially reiterates its prior opinion, determined in Association for Molecular Pathology v. U.S. Patent and Trademark Office that, the Supreme Court's decision in Mayo v. Prometheus notwithstanding, claims to isolated human DNA satisfy the requirements of 35 U.S.C. 101.
At the outset, it must be noted that each of Judge Lourie's majority opinion, Judge Moore's concurring opinion and Judge Bryson's opinion concurring in part and dissenting in part substantially tracks their earlier opinions, as discussed previously (summaries of the earlier opinions can be found here (Judge Lourie), here (Judge Moore), and here (Judge Bryson)). Accordingly, here the focus will be, as it must, on how the individual members of the panel addressed the Supreme Court's remand instruction to reconsider their opinion(s) in view of the Court's decision in Mayo v. Prometheus.
For Judge Lourie (and to some extent, Judge Moore), the answer to the question posed by the intervening Mayo decision is simple: that decision did not change the standards for assessing the patent eligibility for compositions of matter and manufactures as enunciated by the Court in Funk Bros. Seed Co. v. Kalo Inoculant Co. and Diamond v. Chakrabarty.
Judge Lourie's majority opinion is frank in this assessment, stating that "Mayo does not control the question of patent-eligibility of [] claims to compositions of matter, [that are] expressly authorized as suitable patent-eligible subject matter in § 101." For the majority, the claimed isolated DNA molecules are "not found in nature" and are "man-made, a product of human ingenuity." Like all compositions of matter, the claimed molecules are "prepared from products of nature" but that is not enough to render them patent-ineligible per se, according to the opinion:
All new chemical or biological molecules, whether made by synthesis or decomposition, are made from natural materials. For example, virtually every medicine utilized by today's medical practitioners, and every manufactured plastic product, is either synthesized from natural materials (most often petroleum fractions) or derived from natural plant materials. But, as such, they are different from natural materials, even if they are ultimately derived from them. The same is true of isolated DNA molecules.
The "primary framework" for assessing patent-eligibility of composition of matter claims remain "the Supreme Court's decisions in Chakrabarty and Funk Brothers" and "[w]hile Mayo and earlier decisions concerning method claim patentability provide valuable insights and illuminate broad, foundational principles" they do not alter the primacy of these earlier decisions, and in applying these decisions the majority opinion follows its earlier assessment of the patent-eligibility of the claimed DNA molecules.
Judge Lourie's opinion also sets out further grounds for overturning the District Court's decision rendering these claims invalid for being non-statutory subject matter. These include that the District Court "created a categorical rule excluding isolated genes from patent eligibility," something that the opinion considers contrary to the Supreme Court's mandate that such categorical rules not be imposed in deciding subject matter eligibility. The opinion cites Bilski v. Kappos (business methods) and Chakrabarty (living organisms) as cases where the Court has affirmatively rejected such per se rules of patent ineligibility. Isolated DNA "is not and should not be considered a special case for purposes of patent eligibility under existing law" says Judge Lourie, expressly rejecting the District Court's distinction that "DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature."
The opinion also notes that the question as embodied in that portion of the District Court's opinion and as argued by plaintiffs (that it may have an "unusual status as a chemical entity that conveys genetic information") does not permit courts to usurp the prerogative of Congress to address such policy questions, quoting Chief Justice Roberts in Nat'l Fed'n of Indep. Bus. v. Sebelius, 132 S. Ct. 2566, slip op. at 6 (2012) ("[W]e possess neither the expertise nor the prerogative to make policy judgments. Those decisions are entrusted to our Nation's elected leaders, who can be thrown out of office if the people disagree with them."). It is up to Congress to address this issue according to the opinion, which notes that Congress has in fact "enacted a comprehensive patent reform act during the pendency of this case."
