Relying on the US Court of Appeals for the Federal Circuit’s recent decision in Acorda Therapeutics Inc. v. Mylan Pharmaceuticals, Inc., Nos. 15-1456, 15-1460, 2016 WL 1077048 (Fed. Cir. Mar. 18, 2016) and the plain language of 35 U.S.C. §271, the US District Court for the District of New Jersey denied Defendants’ motions to dismiss for lack of personal jurisdiction and failure to state a claim. Helsinn Healthcare S.A. v. Hospira, Inc. Civ. Action No. 15-2077, 2016 WL 1338601 (D.N.J. Apr. 5, 2016) (Cooper, D.J.).

Personal Jurisdiction

Plaintiffs Helsinn Healthcare, Eisai, Inc. and Roche sued Hospira and its subsidiary Hospira Worldwide (Worldwide) alleging infringement of several Orange-book listed patents for Aloxi® (palonosetron HCI injection), which is used to prevent and treat chemotherapy-induced nausea and vomiting. Worldwide markets, sells and distributes Hospira’s products in the United States and would be the entity marketing, selling and distributing generic Aloxi upon approval from the US Food and Drug Administration (FDA).

Defendants moved to dismiss for lack of personal jurisdiction arguing the following:

  1. The court did not have general jurisdiction because
    1. Neither Hospira nor Worldwide were incorporated or had their principal places of business in New Jersey; and
    2. The case did not fall within an exception set forth in the Supreme Court of the United States’ Daimler decision.
  2. Worldwide did not consent to jurisdiction simply because it is registered to do business in New Jersey. The court did not have specific jurisdiction because
    1. Sending its notice letter to Helsinn in New Jersey was not a purposeful direction of activities to a New Jersey resident;
    2. The sale and distribution of Hospira products in New Jersey cannot confer jurisdiction since no sales of generic Aloxi by Defendants had yet to occur; and
    3. Conferring jurisdiction based on the possibility of sale or distribution would confer a “virtually unbounded” opportunity for forum-shopping.

Not reaching the issue of general jurisdiction because consent by registering to do business is the subject of a circuit split and open question at the Federal Circuit, the court found it had specific jurisdiction over Defendants. Analogizing the facts at issue to the Federal Circuit’s Acorda decision, the court found Hospira and Worldwide had minimum contacts with New Jersey because Hospira’s marketing of generic Aloxi “will, at least in some part, take place in New Jersey,” and because Worldwide is registered to do business in New Jersey and will market, sell and distribute its generic Aloxi in New Jersey.

Turning to the fairness factors, the court found no unfairness since Hospira had previously litigated Hatch-Waxman cases in New Jersey, including initiating at least two actions and the court had, and is currently adjudicating, many similar cases related to generic Aloxi. The court also applied the Acorda holding that abbreviated new drug application (ANDA) filings establish a substantial connection to the forum state because they predict the ANDA filer’s future activities within the forum state (e.g., marketing, selling and distributing).

Failure to State a Claim

Defendants next argued that Worldwide should be dismissed from the action because Worldwide did not submit the ANDA to the FDA so they cannot be liable for induced infringement under 35 USC §271  and Plaintiffs inducement claims in their complaint did not pass muster under Twombly and Iqbal. Rejecting these arguments, the court first held that 35 USC §271(e)(2) does not require a party, such as Worldwide, to sign the ANDA in order for it to be a properly named defendant. Second, the court found that an inducement claim under §271(e)(2) requires allegations of future acts committed after the ANDA is approved. Because Plaintiffs alleged facts sufficient to show that Worldwide would benefit as the sole marketer, seller and distributor in the United States of Hospira’s generic Aloxi product and that these acts would constitute infringement, the court denied Defendants’ motion to dismiss Worldwide.