Eli Lilly & Co. File Amicus Brief in AMP v. Myriad

By Kevin E. Noonan --

We are living in an age of retrenchment with regard to patent law, where thirty years of Federal Circuit precedent, from the court created by Congress to harmonize U.S. patent law to great public benefit, is being reconsidered by the inconstant, almost fickle attention of the U.S. Supreme Court.  This has led (somewhat predictably) to a general questioning of patent law and its proper boundaries, evidenced no more clearly by Justice Breyer's ruminations in Mayo Collaborative Services v. Prometheus Laboratories, Inc. regarding what he perceives as the Janus-like qualities of patent protection:

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.

While this analysis smacks more of Goldilocks than patent jurisprudence (and the opinion provides no rationale or evidence for the Justice's prejudice), it does illustrate the Pandora's box that is opened when Kant's admonition to "doubt everything" becomes the basis for decisions that make no precedent firm.

Another case that illustrates the point is, of course, the Myriad case, in which plaintiffs, many amici, and even the Department of Justice are perfectly willing to reverse thirty years of administrative and judicial precedent (not to mention squandering the untold amounts expended to obtain patent protection of DNA molecules) in a grand, Emily Latella-like gesture of "never mind" regarding gene patenting.

There is one claim at issue in the Myriad case that seems the "odd man out," and that is claim 20 of U.S. Patent No. 5,747,282:

20.  A method for screening potential cancer therapeutics which comprises:  growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeutic, growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and comparing the growth rate of said host cells, wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.

Unlike the isolated DNA claims and the method claims for diagnosing/assessing a patient's genetic risk of cancer, claim 20 is directed to a screening method for identifying a compound with potential as a cancer therapeutic by having the property of reducing the growth rate of a cell containing an altered (presumably mutant and cancer-related) BRCA 1 gene and not altering the growth rate of a "normal" cell, i.e. one that does not contain an altered BRCA1 gene.  Although not the product of a rigorous analysis, it is likely that there are at least as many claims of this nature in granted patents as there are claims to isolated DNA molecules.

And yet even this claim has been thrown into question and doubt, a doubt explored in an amicus curiae brief by Eli Lilly & Co.  The brief, written by Robert Armitage and James Kelley, makes a bold request of the Federal Circuit:  to create a "bright line" rule that claims to entirely mental processes "epitomize" patent-ineligible inventions.  Further, the authors argue that a claim reciting multiple steps should be patent-ineligible if even only one of the steps is "entirely mental," and that if a claim like claim 20 does not preclude a step from being performed mentally it should be held patent-ineligible.

Their rationale for this calculus is as follows.  Patent-eligibility should be used as a threshold filter that defines as being patent ineligible any claim that sets out one or more "mental steps."  The brief defines a "mental step" as "a process step drafted in a sufficiently broad manner such that the step includes embodiments that can be carried out mentally" and more specifically "if no limitation in the step precludes the possibility of the human mind performing the step."  This proscription is based as an "unavoidable corollary" on the "abstract idea" prong of the Supreme Court's patent-ineligibility precedents (albeit being an extension thereof), and on statements from the Court in both Bilski v. Kappos and Mayo v. Prometheus.  The brief also argues that a multistep process is a "combination" invention "for which 35 U.S.C. §112(f) (formerly known as §112, 6th paragraph) dictates that each step of the combination must either explicitly set out one or more acts or be limited to the corresponding acts set forth in the specification of the patent."

