Photo: Shutterstock Federal Circuit Tries To Demystify Venue in Hatch-Waxman Actions
The Federal Circuit found that "acts of infringement" for venue purposes occur "only in districts where actions related to the submission of an Abbreviated New Drug Application (ANDA) occur, not in all locations where the future distribution of the generic products specified in the ANDA is contemplated."
November 23, 2020 at 11:25 AM
6 minute read
In Valeant Pharms. N. Am. v. Mylan Pharms., No. 2019-2402 (Fed. Cir. Nov. 5, 2020), the Federal Circuit grappled with two statutory schemes to answer a question that district courts have struggled with since TC Heartland: Where do "acts of infringement" under §1400(b) occur in Hatch-Waxman actions? (Compare Bristol-Myers Squibb Co. v. Mylan Pharm., No. 17-cv-379-LPS, 2017 WL 3980155 (D. Del. Sept. 11, 2017) with Galderma Labs., L.P. v. Teva Pharms. USA, 290 F. Supp. 3d 599, 606-09 (N.D. Tex. 2017). For a more in-depth discussion of some of these district court decisions, please see GT Alert, "New Patent Infringement Cases Provide Guidance on Analyzing Venue in the Wake of TC Heartland," Sept. 19, 2017.) Consistent with the Supreme Court's directive to narrowly interpret §1400(b), the Federal Circuit found that "acts of infringement" for venue purposes occur "only in districts where actions related to the submission of an Abbreviated New Drug Application (ANDA) occur, not in all locations where the future distribution of the generic products specified in the ANDA is contemplated."
Background
Valeant Pharmaceuticals North America, Valeant Pharmaceuticals Ireland Ltd., Dow Pharmaceutical Sciences, and Kaken Pharmaceuticals Co., Ltd. (collectively Valeant or Plaintiff) sued Mylan Pharmaceuticals Inc. (MPI), Mylan Laboratories Ltd. (MLL), and Mylan Inc. (collectively, Mylan) and 18 other ANDA filers in the District of New Jersey for patent infringement under the Hatch-Waxman Act relating to the anti-fungal drug, Jublia. (The Plaintiff also brought a protective suit against Mylan in the Northern District of West Virginia.) None of the Mylan defendants are incorporated in New Jersey. MPI is a West Virginia corporation with a principal place of business in Morgantown, West Virginia; Mylan Inc. is a Pennsylvania corporation with a principal place of business in Canonsburg, Pennsylvania; and MLL is an Indian corporation with a principal place of business in Hyderabad, India.
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