Frequent ANDA Filer May Have Regular and Established Place of Business in Delaware​

The court denied without prejudice defendant's motion to dismiss plaintiffs' ANDA infringement action for improper venue pending discovery on whether defendant had a regular and established place of business in the forum. "[Defendant] is part of [a] family of companies which have a nationwide and global footprint. . . . Within the [company] family, [defendant] appears to serve the role of securing regulatory approval for many of [their] generic products. . . . [I]t appears that a key to [defendant's] success in the generic drug business is its constant involvement in Hatch-Waxman litigation. Historically, the largest number of Hatch-Waxman cases each year are filed in the District of Delaware. . . . [Defendant], as a frequent ANDA filer, appears in front of this Court with regularity for the purpose of getting its generic drugs on the market, and when that litigation concludes in a way that is favorable for [defendant], those generic drugs are distributed to and used by Delaware residents through a distribution network that has been established for that purpose. In the Court's view, this business reality is a pertinent consideration in assessing whether [defendant] has a regular and established place of business in Delaware. . . . While [defendant] has been unable to this point to identify a 'fixed physical presence in the sense of a formal office or store' that [defendant] maintains in Delaware, this is not required. . . . [N]o relationship between a defendant's acts of infringement and its regular and established place of business is necessary to satisfy § 1400(b)."

Bristol-Myers Squibb Company et al v. Mylan Pharmaceuticals, Inc., 1-17-cv-00379 (DED September 11, 2017, Order) (Stark, USDJ)