United States District Court, D. New Jersey
OPINION & ORDER
Stanley R. Chesler, U.S.D.J.
matter comes before the Court on the motion for a preliminary
injunction by Plaintiff Helsinn Healthcare S.A.
(“Helsinn”) against consolidated case Defendants
Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical
Industries, Ltd. (collectively, “Teva”). This
Court held oral argument on this motion on January 22, 2018.
For the reasons stated below, the motion will be denied.
case arises from a patent infringement dispute involving a
pharmaceutical treatment method patent. Helsinn owns U.S.
Patent No. 8, 729, 094 (the “'094 patent”)
directed to, among other things, a method for reducing
chemotherapy-induced nausea and vomiting using palonosetron,
a compound which Helsinn markets under the brand name
Aloxi®. Teva has submitted ANDA No. 090713, which seeks
FDA approval to engage in the commercial manufacture and sale
of generic palonosetron hydrochloride intravenous solutions
prior to the expiration of the '094 patent.
present dispute over the '094 patent is one piece of a
larger group of cases involving various palonosetron patents
and various pharmaceutical companies. In brief, Judge Cooper
of this Court, after conducting a trial in a subset of
related cases, had issued a judgment that found a number of
other palonosetron patents (but not the '094 patent)
valid and infringed. Teva appealed this judgment and, on May
1, 2017, the Court of Appeals for the Federal Circuit
reversed the judgment of infringement, finding the patent
claims at issue to be invalid under the on-sale bar of 35
U.S.C. § 102. Helsinn Healthcare S.A. v. Teva Pharm.
USA, Inc., 855 F.3d 1356, 1375 (Fed. Cir. 2017). Helsinn
then petitioned for rehearing en banc. In September
of 2017, with the petition pending, Helsinn raised with this
Court its concern that, should the Federal Circuit deny
rehearing, Teva would immediately launch its generic
palonosetron product. The parties agreed to complete briefing
on the instant motion while the petition was pending, which
they did. On January 16, 2018, the Federal Circuit denied the
petition for rehearing and stated that the mandate would
issue on January 23, subsequently amended to January 29. This
Court then heard oral argument on the motion on January 22,
grant of a preliminary injunction under 35 U.S.C. § 283
is within the discretion of the district court.”
Curtiss-Wright Flow Control Corp. v. Velan, Inc.,
438 F.3d 1374, 1378 (Fed. Cir. 2006). “A plaintiff
seeking a preliminary injunction must establish that he is
likely to succeed on the merits, that he is likely to suffer
irreparable harm in the absence of preliminary relief, that
the balance of equities tips in his favor, and that an
injunction is in the public interest.” Winter v.
NRDC, Inc., 129 S.Ct. 365, 374 (2008). The Supreme Court
has held that injunctive relief is “an extraordinary
remedy that may only be awarded upon a clear showing that the
plaintiff is entitled to such relief.” Id. at
the requirement that the movant establish that he is likely
to succeed on the merits, the Federal Circuit has held:
[T]he patentee seeking a preliminary injunction in a patent
infringement suit must show that it will likely prove
infringement, and that it will likely withstand challenges,
if any, to the validity of the patent. In assessing whether
the patentee is entitled to the injunction, the court views
the matter in light of the burdens and presumptions that will
inhere at trial. . . .
Titan Tire Corp. v. Case New Holland, Inc., 566 F.3d
1372, 1376 (Fed. Cir. 2009) (citation omitted). “An
accused infringer can defeat a showing of likelihood of
success on the merits by demonstrating a substantial question
of validity or infringement.” Trebro Mfg. v.
FireFly Equip., LLC, 748 F.3d 1159, 1165 (Fed. Cir.
2014). “A preliminary injunction should not issue if an
alleged infringer raises a substantial question regarding
either infringement or validity, i.e., the alleged infringer
asserts an infringement or invalidity defense that the
patentee has not shown lacks substantial merit.”
AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1050
(Fed. Cir. 2010).
Plaintiff has not demonstrated that it is likely to succeed
on the merits.
moves for injunctive relief on the ground that Teva's
generic product will infringe claim 4 of the '094 patent.
Claim 4 depends on independent claim 1, and they state:
1. A method for reducing the likelihood of cancer
chemotherapy-induced nausea and vomiting, comprising
intravenously administering to a human in need thereof a
pharmaceutical single-use, unit-dose formulation comprising a
5 mL sterile aqueous isotonic solution buffered at a pH of
about 5.0.+.0.5, said solution comprising: about 0.05 mg/mL
palonosetron hydrochloride based on the weight of its free
base; about 41.5 mg/mL mannitol; about 0.5 mg/mL EDTA; and a
citrate buffer, wherein said formulation is stable at 24
months when stored at room temperature, and wherein said
intravenous administration to said human occurs before the
start of the cancer chemotherapy.
4. The method of claim 1, wherein said intravenous
administration reduces the likelihood of delayed nausea and