Turning to the question of preemption (more properly, "undue" preemption) that concerned the Supreme Court in Mayo, which focused on its concern that permitting patents on particular subject matter would prevent use of that subject matter by others, the majority responds that "the answer to that concern is that permitting patents on isolated genes does not preempt a law of nature [because a] composition of matter is not a law of nature." The opinion also notes that "a limited preemption" is an inherent property of the patent right. The public benefit in granting that limited right to preempt is that "[w]hen the patent expires, the public is entitled to practice the invention of the patent." In this regard, Judge Lourie notes that "[t]he seven patents being challenged here all expire by December 18, 2015" and that "[a]ny preemption thus is limited, very limited in the case of the present patents."
The majority opinion also rejects the contention, by plaintiffs and certain amici (most notably the government) that "remand of this case for reconsideration in light of Mayo might suggest [] that the composition claims are mere reflections of a law of nature." Simply put, the opinion states that "they are not, any more than any product of man reflects and is consistent with a law of nature. Everything and everyone comes from nature, following its laws. But the compositions here are not natural products. They are the products of man, albeit following, as all materials do, laws of nature."
Turning to the method claims, the Court unanimously held that these claims are not patent-eligible under the Supreme Court's Mayo decision (just as they had previously ruled that the claims were not patent-eligible under the Bilski "machine or transformation" test). In doing so, the panel voiced its opinion that the Court's Mayo decision "made clear that such diagnostic methods in that case essentially claim natural laws that are not eligible for patent." The panel did not apply the Mayo reasoning here, however, because in its view "those method claims cannot stand" under their earlier, arguably more permissive standard for patent eligibility in view of the Mayo decision.
Finally, turning to Claim 20 the panel decided unanimously that this claim is patent eligible because it recites a transformed host cell that is not naturally-occurring, analogous to the bacteria claimed by Chakrabarty. This claim satisfies the Supreme Court's edict from Mayo that "to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words 'apply it'" because it utilizes this man-made cell. And important to the panel's unanimous decision is that "the claim does not cover all cells, all compounds, or all methods of determining the therapeutic effect of a compound" but "[r]ather [] is tied to specific host cells transformed with specific genes and grown in the presence or absence of a specific type of therapeutic" (emphasis in opinion).
The panel also unanimously reaffirmed its earlier decision that Dr. Harry Ostrer, alone among the plaintiffs had standing to bring a declaratory judgment action and thus that the District Court properly denied Myriad's motion to dismiss.
And in perhaps an indication that the panel believed these questions to be more frivolous than the seriousness of the questions presented would suggest, it awarded costs to Myriad.
In her concurring opinion, Judge Moore also asserts that "the Prometheus decision does not control the outcome in this case" but concedes that "it is nonetheless instructive regarding the scope of the law of nature exception" and she rejects Myriad's contention that "Prometheus is constrained to method [claims]," calling it "untenable." Regardless, she agrees with Judge Lourie that "Prometheus did not, however, overturn Funk Brothers or Chakrabarty," which she characterizes as "cases clearly more analogous to the one before us." And using this jurisprudential "framework" she arrives at the same conclusion as Judge Lourie, that the claimed isolated DNA molecules are patent eligible if they represent "a composition of matter with 'markedly different characteristics' from that found in nature with the potential for significant utility." With regard to utility, Judge Moore recognizes that "[t]he ability to use isolated DNA molecules as the basis for diagnostic genetic testing is clearly an 'enlargement of the range of . . . utility' as compared to nature," citing Funk Bros. Regarding the oligonucleotide claims, she distinguished the Supreme Court's rubrics from Mayo on the grounds that "the claims to short isolated strands of DNA are not directed to the relationship between the mutation and cancer, but rather to a new tool that can be used to determine if that relationship exists."
