United States District Court, D. Massachusetts
UNITED THERAPEUTICS CORP. Plaintiff,
WATSON LABORATORIES, INC. Defendant.
ORDER ON UNITED THERAPEUTICS CORP.'S MOTION TO
COMPEL PAREXEL INTERNATIONAL CORP.'S COMPLIANCE WITH
SUBPOENA (Dkt. No. 1)
L. CABELL, U.S.M.J.
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.
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
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.
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).
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. §
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
District of New Jersey Litigation
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.
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
UTC's Subpoena to Parexel
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).
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