Helsinn Healthcare S.A. v. Hospira, Inc.

Applying the Federal Circuit’s recent decision in Acorda Therapeutics, the court denied defendants’ motion to dismiss on grounds of lack of personal jurisdiction, and also denied defendants’ Rule 12(b)(6) motion because § 271(e)(2) does not explicitly require an entity to sign the ANDA in order for it to be a properly-named defendant.

July 21, 2016

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name: Helsinn Healthcare S.A. v. Hospira, Inc., Civil No. 15-2077 (MLC), 2016 U.S. Dist. LEXIS 45826 (D.N.J. Apr. 5, 2016) (Cooper, J.)

Drug Product and Patents-in-Suit: Aloxi® (palonosetron); U.S. Patents Nos. 7,947,724 (“the ’724 patent”), 7,947,725 (“the ’725 patent”), 7,960,424 (“the ’424 patent”), 8,598,219 (“the ’219 patent”), and 8,729,094 (“the ’094 patent”)

Nature of the Case and Issue(s) Presented: Helsinn, incorporated in Switzerland, is an assignee of the patents-in-suit. Helsinn maintains a principal place of business in Switzerland. Helsinn’s distributor, Eisai, and its research and development company, Helsinn Therapeutics, have their principal places of business in New Jersey. Roche Palo Alto is a pharmaceutical company incorporated in Delaware with its principal place of business in California, and is another assignee of the patents-in-suit.

Hospira, a Delaware corporation having its principal place of business in Illinois, identifies itself as “the world’s leading provider of injectable drugs and infusion technologies.” Worldwide, Hospira’s subsidiary, is also incorporated in Delaware with its principal place of business in Illinois. Worldwide, which markets, sells, and distributes drugs for Hospira in the United States, is registered to do business in New Jersey, and has designated an in-state agent to receive service of process.

Hospira mailed its ANDA Paragraph IV certification notice letter to Roche in California, to Helsinn in Switzerland, and to three law firms in Georgia. Helsinn filed suit and Defendants moved to dismiss under Fed. R. Civ. P. 12(b)(2) and 12(b)(6).

Why Plaintiffs Prevailed:  The court first addressed Defendants’ lack-of-personal-jurisdiction arguments. The court agreed with Helsinn that specific jurisdiction may be asserted over Hospira and Worldwide because of Defendants’ suit-related contacts with New Jersey. Under the rationale set forth in Acorda Therapeutics Inc. v. Mylan Pharms. Inc., 817 F.3d 755 (Fed. Cir. 2016), the court found that Hospira’s marketing of generic palonosetron will, at least in some part, take place in New Jersey because Hospira identifies itself as “the world’s leading provider of injectable drugs and infusion technologies.” Although Hospira argued that it did not sell its drugs directly into the state, it admitted that Worldwide had registered to do business in New Jersey and would market, sell, and distribute Hospira’s palonosetron product in the state upon FDA approval. Moreover, the court did not find any unfairness that would override the minimum contacts that Hospira and Worldwide have with New Jersey. Hospira had litigated Hatch-Waxman lawsuits in the District of New Jersey, initiating at least two of those actions. New Jersey had an interest in adjudicating the parties’ dispute because this court had adjudicated and was currently adjudicating many similar Hatch-Waxman cases on generic palonosetron products. Finally, the court noted that the argument raised by Hospira that “simply because Hospira's generic drug products are sold in New Jersey…is no basis for jurisdiction” was rejected by the Federal Circuit in Acorda, which held that ANDA filings establish a substantial connection with a forum state and the ANDA filer because they predict the filer’s activities within the state, i.e., the manufacturing or marketing of a generic product.

Next, the court addressed Defendants’ Rule 12(b)(6) argument. Hospira argued that the claims asserted against Worldwide should be dismissed for failure to state a claim because: (i) Worldwide did not submit the ANDA; (ii) 35 U.S.C. § 271 did not permit an action to proceed on the theory that the defendant induced the submission of an ANDA; and (iii) even if § 271 were to permit an inducement theory, the inducement claims alleged against Worldwide were boilerplate and did not pass muster under Twombly and Iqbal. Helsinn responded that it had stated a claim against Worldwide because: (i) a party was not required to submit an ANDA to be a proper party in Hatch-Waxman litigation; (ii) Worldwide was actively involved in the litigation as Hospira’s marketer, distributor, and seller of its ANDA products; and (iii) contrary to Defendants’ argument, § 271(e) supported an induced infringement action, and in this case, Worldwide had induced Hospira to commit infringement by planning to manufacture, import, market, and sell the ANDA product. Helsinn stated: first, § 271(e)(2) did not explicitly require Worldwide to sign the ANDA in order for it to be a properly-named defendant; second, if the ANDA were approved, Worldwide would become the generic product’s sole marketer, seller, and distributor in the United States. Thus, Worldwide intended to, and certainly would, benefit from the ANDA if it were approved. Third, Helsinn pled that if Hospira, through Worldwide, “commercially manufactures, uses, offers for sale, or sells it proposed generic versions” of Aloxi, or if Worldwide otherwise induces these acts, Hospira and Worldwide will have infringed the Aloxi patents. Those allegations were sufficient to raise a right to relief above the speculative level. Accordingly, the court denied Defendants' Rule 12(b)(6) motion.

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