by Dennis Crouch
Eli Lilly and Company v. Erfindergemeinschaft UroPep GbR, SCT Docket No. 18-1515 (Supreme Court 2019)
Lilly’s new petition for writ of certiorari asks an easy question:
Whether a single-step patent claim that describes its point of novelty solely in functional terms violates the rule against functional claiming set forth in Halliburton Oil Well Cementing Co. v. Walker, 329 U.S. 1 (1946).
The question as posed is easy to answer. Any patent claim that describes its point of novelty solely in functional terms is invalid violates the rule set forth in Halliburton. Of course, Halliburton was abrogated by the 1952 Patent Act with the adoption of what is now known as 35 U.S.C. 112(f):
Element in Claim for a Combination. — 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.
Note here that the 1952 patent act only discussed the treatment of functionally claimed elements in “a claim for a combination.” The real question here is whether Halliburton is still good law for “single-step patent claims.” I’m betting the Supreme Court would say yes — A claim with a single element would be invalid if that element was claimed solely in functional terms.
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The petition reads a bit like a mystery novel.
A few months [after Lilly obtained FDA approval to market tadalfil for BPH treatment], respondent—a shadowy non-practicing entity based in Germany—filed the patent application that ultimately became the patent at issue here,
claiming priority to an application from 1997.
Here, UroPep’s patent covers a one step method of treatment/prophylaxis claim for BPH. The one step is as follows:
administering to a person in need thereof an effective amount of an inhibitor of phosphodiesterase (PDE) V [excluding eight particular compounds].
Back in 1997, PDE V inhibitors where already known, and tadalafil in particular was known to be a PDE V inhibitor. The 1997 priority document mentions ten different PDE V compounds, but does not mention tadalafil, and the claim excludes eight of those ten.
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Lilly’s question presented includes an important and disputed presumption — that the claim “describes its point of novelty solely in functional terms.” In its decision, the district court held that the claimed step of administering a PDE V inhibitor was not wholly functional.
Even if means-plus-function analysis would apply to a product claim to “an inhibitor of PDE V,” it does not apply to a method claim reciting a method of administering that substance to a patient.
District Court Decision. The jury then awarded $20 million in damages. On appeal, the Federal Circuit affirmed without opinion (R.36) — setting up this current petition.
To be clear, the district court analysis here asks whether this fits under 112(6), not whether it comports with Halliburton. That case states that a claim which “describes [its] most crucial element … in terms of what it will do, rather than in terms of its own physical characteristics … is invalid as a violation of Rev.Stat. § 4888 [indefiniteness].” In General Elec. Co. v. Wabash Appliance Corp., 304 U.S. 364 (1938), the court similarly wrote invalidated claims where the inventor “uses conveniently functional language at the exact point of novelty.”
There are several ways that these cases could be applied here. Example: (A) Since PDE V inhibitors were already known, their existence was not the point of novelty. Rather, the point of novelty is administering those known drugs in order to treat a particular condition — and that “administering” portion of the claim was not described functionally. (B) Another way of thinking here is that the novelty of the claim is administering a particular drug — but we don’t know the details of that particular drug is because it is described functionally.