The Mayo Framework Does Not Moot Preemption

By Irena Royzman & Alicia Russo
September 10, 2015

Editorial Note: The following post is taken from the NYIPLA amicus brief filed in Ariosa v. Sequenom. Dorothy Auth, President of the NYIPLA, as well as John Murnane, Irena Royzman, Alicia Russo, and David Ryan, and Erin Austin were authors on the brief.  Charles Macedo, Irena Royzman and David Ryan are Co-Chairs of NYIPLA’s Amicus Briefs Committee and Robert Isackson is the NYIPLA Board Liaison.

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SCOTUS_building-335The Supreme Court has long recognized that the proper test for determining patent eligibility is whether the claimed subject matter falls within one of the four statutory classes of subject matter and does not preempt what this Court has called a “fundamental principle” (i.e., abstract idea, natural phenomena or law of nature). See Diamond v. Diehr, 450 U.S. 175, 185 (1981) (citing Parker v. Flook, 437 U.S. 584 (1978); Gottschalk v. Benson, 409 U.S. 63, 67 (1972); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948)). Neither Mayo nor Alice changed this.

While Mayo and Alice presented a two-part “framework” to address when a particular claimed invention preempts a “fundamental principle,” neither case purported to have that framework replace a preemption inquiry nor authorize a court to ignore the ultimate question, i.e., does the claim preempt a fundamental principle instead of merely claim a practical application of such a principle?

The claims in Sequenom’s U.S. Patent No. 6,258,540 (“the ‘540 patent”) are directed to noninvasive detection of paternally inherited cell-free fetal DNA (“cffDNA”) in the blood or plasma of pregnant women, allowing for early detection of certain genetic traits without the serious risks posed by prior procedures, such as amniocentesis. Sequenom offered evidence that there are other uses of cffDNA other than those claimed in the ‘540 patent and thus, preemption did not exist.

In this case, the Panel held that several claims in the ‘540 patent were invalid because they were not directed to patent-eligible subject matter under the Mayo framework. The Panel further concluded that “[w]here a patent’s claims are deemed only to disclose patent ineligible subject matter under the Mayo framework, as they are in this case, preemption concerns are fully addressed and made moot.” Op. at 14-15 (emphasis added). The Panel did so while acknowledging that “[t]he Supreme Court has made clear that the principle of preemption is the basis for the judicial exceptions to patentability.” Id. at 14 (citing Alice, 134 S. Ct. at 2354). Amicus Curiae respectfully submits that the Panel’s conclusion is clear error and needs to be corrected.

The Panel erroneously applied the Mayo framework in a mechanical manner (much like the machine or transformation test, Friedman-Walter-Abele and technological arts tests had been applied in the past), ignoring the goal of the inquiry—to determine if the claim includes enough “something more” to avoid preempting the fundamental principle in question. This type of rigid analysis of prior Supreme Court patent-eligibility frameworks was rejected in Bilski v. Kappos, 561 U.S. 593 (2010) and is likewise incorrect here.

It is well-settled that the proper test for determining patent eligibility is whether the claimed subject matter falls within one of the four statutory classes of subject matter and does not preempt a so called fundamental principle. Diehr, 450 U.S. at 185. In Diehr, the Supreme Court acknowledged these as “long- established standing principles.” Id. (referring to Parker, 437 U.S. 584 and Gottschalk, 409 U.S. 63).

The Supreme Court has also made clear that patents that “pose no comparable risk of pre-emption … remain eligible for the monopoly granted under our patent laws”:

In applying the § 101 exception, we must distinguish between patents that claim the “‘buildin[g] block[s]'” of human ingenuity and those that integrate the building blocks into something more, Mayo 566 U.S., at ___, 132 S. Ct. at 1303, thereby “transform[ing]” them into a patent-eligible invention, id., at ___, 132 S. Ct. at 1294. … The latter pose no comparable risk of pre-emption, and therefore remain eligible for the monopoly granted under our patent laws.

Alice, 134 S. Ct. at 2354-55 (emphasis added).

The failure to consider preemption has resulted in courts and the PTO over-using §101 in a gatekeeper or threshold fashion for which it was never intended to be used, either as enacted by Congress or as interpreted by the Supreme Court. Cf. Dann v. Johnston, 425 U.S. 219, 221 (1976) (avoiding a §101 determination in favor of a §103 analysis).

Accordingly, Amicus Curiae respectfully submits that the Panel should have considered preemption when applying the framework of Mayo. The full Court should grant rehearing to correct this legal error en banc.

The Author

Irena Royzman

Irena Royzman concentrates on biotech and pharmaceutical litigation and is Co-Chair of the firm’s Biotechnology Practice. She has successfully represented biotech, pharmaceutical and medical device companies as plaintiffs and defendants in patent litigation on a wide variety of subject matters, such as small molecules, biologics, crystal forms, manufacturing processes, analysis of polymerase chain reaction (PCR) products, genetic transformation techniques, and drug-eluting coatings. Ms. Royzman has significant experience in litigating cases brought under the Hatch-Waxman Act and is also representing an innovator pharmaceutical company in one of the first cases under the legislation for biosimilars (BPCIA). Ms. Royzman holds a Ph.D. in Biology from the Massachusetts Institute of Technology, where she was a NSF fellow and studied the regulation of DNA replication and amplification. Through her research at MIT and the Whitehead Institute, Ms. Royzman has hands-on experience in recombinant DNA technology, cell biology and genetics. CLICK HERE to view Ms. Royzman's firm profile page.

