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

In a decision that substantially reiterates its prior opinion, the Federal Circuit decided today in Association for Molecular Pathology v. U.S. Patent and Trademark Office (the Myriad case) that, the Supreme Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. notwithstanding, claims to isolated human DNA satisfy the requirements of 35 U.S.C. 101:

On the threshold issue of jurisdiction, we affirm the district court's decision to exercise declaratory judgment jurisdiction because we conclude that at least one plaintiff, Dr. Harry Ostrer, has standing to challenge the validity of Myriad's patents.  On the merits, we reverse the district court's decision that Myriad's composition claims to "isolated" DNA molecules cover patent-ineligible products of nature under § 101 because each of the claimed molecules represents a nonnaturally occurring composition of matter.  We also reverse the district court's decision that Myriad's method claim to screening potential cancer therapeutics via changes in cell growth rates of transformed cells is directed to a patent-ineligible scientific principle.  We affirm the court's decision, however, that Myriad's method claims directed to "comparing" or "analyzing" DNA sequences are patent ineligible; such claims include no transformative steps and cover only patent-ineligible abstract, mental steps.

Further analysis will be provided in subsequent posts.  The opinion of the Court can be found here.