Vanda Pharms. Inc. v. Teva Pharms. USA, Inc. Hetlioz® (Tasimelteon)

Robins Kaplan LLP

Robins Kaplan LLP

Case Name: Vanda Pharms. Inc. v. Teva Pharms. USA, Inc., No. 2023-1247, 2023 WL 3335538 (Fed. Cir. May 10, 2023) (Circuit Judges Dyk, Bryson, and Prost presiding; Opinion by Dyk, J.) (Appeal from D. Del., Connolly, J.)

Drug Product and Patent(s)-in-Suit: Hetlioz® (tasimelteon); U.S. Patents Nos. RE46,604 (“the ’604 patent”), 10,149,829 (“the ’829 patent”), 9,730,910 (“the ’910 patent”), and 10,376,487 (“the ’487 patent”)

Nature of the Case and Issue(s) Presented: Vanda sued Teva and Apotex, alleging that their ANDAs infringe four patents. The asserted claims relate to methods of treating Non-24-Hour Sleep-Wake Disorder (“Non-24”) with tasimelteon. The district court held that all of the asserted claims were invalid as obvious. The Federal Circuit affirmed.

Why Defendants Prevailed: On appeal, the Federal Circuit held that the district court did not err in finding an expectation of success, crediting expert testimony explaining similarities between melatonin and tasimelteon, or in relying on ramelteon studies to inform tasimelteon drug interactions. Vanda asked for too high a standard, essentially a confirmation of success. But “[o]bviousness does not require certainty—it requires a reasonable expectation of success.”

Further, the Federal Circuit held that the district court did not err in determining that it would have been obvious to try administering tasimelteon without food. Citing KSR and established case law regarding a “finite number of identified, predictable solutions,” the Federal Circuit determined that the district court had sufficient evidence (e.g., market pressure to determine if food would have an effect on the efficacy of a drug, FDA food-effect guidance) to find it “obvious to try” administering the drug without food.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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