Amici's detailed argument begins by recognizing the difficulties in consistently and rationally applying the Supreme Court's nebulous criteria for what it a "natural law, natural phenomenon or abstract idea."  One "useful analytical kernel" the authors draw from the Supreme Court case law is that the Court abjures patenting for mental concepts (natural laws) expressed symbolically (explaining the penchant for cases as diverse in outcome as Diamond v. Chakrabarty and Mayo v. Prometheus to cite Einstein's equation relating mass and energy).  This leads the authors to their position that it may be more analytically rigorous, and easier to apply, a "mental step" filter instead of the "tripartite test for exclusion" used by the Supreme Court.  The policy rationale is that "[t]here can be little doubt that the patent laws were never intended to sanction patentability for inventions that are embodied specifically and exclusively in human thought, human thinking, or human thought processes," if only because infringement of such a claim would involve "no act, just thought."  The brief cites In re Heritage, 150 F.2d 554, 556 (CCPA 1945), for the proposition that claims directed to "purely mental processes" are not patent eligible, and that the dissent in Diamond v. Diehr made a similar point, that there is a "mental step" exclusion from subject matter eligibility.

The brief further sets out a "poison species" and a "poison step" approach wherein the presence of even one step that can be characterized as a mental step is enough to bar patent eligibility for the claim.  The "poison species" rule is derived from the requirements for novelty, non-obviousness, written description, and enablement, where even a single non-novel or obvious species falling within the scope of a claim, or a single undescribed or non-enabled species, renders a claim unpatentable.  The same principles should apply to patent eligibility according to the brief authors.  The brief argues that this position is consistent with the Mayo Court's admonition against using "artful claim drafting" to render a claim patent eligible (an admonition that seems to misapprehend the nature of patent claiming; see "Mayo Collaborative Services v. Prometheus Laboratories -- What Should We Do? (or Can These Claims Be Saved?)").  In this regard, the brief identifies as "draftsman's machinations" claims written where the "mental step" is rendered patent eligible by the "trick of generically extending the reach of the claim to encompass embodiments to be performed by a machine, rather than the human mind."  This immediately raises the question of when does the "trick" change from merely a quantitative difference (in speed of a calculation, or the number of variables involved) to something qualitative (i.e., something a machine can do that the human mind cannot -- a patenting version of the Turing test).  The brief recognizes that the "poison step" rule is contrary to longstanding precedent under 35 U.S.C. §§ 102 and 103, where the claims are considered as a whole and not cherry-picked step-by-step, but the Supreme Court's disregard for the niceties of the statutory distinctions make this less a disability in the argument than it might have been before the Mayo decision.  Indeed, one purported benefit of the amici's approach is to "avoid[] the confusion caused by conflation of novelty, inventiveness, and patent-eligibility considerations evident in Supreme Court dicta.  Mayo, 566 U.S. ___, 132 S. Ct. at 1299."

Much of the brief's argument is based on defining a process claim as being a "combination" claim as set forth in 35 U.S.C. § 112(f):

An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.

However, it is equally true that the patent statute defines the meaning of a "process" in 35 U.S.C. § 100(b):

The term "process" means process, art, or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material.

On its face this definition is broader than the definition in § 112(f), a conclusion consistent with the interpretation that § 112(f) sets forth a way of claiming using "means for" or "steps for" achieving a result without specifying the means or steps expressly in the claims.  The argument, particularly in Section E of the brief, is thus weakened by the implication that all method claims are governed by § 112(f).

The "mental steps" identified in the brief present in claim 20 include "determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound," "comparing the growth rate of said host cells" and (perhaps) "wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic," and the brief thus concludes that the claims are ineligible for patenting.

The sweep of patent-ineligibility that would result from the Federal Circuit adopting such a bright line rule is breathtaking and suggests several verities highlighted by the Myriad appeal.  The first is that human beings have a strong capacity for deriving theoretical constructs that produce paradoxical or inefficient results; medieval scholars really did seriously consider questions like "how many angels can dance on the head of a pin," despite the irrelevancy of the question to the modern mind.  Here, the proposed bright line rule would make the analysis of patent eligibility easier by simply rendering most method claims patent ineligible (other than methods performed exclusively by machines).  Another is that the desire to produce "bright line" rules by the Federal Circuit can be seen, as is argued frankly in Lilly's brief, as a reaction against the somewhat "less than pellucid" clarity of Supreme Court teachings in patent law (and the Supreme Court's rejection of the Federal Circuit's bright line rules can be seen as a reflection of its tendency to consider the "totality of the circumstances" without regard to creating legal certainty).  It should also be appreciated that, like the medical amici in Mayo, Eli Lilly & Co. is not generally a "producer" of the types of inventions represented by claim 20 but a consumer.  It has been predominantly universities and biotechnology companies that have identified the molecular targets for drug discovery and development and have sought anf obtained claims like claim 20, and these entities (non-practicing though they may be in some circumstances) represent a potental source of increased cost to future drug discovery that the Lilly brief's authors could not fail to recognize.

