On April 13, 2018, the Federal Circuit held that 35 USC 271(e) infringement applies for ANDA amendments including paragraph IV certification for later-issued patent. Vanda Pharma. Inc. v. West-Ward Pharma. Int'l Ltd., No. 16-2707 (Fed. Cir. Apr. 13, 2018). Vanda owns '610 patent for schizophrenia treatment using iloperidone and has an exclusive license to expired '198 patent which covers the iloperidone compound. Vanda owns a NDA for antipsychotic drug Fanapt (iloperidone) and West-Ward filed an ANDA before '610 issued or was listed in the Orange Book. Vanda sued West-Ward for infringement of '198 patent. After '610 patent issued, Vanda sued for infringement of '610 patent and then Vanda listed '610 patent in the Orange Book. West-Ward amended its ANDA to contain para IV certification that '610 patent is invalid and/or not infringed and sent Vanda the para IV notice re '610 patent. The district consolidated the two lawsuits and found that West-Ward's submission of para IV certification for '610 patent was an act of infringement.
On appeal, the Federal Circuit, in a split decision, held that amending the ANDA by submitting a para IV certification is an act of infringement under the Hatch-Waxman act even if the patent issued after the ANDA filing but before FDA approval. The majority reasoned that the legislative history supports the conclusion that "application," as referred to in Section 271(e)(2)(A), includes ANDA amendments.
Full text of the opinion is available here.
On appeal, the Federal Circuit, in a split decision, held that amending the ANDA by submitting a para IV certification is an act of infringement under the Hatch-Waxman act even if the patent issued after the ANDA filing but before FDA approval. The majority reasoned that the legislative history supports the conclusion that "application," as referred to in Section 271(e)(2)(A), includes ANDA amendments.
Full text of the opinion is available here.
RSS Feed
