Pfizer Inc. v. Synthon Holding, B.V.

386 F. Supp. 2d 666, 2005 U.S. Dist. LEXIS 24544, 2005 WL 2205019
CourtDistrict Court, M.D. North Carolina
DecidedSeptember 7, 2005
Docket1:05CV39
StatusPublished
Cited by6 cases

This text of 386 F. Supp. 2d 666 (Pfizer Inc. v. Synthon Holding, B.V.) is published on Counsel Stack Legal Research, covering District Court, M.D. North Carolina primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Pfizer Inc. v. Synthon Holding, B.V., 386 F. Supp. 2d 666, 2005 U.S. Dist. LEXIS 24544, 2005 WL 2205019 (M.D.N.C. 2005).

Opinion

MEMORANDUM OPINION

BEATY, District Judge.

This case is a patent infringement action brought by Plaintiff Pfizer Inc. (“Plaintiff’) against Defendants Synthon Holding, B.Y., Synthon, B.V., Synthon Pharmaceuticals, Ltd., and Synthon Laboratories, Inc. (“Defendants”). The matter is presently before the Court on two motions: (1) Defendant Synthon Laboratories’ (“Synthon Labs”) Motion to Transfer or Dismiss [Document # 12] based on its contention that this Court does not have personal jurisdiction over it; and (2) Defendants’ Motion to Transfer [Document #21] pursuant to 28 U.S.C. § 1404(a) based on their contention that the Eastern District of Virginia is a more convenient forum.

As discussed below, the Court finds that Synthon Labs had significant contact with North Carolina and worked with affiliated entities in North Carolina to prepare and submit an Abbreviated New Drug Application (“ANDA”). This lawsuit arises directly out of that ANDA and those contacts. Therefore, this Court has specific personal jurisdiction over Synthon Labs with respect to this patent infringement claim. In addition, the Court finds that Synthon Labs was dominated and controlled by the other Synthon entities, and is the “alter ego” of the Synthon entities in North Carolina. Therefore, this Court has personal jurisdiction over Synthon Labs as the alter ego of the North Carolina entities. For both of these reasons, Defendant Synthon Labs’ Motion to Dismiss or Transfer will be denied. With respect to the Motion to Transfer made pursuant to 28 U.S.C. § 1404(a), the Court concludes that Defendants have failed to demonstrate that the Eastern District of Virginia would be a more appropriate or convenient forum, and the Court finds that the balancing of factors favors retaining venue in this Court. Therefore, Defendants’ Motion to Transfer pursuant to 28 U.S.C. § 1404(a) will also be denied.

I. FACTUAL BACKGROUND

Plaintiff holds two patents related to its heart medication Norvasc: the ’303 patent and the ’909 patent. The ’909 patent expires on January 31, 2007. The ’303 patent expires on September 28, 2007. Syn-thon Labs filed an ANDA for a generic equivalent to Norvasc on March 5, 2004. The ANDA was accepted by FDA for substantive review on December 23, 2004. The ANDA included a “Paragraph IV certification” which alleged that the ’909 patent is invalid and that the ’303 patent is not infringed by Synthon’s generic product. 1 With respect to the present Motions *671 to Transfer, the Court makes the following factual findings.

The ANDA at issue in this case was prepared by Defendant Synthon Pharmaceuticals, Ltd. (“Synthon Pharma”) in North Carolina. Synthon Pharma is a North Carolina corporation with its principal place of business in North Carolina. Synthon Pharma is a subsidiary of Defendant Synthon Holding, B.V. (“Synthon Holding”). Synthon Holding is a privately-held Dutch company owned and controlled by Dr. Jacques Lemmens. Syn-thon Holding has over 20 wholly-owned direct or indirect subsidiaries. All of the Synthon defendants in this suit are wholly-owned direct or indirect subsidiaries of Synthon Holding. The Synthon organization in the United States is headquartered in North Carolina. Dr. Lemmens serves as President of Synthon Holding and CEO of Synthon Pharma, in addition to other positions with other of the Synthon entities.

