Published on:

Judge Robinson Dismisses Hatch-Waxman Litigation for Lack of Personal Jurisdiction

Judge Robinson recently granted a motion to dismiss a Hatch-Waxman case for lack of personal jurisdiction because the defendant had almost no connection to Delaware. Although Defendant currently conducts drug and business development only in Massachusetts and New York and is incorporated in Virginia, Plaintiff “point[ed] to [Defendant’s] long-standing former incorporation in the State of Delaware . . . from 2002 to 2014” in support of jurisdiction. Purdue Pharma L.P., et al. v. Collegium Pharm., Inc., C.A. No. 15-260-SLR, Memo. Op. at 7-8 (D. Del. Aug. 6, 2015). Recognizing that “the traditional grounds for exercising general jurisdiction over drug company defendants in Hatch-Waxman litigation have been narrowed” recently, Judge Robinson granted the motion to dismiss because there was no general jurisdiction: “[Defendant] is not currently incorporated in Delaware, nor is Delaware its principal place of business.” Id. at 8-9. Further, “the grounds for establishing specific jurisdiction asserted at bar are not compelling . . . . [Defendant] did not send its Paragraph IV Notice Letter to [Plaintiff] in Delaware; [Defendant] is not registered to do business in Delaware; [Plaintiff] did not prepare its NDA in Delaware. Although [Defendant] worked with a Delaware corporation to conduct clinical trials for its NDA submission, there is no indication of record that the trials themselves took place in Delaware. Likewise, although oxycodone, the API used in [Defendant’s proposed] product, is manufactured in Wilmington, Delaware . . . oxycodone is a basic API that is the subject of numerous patents and is commercially available in at least two dosage forms. Even if such a contact were held to satisfy Delaware’s long-arm statute, the court concludes that it would not pass constitutional muster.” Id. at 10.

Having found that the Court lacked jurisdiction, Judge Robinson next had to decide between transfer to the Southern District of New York, where Defendant had consented to jurisdiction and favored transfer, and the District of Massachusetts, where Plaintiff had filed a “back-up action” and favored: “There is no doubt that jurisdiction can be exercised over [Defendant] in Massachusetts, where [Defendant] continues to be headquartered and to engage in drug and business development and investment activities. . . . [A] straightforward venue like Massachusetts is the most reasonable solution to the parties’ dispute in this regard.” Id. at 11-12.

Contact Information