Eli Lilly Suggests Bright-Line Rule In Myriad Amicus Brief

20 June 2012 PharmaPatents Blog

Eli Lilly filed an interesting amicus brief in the remand of Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU ”gene patenting”/BRCAI case). The Lilly brief focuses on claim 20 of Myriad’s U.S. Patent 5,747,282, and urges the Federal Circuit to adopt a bright-line rule that would hold any method claim that includes a step that “may be performed mentally” not eligible for patenting under 35 USC § 101.

Claim 20

It is hard to imagine a § 101 challenge to claim 20 of U.S. Patent 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.

Lilly’s Poison Step Rule

Lilly urges the Federal Circuit to apply a “threshold patentability filter” to multi-step process claims that would “reject patent eligibility whenever one or more ‘mental steps’” are recited. For the purpose of this test, Lilly 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.”

Lilly argues that such a test not only is consistent with Supreme Court precedent, but actually is required by it. According to Lilly, given the “fundamental principle” that “an entirely mental process” is not patent eligible, a process that includes even a single mental step likewise in not patent eligible. Lilly reaches this conclusion by analogy to the requirements for novelty, non-obviousness,  enablement and written description, where claims that encompass some embodiments that satisfy these requirements and some that do not are held not patentable.

Lilly Invokes 35 USC § 112, Sixth Paragraph

Lilly confusingly invokes what it refers to as 35 USC § 112(f) (§ 112, sixth paragraph):

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.

While this paragraph of § 112 is generally understood as permitting “means-plus-function” or “step-plus-function” claim language, Lilly asserts that it places requirements on all multi-step process claims, which it characterizes as “combination” claims that full under this paragraph. Lilly takes the position that this portion of the statute requires each step of a process claim to be defined by an “act” and asserts that “[a] ‘thinking’ or thought-process step is not an act” as that term is used in this paragraph of § 112.

Lilly summarizes its position as follows:

Whenever a process claim is construed as having at least one step not limited to exclude the possibility of being performed mentally, then the Court should, without further inquiry, hold the claim ineligible for patenting.

Lilly Looks At Claim 20

Lilly indicates that before the patent-eligibility of claim 20 can be assessed, the claim must be construed to determine whether it recites any mental steps. Lilly points specifically to two steps:

  • 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

Lilly also raises questions about the wherein clause:

  • wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic

A Modest Proposal?

While many innovators in the fields of biotechnology and personalized medicine are working to limit the reach of Mayo and Myriad and preserve a broad view of patent-eligibility, it is curious to see a large pharmaceutical company like Lilly taking a nearly opposite approach. Most patent professionals believe that claim 20 will survive scrutiny under the Supreme Court’s decision in Mayo, but here Lilly urges the Federal Circuit to adopt a strict, bright-line test that would place even that claim in jeopardy.

There is one part of Lilly’s brief that I do agree with:

The exclusions for natural phenomena and laws of nature are equally burdened with a potential for creating confusion. All inventions depend upon natural phenomena for their operation, and no invention can operate other than in harmony with all laws of nature. Defining what is to be ineligible for patenting in terms of what every invention must embody is a problematic basis for devising any line to separate eligibility and ineligibility, much less a bright one.

Perhaps by suggesting a bright-line rule that would be easy to apply but likely would invalidate numerous legitimate patents and jeopardize the patent-eligibility of countless concrete methods, Lilly is showing the court that applying § 101 as anything other than a coarse filter is an untenable solution to an admittedly difficult problem. It is more likely, though, that Lilly believes that it can protect its own innovations with patents directed to “method[s] of treating a patient with a medicine,” which it asserts “epitomize[] … patent-eligible process[es].” Hopefully the Federal Circuit will understand what havoc Lilly’s proposed rule would wreak and will not let Lilly’s arguments go further than this amicus brief.

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