Chief Judge Leonard Stark of the District of Delaware recently shed some light on the venue analysis in Hatch-Waxman litigation.  Bristol-Myers Squibb Company et al v. Mylan Pharmaceuticals Inc., No. 1-17-cv-00379 (D. Del. November 28, 2017).  Mylan moved to dismiss pursuant to Rule 12(b)(3), arguing that its corporate subsidiary and affiliate’s places of business cannot be relied upon to establish venue.  In response, Bristol-Myers Squibb Co. and Pfizer Inc. (“Plaintiffs”) sought discovery related to the facts underlying Mylan’s position, which the Court granted.

Mylan contended that the requested discovery was frivolous based on the Federal Circuit’s decision in In re Cray Inc., 871 F.3d 1355 (Fed. Cir. Sept. 21, 2017).  In Cray, the Federal Circuit held that the presence of two employees living and working within the Eastern District of Texas did not satisfy the “regular and established place of business” requirement.  Among other reasons, Cray declined to give weight to the employees domicile because employees can change jobs and it would be illogical to treat the employee’s home as the place of business of the defendant.

Judge Stark identified two potential facts that could distinguish Mylan’s relationship to the venue from the facts presented by Cray.  First, unlike the employees in Cray, a company cannot readily terminate a relationship with its corporate affiliate.  Second, while a company does not often ratify or choose the domicile of its employees, the facts may show that Mylan established or ratified the location of its corporate affiliate.

Judge Stark also noted that it is not necessary for the plaintiff to establish a relationship between the related entities and the ANDA at issue in the lawsuit.

While Judge Stark’s order did not resolve the issue of venue, it does shed light on potential ways for plaintiffs to establish venue in ANDA litigation in the District of Delaware.