Providing API to ANDA Applicants Is Within Section 271(e)(1) Safe Harbor: Federal Circuit | Practical Law

Providing API to ANDA Applicants Is Within Section 271(e)(1) Safe Harbor: Federal Circuit | Practical Law

In Shire LLC v. Amneal Pharmaceuticals, LLC, the US Court of Appeals for the Federal Circuit reversed the district court's judgment that defendant Johnson Matthey had induced infringement of the compound patent claims at issue, holding that Johnson Matthey's act of supplying the active pharmaceutical ingredient (API) to other defendants who used the API to file an Abbreviated New Drug Application (ANDA) was reasonably related to the submission of the ANDA and therefore protected by the safe harbor provided by 35 U.S.C. § 271(e)(1).

Providing API to ANDA Applicants Is Within Section 271(e)(1) Safe Harbor: Federal Circuit

by Practical Law Intellectual Property & Technology
Published on 29 Sep 2015 • USA (National/Federal)
In Shire LLC v. Amneal Pharmaceuticals, LLC, the US Court of Appeals for the Federal Circuit reversed the district court's judgment that defendant Johnson Matthey had induced infringement of the compound patent claims at issue, holding that Johnson Matthey's act of supplying the active pharmaceutical ingredient (API) to other defendants who used the API to file an Abbreviated New Drug Application (ANDA) was reasonably related to the submission of the ANDA and therefore protected by the safe harbor provided by 35 U.S.C. § 271(e)(1).
On September 24, 2015, in Shire LLC v. Amneal Pharmaceuticals, LLC, the US Court of Appeals for the Federal Circuit reversed the US District Court for the District of New Jersey's judgment that defendant Johnson Matthey Pharmaceutical Materials had induced infringement of the asserted compound patent claims (Nos. 2014–1736, -1737, –1738, –1739, –1740, –1741, (Fed. Cir. Sept. 24, 2015)). The court held that Johnson Matthey's act of supplying the active pharmaceutical ingredient (API) to other defendants, who then used the API to each file an Abbreviated New Drug Application (ANDA), was reasonably related to the submission of the ANDAs and therefore protected by the safe harbor in 35 U.S.C. § 271(e)(1). The Federal Circuit also affirmed the district court's holding on non-obviousness and its denial of defendants' motion to amend their invalidity contentions.
This case involved four patents assigned to Shire LLC that cover amphetamine derivatives, which are used to treat various disorders including attention deficit hyperactivity disorder (ADHD). Shire markets Vyvanse for the treatment of ADHD. Vyvanse capsules contain a dimesylate salt of LDX, an amphetamine derivative, and are covered by the claims of the asserted patents. Several companies filed ANDAs (ANDA defendants) seeking approval to market their generic versions of Vyvanse before the asserted patents expired and submitted Paragraph IV certifications to Shire (21 U.S.C. § 355(j)(2)(A)(vii)(IV)). Subsequently, Shire sued the ANDA defendants for patent infringement. In its suits, Shire also sued Johnson Matthey who:
  • Supplied the ANDA defendants with LDX dimesylate, the API in their proposed generic products.
  • Filed a drug master file with the FDA for the API in support of the defendants' ANDAs under 21 C.F.R. § 314.420.
  • Did not itself file an ANDA.
Shire then filed a motion for summary judgment, which the district court granted in part and denied in part. With respect to Shire's claims against Johnson Matthey, the district court held that Johnson Matthey had induced infringement of the compound claims of the asserted patents.
On appeal, the Federal Circuit reversed the district court's determination with respect to the claims against Johnson Matthey. The court explained that:
The Federal Circuit also affirmed the district court's decisions that:
  • The defendants' cited references did not raise a genuine issue of material fact with respect to obviousness.
  • The defendants' motion to amend their invalidity contentions was untimely and lacked good cause.