Redefining Patent Utility: The Functional Relationship Test's Answer to Super-Utility Claims

"Bayer's U.S. Patent No. 10,828,310, which claims methods for reducing cardiovascular events in certain patients by administering specific doses of rivaroxaban (2.5 mg twice daily) and aspirin (75-100 mg daily) "in amounts that are clinically proven effective." Generic manufacturers Mylan, Teva, and Invagen successfully challenged the patent in IPR proceedings - finding the claim term non-limiting. The Federal Circuit agreed that the term did not provide patentable weight - but through a different analytical path."

"The PTAB concluded "clinically proven effective" was non-limiting, reasoning that because the claims already recited specific dosage amounts (2.5 mg rivaroxaban twice daily and 75-100 mg aspirin daily), the additional characterization of these amounts as "clinically proven effective" was merely redundant. Drawing on Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368 (Fed. Cir. 2001), the PTAB found the phrase constituted an "expression of intended result [that] essentially duplicates the dosage amounts recited in the claims.""

"On appeal though, the Federal Circuit took a markedly different approach, declining to decide whether "clinically proven effective" was limiting at all. Instead, the court applied the functional relationship test from King Pharms, concluding that even if the phrase were limiting, it constituted a "functionally unrelated limitation" that could not rescue an otherwise anticipated method from unpatentability. The court reasoned that clinical proof of efficacy "in no way transforms the process of taking the drug[s]" at the specified amounts"

Bayer's U.S. Patent No. 10,828,310 claims methods for reducing cardiovascular events by administering rivaroxaban 2.5 mg twice daily and aspirin 75-100 mg daily "in amounts that are clinically proven effective." Generic challengers Mylan, Teva, and Invagen prevailed in IPRs, with the PTAB finding the "clinically proven effective" phrase non-limiting as redundant to the recited dosages. The Federal Circuit declined to resolve whether the phrase is limiting and instead applied the King Pharms functional relationship test, holding that clinical proof of efficacy is functionally unrelated to the claimed act of taking the drugs and cannot rescue an anticipated claim.

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