As she did in her previous concurring opinion, Judge Moore states that, "[i]f deciding this case on a blank canvas" she "might conclude that an isolated DNA sequence that includes most or all of a gene is not patentable subject matter," noting that "[t]he scope of the law of nature/manifestation of nature exception was certainly enlarged in Prometheus." However, as she opined previously she recognized here that this case is not decided on such a blank canvas, in view of the "expansive scope of patentable subject matter" authorized by Congress "for centuries." She also once again cites the "decades" of U.S. Patent and Trademark Office practice in granting patents on isolated DNA molecules and the "thousands of patents with claims to isolated DNA, and some unknown (but certainly large) number of patents to purified natural products or fragments thereof." Turning to an important and unaddressed concern underlying the "product of nature" argument espoused by plaintiffs and certain amici (once again, particularly the government), Judge Moore writes:
[P]urifying or isolating natural products has historically been exactly the kind of discovery protected by the patent statutes. There is a century-long history of affirming patent protection for isolated and purified biological products ranging from hormones to vitamins to proteins to antibiotics. These inventions must have seemed miraculous at the time, providing previously unknown therapeutic options to treat sickness. The fact that these molecules might have existed in nature did not foreclose patent protection in view of the extraordinary benefits accessible to man after isolation.
In view of this history, for Judge Moore "[w]e cannot, after decades of patents and judicial precedent, now call human DNA fruit from the poisonous tree, and punish those inquisitive enough to investigate, isolate, and patent it" regardless of whether there are "moral, ethical, or theological components" to the policy question of whether DNA molecules should be patented. Now as previously, Judge Moore believes that the patent eligibility of isolated DNA molecules "is a debate for Congress to resolve" and she once again is unwilling to "strip an entire industry of the property rights it has invested in, earned, and owned for decades unchallenged under the facts of this case."
As is the case with his judicial brethren, Judge Bryson substantially repeats his earlier opinion concurring in part and dissenting in part, parting company with the majority as to the patent eligibility of isolated genomic DNA molecules and oligonucleotides. Unlike the majority, Judge Bryson finds the Supreme Court's Mayo decision to be "instructive" although he also voices the opinion that the Mayo decision "does not decide this case." In analogy to the Court's requirement that there be something "inventive" added to the law of nature so that the claims add "enough" to be more than a mere statement of a natural law, Judge Bryson enunciates a requirement that "a patent involving a product of nature should have an inventive concept that involves more than merely incidental changes to the naturally occurring product." Here, the question for Judge Bryson is whether claims to a composition of matter "that is nearly identical to a product of nature" is "enough" for the applicant to have made an "inventive contribution" to the product of nature. On these grounds, Judge Bryson comes to the same conclusion as he has previously, joining the majority as to the cDNA claims but disagreeing that isolated genomic DNA or oligonucleotides are sufficiently "inventive" to be eligible for patenting. And as he has previously indicated, Judge Bryson is apparently convinced that because "[t]he informational content of the nucleotide sequences is the critical aspect of these molecules" the identity of the informational content of the claimed molecules and the molecules as they exist in nature is enough for Judge Bryson to conclude that these claims are not patent eligible.
In many ways, this decision reestablishes the status quo ante, and invites the Supreme Court to revisit its watershed decision on the expansive scope of patent eligibility, the Chakrabarty decision. Keeping in mind that Chakrabarty was decided by a vote of 5-4, this prospect, particularly in view of the (easily) perceived concerns and prejudices of the present Court, is disquieting. Perhaps that is why the introductory portion of the majority opinion took pains to announce what the case was "not" about:
Before reviewing the applicability of the Supreme Court's Mayo holding to the claims of the Myriad patents, however, it is important to state what this appeal is not about. It is not about whether individuals suspected of having an increased risk of developing breast cancer are entitled to a second opinion. Nor is it about whether the University of Utah, the owner of the instant patents, or Myriad, the exclusive licensee, has acted improperly in its licensing or enforcement policies with respect to the patents. The question is also not whether is it desirable for one company to hold a patent or license covering a test that may save people's lives, or for other companies to be excluded from the market encompassed by such a patent -- that is the basic right provided by a patent, i.e., to exclude others from practicing the patented subject matter. It is also not whether the claims at issue are novel or nonobvious or too broad. Those questions are not before us. It is solely whether the claims to isolated BRCA DNA, to methods for comparing DNA sequences, and to a process for screening potential cancer therapeutics meet the threshold test for patent-eligible subject matter under 35 U.S.C. § 101 in light of various Supreme Court holdings, particularly including Mayo. The issue is patent eligibility, not patentability.