As was clearly evinced in the debates surrounding the Leahy-Smith America Invents Act, the types of questions presented by Mayo and Myriad elicit positions and responses that are political as well as legal in nature.  Under the current circumstances, it should not be surprising that self-interest (enlightened or otherwise) will provide at least some motivation for positions advocated by amici as well as the parties involved.  It will be up to the Federal Circuit and perhaps one day the Supreme Court to see past these partisan positions to define patent eligibility in a way that does not kill the innovation goose in an effort to save it from an uncertain and unsubstantiated risk from excessive patenting.  With luck these courts will be up to the task.

Comments

[Skeptical]

I thought the Armitage brief such a travesty in form and content that I even Googled Armitage.

I was amazed that the man had the credentials he does, and thus even more sickened by the brief.

My biggest fault with the brief is that it has far too many novel interpretations of law supported by far too few citations. Further, some of the citations that do exist are improperly made, incorrectly signaling the supporting case law. It is almost as if the writer thought himself so brilliant that he need not hew to the conventions of law that bind lesser men.

When a statement is made such as "Natural phenomena—gravity being one example—are again concepts." such lack of veracity weighs heavily on my mind. Gravity is more than a concept. And brief writing should be more than an opportunity for commercial expression of fantastical, philosophical, law-should-be-thus pipedreams. We as advocates have a responsibility to advance colorable arguments. The Lilly brief falls far short in this respect.

[EG]

Kevin,

As you astutely point out, Eli Lilly's "ox" won't be "gored" if Myriad's patents go down. It is also consistent with who pushed for the AIA (the Abominable Inane Act): the multi-national Goliaths.

You are more optimistic than I about the Supreme Court paying attention to this David vs. Goliath issue. So far, the Justices at the Supreme Court (including Breyer) are not taking into account how decisions like Mayo Collaborative Services will continue to slant the playing field in favor of the multi-national pharma Goliaths against the biotech and university Davids. The only mantra that appears to drive the Supreme Court on patent law questions is that all patents are essentially "bad," no matter who gets them (Microsoft v. i4i being the one notable exception).

[Stan E. Delo]

Kevin-

An excellent analysis, which points out the real sticking points very clearly. I really hope that there are many more impartial and objective opinions expressed like yours, and if we keep at it, the Supremes might actually start to listen in spite of their prior predilections. They seem to forget that Congress can pull the plug on their decisions, by just legislating around them.

That presupposes that enough people are amicably curious enough about their past decisions to suggest that they might have gotten it wrong, and perhaps even doubt their wisdom as regards their qualifications to render decisions like this that are so vitally important.

If they continue, it may take decades to try to *fix* what they wrote.

Best wishes,
Stan~

[Keep It Real]

Stan: "I really hope that there are many more impartial and objective opinions expressed like yours"

Heh -- yes, we all remember how impartial Kevin was when it came to understanding the glaring problem that doomed Prometheus' claims.

You do agree, Kevin, that claims which literally encompass purely mental processes are ineligible for patenting, do you not?

And you do agree that after Prometheus there is no doubt that the mere recitation of an old, conventional step (e.g., "analyzing a blood sample") can not rescue a claim whose only novel feature is thinking a novel thought (e.g., "wherein the presence of X in the sample indicates Y")? Right? Surely you are no longer confused about this predictable result *after* the Prometheus decision.

Or do you find these uncontroversial positions "breathtaking"?

If so, I suggest you get more exercise.

