[author: Kevin E. Noonan]
On Halloween, Myriad Genetics filed its brief in opposition to plaintiffs' petition for certiorari in Association for Molecular Pathology v. Myriad Genetics, Inc. (plaintiffs nominally being the Association for Molecular Pathology et al., but actually the American Civil Liberties Union and the Public Patent Foundation). In doing so, Myriad no doubt understands the position of the boy encountered by St. Augustine who was trying to empty the ocean into a hole in the sand on the beach; in reality, Myriad faces not only petitioners by the plethora of amici from a variety of academics, patients, doctors, and civil liberties groups clamoring for the Court to grant cert. (see "AMP v. Myriad Briefed and Distributed for Conference").
Petitioners presented three questions to the Court, all countered by Myriad in its respondents' brief:
1. Are human genes patentable?
2. Did the court of appeals err in upholding a method claim by Myriad that is irreconcilable with this Court's ruling in Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012)?
3. Did the court of appeals err in adopting a new and inflexible rule, contrary to normal standing rules and this Court's decision in MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007), that petitioners who have been indisputably deterred by Myriad's "active enforcement" of its patent rights nonetheless lack standing to challenge those patents absent evidence that they have been personally and directly threatened with an infringement action?
Myriad's brief begins by setting out the context in which this case was brought, long (~30 years) after the U.S. Patent and Trademark Office began granting patents on isolated genes. Citing the PTO's "specific expertise in issues of patent law" (and reminding the Court that it was content to rely on that expertise as recently as its decision in J.E.M. AG Supply, Inc. v. Pioneer Hi-Bred Int'l. Inc.), the brief recites not only a brief history of gene patenting but also instances where the Office established rules to ensure that such claims were properly within the scope of 35 U.S.C. §§ 101 and 112 (i.e., the 2001 Utility Guidelines). And the brief reminds the Court that the biotechnology industry has relied on the determination that genes are patent-eligible during that time, and the societal benefits that have accrued as a result. Turning specifically to Myriad, the brief recounts how it was that the company isolated the genes and then determined which mutations were relevant to a breast or ovarian cancer diagnosis, and the extent to which these accomplishments required human ingenuity, effort, and invention. The brief sets forth the accolades Myriad (rightfully) received for this achievement, and then discusses the extent to which the protection Myriad obtained from its patents was commensurate in scope with its contributions.
Importantly, the brief also rebuts some of the untruths espoused by petitioners and their amici, regarding the effects of the Myriad patents on the field and particularly the efforts of others, unimpeded by Myriad's patents, to undertake genetic experimentation including the Human Genome Project and continuing into the present day with individual genome sequencing. In so doing, the brief lays to rest another misstatement by petitioners (no doubt motivated by the effect the argument had on Judge Bryson at the Federal Circuit), that Myriad's claims would somehow interfere with such individual genomic sequencing, citing Chris Holman's 2012 law review article, "Will Gene Patents Derail the Next Generation of Genetic Technologies?: A reassessment of the Evidence Suggests Not," 80 UMCK 563, as well as noting alternative technologies by which mutations in the BRCA1 and BRCA2 genes could be detected that would not infringe Myriad's claims (without accentuating for the Court that these technologies could not be so used if Myriad had not identified the mutations in the first place).
Following this introduction, the brief sets forth the proceedings in the District Court and Federal Circuit below before returning to its argument countering petitioners and their amici. In so doing, the brief highlights for the Court the political motivations behind this case, stating that "[p]laintiffs' counsel hand-selected the challenged claims. As part of a strategy of 'pick[ing] one case' for a broad assault on all patents covering similar subject matter." Thereafter the brief provides the Court with "corrections of petitioners' misstatements," necessary not only to prevent the Court from relying on these falsehoods but for provoking in the Justices the question of why plaintiffs' petition is based on such misstatements in the first place. These include:
1. The first question presented bears no relation to the uncontroverted facts of this case. Petitioners seek to present this case as asking whether "human genes" are patent-eligible. Of course, the genetic material naturally existing in every human being is not an "invention," i.e., it is not the product of human ingenuity. But this case does not involve claims to such "native" human genes. The challenged composition claims are instead narrowly drawn to specific, defined DNA molecules, isolated by human scientists in laboratories, that do not naturally occur. As Judges Lourie and Moore explained, molecules of isolated BRCA1 and BRCA2 DNA are chemical "composition[s] of matter" that are just as deserving of patent eligibility as any other human-made molecule. Indeed, numerous pharmaceutical and biotechnical inventions are claimed as specified molecules. This perhaps explains petitioners' insistence on framing their first question as "Are human genes patentable?", instead of addressing the question actually presented to and answered by the lower courts regarding the patent-eligibility of molecules defined, cultivated, and isolated by men and women through the application of human ingenuity.
