Obviousness: Cannot Forget The Motivation To Combine Or Modify

• Published date: 05 September 2022
• Subject Matter: Intellectual Property, Patent
• Law Firm: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
• Author: Ms Melanie Magdun, Hira Javed, Adriana Burgy and Stacy Lewis

Holding:

In Tris Pharma Inc. v. Actavis Laboratories FL, Inc., No. 21-1495 (Fed. Cir. July 7, 2022) (non-precedential), the Court of Appeals for the Federal Circuit ("Federal Circuit") affirmed the district court's holding that Actavis failed to show that the challenged claims would have been obvious.

Background:

Tris Pharma, Inc. ("Tris") owns U.S. Patent Nos. 8,465,765 ("the '765 patent"), 8,563,033 ("the '033 patent"), and 8,778,390 ("the '390 patent"), which have claims related to a liquid methylphenidate ("MPH") oral suspension with certain pharmacodynamic and pharmacokinetic properties. MPH is used to treat attention deficit hyperactivity disorder.

Tris asserted claims of all three patents against Actavis Laboratories FL, Inc. ("Actavis") in the U.S. District Court for the District of Delaware. The district court judge held that all asserted claims would have been obvious under 35 U.S.C. ' 103. Tris Pharma, Inc. v. Actavis Lab'ys FL, Inc., 276 F. Supp. 3d 226, 249 (D. Del. 2017). Tris then appealed that decision to the Federal Circuit, which held that the district court "failed to make the necessary factual findings and provide sufficient analysis of the parties' arguments to permit effective appellate review" and subsequently vacated and remanded for further fact-finding. Tris Pharma, Inc. v. Actavis Lab'ys FL, Inc., 755 F. App'x 983, 989 (Fed. Cir. 2018) (Tris I).

On remand, as in the original district court proceeding, Actavis relied on five commercially available MPH formulations, a U.S Patent Application Publication (Scicinski), and several scientific articles as prior art. Tris Pharma, Inc. v. Actavis Lab'ys FL, Inc., 503 F. Supp. 3d 183, 191 (D. Del. 2020) (Remand Decision). The district court, Judge Connolly presiding, concluded that each aspect of the asserted claims was disclosed by a piece of prior art, but no single reference disclosed all the claim limitations. Id. at 195. Further, Actavis failed to prove by clear and convincing evidence that a person of ordinary skill in the art would have been motivated to combine the prior art references with a reasonable expectation of success, thus the asserted claims would not have been obvious. Id. at 202-03 (D. Del. 2020). Actavis appealed this decision.

Federal Circuit Decision:

On appeal, the Federal Circuit reviews a district court's legal conclusions regarding obviousness de novo and any factual findings for clear error. Tris Pharma Inc. v. Actavis Laboratories FL, Inc., No. 21-1495, at *7...