District Court Denies Motion to Dismiss for Lack of Personal Jurisdiction Where Plaintiff Sent ANDA Notice Letter
Defendants, Nang Kuang Pharmaceutical Co., Ltd. ("Nang Kuang") and CANDA NX-2, LLC ("CANDA") (collectively, "Defendants") filed a motion to dismiss, asserting that the patent infringement action filed by Plaintiffs, Eli Lilly and Company ("Lilly") and the Trustees of Princeton University (collectively, "Plaintiffs"), should be dismissed for lack of personal jurisdiction.
As explained by the district court, "Nang Kuang is a Taiwanese generic drug manufacturer seeking approval from the FDA to market generic versions of ALIMTA®. CANDA, a Texas limited liability company, entered into an agreement with Nang Kuang whereby Nang Kuang agreed to exclusively manufacture and supply the ANDA Product to CANDA, and CANDA agreed to assist Nang Kuang with the U.S. litigation arising from Nang Kuang's submission of the ANDA, and find marketing partners to market, sell and distributed the ANDA Product if the ANDA application is approved by the FDA. As of this date, the FDA has not approved the ANDA, and neither Nang Kuang nor CANDA has commercially manufactured, used, sold or offered for sale in, or imported into, the United States any ANDA Product. On August 25, 2014, Nang Kuang and CANDA jointly provided a notice of certification to the required parties pursuant to 21 C.F.R. § 314.95(a) ('Notice Letter'), including Lilly's Indianapolis-based General Counsel and its Indianapolis trial counsel. The submission of the Notice Letter triggered the forty-five day period in which Lilly had to file the instant Hatch-Waxman action to challenge the ANDA and seek an order that the effective date of any approval of Nang Kuang's ANDA be not earlier than the expiration date of Plaintiffs' patents."