[Keep It Real]

Skeptical "When a statement is made such as "Natural phenomena—gravity being one example—are again concepts." such lack of veracity weighs heavily on my mind. Gravity is more than a concept."

But it surely is a concept, particularly when conceptualizes it. A method of thinking about gravity or any other law of nature or any other fact or even a non-fact is ineligible under 101. And tossing in an old, coventional step isn't going to rescue that claim from ineligibility. The Supreme Court wisely (and predictably) put an end to that game.

If you believe that you can patent a method of thinking about a new concept (any concept, whether true or false, whether rigorous or fanciful, whether useless or profoundly useful) go ahead and try it. You will fail. I mean, some useless examiner at the USPTO might let it slip through the first time but you'll be holding a worthless piece of paper.

[Kevin E. Noonan]

Real, Real, Real - take a breath (keeping with the theme of this thread).

The "breathtaking" aspect of the brief is the scope of Lilly's proposed exclusion - claims that not only actually recite a step requiring human thought, but exclusing claims if a step could be performed by human thought, with no exemption if such step could not be (and as you know, it is very had to prove a negative).

As for Prometheus (and this is now pretty old ground), I think there was room to construe the claim so that both the patentee and the Supreme Court could be satisfied - but as I have subsequently learned, Prometheus was not asserting the claim that way. It is certainly the case that you can prevent that sort of extension by merely exclusing the subject matter entirely, but there are babies in that bathwater (and claim 20 is one of them) and I think those claims should be patented. If only because if not, we will return to academic scientists publishing scientific results - target identification - and having that work expropriated by companies foreign and domestic.

There are many who argue that the public should get a benefit from government-sponsored research, and arguably they do when universities support further research or facilities with royalty dollars. I just don't think it is preferable to preclude such a beneficial outcome using per se rules.

And do you seriously think Justice Breyer's opinion is more solid jurisprudence than special pleading regarding his pet peeve/prejudice of the week?

Thanks as always for the engaging dialog.

[Keep It Real]

"The "breathtaking" aspect of the brief is the scope of Lilly's proposed exclusion - claims that not only actually recite a step requiring human thought, but exclusing claims if a step could be performed by human thought, with no exemption if such step could not be (and as you know, it is very had to prove a negative)."

It seems that an acceptable middle ground would be for the Supreme Court (or the Federal Circuit, if they wish to get ahead of the game) to simply hold that any time a practitioner of the prior art is accused of infringing a claim merely because that practitioner has (allegedly) begun *thinking* a "new" thought about the results of his/her conventional measurements, that claim is ineligible under 101.

That approach is entirely consistent with Prometheus and avoids unnecessary speculation about exactly what a human brain is capable of doing.

[Skeptical]

KIR,

Based on your posts on Patently-O under the pen name MM, I am skeptical that you understand what "approach is entirely consistent with Prometheus" means at all.

You seem to be a one-trick pony with your "new thought" mantra. The many questions you leave unanswered suggest that instead of trotting out that pony you should be shoring up your legal position.

[Keep It Real]

Skeptical: "many questions you leave unanswered"

If you have a question, Septical, go ahead and ask it. Free country and all that.

I would advise reading my comments carefully before doing so, however, lest you appear to be putting words in my mouth or (worse) trolling.

[Keep It Real]

Skeptical: "I am skeptical that you understand what "approach is entirely consistent with Prometheus""

Maybe you have a different understanding of the term "entirely consistent" than the rest of the world. Consider the following:

Does the claim as properly construed prevent any member of the public who is otherwise not infringing a claim from freely (i.e., without infringing) performing acts that are ineligible for patenting? If so, then the claim is ineligible under 101.

Let me know if you believe that the above is inconsistent with the Supreme Court's decision in Prometheus. As you ponder this question, you should be asking yourself: are there any (real or hypothetical) claims that would be found ineligible under that test which the Supreme Court would uphold as eligible under your (thus far not articulated) view of Prometheus? If so, please provide examples of such claims and your reasoning.

Thanks for the engaging dialog.