* * *
Accordingly, we once again conclude that claims 1, 2, 5, 6, and 7 of the '282 patent; claims 1, 6, and 7 of the '492 patent; and claim 1 of the '473 patent directed to isolated DNA molecules recite patent-eligible subject matter under § 101. Mayo does not change that result. In so doing, we reiterate that the issue before us is patent eligibility, not patentability, about which we express no opinion.
Perhaps the Supreme Court will take these sentiments into consideration if (realistically, when) it finally hears this case.
Association for Molecular Pathology v. United States Patent and Trademark Office (Fed. Cir. 2012)
Panel: Circuit Judges Lourie, Bryson, and Moore
Opinion by Circuit Judge Lourie; concurring in part opinion by Circuit Judge Moore; concurring in part and dissenting in part opinion by Circuit Judge Bryson
"keeping in mind that Chakrabarty was decided by a vote of 5-4, this prospect, particularly in view of the (easily) perceived concerns and prejudices of the present Court, is disquieting."
Your disquiet is my content. But I don't think they need to undo Chakrabarty, merely clarify it. As I've argued before, sometimes man makes natural products (my synthetic O2 example), and Chakrabarty stands for the exceptions of: abstract ideas, natural phenomena, and laws of nature as well as the dictum that "everything under the sun, made by man" should be eligible. Chakrabarty's invention met the criteria I claim matter, the presence both of man's intention and design in the product. Neither O2 if synthesized, nor the genes at issue in Myriad meet those criteria. As I argue in my latest post, Bryson's reasoning approaches this formulation, and I think it will rule the day in the Supreme Court too. We shall see.
Posted by: David Koepsell | August 17, 2012 at 01:42 AM
Dr. Noonan,
Do you think the attempt at innoculation of "Perhaps that is why the introductory portion of the majority opinion took pains to announce what the case was 'not' about" will be effective in shepparding what the Supreme Court says?
I am skeptical.
Posted by: Skeptical | August 17, 2012 at 06:24 AM
"but rather to a new tool that can be used to determine if that relationship exists.""
A new tool or the only "new" tool J. Moore?
Posted by: 6 | August 19, 2012 at 09:22 PM
"Keeping in mind that Chakrabarty was decided by a vote of 5-4, this prospect, particularly in view of the (easily) perceived concerns and prejudices of the present Court, is disquieting. "
As usual Kev, even though you are no doubt against a finding of invalidity on preemption grounds, you are at least perceptive enough to know when it is coming.
Posted by: 6 | August 19, 2012 at 09:30 PM
One other thing to keep in mind David is what has Congress said, explicitly or implicitly, about the USPTO's policy of approving the award of patents on isolated gene sequence for at least a decade. As was pointed out by Judge Lourie in the original AMP decision (see slip opinion at pages 29-30), Congress included language in its 2004 appropriation for the USPTO affirming the USPTO's policy of not granting patents on human organisms. At the same time, Congress also stated that this appropriation language didn't change the USPTO policy of granting patents on "genes, stem cells, or similar inventions."
More significantly, Judge Lourie said the following at page 50 of the slip opinion in the AMP remand:
"Congress is presumed to have been aware of the issue, having enacted a comprehensive patent reform act [i.e., the America Invents Act] during the pendency of this case, and it is ultimately for Congress if it wishes to overturn case law and the long practice of the PTO to determine that isolated DNA must be treated differently from other compositions of matter to account for its perceived special function."
In other words, Congress had the chance to speak on this issue in the AIA but chose not to do so. (There are also the Becerra bills that tried to similarly exclude the same or similar subject matter as Myriad's but have gotten nowhere.) So when you, the ACLU, PubPat and others talk about resolving this issue based on "policy" or "philosophy," you need to keep in mind what Congress has already said (or chose not to say) on this issue.
