Myriad Sets Forth Its Case to the Supreme Court

By Kevin E. Noonan --

Myriad Genetics filed its responsive  brief with the Supreme Court last Thursday in AMP v. Myriad Genetics ("the Myriad case").  It is a certainly a serviceable brief that makes the patent law arguments that need to be made and cites at least some of the precedent that should be cited.  But reading the brief leaves nothing so much as the impression that Myriad has squandered its opportunity to submit a brief the Supreme Court would listen to.

The brief begins by expanding on the Question Presented by Petitioners (and for which certiorari was granted, i.e., "Are human genes patentable") to the following:

Did the Federal Circuit correctly apply 35 U.S.C. § 101 to conclude that these particular molecules are "product[s] of human ingenuity 'having a distinctive name, character [and] use,'" particularly where the general legal rule followed by courts for 30 years has been to allow such patent claims, where the U.S. Patent and Trademark Office ("USPTO") has issued similar patents since at least 1982 and confirmed in the 2001 Utility Guidelines that such isolated molecules are patent-eligible as human-made inventions under § 101, where investors and technology companies have placed significant reliance in these settled property rights over the last 30 years, where the alternative dividing line is indefensible under law or science, and where the challenged claims do not preempt or preclude the use of alternative technologies to identify a patient's cancer predisposition?

The brief then makes many of the points that have been made by Myriad and its amici throughout this litigation:  that the scope of Section 101 of the Patent Act is broad, the Federal Circuit came to the correct decision, the requirements in Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980), are controlling precedent and Myriad's claims satisfy these requirements, and that the government's and Petitioner's arguments and interpretations of the law are incorrect.  The brief emphasizes the distinctions between isolated DNA and DNA as it exists in nature, and the new utilities imparted upon isolated DNA as the result of its isolation.  Myriad distinguishes claims to isolated human DNA from the unpatentable claims in Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948) (properly stating that Funk Bros. was a case about "invention," i.e., non-obviousness and not patent-eligibility), and relies heavily on the Court's interpretation of the scope of Section 101 in J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc., 534 U.S. 124 (1996).  The brief makes the following analogy (among many):

No one would doubt the patent-eligibility of a newly-created chemical composition that, when applied in a laboratory to a person's blood or tissue sample, could detect a mutation genetically predisposing her to a risk of breast or ovarian cancer, thereby allowing her to take proactive measures to prolong her life even before cancer actually strikes.  That is what Myriad's patented molecules are -- and they were never available to the world until Myriad's scientists applied their inventive faculties to a previously undistinguished mass of genetic matter in order to identify, define, and create the isolated DNA molecules.

Myriad argues that there are other provisions of the Patent Act that can properly cabin claims to their proper scope, and that what Section 101 requires is "invention," drawing a parallel with analogous concepts in copyright law (specifically, "the eligibility threshold of copyright law, which requires authorial 'originality' -- defined as a "minimal level of creativity."  Feist Pub., Inc. v. Rural Tel. Serv. Co., 499 U.S. 340, 358-59 (1991)).

And the brief reminds the Court that the USPTO has been granting patents on isolated DNA (and the Federal Circuit upholding them) since 1982 as an application of the broad interpretation of patent eligibility enunciated by the Court in Chakrabarty.  Myriad emphasizes efforts by the PTO to ensure that the scope of claims granted on isolated DNA was appropriate, for example, as having "specific, substantial and credible" utility," citing both the 1995 (Utility Examination Guidelines, 60 Fed. Reg. 36,263 (July 14, 1995)) and 2001 (Utility Guidelines. 66 Fed. Reg. 1092 (Jan. 5, 2001)) versions of the Office's Utility Guidelines.  In this regard, Myriad cites numerous precedent to support the statement that "isolates or extracts of natural products may be patented"; examples include digitalis (U.S. Patent No. 1,898,199), rapamycin (U.S. Patent No. 3,929,992) and (perhaps infelicitously) the HIV virus (U.S. Patent No. 5,135,864), among others.

