Federal Circuit narrows the scope of Venue in Hatch-Waxman (ANDA) Litigation


US Court of Appeals for the Federal Circuit, in the Valeant Pharmaceuticals v. Mylan pharmaceuticals, held that “acts of infringement” in Hatch-Waxman litigation occurs where actions related to the submission of an Abbreviated New Drug Application (“ANDA”) occur, not where the future distribution of a generic product specified in an ANDA is planned.

Background Of The Case

On September 26, 2018, Valeant filed a suit in the District of New Jersey against generic drug makers Mylan (Mylan Pharmaceuticals Inc. (MPI)/ Mylan Laboratories Ltd.(MLL)/ Mylan Inc.), alleging infringement of Dow’s Orange Book patents protecting Jublia®. In 2019, Mylan moved to dismiss Valeant’s New Jersey District Court complaint against Mylan for the improper venue on the basis that the alleged infringement, submission of an ANDA occurred in West Virginia. Further, Mylan contended that the venue was improper under § 1400(b) because the Mylan does not reside in New Jersey and the Mylan do not have regular and established places of business in New Jersey. In response, Valeant argued that the venue for the Mylan was appropriate in New Jersey because they planned future acts, i.e., the sale of Mylan’s ANDA products across the U.S., including in New Jersey. The district court granted Mylan’s motion, reasoning that planned future sales were not “acts of infringement” under § 1400(b). Valeant appealed the district court’s decision.


Venue in ANDA Litigation

Abbreviated New Drug ApplicationThe statute governing the patent venue in the Hatch-Waxman litigation is codified in 28 U.S.C. § 1400 (b), which states: “Any civil action for patent infringement may be brought in the judicial district where the defendant resides, or where the defendant has committed acts of infringement and has a regular and established place of business.”

In TC Heartland LLC v. Kraft Foods Grp. Brands LLC, the Supreme Court held that for the purposes of 28 U.S.C. § 1400(b) a corporation ‘resides’ only in the state in which it is incorporated. Further, the Supreme Court held that the patent cases require the more specific venue statute and do not consider the definition of “resides” from the general venue statute.

Decision Of The Federal Circuit

The Federal Circuit notes that under ANDA cases, submission of an ANDA is an act of infringement. Federal Circuit further framed that the question to be answered in this appeal is “whether the act of infringement identified in § 1400(b) occurs only when and where an ANDA-filer submits its ANDA to the FDA or occurs wherever future distribution of the generic is contemplated”. The Federal Circuit noted that the court is bound by the “TC Heartland” decision of the Supreme Court in deciding the venue of Hatch-Waxman litigation.

The Federal Circuit said that § 1400(b) requires a past act of infringement which was agreed by both parties.  The Federal Circuit reasoned that plain language reading of the Hatch-Waxman Act concludes that it is the submission of the ANDA, and only the submission, that constitutes an act of infringement in this context. The federal circuit rejected the Valeant’s argument of proper venue since MPI has not submitted ANDA from New Jersey. Further, the court noted that the future distribution of the product has no relevance in the Hatch-Waxman litigation.

Therefore, the Federal Circuit came to the conclusion that the venue is proper only in those districts that are sufficiently related to the ANDA submission.

Venue For Foreign Defendants

The Federal Circuit came to a different conclusion as to the foreign defendant (MLL), stating that MLL is a foreign entity incorporated in Hyderabad, India, and is properly subject to venue in any judicial district, including the District of New Jersey. Thus, the Federal Circuit reversed the district court’s venue-based dismissal as to MLL and remanded it for further consideration.

About the author: Mr. Dhakshina Moorthy, a legal practitioner at Global Patent Filing. In case of any queries please contact/write back to us at support@globalpatentfiling.com.

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