2. Petitioners also contend that "[s]tandard isolation results in random DNA fragments that are identical to those that exist naturally in the body." . . . By definition, however, an "isolated" DNA molecule has been removed from its naturally occurring environment. . . . A molecule cannot simultaneously be "removed from its naturally occurring environment" and "exist naturally in the human body" -- its naturally occurring environment. As Judge Lourie explained in his lead opinion: "It is undisputed that Myriad's claimed isolated DNAs exist in a distinctive chemical form -- as distinctive chemical molecules -- from DNAs in the human body," because of "human intervention to cleave or synthesize a discrete portion of a native chromosomal DNA, imparting on that isolated DNA a distinctive chemical identity as compared to native DNA." . . . Petitioners' belated factual claim that covalent bonds of DNA molecules may be broken in the body . . . is irrelevant. This assertion omits critical elements of the definition of "isolated" DNA. Isolated DNA is not merely DNA that has had bonds broken; the breaking of covalent bonds, while important, is but one part. Isolation further requires separation of the specific DNA of interest from the rest of the DNA in the body and even the rest of the fragmented DNA that may be present in a test tube outside the body. Even setting aside the human-engineered initial fragmentation breaking the covalent bonds, such specific, precisely defined (i.e., targeted) separation does not naturally occur in the body. Thus, it is a contradiction in terms to say that "isolated" DNA exists within the body. . . .
3. Contrary to petitioners' cursory and unsupported assertions, neither Myriad nor its patents hinder research of BRCA genes. One named plaintiff concedes that she "could sequence the BRCA1 and BRCA2 genes for purely research purposes," and has been doing so without impediment. . . . The undisputed facts further demonstrate that 18,000 researchers have conducted studies on BRCA1/2 genes, over 8,000 relevant papers have been published on BRCA1/2 genes, and over 130 clinical trials regarding BRCA1/2 genes have commenced since Myriad publicly disclosed its inventions. . . . Moreover, multiple laboratories provide "second opinions" regarding BRCA1/2 test results. In short, Myriad's patents do not hinder research. . . .
4. Petitioners allege that Myriad has "stopped other laboratories from creating and offering new and improved testing procedures" and has "the right to exclude the rest of the scientific community from examining the naturally-occurring genes of every person in the United States." . . . These statements are false. The challenged claims do not preempt, preclude, or prohibit others from creating and offering new and improved testing services. To the contrary, Myriad's composition claims are limited to the precise isolated molecules it created and that are recited in the patents. These claims do not preempt or preclude other technologies that have been developed and are currently being used to study the human genome and identify genetic mutations to assess a patient's cancer predisposition -- e.g., gene expression profiles, whole-genome sequencing, untargeted single-molecule sequencing, and protein-truncation testing. . . . These technologies "sequence" DNA without the need for "isolation."
In fact, earlier in this case (January 2010), petitioners stated: "It is only humans' inability -- currently -- to sequence DNA while it is in the body that requires scientists to isolate it." . . . This falsely suggests there are only two options: sequence in the body or sequence "isolated" DNA. While DNA still cannot be sequenced in the body, DNA extracted from the body but not "isolated" can be, and has been, sequenced. For example, random sequencing and protein-truncation testing have been used for years to identify genomic variations, including BRCA mutations. More recently, multiple companies, e.g., Oxford Nanopore and Pacific Biosciences, have developed single-molecule technologies that can perform untargeted sequencing of DNA, which may include BRCA genes, without infringing the challenged claims.