I'm well aware of you O2 example, and you need to address this from the standpoint of science/chemistry and patent claim terminology, not philosophy as you've done. First, I would agree that no one could claim O2 per se as O2 exists in nature (just as no one could claim native DNA). But there's a big difference between O2 in its native state in say air where it's present at ~20% with the other ~80% being nitrogen, and having say a tank containing 100% O2 (which to my knowledge doesn't exist in nature). And thank goodness there is, or our atmosphere would autoignite. Please also note here that I'm talking the difference between a native composition containing O2 (i.e., air) and one created by man (tank containing 100% O2), be it synthesized or purified.
The same is true of Myriad's isolated DNA sequences (as Myriad has defined them and as molecular biology defines them) versus native DNA. Native DNA and Myriad's isolated DNA sequences are different chemical molecules, and Myriad certainly doesn't "own" native DNA (yours, mine, or anyone elses). In fact, without man creating it, there is no Myriad "isolated DNA sequence." Also, for the purposes that Myriad's isolated DNA sequences are used for, native DNA is essentially worthless. And as Kevin and others have stated, researchers are free to investigate native DNA to their heart's content, and are even free to think about, talk about, and even write about Myriad's isolated DNA sequences.
I realize that you and I come from different viewpoints to this issue, and that's fine. But as far as I'm concerned, the question before us in the AMP case isn't about "philosophy," it's about the science/technology involved, what the terms in a patent claim mean (and what they actually cover), and what 35 USC 101 permits to be patent-eligible as deemed by Congress and without resort to "policy questions" that Congress has chosen not address expressly or implicitly.
Posted by: EG | August 20, 2012 at 01:45 PM
"and having say a tank containing 100% O2 "
Are you claiming the tank of 100% O2 or just O2 by itself?
Posted by: 6 | August 20, 2012 at 02:22 PM
"native DNA is essentially worthless."
Excepting of course to make the isolated genes and then use them for those purposes. Because you arbitarily determine that the native gene is not useful for that purpose because, gasp, the patent, by its existence means you can't attribute the usefulness of the claimed isolated gene to the native gene TOO. Which is of course nonsense.
Posted by: 6 | August 20, 2012 at 02:24 PM
"Because you arbitarily determine that the native gene is not useful for that purpose because, gasp, the patent, by its existence means you can't attribute the usefulness of the claimed isolated gene to the native gene TOO. Which is of course nonsense."
I agree that what you just wrote here is nonsensical. Care to try again?
Posted by: Keep It Real | August 20, 2012 at 03:30 PM
MM, I'm simply pointing out that the native gene is not worthless. It has worth at least in enabling the procedure of creaing an isolated gene which then has many uses. All those uses could be attributed to the native gene just as well as they could to the isolated gene except for the arbitrary distinction which patent lawlyers like to try to make. They assert that, at the point where their claimed subject matter comes in is where the "worth" or usefulness all begins.
Obviously this is not factually the case in many cases. In the instant case, the natural gene has worth in so far as it allows the construction of a specific isolated gene. That is a substantial use. You could, for instance, claim the method of creating an isolated gene from the natural gene and it would posssess utility even if it went down for other reasons. Just the same for the natural gene.
In just the same manner one can attribute the downstream uses of the isolated gene to the natural gene just as well. We say, for instance, that aluminum is useful to make bicycles with. Silicon is useful to make semiconductors with. In just the same way you could say that aluminum is useful for making this bike, specifically:
http://www.amazon.com/Aluminum-Road-Bike-Commuter-Wheels/dp/B008CE9KKM/ref=sr_1_1?s=sporting-goods&ie=UTF8&qid=1345508028&sr=1-1&keywords=aluminum+bicycle
Or you could say that silicon is useful for making a very specific transistor.
To take it even a step further, you can say that aluminum ore, or a single teeny tiny crystal of silicon is useful to make those things.
Just so with the natural gene, it is useful to perform all those downstream applications of the isolated gene.