Myriad's response to the government's position is that it is inconsistent with the government's previous position permitting patents on isolated DNA in "[o]ver thirty years of precedent."  Myriad criticizes the government for arguing that the "line" should be drawn between cDNA (patent eligible) and "other isolated DNA molecules (not)."  The line has been drawn elsewhere under established government (PTO) practice, and this "'established general legal rule' -- not to mention the enormous reliance interests and property rights arising from that practice -- is far more worthy of respect than the arbitrary line now being offered as a mere litigating position by the United States" says Myriad, citing Bowen v. Georgetown Univ. Hosp., 488 U.S. 204, 212 (1988).

These arguments are followed in the brief by an argument related to the "[c]ountless companies and investors [that] have risked billions of dollars to research and develop advances under this promise of stable patent protection," followed almost immediately by a disquisition on the differences between isolated DNA and how it exists in nature, and a brief history of "the little biotech company that could" (i.e., Myriad) and the benefits to human health that resulted from the availability of patent protection (although it does not explain how claims to isolated, full-length BRCA1 and BRCA2 genes are relevant to genetic diagnostic testing, then or now).  The brief does Myriad a great service in getting before the Court some of the facts regarding the credit Myriad is amply due in providing genetic diagnostic testing for breast and ovarian cancer and setting forth the reality (as opposed to Petitioners' fantasies) regarding the true costs of the tests and the number of women for whom Myriad's BRCA gene tests are available.  As has been noted by others, Myriad also informs the Court that its "gene patents" have not impeded research, citing the evidence that "since the patents issued, over 18,000 researchers have conducted studies on BRCA1/2 genes, published over 8,000 papers, and conducted over 130 clinical trials."

Turning to Petitioner's arguments, the brief catalogs the many ways that Plaintiffs have mischaracterized the evidence and the law in making their arguments.  This starts, according to Myriad, with focusing on the similarities between isolated and naturally occurring human DNA, because there will always be such similarities with any naturally occurring product.  What is relevant, according to Myriad, are the differences, because it is in the differences that will be illustrated "whether a claimed composition is ''a product of human ingenuity 'having a distinctive name, character and use'' from a natural product," citing Chakrabarty.  The brief uses an analogy plucked from the opinion below to make this point:

A patent-eligible baseball bat, though shaped and formed by human hands, will share the characteristics of the wood embedded in the tree from which the bat was formed.  But the fact that the bat shares the properties of natural wood does not make the resulting, human-made product ineligible for patenting.

And the brief addresses in this regard Petitioner's "information content" argument, i.e., that Myriad's claims are unpatentable because the sequence of the isolated DNA and the DNA as it exists in nature are identical, pointing out that that to be useful the sequence of the DNA:

[I]n combination with the inventors' scientific work and ingenuity in characterizing and defining the molecule's starting and end points, the severing of covalent bonds, and the removal of the specific defined molecule from other materials in its native environment to create new functionality as a probe or primer.  Only because of the addition of human invention do these molecules exist to help patients chart their own course of medical treatments.

(In a short section, the brief also addresses the 1st and 14th amendment arguments with regard to the absence of any threat to a woman's access to information regarding her health.)  Perhaps the most apt application of these principles comes in the brief's argument that, assessed as Petitioner would have patent eligibility assessed, Chakrabarty's bacterium would not have been sufficiently different from naturally occurring Pseudomonas bacteria to be eligible for patenting.

