Genpharm Inc. v. Pliva-Lachema A.S.

361 F. Supp. 2d 49, 2005 U.S. Dist. LEXIS 4225, 2005 WL 638273
CourtDistrict Court, E.D. New York
DecidedMarch 19, 2005
Docket03-CV-2835 (ADS)(JO)
StatusPublished
Cited by9 cases

This text of 361 F. Supp. 2d 49 (Genpharm Inc. v. Pliva-Lachema A.S.) is published on Counsel Stack Legal Research, covering District Court, E.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Genpharm Inc. v. Pliva-Lachema A.S., 361 F. Supp. 2d 49, 2005 U.S. Dist. LEXIS 4225, 2005 WL 638273 (E.D.N.Y. 2005).

Opinion

MEMORANDUM OF DECISION AND ORDER

SPATT, District Judge.

This is an action for breach of contract arising out of an alleged agreement between Genpharm Inc. (“Genpharm” or the “Plaintiff’), and Pliva-Lachema a.s. (“Pli-va-Lachema”), to manufacture and supply Genpharm with a pharmaceutical ingredient used in the production of warfarin sodium tablets, the generic form of the anticoagulent drug marketed under the brand name “Coumadin.” Currently pending before the Court are several motions by Pliva-Lachema and Pliva d.d. (“Pliva”) (collectively, the “Defendants”) to dismiss for lack of subject matter jurisdiction under Fed.R.Civ.P. 12(b)(1); lack of personal jurisdiction under Fed.R.Civ.P. 12(b)(2); or in the alternative forum non conveniens.

BACKGROUND

I. The Parties.

Genpharm is a corporation located in Ontario, Canada, in the business of devel *52 oping, marketing, and manufacturing generic pharmaceutical products. Pliva-Lachema, formerly known as Lachema before it was acquired by Pliva in 1999, is a corporation located in Brno, Czech Republic, allegedly in the business of developing, manufacturing, and selling active pharmaceutical ingredients (“API”). Pliva is a corporation organized under the laws of the Republic of Croatia with its principal place of business in Zagreb, Croatia. In 1999, two companies owned by Pliva acquired Phva-Lachema: Pliva Krakow, S.A., a Polish corporation of which Pliva is the majority shareholder, and Pliva Phar-ma Holding, a Pliva wholly-owned subsidiary. Pliva alleges that Pliva-Lachema functions independently from Pliva and that it has no involvement in Pliva-Lache-ma’s day-to-day operations.

According to the amended complaint, Pliva, like Phva-Lachema, also develops, manufactures, and sells APIs to various pharmaceutical companies. One of those companies is Pliva USA, Inc. (“Pliva USA”), a New York corporation with its principal place of business in New York, New York. Aliapharm GMBH Frankfurt (“Aliapharm”) is a German company that deals in various pharmaceuticals and chemicals produced in the Czech Republic, the Slovak Republic, Germany, and Italy. The complaint alleges that Aliapharm also acted as a distributor agent for the Defendants.

II. Factual Background

In 1997, Genpharm began the preliminary development work necessary to prepare and submit an Abbreviated New Drug Application (“ANDA”) to the Federal Drug Administration (“FDA”) for generic warfarin sodium tablets to sell in the United States. As part of this development effort, Genpharm sought an API manufacturer to supply all of its developmental and future commercial warfarin API requirements. In February 1997, Genpharm purchased its first developmental quantities of warfarin from Phva-Lachema and discussed the possibility of the Defendants becoming Genpharm’s sole supplier of warfarin API. Shortly thereafter, it is alleged that the companies understood that Genpharm would rely solely on the Defendants to obtain ANDA approval and that the Defendants would be Genp-harm’s sole supplier of warfarin API.

As part of the ANDA application process, a generic manufacturer must identify the API supplier who will be used to manufacture the finished drug product. Specifically, FDA regulations require an ANDA to include a Chemistry, Manufacturing and Controls (“CMC”) section devoted to the manufacturing process and facilities used to make the API. The CMC section can either describe the process itself or, as in this case, incorporate by reference an API suppher’s Drug Master File (“DMF”). A DMF explains in detail the equipment, manufacturing steps, raw materials, laboratory controls, and facilities used to make the API.

On or about November 19, 1999, Pliva-Lachema sent a “Letter of Access” to FDA for its warfarin DMF. In this letter, it is alleged that Pliva-Lachema authorized the FDA to refer to its DMF in support of any ANDA filed by Genpharm, and provided the assurance that it would provide advance notice to both Genpharm and the FDA of any change in the manufacturing site. At that time, Pliva-Lache-ma was manufacturing warfarin at its facility in Brno, Czech Republic. On May 23, 2000, Genpharm filed an ANDA application with the FDA identifying the Defendants as its sole manufacturer of the war-farin API.

The amended complaint alleges that on February 13, 2001, Genpharm and Pliva-Lachema entered into a written Manufacturer Agreement under which Pliva- *53 Lachema became Genpharm’s: only approved manufacturer of warfarin API. Under the terms of the agreement, Genpharm was to be notified in a timely fashion if there are any changes to the manufacturing site for the warfarin. Pliva-Lachema further agreed that written approval must be obtained from Genpharm prior .to implementation of any changes to the manufacturing site. On February 20, 2001, Genpharm entered into a similar Distributor Agreement with Pliva-Lachema’s alleged agent and representative, Aliap-harm. This agreement also required that for any changes to the manufacturing site for warfarin, Genpharm was to receive timely notice prior to the implementation of such change.

On April 24, 2001, the defendants submit that Pliva-Lachema and Aliapharm entered into a contract for the sale of warfa-rin over the next five years. Genpharm is not a party to the contract but it identifies Genpharm as an “Aliapharm customer.” The defendants contend that the contract, which is written in the Czech and German languages, specifically prohibits Pliva-Lachema from selling warfarin in the United States, Canada, and other designated countries. The contract also contains a dispute resolution provision agreeing to arbitration governed by the laws of the Czech Republic.

On February 27, 2002, the FDA informed Genpharm that an FDA inspection of Pliva-Lechema’s warfarin manufacturing site in Brno, Czech Republic, was the only outstanding item necessary for FDA to complete its review and approval of Genpharm’s ANDA. On March 7, 2002, FDA notified Pliva of the necessity for a preapproval inspection of its Brno facility. Pliva-Lachema refused to permit this inspection. On or about March 15, 2002, Pliva-Lachema notified the FDA and Genpharm that its manufacturing site for warfarin API was being transferred to Zagreb, Croatia.

On June 6, 2003, Genpharm brought this action alleging breach of contract. The Defendants moved to dismiss for lack of subject matter jurisdiction and personal jurisdiction. On December 15, 2003, Genpharm filed an amended complaint in lieu of a response. On January 26, 2004, the Defendants filed a second motion to dismiss the complaint for lack of personal jurisdiction. On August 9, 2004, the Defendants filed a third motion to dismiss for lack of subject matter and personal jurisdiction or in the alternative, for application of the forum non conveniens doctrine.

DISCUSSION

I. Subject Matter Jurisdiction

Federal courts are courts of limited jurisdiction and may only entertain disputes as specifically authorized by the Constitution or statute. Kokkonen v. Guardian Life Ins. Co. of America,

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361 F. Supp. 2d 49, 2005 U.S. Dist. LEXIS 4225, 2005 WL 638273, Counsel Stack Legal Research, https://law.counselstack.com/opinion/genpharm-inc-v-pliva-lachema-as-nyed-2005.