Judge Sleet’s recent decision in Millenium Pharmaceuticals v. Pharmascience extended the Federal Circuit’s AstraZeneca decision regarding personal jurisdiction in Hatch-Waxman cases, rejecting an argument that AstraZeneca did not apply to certain ANDA applicants without other contacts with Delaware.
PSI, one of the two defendants in the case, asserted that “unlike Mylan [in the Federal Circuit’s decision], the ANDA is PSI’s sole contact with Delaware” and that “in its analysis, the Federal Circuit pointed to other contacts that Mylan had with Delaware.” PSI argued that it was different because it “is a Canadian company with a principal place of business in Montreal. According to PSI, it prepared the ANDA in Canada, the ANDA was submitted to the FDA in Maryland, and PSI sent its Paragraph N Letter to Millennium in Massachusetts. PSI asserts that it is not incorporated in Delaware, is not registered to do business in Delaware, and it has no employees or agents in Delaware, does not maintain a post office box, mail drop, telephone number, office, or any place of business in Delaware. PSI does not have any bank accounts in Delaware, nor does it file taxes in Delaware. PSI claims that it does not have any distribution channels or an agent to accept service of process in Delaware. PSI asserts that it has only defended itself in one Delaware litigation, which was unrelated to this case. Finally, unlike Mylan, PSI claims it does not have an approved and active ANDA, does not import any drug products into the United States, and has no sales of any drug products in the United States, including Delaware.” Millenium Pharmaceuticals, Inc. v. Pharmascience Inc., et al., C.A. No. 15-702-GMS, Memo at 6-7 (D. Del. June 10, 2016).
Rejecting this argument, Judge Sleet explained that “The Acorda court noted that Mylan was incorporated in West Virginia, prepared its ANDA primarily in West Virginia, and filed its ANDA in Maryland. The court also acknowledged that Mylan was registered to do business in Delaware and AstraZeneca and Acorda are incorporated in Delaware, however, the holding in the case was not based upon these facts. Thus, the court must conclude that specific personal jurisdiction over PSI exists in this case based upon PSI’’s ANDA filing. Delaware is a state where PSI will engage in marketing if the ANDA is approved and that marketing is directly related to this suit.” Id. at 7.
Judge Sleet also found, however, that the other defendant in the case, PSL, should be dismissed because Millennium had not supported with reasonable particularity its allegation that PSL collaborated with PSI to file the ANDA in question. Id. at 8-9.