MEMORANDUM OF DECISION AND ORDER
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
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-
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,
The CISG is an international treaty that governs the formation of international sales contracts as well as the rights and
There are only a handful of American cases interpreting the CISG. In deciding issues under the treaty, courts generally look to its language and to the principles upon which it is based.
Delchi Carrier,
(1) In the interpretation of this Convention, regard is to be had to its international character and to the need to promote uniformity in its application and the observance of good faith in international trade.
(2) Questions concerning matters governed by this Convention which are not expressly settled in it are to be settled in conformity with the general principles on which it is based or, in the absence of such principles, in conformity with the law applicable by virtue of the rules of private international law.
CISG, art. 7.
Article 3 of the CISG distinguishes sales of goods from contracts for services:
(1) Contracts for the supply of goods to be manufactured or produced are to be considered sales unless the party who order the goods undertakes to supply a substantial part of the materials necessary for such manufacture or production.
(2) This Convention does not apply to contracts in which the preponderant part of the obligations of the party who furnishes the goods consists in the supply of labour or other services.
CISG, art 3.
In a case with similar facts, another court in the Second Circuit applied the CISG in determining whether an implied-in-fact contract was created for the sale of clathrate, a raw material used in the production of warfarin.
Geneva Pharms. Tech. Corp. v. Barr Labs., Inc.,
The instant dispute presents strikingly similar allegations. Genpharm alleges that it purchased research and development quantities of warfarin from Pliva-Lachema and invested money in developing warfarin while relying on Pliva-Laehe-ma for a supply of the API. Most important, Genpharm alleges that it “relied on the reference letter provided by [Pliva-Lachema] in connection with the ANDA for warfarin sodium that it submitted to the FDA.”
Id.
at 284. Therefore, it appears that the arrangement between the
This result would also be appropriate if analyzed under the UCC. The Second Circuit has recognized that “[cjaselaw interpreting analogous provisions of Article 2 of the Uniform Commercial Code (‘UCC’), may also inform a court where the language of the relevant CISG provisions tracks that of the UCC. However, UCC caselaw ‘is not per se applicable.’ ”
Delchi Carrier,
Here, the Court finds that caselaw interpreting contract formation under Article 2 of the UCC is helpful. Courts look to the “essence” or main objective of the agreement when deciding whether an agreement is a contract for the sale of goods covered by the UCC.
Medinol Ltd. v. Boston Scientific Corp.,
There can be no question that the instant dispute involves an agreement to supply goods. Indeed, it is clear that the only reason Genpharm and the Defendants had any relationship at all was for the international sale of warfarin, which is undeniably a “good.” In addition, it makes no difference whether the agreements may or may not contain price or quantity. The CISG expressly provides that it “governs only the formation of the contract of sale and the rights and obligations of the seller and buyer arising from such contract.” CISG, art 4. The applicability of the CISG is not restricted to contracts after formation or contracts containing definite prices or quantities. Therefore, this dispute falls within this Court’s treaty jurisdiction, and this Court’s subject matter jurisdiction.
II. Personal Jurisdiction
A. Legal Standard
In a motion to dismiss the complaint pursuant to Fed.R.Civ.P. 12(b)(2) for lack of personal jurisdiction, the plaintiff bears the burden of demonstrating that the court has jurisdiction over the defendants.
See Bank Brussels Lambert v. Fiddler Gonzalez & Rodriguez,
Motions to dismiss under 12(b)(2) test the plaintiffs theory of jurisdiction and test the facts supporting the jurisdictional theory.
See Credit Lyonnais Sec. (USA), Inc. v. Alcantara,
In reaching a decision as to whether jurisdiction is appropriate, the Court need only determine whether the facts alleged
Genpharm’s theory of how this Court has jurisdiction over the foreign corporations is three phased. First, Genpharm alleges that this Court has personal jurisdiction over Pliva because it is engaged in a continuous and systematic course of business in New York. Second, Genpharm argues that Pliva USA is an agent of Pliva in New York. Further, Genpharm argues that Pliva-Lachema is subject to personal jurisdiction as the alter-ego of Pliva. The Defendants argue that this court lacks “general” jurisdiction over Pliva and that both Pliva-Lachema and Pliva USA are separate corporate entities.
B. Applicable Law
In federal question cases involving defendants that reside outside the forum state, the courts look to the forum state’s personal jurisdiction rules, unless the applicable federal statute provides for nationwide service of process.