5. Petitioners contend that the challenged composition claims "define[] the gene according to how it functions in the body -- i.e., that it codes for and produces a polypeptide or protein." . . . That is untrue. Each claim is a specific, defined molecule isolated from the body; none is claimed in terms of its "function." Terms such as "encoding" or "coding for" are commonly used in DNA patent claims to recite physical structure, not function -- they are "structural terms" that define Myriad's human-made molecules. . . . Petitioners' contentions to the contrary, like their insistence upon redefining the question presented as "Are human genes patentable?", reflect a misunderstanding of basic scientific principles, well-established case law, and the nature of the composition claims at issue; at a minimum, they demonstrate that the petition is grounded on disputed antecedent facts.
(citations omitted, emphasis added).
Having dispensed with (or at a minimum bringing the Court's attention to these fanciful misstatements, the brief then sets forth Myriad's reasons the Court should deny the writ. Put simply, Myriad argues that the Federal Circuit has properly applied Supreme Court precedent in Chakrabarty, Mayo, and MedImmune in reaching its decision below and that the case is not in the proper posture for the Court to intervene. Applying each line of precedent in turn, Myriad argues that the Federal Circuit applied the Court's § 101 jurisprudence regarding the composition of matter claims to isolated genes, specifically the rubrics set forth in the seminal Chakrabarty case. Myriad argues that "faithfully applying Chakrabarty in view of Mayo," the Federal Circuit came to the correct conclusion that the isolated DNA claims recited patent-eligible subject matter. The brief characterizes the Court's J.E.M. case as being "on all fours" with this case, because there the Court decided plants were patent-eligible because § 101 should be given "broad scope and applicability" and the PTO have been granting utility patents on plants (~1800 patents) for 16 years (in contrast, the brief notes that the PTO has been granting patents on isolated DNA for 30 years and there are ~40,000 isolated DNA patents). Citing Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushki Co. (applicable here through the auspices of Judge Moore's citation of the precedent in her concurring opinion below), "[t]o change so substantially the rules of the game now [] could very well subvert the various balances the PTO sought to strike when issuing the numerous patents which have not yet expired" (covering isolated DNA, an argument that will resonate only insofar as the Court believes that the PTO's decisions deserve some deference).
The brief next argues that the Federal Circuit's decision is not in conflict with any Supreme Court precedent, including Mayo, Chakrabarty, Funk Bros. Seed Co., and American Fruit Growers, Inc. In distinguishing Mayo, the brief also addresses the "preemption" argument advanced in petitioners' brief, reminding the Court that "all patent claims are preemptive." The concerns enunciated by the Court in Mayo regarding preemption are not implicated here on the facts, including that diagnosing risk for breast and ovarian cancer based on the presence of BRCA mutations can be accomplished using several alternative, non-infringing methods. The other three Court decisions are consistent with the Federal Circuit opinion below based on their facts, according to Myriad's brief, and in this regard point to another misstatement by petitioners:
In arguing that the results in Funk Brothers and American Fruit Growers should govern, petitioners mischaracterize the claims here as merely a "blueprint" for "coding for" the genetic material in the body; under this view, petitioners say, the patents claim only a natural function. . . . This is factually incorrect and mischaracterizes the claim language. The patents do not claim the compositions with reference to their functions; and the "coding for" language is a structural, not a functional, limitation in the claims. See In re Deuel, 51 F.3d at 1557-58. The composition claims are limited to claims for a specific, precisely defined composition with a specific, non-naturally occurring structure -- a particular, human-defined, isolated DNA molecule. . . . As the Federal Circuit ruled, the claims are directed to a specific and new chemical entity that does not exist in nature and that has uses unrelated to how the "code" operates in the body (unlike natural DNA "exist[ing] in the body as one of forty-six large, contiguous DNA molecules," the claims are drawn to "a free-standing portion;" . . . the claims "are truncations" that "are not naturally produced without the intervention of man").
(citations omitted).
Having dispensed with petitioners' argument regarding the patent eligibility of the composition of matter claims, the brief then turns to the other two questions presented. Regarding the screening method claim (claim 20 of U.S. Patent No. 5,747,282), the brief rebuts yet another factual misstatement: that [petitioners] proclaim -- without record support -- that 'transformed cells containing altered DNA are conventional products widely available for purchase.'" Rather, the brief properly informs the Court that the cells are "a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer" which is "a new and useful product of human ingenuity," and thus can be distinguished from the Mayo claims because it recites something that is neither a product nor a law of nature and in so doing Claim 20 does "significantly more than describe a natural law." In addition, the brief corrects the petitioners "overstatement" that this claim would prevent "any researcher from engaging in this science to find a cancer treatment" by noting that the claim "is tied to specific host cells transformed with specific genes and grown in the presence or absence of a specific type of therapeutic," reducing the temperature of petitioners hyperbolic arguments to comport with reality (emphasis in original).