Irena Royzman

Alicia Russo has experience in complex patent litigation, as well as in oil and gas, biotechnology, bioinformatics, vaccine, therapeutic antibodies, and pharmaceutical patent prosecution. Her primary focus is in the area of pharmaceuticals and biotechnology. She has successfully represented clients in reexaminations and interferences before the U.S. Patent and Trademark Office. Ms. Russo’s scientific career spanned 12 years and she is extensively published in noteworthy scientific journals, such as Science, Nature, Cell and the Proceedings of the National Academy of Sciences, with cover articles in both Nature and Cell. CLICK HERE for her firm biography page.

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Discuss this

There are currently 3 Comments comments.

  1. David Stein September 11, 2015 1:27 am

    Hmm. I must admit that I really don’t understand this argument.

    The article treats the Mayo framework and “preemption” as separate concerns – bolstered by the Panel comment that if Mayo is applied, then “preemption” is not a concern.

    But I don’t see them as discrete concepts. I see the restriction as “preempting an abstract idea” as a simple statement, and the Mayo and Alice framework as the specific, stepwise test that the courts now use to make that determination.

    The language of the Panel was confusing, but I don’t believe that it meant: “We do not need to perform Test A, because we are applying Test B instead.” I believe that it meant: “Test B gives us the answer to the more general question of Test A.”

    I believe that this process mirrors the other requirement in 35 USC 101 – that patents can only issue for “new” inventions. “New” is not a separate test from 102 and 103: rather, 102 and 103 provide the details by which the question of “new” is to be evaluated.

    I also have problems with the argument that 101 is being “over-used,” and that “preemption” should be used more often – since, of late, the courts have consistently identified preemption as a patent-eligibility issue. (Although I have yet to see any clear statement by the courts about which sections of 35 USC provide the “preemption” requirement – or, for that matter: “abstract,” “laws of nature,” etc. – I have always understood all of this rhetoric as being stapled to the 35 USC 101 term: “useful.”)

    To be clear: I wholeheartedly believe that 101 is a mess for many reasons, including its overuse – since 90% of the Alice invalidations I’ve seen could more persuasively have been invalidated under 102/103. But honestly, the arguments in this article seem like… hair-splitting. I am genuinely hoping that the authors, or anyone else, can change my mind.

  2. Paul F. Morgan September 11, 2015 10:13 am

    Re: “Sequenom offered evidence that there are other uses of cffDNA other than those claimed in the ‘540 patent and thus, preemption did not exist.”
    But is that really true of the broadest claims? By what claim language therein? And were any of of the specific claimed uses of this [pre-existing] material novel? Or found or used by any novel method or apparatus? Is not the alleged novelty here in where the material was found? Like the Curie’s unexpected discovery of very small amount of a “new” [but pre-existing] element radium in large amounts of pitchblende? [Wining a well-deserved Nobel prize but not a patent.]

  3. Paul Cole September 13, 2015 2:17 am

    I have perhaps very belatedly become persuaded of a new viewpoint
    by the repeated and vehement protests of EG, Knight Writer, Anon and the like.

    As broadly expressed in Mayo and Myriad the judicial exceptions are not in conflict with the clear language of the statute because they relate to subject matter that no reasonable person would consider fall within that clear language.

    However, the exceptions have been judicially extended to cover claimed subject matter that has the appearance of falling within the statutory language e.g. because it is dressed up as a composition of matter claim or a process claim, whereas on closer examination it is not. The normal canon of construction for such exclusions is that they should be narrow, and doubly so when their effect is to encroach on language passed by Congress. Furthermore, the enhanced exclusions are based on a de minimis rule clearly set out in Mayo and Myriad and which is by its fundamental nature of narrow application. It follows that if the lower courts are falling into error by a wide interpretation to exceptions that are inherently narrow.

    A disturbing side-effect of this tendency is that doctrines such as preemption take on a life of their own and are used to extend the de minimis addition to the judicial exceptions and increase the degree to which those exceptions encroach on statute.

    Paul Morgan applies the judicial exceptions and preemption to the case of radium where he would have done better to start with the clear language of the statute. Radium does not qualify as a composition of matter because it is neither a mixture of materials nor a product created by chemical synthesis. In its purified form it qualifies, if at all, as a new manufacture. The ruling precedent on that issue is Hartranft which has been quoted with approval in a number of Supreme Court cases including Chakrabarty and Myriad. If radium is produced in a new form having substantial new utility then it might have qualified under Hartranft as a new manufacture. It seems that the new utility (luminous paint for watch dials, cancer treatment) followed some years after the original discovery, so that the original discovery was a chemical curiosity rather than an invention qualifying under Hartranft. I do not think that there is conflict between this analysis and that in e.g. adrenalin.

    Similarly the outcome in Myriad could have been reached in Myriad without considering the judicial exceptions and instead relying on the plain language of the statute. Isolated BRCA1 is not a composition of matter because it is neither a mixture of substances nor a new compound produced by chemical synthesis. If it qualifies at all, it must fall within the term “manufacture”. But to so qualify it must exhibit relevant new utility, and that was held to be lacking.

    The present case is in no way analogous to radium because it starts with a new and hitherto discarded material, amplifies a portion of the DNA found in it and uses that amplified DNA for significant and immediately valuable medical tests. If the Curies had discovered a way of isolating radium from pitchblende, and the isolated radium so produced had immediate practical and industrial utility, then the grounds for applying the judicial exceptions would have been weak, as they are in the present case.