On September 24 2015 the Federal Circuit issued an opinion addressing infringement liability for active pharmaceutical ingredient (API) suppliers in Hatch-Waxman cases. In particular, the court held that API supplier Johnson Matthey's activities were protected by the safe harbour provision of 35 USC § 271(e)(1), and that it did not induce infringement under 35 USC § 271(b) by providing APIs to abbreviated new drug application (ANDA) applicants for use in obtaining Food and Drug Administration (FDA) approval.
Shire's drug Vyvanse (lisdexamfetamine dimesylate) is a central nervous system stimulant approved to treat attention deficit hyperactivity disorder and moderate to severe binge-eating disorders. Several generic drug companies filed ANDAs seeking approval to market generic versions of Vyvanse before the expiration of its Orange Book-listed patents.
In addition to suing the ANDA applicants, Shire sued its API supplier, Johnson Matthey Pharmaceutical Materials. The district court granted summary judgment that, among other things, the ANDA applicants had infringed the asserted compound claims and Johnson Matthey had induced infringement of the compound claims. The district court interpreted the Federal Circuit's prior decision in Forest Labs, Inc v Ivax Pharms, Inc(1) as standing for the proposition that the filing of an ANDA can create inducement liability for the ANDA applicant's manufacturer or supplier.
The Federal Circuit affirmed the district court's holdings that the asserted claims were non-obvious and that Johnson Matthey did not directly infringe under 35 USC § 271(e)(2) because it did not submit an ANDA. However, it reversed the district court's decision on the issue of inducement, stating that the Section 271(e)(2) safe harbour provision protected Johnson Matthey's activities thus far, which consisted of providing material for use by the ANDA applicants in obtaining FDA approval. The court distinguished Forest, stating that Forest involved the scope of an injunction under Section 271(e)(4), whereas no injunction had been issued against Johnson Matthey in this case.
For further information on this topic please contact Tara A Byrne or Erin JD Austin at Fitzpatrick, Cella, Harper & Scinto by telephone (+1 212 218 2100) or email (firstname.lastname@example.org or email@example.com). The Fitzpatrick, Cella, Harper & Scinto website can be accessed at www.fitzpatrickcella.com.
(1) 501 F 3d 1263 (Fed Cir 2007).
ILO - This article was first published by the International Law Office, a premium online legal update service for major companies and law firms worldwide. Register for a free subscription.