Finally, the brief addresses the jurisdictional issue, substantially repeating the evidence that the one plaintiff found to have standing, Dr. Harry Ostrer, may have destroyed that standing by moving from NYU (which supported his for-profit diagnostic activities) to Montefiore Hospital, which does not (or, more properly, petitioners have not presented any evidence that Montefiore would do so).
The brief ends with a section presenting six reasons why this case is not a good "vehicle" for review by the Court. In truncated versions, these are:
First, this case represents an abstract challenge to Myriad's patents. Petitioners alone selected the particular claims to challenge, leaving unchallenged several claims that they concede will continue to impede BRCA sequencing and other conduct in which they seek to engage . . . . Accordingly, there exist significant issues of redressability, yet another antecedent jurisdictional problem with the petition. See, e.g., Lujan v. Defenders of Wildlife, 504 U.S. 555, 561 (1992).
Second, Myriad was unable to assert counterclaims of infringement because no plaintiff was actually conducting any BRCA-related testing services; accordingly, this Court's review would be inhibited because the exact scope of the challenged claims has not been defined. The district court performed only limited claim construction, and without infringement assertions the courts had no reason to determine the precise scope of the claims' exclusionary rights. . . . Moreover, much of petitioners' effort to obtain this Court's review is premised on their unsubstantiated speculation that Myriad's claims will inhibit those "who want to undertake testing and research involving the patented genes in order to improve diagnosis and treatment for patients" and will "exclude the rest of the scientific community from examining the naturally-occurring genes of every person in the United States." . . . Such assertions have never been tested in any adversary proceeding. And had they been tested, they would have been exposed as false, for several non-infringing technologies for determining a patient's cancer predisposition are currently available. . . . Likewise, with no review of the form of testing petitioners might utilize, to determine whether such testing would infringe, there has been no analysis of what the claims do not cover, e.g., whole-genome sequencing.
Third, as to the patent-eligibility of the challenged composition claims, there is not a single opinion for the panel. Petitioners seek to make this a reason for review. . . . But, had there been a true need to reconcile divergent judicial viewpoints, it would have been appropriate for petitioners to first seek en banc review from that court. . . . For whatever reasons, they did not.
Fourth, the relevance of patenting isolated human DNA is ever diminishing in light of the publication of the entire human genome in 2001 (several years after the 1994 and 1995 filing dates of the patents-in-suit), thus presenting arguable bars to patentability under other provisions of the Patent Act (such as obviousness under § 103) for any claims to isolated human DNA molecules sought after that date. Further, such patents issued before the 2001 publication of the entire human genome will soon expire -- Myriad's patents-in-suit all expire by 2015. Thus, the unique facts of this case, presenting issues unlikely to recur, make it an inappropriate candidate for certiorari.
Fifth and finally, despite over 30 years of isolated DNA patents, this case is the first and still only appellate decision to address the patent-eligibility of such compositions. In nonetheless challenging these ruling, a change in the settled understanding of § 101 that allows patents on isolated genetic molecules. . . . Such efforts, particularly with the deeply settled reliance interests of the technology and investing communities at stake, should be addressed to Congress, not the courts. . . . Moreover, any consideration of the settled expectations that isolated molecules are patent-eligible should take into account the consequences of a legal rule that would apply far beyond the realm of human DNA. Many biotechnology companies' intellectual-property endeavors, and the investors on which those companies rely, depend on patents covering isolated DNA corresponding to non-human genes. . . . Altering the expectations that these useful developments will be patent-protected is the role of policymaking, not adjudication.
(citations omitted).
The best that can be said is that Myriad has countered every misstatement and done its best to inform the Court regarding the facts, the law, and the consequences of granting certiorari here. It remains to be seen whether the Court will be able to resist the siren song of this politically charged question, or will dive headfirst into another foray of trying to be the final arbiter of the scope and direction of American innovation.