Myriad also has "its day in court" by taking the opportunity to illustrate the fanciful nature of the litigation, citing quotes from lawyers representing the ACLU and the Public Patent Foundation (PubPat) that they were just looking to "sue somebody" over patents to isolated DNA and that the goal was to "rend[er] invalid patents on many other genes . . . .  We just had to pick one case as our case."  However tempting, this portion of the argument, and indeed the entire first section of the brief, is devoted to Myriad's failed attempt below to convince the lower court that the one plaintiff found by the Federal Circuit to have standing (Dr. Harry Ostrer) in fact does not, either by virtue of a lack of "immediacy" in the threat to his activities posed by Myriad's 1998 letter offering a license to Myriad's patents to his then employer, NYU, or by virtue of his move from NYU to Montefiore Hospital at the Albert Einstein College of Medicine (which had never received a "cease and desist" or license offer letter).  This portion of the brief goes over the same ground trod extensively below, and one that the Court dismissed sub silentio by not including it as a basis for granting certiorari (albeit as part of Petitioners' Questions Presented that the Federal Circuit had been overly exclusive in finding a lack of standing among the various Plaintiffs).  If only by emphasizing this argument by primacy of placement Myriad seems to have made a misjudgment on why the Court granted cert. and what it was interested in deciding.

Even ignoring this strange choice in presenting the order of its arguments, the real problem with the brief is that it seems tone deaf to the tenor of this Supreme Court.  Its emphasis on deference -- to the USPTO or earlier precedent, including especially the Federal Circuit's decision below -- ignores frank and explicit statements and signals from this Court that deference is not on its menu.  The brief seemingly ignores the difference between the Chakrabarty Court's understanding of its role as a coequal branch:

Our task, rather, is the narrow one of determining what Congress meant by the words it used in the statute; once that is done our powers are exhausted.  Congress is free to amend §101 so as to exclude from patent protection organisms produced by genetic engineering.  Compare 42 U.S.C. §2181, exempting from patent protection inventions "useful solely in the utilization of special nuclear material or atomic energy in an atomic weapon."  Or it may choose to craft a statute specifically designed for such living things.  But, until Congress takes such action, this Court must construe the language of §101 as it is.

Diamond v. Chakrabarty.

And this Court's:

[W]e must recognize the role of Congress in crafting more finely tailored rules where necessary.  Cf. 35 U.S.C. §§161–164 (special rules for plant patents).  We need not determine here whether, from a policy perspective, increased protection for discoveries of diagnostic laws of nature is desirable.

(i.e., if Congress does not agree with us they can "craft[] more finely tailored rules").  (Indeed, some members of the Court indicated recently at oral argument in Shelby County v. Holder that the Court need not defer to a 98-0 vote in the Senate reauthorizing the Section 5 of the Voting Rights Act.)

The brief's reliance on deference to the PTO's decisions granting gene patents and the rules it has implemented to do so (like the 2001 Utility Guidelines) lose much of its force in view of the brief filed by the government, that these practices were inconsistent with law and these patents should not have been granted.  While the brief notes that the PTO did not join the brief (and the unprecedented nature of this omission), the Court is certain to be familiar with the concept of the "unified Executive" and thus likely to come to the conclusion that the PTO is stubbornly resisting its comeuppance in a hidebound application of incorrect law.  The brief might have more aptly noted that it is this type of changing positions that is not due deference, as argued recently in Par Pharmaceuticals' brief in FTC v. Actavis:

"[W]hatever deference you are entitled to is compromised by the fact that your predecessors took a different position."  Transcript of Oral Argument at 44, Kiobel v. Royal Dutch Petroleum, No.10-1491 (Oct. 1, 2012) (Roberts, C.J.)

Such a citation might have given the Court pause regarding whether the government's position was persuasive, but the opportunity to make that case was lost.

Similarly, the brief focuses on applications of all the other sections of the Patent Act -- §§ 102, 103, 112 -- in making its arguments, with the rationale that these sections are more appropriate or more flexible or more nuanced in their application to the question before the Court.  This type of argument was made in Mayo, by the government, and rejected:

The Government does not necessarily believe that claims that (like the claims before us) extend just minimally beyond a law of nature should receive patents.  But in its view, other statutory provisions -- those that insist that a claimed process be novel, 35 U. S. C. §102, that it not be "obvious in light of prior art," §103, and that it be "full[y], clear[ly], concise[ly], and exact[ly]" described, §112 -- can perform this screening function.  In particular, it argues that these claims likely fail for lack of novelty under §102.

