[author: Alex Grabowski]

Addressing a motion to dismiss for improper venue following TC Heartland, a Delaware district court held that an abbreviated new drug application (ANDA) filer that intends to market an allegedly infringing drug in a certain jurisdiction “has committed acts of infringement” in that jurisdiction for purposes of the venue statute. Bristol-Myers Squibb Co. v. Mylan Pharms. Inc., Case No. 17-cv-379 (D Del., Sept. 11, 2017) (Stark, J). The court did not address the ultimate issue of venue, instead deciding that discovery was necessary regarding whether Mylan met the other requirements of the venue statute.

The dispute before the court arose out of a 12(b)(3) motion to dismiss Bristol-Myers’ case for improper venue following the Supreme Court of the United States’ decision in TC Heartland, which curtailed the appropriate venues available in patent cases. Post-TC Heartland venue is only proper in one of two places: (1) where the defendant resides, or (2) “where the defendant has committed acts of infringement, and has a regular and established place of business.” The court held that the first category was clearly not met and thus focused its analysis on the second.

The court determined that Mylan had committed acts of infringement in Delaware, although coming to that conclusion required extensive analysis. The main issue the court grappled with was how to determine what constituted an act of infringement under the venue statute in Hatch-Waxman litigation. As is often repeated, Hatch-Waxman litigation is predicated on “a highly artificial act of infringement,” the filing of an ANDA. The court did not limit acts of infringement to the filing of an ANDA for the purposes of venue, however. Instead, the court relied on Acorda to hold that future intended acts of infringement were relevant to the venue analysis because the purpose of the Hatch-Waxman statute was to accelerate what would otherwise be an ordinary infringement action. Thus, Mylan’s intention to market its allegedly infringing product in Delaware if it was approved would be a putative act of infringement in Delaware.

That was not the end of the court’s analysis, as it also had to determine whether Mylan had a regular and established place of business in Delaware. The court considered several previous cases to develop a framework for what would constitute a regular and established place of business. Specifically, a defendant has a regular and established place of business when it has a permanent and continuous presence in the district. Such presence does not require a formal office or store, but it does require a physical presence, not a mere website or registration to do business. Ultimately, the court was unable to come to a conclusion on this prong based on the record in front of it, and dismissed the motion without prejudice pending limited discovery on the issue.