Lilly Urges "Poison Species" Test for Process Patents

22 June 2012 Personalized Medicine Bulletin Blog

June 15th, 2012 was the deadline for the parties and interested parties to file briefs in the controversial ACLU gene patenting case (see our post of March 26th, 2012), remanded to the Federal Circuit after the U.S. Supreme Court’s recent Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. __, 132 S.Ct. 1289 (2012) (“Prometheus”) decision which held that certain claims to medical methods are not patent-eligible for failing to satisfy 35 U.S.C. § 101. On June 12th, Eli Lilly and Company (“Lilly”) filed an amicus brief that urged the Federal Circuit to review the U.S. Supreme Court’s holding in Prometheus as it applies to multi-step process claims. Lilly’s amicus brief, filed in support of neither party, argued that new test is required to simplify the line between patent-eligible and ineligible subject matter, as [i]t is as best intellectually challenging to meaningfully apply the tripartite exclusions from patenting for laws of nature, natural phenomena and abstract ideas.”[1] The issue of whether or not the DNA claims are patent-eligible, the most contentious issue in this proceeding, was not briefed by Lilly. Rather, in footnote 1 of the brief, Lilly stated that only the appealed process claim is addressed because Prometheus “appears to be irrelevant to the manifest patent-eligibility of man-made materials that are nowhere to be found as such in nature.”[2]

Claim 20 of U.S. Patent No. 5,747,282

Lilly offered claim 20 of U.S. Patent No. 5,747,282 as an exemplary claim for review and application of a new test. Claim 20 recites:

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.

“Poison Species,” Poison Claims

A process claim would fail under the “poison species” test for patent-eligibility if the claim contains at least one step that may be performed mentally. Whenever a patent claim is construed as having at least one step not limited to exclude the possibility of being performed mentally, then a court should, without further inquiry, hold the claim ineligible for patenting. Lilly argued that such a test would preclude commingling unpatentable (i.e., “patent ineligible”) species together with patentable ones. Thus, patent-drafting ‘tricks” to rescue a patent-ineligible claim by extending the reach of the claim to encompass embodiments to be performed by a machine, rather than the human mind, would be excluded.

An Opportunity for a Simple, Bright Patent-Eligibility Line

Lilly urged the adoption of a new bright-line test for multistep process claims because the tripartite exclusion test because is difficult to apply. For example, while ideas themselves cannot be patented, it is “confusing to posit that only ‘abstract ideas’ are excluded from eligibility for patenting.” The exclusions for natural phenomena and laws of nature also create confusion as to patent-eligibility, because “[a]ll inventions depend upon natural phenomena for their operation, and no invention can operate other than in harmony with all laws of nature.”[3]

“Poison Species” Test Aligns Patent-Eligibility Test With Written Description, Enablement, Novelty and Non-Obviousness

Lilly argued that application of the “poison species” test is consistent with the application of enablement, written description, novelty or non-obviousness (35 U.S.C. § 112, first paragraph and second paragraph, 102 and 103). The common feature among the statutory provisions is that the claim is examined for compliance with each of these statutory provisions across the full scope of the claim. In addition, multiple step process claims are combination claims as used in 35 U.S.C. § 112(f)[4] which is argued to indicate that each discrete element of a claim drawn to a combination must expressly recite the structure or material acts to which the claim is to be limited. Otherwise, the claim will be limited to the corresponding structure, material or acts described in the specification. Lilly focused on the term “acts” within the statute, and that the requirement for “acts” to be a strong clue from Congress that individual steps of a multi-step process are intended to be confined to the exclusion of thoughts.

Application of “Poison Species” Test to Claim 20

Under the proposed Poison Species test, claim 20 is stated to fail the test because the “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” would not specifically exclude the mental performance of the steps.[5] In addition, Lilly argued, that if the clause “wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic” is construed to be a ‘step,’ then it too may be a mental activity, and therefore not eligible for patenting.”

Prometheus Plus More

After Prometheus, there was considerable negative reaction by the patent bar to the Supreme Court’s holding that patents claiming a method to optimize therapeutic efficacy for the treatment of immune-mediated gastrointestinal disorders were invalid. Thus, it is surprising and a bit curious that Lilly would take the Prometheus holding and urge the Federal Circuit to create a bright line rule based on the possible interpretation of a single element in a multi-step claim. Lilly’s bright line rule would exclude from patenting any process claim that has any step that could be performed mentally even if the specification supports one or more purely technical interpretation of that step. Application of this rule could effectively preempt from patent protection the use of compounds or agents to compare therapeutic efficacy of compounds. Moreover, similar to the effect of Prometheus, innovators who have invested in protecting their inventions to the fullest extent, based on the reliance of precedent and practice, would lose that investment and protection.

Lilly’s Brief is attached Lilly_Brief.

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Footnotes

1. See Page 6 of the Brief.

2. Id.

3. See Page 7 of the Lilly’s Brief, emphasis in original.

4. 35 U.S.C. § 112(f) “sixth paragraph” recites that ‘[a]n 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.”

5. See Pages 13-14 of the Brief.

 

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