This approach, however, would make the "law of nature" exception to §101 patentability a dead letter.  The approach is therefore not consistent with prior law.

*  *  *

These considerations lead us to decline the Government's invitation to substitute §§102, 103, and 112 inquiries for the better established inquiry under §101.

(emphasis added).

The fact is that the Supreme Court doesn't consider patent questions like you or I, and patent lawyers would do well to recognize and adapt to that fact.  This brief does not, and its persuasive punch before the Court is likely much reduced as a consequence.

Finally, the Court should have put to bed any comprehension that the "settled expectations" or "economic investment" arguments, such as the brief's argument that "[c]ountless companies and investors have risked billions of dollars to research and develop advances under this promise of stable patent protection," will have much traction, in finding more persuasive the arguments of consumers rather than producers of technology and rejecting the position of respondent and amici like the Biotechnology Industry Organization in Mayo:

Patent protection is, after all, a two-edged sword.  On the one hand, the promise of exclusive rights provides monetary incentives that lead to creation, invention, and discovery.  On the other hand, that very exclusivity can impede the flow of information that might permit, indeed spur, invention, by, for example, raising the price of using the patented ideas once created, requiring potential users to conduct costly and time-consuming searches of existing patents and pending patent applications, and requiring the negotiation of complex licensing arrangements.  At the same time, patent law's general rules must govern inventive activity in many different fields of human endeavor, with the result that the practical effects of rules that reflect a general effort to balance these considerations may differ from one field to another.

The ACLU and PubPat have prevailed -- at the District Court and the court of public opinion -- by making this case about everything but patent law.  While in a different time it might have been sufficient to emphasize patent law in this argument, that time has passed (at least for now).  The Court has evinced a concern that its decisions now may inhibit future progress (a salient concern, in view of the Constitutional imperative that patents and patent law "promote the progress"), as noted in Bilski v. Kappos:

It is important to emphasize that the Court today is not commenting on the patentability of any particular invention, let alone holding that any of the above-mentioned technologies from the Information Age should or should not receive patent protection.  This Age puts the possibility of innovation in the hands of more people and raises new difficulties for the patent law.  With ever more people trying to innovate and thus seeking patent protections for their inventions, the patent law faces a great challenge in striking the balance between protecting inventors and not granting monopolies over procedures that others would discover by independent, creative application of general principles.  Nothing in this opinion should be read to take a position on where that balance ought to be struck.

Emphasizing the negative consequences on progress and innovation of a decision in the ACLU's favor would have provided the Court with greater motivation to pause before taking a broad, sweeping and unnecessary position on where the balance should be struck on patenting isolated human DNA.  Myriad's brief gives the Court no basis for doing so.

Comments

[Cynical Cy]

Very disquieting. Hal Wegner (and others) have wondered publicly why Myriad continues to pursue this case; this weak filing only heightens the puzzlement. I'm not a conspiracy theorist, but Myriad's behavior makes one wonder if money has changed hands under the table to ensure that Myriad loses this unnecessary litigation in a way that poisons the waters for many other patentees and applicants.

[Skeptical]

Well written Dr. Noonan, I look forward to reading the brief later today.

[EG]

"Emphasizing the negative consequences on progress and innovation of a decision in the ACLU's favor would have provided the Court with greater motivation to pause before taking a broad, sweeping and unnecessary position on where the balance should be struck on patenting isolated human DNA. Myriad's brief gives the Court no basis for doing so."

Kevin,

It is unfortunate that Myriad didn't argue in their brief as you suggest. It's really important that SCOTUS understand the "realities" and especially the adverse impact their decision could have (and has had as a result of Mayo) on innovation, especially American innovation, in view of SCOTUS' currently myopic view of the scope of patent-eligible subject matter under 35 USC 101. Again, and contrary to what SCOTUS might otherwise believe, research & development on biotech, like money, doesn't grow on trees. If you render decisions like Mayo that don't nurture innovation, it will eventually wither and die. And as Joe Allen has said, there are stories that exist, and need to be told to SCOTUS that the ACLU/PubPat would like to see remain hidden of patients begging (correct, "begging") that patents be granted on certain technologies so that these technologies would be developed to cure conditions they're currently dying of. Put differently, there are also "bleeding heart" stories in favor of patenting technology that need to be brought to SCOTUS' attention.

