Earlier this month, Valeant Pharmaceuticals North America LLC (“Valeant”) filed a petition for rehearing en banc in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., No. 2019-2402, arguing that the Federal Circuit panel’s decision limiting venue in Hatch-Waxman cases conflicts with precedent regarding “what the act of infringement is” and “where the act of infringement occurs” under Section 271(e)(2) of the Patent Act. Dkt. 75 at 15, 20. In its panel decision, the Federal Circuit held that venue in Hatch-Waxman cases brought under 35 U.S.C. § 271(e)(2)(A) is proper “only in districts where actions related to the submission of an Abbreviated New Drug Application (‘ANDA’) occur, not in all locations where future distribution of the generic products specified in the ANDA is contemplated.”
In its petition, Valeant contends that the “panel’s ruling is legal error that departs from [the Federal Circuit’s] long-standing precedents regarding both what is included in the § 271(e)(2) act of infringement and where acts of infringement occur.” Dkt. 75 at 11. Valeant further asserts that the decision, if left unchanged, “would effect a detrimental and seismic shift in Hatch-Waxman pharmaceutical patent litigation that will increase uncertainty, delay, and costs, all at the expense of judicial economy.” Id. at 11-12. For support, Valeant points to the Federal Circuit’s earlier decisions in Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562 (Fed. Cir. 1997) and Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1346 (Fed. Cir. 2003). It further argues that the statutory language of 35 U.S.C. §§ 271(e)(4) “makes clear that Congress intended to treat the proposed acts of making, using, and selling the generic products as having been committed in the past with the submission of the ANDA.” Id. at 18. Valeant also raises concerns about properly identifying the location of an ANDA submission, asserting that “the ambiguities and logical consequences of the panel decision are far-reaching and fraught with uncertainty” because, inter alia, “the panel does not address how the location of ‘submission’ is to be determined.” Id. at 12, 23.