Synthon Pharma began work on the ANDA at issue in 2002. From 2002 through 2004, Synthon Pharma did substantially all of the work in preparing and coordinating the ANDA. In a 2002 Agreement between Synthon Pharma and Syn-thon Research Ltd., Synthon Pharma was granted ownership of any ANDA resulting from any work under the agreement. During this time frame, Synthon Pharma contracted for, coordinated, and supervised the manufacture and testing of the ANDA product. Synthon Pharma also contracted for, supervised, and monitored the necessary bioequivalence studies. Synthon Pharma compiled, formatted and assembled this information into the ANDA. All of this work by Synthon Pharma was undertaken in North Carolina.

While this work was being done by Syn-thon Pharma, Mr. Joe Marchetti was a Vice President at Synthon Pharma in North Carolina. In late 2003, Dr. Lem-mens decided to establish Synthon Labs as a new corporate entity in Virginia. According to Mr. Marchetti, Dr. Lemmens approached him and said “I’m thinking about setting up a new company [Synthon Labs] ... are you interested in running that company?” (Dep. of J. Marchetti at 49.) Mr. Marchetti agreed, and beginning on January 1, 2004, Mr. Marchetti became the sole officer, director, and employee of Synthon Labs. Mr. Marchetti moved to Virginia and set up a small single-room office in Virginia for Synthon Labs. Syn-thon Labs was initially capitalized by a sale of 100 shares of common stock for $150,000 to another Synthon entity, Syn-thon Luxembourg Holding. Synthon Labs’ 2004 financial statement was prepared by officers and attorneys of Synthon Holding. Mr. Marchetti testified that Syn-thon Research Ltd., another Synthon entity, agreed to pay Synthon Labs for work done related to the ANDA, and also gave Synthon Labs an “ownership interest” in the ANDA, even though Synthon Research had already granted the ownership of the ANDA to Synthon Pharma. Thus, without any agreement or consideration to Syn-thon Pharma, and after years of work by Synthon Pharma in preparing the product and studies, Synthon Research Ltd. purported to give the ANDA rights to Syn-thon Labs without regard to the prior agreement giving those same ANDA rights to Synthon Pharma. The agreement between Synthon Research and Syn-thon Labs giving Synthon Labs the right to market the ANDA product was backdated to January 1, 2004, but was not *672 actually signed until January 2005, apparently after this lawsuit was filed.

After Synthon Labs was established in 2004, Mr. Marehetti worked with individuals at Synthon Pharma in North Carolina to review and finalize the ANDA. As part of this effort related to the ANDA, Mr. Marehetti had ongoing e-mail and telephone contact with individuals at Synthon Pharma in North Carolina, usually several times a day over a period of several months, as well as at least three visits to North Carolina to meet with officials and employees of Synthon Pharma and Synthon Holding. While the ANDA was being prepared, Mr. Marehetti made the decision to include the Paragraph IV certification alleging that the ’909 patent was invalid. However, this decision was made on the advice of Mr. Buscher, who was a former in-house attorney for Syn-thon Pharma, and who had previously provided advice (but no formal opinion) to Synthon Pharma and Synthon Holding regarding the ’303 and ’909 patents. The Paragraph IV certification was included in the ANDA by Synthon Labs in coordination with Synthon Pharma’s efforts in North Carolina in coordinating and preparing the product itself, the necessary bioequivalence studies, and all other aspects of the ANDA. Other than his involvement in the Paragraph IV certification, Mr. Marchetti’s only other role with respect to the ANDA was primarily administrative.

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Bluebook (online)
386 F. Supp. 2d 666, 2005 U.S. Dist. LEXIS 24544, 2005 WL 2205019, Counsel Stack Legal Research, https://law.counselstack.com/opinion/pfizer-inc-v-synthon-holding-bv-ncmd-2005.