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United Therapeutics Corp. v. Watson Laboratories, Inc.

United States District Court, D. Massachusetts

September 22, 2016

UNITED THERAPEUTICS CORP. Plaintiff,
v.
WATSON LABORATORIES, INC. Defendant.

          ORDER ON UNITED THERAPEUTICS CORP.'S MOTION TO COMPEL PAREXEL INTERNATIONAL CORP.'S COMPLIANCE WITH SUBPOENA (Dkt. No. 1)

          DONALD L. CABELL, U.S.M.J.

         The present motion arises from a patent infringement lawsuit pending in the District of New Jersey. United Therapeutics Corp. (UTC) has sued Watson Laboratories, Inc. (Watson) for allegedly infringing three patents related to one of UTC's products, the Tyvaso Inhalation Solution. (United Therapeutics Corp. v. Watson Laboratories, Inc., No. 15-cv-05723 (D.N.J. filed Jul. 22, 2015)). Paraxel International Corporation (Paraxel) is not a party to the lawsuit but it acquired some Tyvaso Inhalation System Starter Kits from the Glendale Adventist Medical Center (Glendale Adventist) and subsequently conducted some research on the product. UTC initially believed that Parexel used the Starter Kits to assist Watson in developing a generic version of Tyvaso, but apparently now accepts Parexel's representation that it was not Watson for whom it performed its work. Still, UTC seeks documents from Parexel relating to the work it did do and has served Parexel with a subpoena demanding such information. Parexel objects on the grounds that the subpoena is overbroad and seeks documents that are wholly irrelevant to the lawsuit between UTC and Watson.

         Having reviewed the parties' submissions and heard argument on UTC's motion, the Court agrees that UTC has not met its burden of establishing that the documents it seeks are relevant to the claims and defenses in the UTC/Watson litigation. For that reason, UTC's motion to compel is denied.

         I. Background

         The action pending before this court was filed solely to compel compliance with a subpoena served upon Parexel, a life sciences consulting firm located in this district. UTC served the subpoena in a District of New Jersey patent infringement suit, United Therapeutics Corp. v. Watson Laboratories, Inc., No. 15-cv-05723.

         A. Hatch-Waxman Act

         UTC sued Watson pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585, more commonly known as the Hatch-Waxman Act. The Hatch-Waxman Act creates an expedited process by which the manufacturers of generic drugs can obtain approval of generic drugs. See 21 U.S.C. § 355(j).

         Where a generic drug contains the same active ingredients and is administered in the same way and with the same dosage as the branded drug, the generic drug manufacturer may file an Abbreviated New Drug Application (ANDA). The ANDA filing process requires that the applicant certify that the name brand drug is not patented, that the patent has or will expire before the generic is put on the market, or that the patent is invalid. A certification that the name brand drug patent is invalid is known as a “Paragraph IV” certification. 21 U.S.C. § 355(j)(2)(vii)(IV).

         Paragraph IV certifications must be served on the patent holder. Under the Hatch-Waxman Act, the patent holder is entitled to file a patent infringement suit immediately upon receiving the notice letter from the generic manufacturer. 35 U.S.C. § 271(e)(2). UTC's patent infringement suit against Watson is one such section 271(e)(2) suit.

         B. District of New Jersey Litigation

         UTC holds three patents related to Tyvaso, an inhaled drug that treats pulmonary arterial hypertension. Pulmonary arterial hypertension is high blood pressure in the pulmonary arteries, which carry blood from your heart to your lungs. This type of high blood pressure places a strain on the heart, potentially leading to heart failure or death.

         On July 22, 2015, UTC filed a six count patent infringement complaint against Watson in the District of New Jersey. The complaint alleges that Watson submitted an ANDA seeking to manufacture, market and sell a generic version of Tyvaso. The ANDA contained a paragraph IV certification claiming that all three of UTC's Tyvaso patents are invalid. UTC alleges that its patents are valid and that Watson's plan to manufacture and sell a generic version of Tyvaso before the patents' expiration constitutes willful patent infringement.

         C. UTC's Subpoena to Parexel

         Patients who have been prescribed Tyvaso receive the Tyvaso Inhalation System Starter Kit. The kit contains an inhaler device, accessories, a case, a power supply, the Tyvaso itself and various literature. In December 2015, UTC learned that Parexel obtained several Tyvaso Starter Kits from Glendale Adventist. UTC initially believed that Parexel obtained the kits “to assist Watson in developing the ANDA Product [i.e., the generic version of Tyvaso].” (Dkt. No. 2 at p. 2).

         On February 23, 2016, UTC served a subpoena on Parexel seeking 28 categories of documents. Parexel responding with a letter in which it objected to the subpoena in its entirety, and refused to produce any documents. UTC subsequently agreed to narrow the subpoena to five requests (request nos. 2-6) seeking information about the relationship between Parexel and Glendale Adventist, and Parexel's use of the Tyvaso ...


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