[Geoff Karny]

Why does Myriad continue to pursue this case? Could it be the same blinders that caused them to ignore making their case in the court of public opinion years ago?

[EG]

Kevin,

The "story" I noted from Joe Allen's excellent article "Gene Patents: Gettying Beyond Witch Trials" posted on IPWatchdog:

Linda Bruzzone, a Lynch syndrome patient and Executive Director for Lynch Syndrome International made a telling point. Lynch syndrome is an inherited condition predisposing victims to aggressive cancers, often at a young age. It is a forgotten disease that’s vastly underdiagnosed even though genetic tests are available. Doctors have little awareness of the tests, which insurance companies inconsistently reimburse. Thus: “Our family members are dying.”

Patients with familial breast cancer are referred twice as often for genetic testing than Lynch Syndrome patients, even though the two conditions are equally common. When Lynch patients are lucky enough to be referred, tests vary between laboratories as each works in different ways with different parameters. Ms. Bruzzone said it’s critical to educate physicians on the availability and importance of testing, and for producing clinical data needed for insurance coverage. Because the companies offer slightly different tests, no individual company will invest to solve these issues.

She concluded if Lynch syndrome testing were like BRCA testing with a patent and a company committing the required resources promoting the test, our families could be as fortunate having access to early diagnosis as families affected by hereditary breast cancer.

Again, there are two sides to this one-sided gene patenting "story" as presented by the ACLU/PubPat.

[AA]

Were we reading the same brief? I thought the Myriad brief was excellent and did exactly what it had to do in emphasizing the role of human invention and ingenuity in Myriad's inventions, dismissing the ACLU/PubPat (and the government's) fuzzy test(s), showing how those tests would cause 101 to cannibalize the intended role of 103, and pointing out all of the negative consequences of a contrary ruling. You, on the other hand, seem already willing to concede defeat on the law because you read the Bilski and Mayo method-claim cases as harbingers of doom. But you forget that Chakrabarty itself was GVRed in light of Flook, which was seen at the time as a similar harbinger of doom, yet the CCPA's decision (which stated, if I recall, that Flook was "irrelevant" to the consideration of product/manufacture claim eligibility) was affirmed by SCOTUS. The brief you wish was submitted might be a useful amicus brief, I suppose, but that's about all.

[Bruce Magnusen]

AA makes good points, especially with regard to the Myriad's briefing on the superior suitability for 102/103/112 for handling these claims.

After all this time, Kevin, you still seem to be struggling with the Prometheus case and its inevitable and necessary result. Myriad's composition claims are profoundly and fundamentally different from the method claims in Myriad. The reason the Supreme Court rejected the 102/103 approach suggested by the government for handling Prometheus' claims is because that approach required that the mental step (thinking about the correlation) be read out of the claim. The Supreme Court reasonably noted that (1) there was no precedent to justify that approach and (2) it would turn the well-understood prohibition under 101 against claims protecting abstractions/mental processes into a dead letter.

These issues do not arise in the case of Myiad's composition claims. Even under the ACLU's unworkable test, a clear understanding of the claim scope (i.e., the structure of the molecule) and its relationship to the prior art is essential. Where the structure isn't clear or enabled, you have a 112 problem (that was the problem with the Funk Brothers claim). If it captures the prior art (i.e., so-called "naturally occuring" compositions), then the claim is invalid under 102/103. Myriad's claims, by the way, are almost certainly invalid under one or more of these statutes.

Breyer and his fellow Justices knew what they were doing when they wrote Prometheus: they were closing the door on the practice of effectively patenting ineligible subject matter (abstractions/mental steps or natural laws) by tying the mere recitation of those abstractions to some old patent-eligible step. That issue is completely absent in the case of a structurally described composition claim.