Eli Lilly Suggests Bright-Line Rule In Myriad Amicus Brief


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 "threshhold 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...

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