See Sunward Elecs., Inc. v. McDonald,
Under New York law, the predicate for jurisdiction over a foreign corporation is the fact that it is doing business in the state and has thus created a constructive presence over which a New York court can exert jurisdiction.
Flick v. Stewart-Warner Corp.,
“The test for ‘doing business’ is a ‘simple [and] pragmatic one,’ which varies in its application depending on the particular facts of each case....”
See Landoil Resources Corp. v. Alexander & Alexander Servs., Inc.,
It is undisputed that Pliva maintains no office in New York, has no bank account in New York, and does not have employees in New York. However, Genpharm alleges that Pliva is engaged in a continuous, systematic, and substantial course of business in New York by: (1) selling and shipping pharmaceutical products to this forum; (2) obtaining substantial revenue from the products it sells in New York; (3) entering into multiple contracts for the sale of its products within New York; (4) distributing its products into the stream of commerce in New York. .In addition, Genp-harm alleges that Pliva has engaged in substantial solicitation of business in New York and promoted its pharmaceuticals. The Defendants assert in their affidavits that from 2001 to 2003, Pliva shipped, on a “CIP” basis, that is with title passing in Croatia, approximately $5,830,000 worth of APIs to an independent distributor in New York. The Court assumes this figure does not include the products it shipped to its wholly-owned subsidiary, Pliva USA.
Courts have consistently held that the mere sale of foreign manufacturer’s goods in New York, by itself, is not sufficient for personal jurisdiction.
See Delagi v. Volkswagenwerk AG of Wolfsburg,
Here, not only has Genpharm alleged that Pliva has engaged in substantial solicitation, it appears from Pliva’s submissions that it probably has solicited business. Pliva has not refuted Genpharm’s allegations of solicitation and admits to selling over five-million dollars worth of pharmaceuticals in New York from 2001 to 2003. Therefore, construing all of the allegations in favor of the Plaintiff, the Court finds that Genpharm has met its burden of making a prima facie showing of personal jurisdiction under CPLR 301.
In addition, Genpharm claims that Pliva “does business” in New York by virtue of the activities of its subsidiary, Pliva USA. The mere presence of a subsidiary in New York does not establish the parent’s presence in the state.
Volkswagenwerk Aktiengesellschaft v. Beech Aircraft Corp.,
Genpharm’s amended complaint alleges, in pertinent part:
[Pliva] has created various subsidiaries in the United Stated that serve no other business purpose or goal except to act solely as agents of Pliva; these subsidiaries include a wholly-owned subsidiary ... with the same name ... that serves no other business purpose or goal except to act solely as Pliva’s agent to distribute and facilitate the sales, promotion, and market research of Pliva’s pharmaceutical products and API in the United States and within this District and to solicit buyers of these pharmaceutical products.
Pit’s Compl. at ¶ 21
The Defendants argue that Pliva USA is a wholly-owned subsidiary that observes all the corporate formalities and does business in its own name separate and apart from Pliva. This averment, by itself, does not contradict Genpharm’s allegations that Pliva USA acts as Pliva’s agent. The only other assertions that the Defendants make regarding the relationship between Pliva and its wholly-owned subsidiary Pliva USA is that Pliva sells and ships products to Pliva USA, which then resells them as property of Pliva USA. In sum, when construed in the light most favorable to the Plaintiff, Pliva’s submissions do not refute Genpharm’s allegations. Therefore, the Court finds that Genpharm has sufficiently alleged jurisdiction over Pliva through its subsidiary Pliva USA.
The Court also finds that jurisdiction over Pliva, if proven, would not run afoul of the Defendants’ rights under the Due Process Clause of the Fifth Amendment. “[W]hen the cause of action does not arise out of or relate to the foreign corporation’s activities in the forum State, due process is not offended by a State’s subjecting the corporation to its in person-am jurisdiction when there are sufficient contacts between the State and the foreign corporation.”
Helicopteros Nacionales de Colombia, S.A. v. Hall,
As for Pliva-Lachema, Genpharm asserts that it is an alter-ego of Pliva. Again, the Defendants claim that Pliva-Lachema, like Pliva USA, acts as an independent entity that observes all the formalities. When the activities of a parent corporation show a disregard for the separate corporate existence of the subsidiary, New York law allows jurisdiction to be asserted over the subsidiary.
