Impax Laboratories Inc. v. Lannett Holdings Inc., No. 17-2020 (Fed. Cir. 2018)Annotate this Case
Triptans are selective serotonin receptor agonists, developed in the 1980s. When Zolmitriptan became available in the U.S. in oral tablet form in 1999 under the name Zomig® it was among several triptans on the market or under development. AstraZeneca owns the 237 and 767 patents, which relate to formulations of zolmitriptan for intranasal administration, and the New Drug Application for Zomig® (zolmitriptan) Nasal Spray, approved by the FDA for treatment of migraines. The patents are listed in connection with Zomig® Nasal Spray in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). In 2012, AstraZeneca and Impax entered into an agreement, granting Impax an exclusive license to AstraZeneca’s patents covering the Zomig® products, for the payment of $130 million and additional payments at varying royalty rates. In 2014, Lannett notified AstraZeneca that it had filed an Abbreviated New Drug Application, seeking approval for a generic version of Zomig® Nasal Spray, with a Paragraph IV certification (21 U.S.C. 355(j)(2)(A)(vii)(IV)), alleging noninfringement or invalidity of the 237 and 767 patents. In the subsequent infringement suit, 35 U.S.C. 271(e)(2)(A), the district court issued its claim construction opinion, the parties stipulated to infringement, and the court held that Lannett failed to prove by clear and convincing evidence that the asserted claims were invalid or would have been obvious over prior art. The Federal Circuit affirmed, upholding the entry of an injunction.
The court issued a subsequent related opinion or order on July 2, 2018.