It's the same old nonsense that people advocating for B claims and claims to "programmed computers" (which they presume are new machines per alappat) use. What they do is state that the underlying subject matter (usually judicially excepted like the native gene, or the programming/software per se) is worthless by itself, and then assert that once you have added a further layer of "the hand of man" by either isolating the gene or programming a computer, you have achieved some end which you could not before. They do this by attributing the "ends" that flow from the claimed subject matter solely to that which has been claimed, rather than ALSO to the underlying subject matter (natural gene, software etc.) which is (usually) preempt by the claim.
If it doesn't make sense to you, sorry brosensky I don't have all night to hold your hand through it, nor am I being paid to.
Posted by: 6 | August 20, 2012 at 07:20 PM
EG, you have never been coherently able to state your position on my claim that your view violates the law of identity. Logic is the background against which all of reality can be understood, especially science, without it, we have mere "texts" or "narratives." I am always astounded by the prevalence of postmodernists in patent law, and saddened. Did man design O2 and intend it to be as it is? No, no more so than man designed the relations between metabolites and safe dosing in the Mayo case. Anyway, as I mentioned in a previous post, my challenge remains at my blog, where I prefer to consolidate my discussions htt://whoownsyou-drkoepsell.blogspot.com
Give me a counterexample, just one, of something man-made but not the product of man's intention and design, that is clearly not a product of nature.
You might also benefit from my course, Logic for Lawyers ;)
Posted by: David Koepsell | August 21, 2012 at 01:27 AM
Once again 6 you paraphrase what I said out of context. What I said was that native DNA is worthless "for the purposes that Myriad's isolated DNA sequences are used for." I didn't say that native DNA is worthless in general. Please keep the context in mind before making such statements.
Posted by: EG | August 21, 2012 at 06:46 AM
"you have never been coherently able to state your position on my claim that your view violates the law of identity."
Only because you want to play on your "philosopher's" playing field, whereas I'm talking about the "science" and "patent law" playing fields. Let's face it Dave, we simply don't speak the same language.
And I've already given you a "counter example" to your O2 scenario, namely a tank containing 100% O2. Tell me/show me where in nature that exists?
Thanks but no thanks on your invitation to your course. I've had more than enough "schooling" from professors, and certainly enough mention by law professors about "logic" and "thinking like a lawyer," only to find out that many of the court cases I read in law school were driven not by "logic," but instead by "politics" and "philosophy." As one who got a degree in chemistry (and a liberal arts education to boot), I had a far better understanding of "logic" before I got to law school.
Posted by: EG | August 21, 2012 at 01:28 PM
"Once again 6 you paraphrase what I said out of context."
If your context makes a difference here then I appologize for my having missed it. I saw nothing more than the rank and file arguments of a patent lawlyer made just as they are in other cases.
" What I said was that native DNA is worthless "for the purposes that Myriad's isolated DNA sequences are used for.""
I understand what you want that to mean, and the distinction you desire to create, but I also know what you said actually does mean. It means that you do not attribute all the purposes that Myrad's isolated DNA sequence are put to unto the natural gene which they discovered. But, just as we can attribute all Si based semiconductors to the single crystal used to make the beginning boule, or the aluminum ore used to make the aluminum in a bicycle all those purposes ARE attributable to the natural gene. Factually speaking of course.
Sorry if you took my comments about worthlessness to mean something different. Surely you were aware that it can be used to make an isolated gene. I do not mean to say that you believe otherwise. I merely mean to say that you do not attribute the downstream purposes that Myriad puts the isolated gene to unto the natural gene as is just as well proper to do.
Posted by: 6 | August 21, 2012 at 03:15 PM
EG,
I have answered your questions before but here we go again, the quantity of O2 is an artifact, but the O2 molecules are not. No claim could logically encompass the molecule O2 despite its origin through manufacture, as no matter its source, it will always be a product of nature, not of man.
Your disrespect for the universal nature of logic is truly remarkable. I too was disturbed by the rule of politics and power, rather than logic in law school and practice. I'd think then that we would find common ground in pulling for its resurgence. There was, in fact, a time when it was taught in law schools, and if you ask me, things have gone downhill since its departure.
peace,
David
Posted by: David Koepsell | August 22, 2012 at 02:38 AM