See Public Administrator v. Royal Bank,
The Court finds that the jurisdictional landscape painted by the parties is quite murky, and basically unhelpful to resolving this issue. A court may allow discovery to aid in the determination of whether it has personal jurisdiction.
See Winston & Strawn v. Dong Won Securities Co.,
No. 02-0183,
In this case the Court is faced with substantial questions of fact regarding the relationship of the Defendant companies with each other, with Pliva USA, and with New York. Discovery will lead to a more open and fruitful examination of the true character of the business dealings Pliva and Pliva-Lachema have in this forum. In addition, discovery will allow the parties to paint a better picture for the Court of the corporate structure of the various entities. Without these essential elements, the Court is unable to determine whether Pli-va-Lachema is the alter-ego of Pliva so as to meet the requirements of New York’s jurisdictional statute.
III. Forum Non-Conveniens
At the outset of their forum non conveniens response, the Plaintiff suggests that the Defendants late motion to dismiss for forum non conveniens makes it ineligible for consideration. The Court disagrees. There appears to be “no time limit on when a motion to dismiss on the ground of forum non conveniens can be made.” 15 Charles Alan Wright, Arthur R. Miller, & Edward H. Cooper Fed. Prac. & Proc. § 3828 (2d ed.2004);
see Jacobs v. Felix Bloch Erben Verlag fur Buhne Film und Funk KG,
A district court has the inherent power to dismiss an action under the doctrine of forum non conveniens when it appears that a foreign forum would be more convenient.
Schertenleib v. Traum,
A. The Deference Owed to the Plaintiffs Choice of Forum
The Second Circuit has established a “sliding scale” approach to determine the proper deference to accord a plaintiffs choice of forum.
Id.
at 71. Under that scale, “the greater the plaintiffs or the lawsuit’s bona fide connection to the United States and to the forum of choice and the more it appears that considerations of convenience favor the conduct of the lawsuit in the United States ... ,[the greater deference must be accorded the plaintiffs choice of a forum; and] the more difficult it will be for the defendant to gain dismissal for forum non conveniens.”
Id.
at 72. Where, as here, the Plaintiff chooses to
B. The Alternative Forum
Next, the Court must determine whether an adequate alternative forum exists. “An alternative forum is adequate if: (1) the defendants are subject to service of process there; and (2) the forum permits ‘litigation of the subject matter of the dispute.’ ”
Alfadda v. Fenn,
C. The Balancing of the Interest Factors
Having determined that an adequate alternative forum exists, the Court must weigh the Defendants’ hardships if jurisdiction is retained in the forum of the Plaintiffs choice against the Plaintiffs hardships if the motion to dismiss is granted and the Plaintiff is forced to begin the suit anew in the Czech Republic.
See Pollux,
The Second Circuit has endorsed the non exclusive list of factors delineated in the seminal case of
Gulf Oil Corp. v. Gilbert
in evaluating a forum non conveniens motion.
The private interest factors favor the Plaintiffs. This case has been pending since June 6, 2003. Although the parties have not engaged in extensive discovery, the Defendants have sought to stay and delay discovery at every step of the case. In addition, as noted above, the Court can consider the fact that the Defendants have moved for dismissal based on forum non conveniens more than a year after the case was filed.
See Breindel & Ferstendig,
The public interest factors also favor the Plaintiff. The alleged contract involves the development of a drug intended for sale in the United States. From the allegations in the amended complaint, it
The Defendants request that this Court follow a case from the Northern District of California,
Chateau des Charmes Wines Ltd. v. Sabate USA, Inc.,
No. 01-4203,
This case centers around an alleged breach of contract for the production of a generic pharmaceutical, which involved the FDA’s complex approval process. A United States Federal District Court is uniquely suited to handle issues involving the FDA approval process as compared to a foreign court. The Chateau case involved a contract for cork-based closures used in bottling wine, an issue that can be handled by any competent court. In addition, the generic drug was intended for sale in the United States, and as such, may have ben-efitted the citizens of this country.
Based upon a review of the private and public interest factors, the Court finds that the defendants have failed to show that the Czech Republic is a more convenient and just forum than the Eastern District of New York. Accordingly, the motion to dismiss the amended complaint on the ground of forum non conveniens is denied.
CONCLUSION
Based on the foregoing, it is hereby
ORDERED, that the Defendants motion to dismiss is DENIED in its entirety.
SO ORDERED.
