Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Helsinn Healthcare S.A. v. Dr. Reddy's Laboratories, Ltd.

United States District Court, D. New Jersey

January 30, 2018

HELSINN HEALTHCARE S.A., Plaintiff,
v.
DR. REDDY'S LABORATORIES, LTD. et al., Defendants.

          OPINION & ORDER

          Stanley R. Chesler, U.S.D.J.

         This 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.

         BACKGROUND

         This 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.

         The 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, 2018.

         APPLICABLE LEGAL STANDARDS

         I. Preliminary Injunction

         “The 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 376.

         As to 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).

         ANALYSIS

         I. Plaintiff has not demonstrated that it is likely to succeed on the merits.

         Helsinn 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 ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.