federal circuit limits anda venue
On Nov. 5, 2020, the Federal Circuit affirmed a lower court's order dismissing the claims against two defendants for improper venue. Valeant Pharm. v. Mylan Pharm., No. 19-2402 (Fed. Cir. Nov. 5, 2020). The Federal Circuit concluded that for venue purposes in ANDA cases, infringement occurs only in districts where actions related to the submission of an ANDA occur and not all locations where future distribution of the generic products is contemplated.
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.
lack of jurisdiction over interlocutory discovery order in bpcia, rules federal circuit
On Aug. 10, 2017, the Federal Circuit dismissed an interlocutory appeal of a denied discovery order for lack of jurisdiction and denied the writ of mandamus seeking to compel discovery in a patent infringement case under Biologics Price Competition and Innovation Act of 2009 (BPCIA). Amgen Inc. v. Hospira, Inc., No. 2016-2179 (Fed. Cir. Aug. 10, 2017). Amgen alleged that Hospira, which filed a subsection (k) application for a biosimilar of EPOGEN, failed to comply with paragraph (l)(2)(A) for failing to provide information concerning the process used to manufacture the biological product. Despite this disagreement over Hospira’s compliance, Amgen listed the patents relating to the biological product but didn’t identify any cell-culture patent as part of its own BPCIA disclosures. Amgen filed suit against Hospira and sought discovery on the composition of Hospira’s cell-culture medium. Amgen filed a motion to compel after Hospira rejected Amgen’s discovery requests. In denying Amgen’s motion, the district court reasoned that the cell-culture information had no relevance to the asserted patents. In dismissing the appeal, the Federal Circuit stated rulings on discovery do not qualify for the collateral order doctrine’s exception to the final judgment rule and the lack of immediate appeal over such discovery orders does not render them effectively unreviewable.
Full text of the opinion is available here.
In its first post-Actavis action against pharmaceutical companies, the FTC sued AbbVie, Abbott Labs, Unimed Pharmaceuticals, Besins Healthcare and Teva Pharmaceuticals under Section 5(a) of the FTC Act alleging that the defendants engaged in unfair methods of competition regarding the prescription drug AndroGel. FTC v. AbbVie, Inc., No. 2:14-cv-05151 (E.D. Penn. Sept. 8, 2014) The complaint alleges that defendants AbbVie and Besins filed a sham litigation against Teva by suing it for patent infringement. Teva entered into a pay-for-delay agreement with AbbVie and Besins and as a result, Teva agreed not to introduce the generic version of AndroGel until a certain time period. The FTC alleges that AbbVie's filing of sham litigation against Teva and the agreement among the defendants violates Section 5(a) of the FTC Act.
Full text of the FTC's complaint is available here.
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