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Par Pharm., Inc. v. Hospira, Inc.

United States District Court for the District of Delaware

April 27, 2018, Decided; May 11, 2018, Filed

Civil Action No. 17-944-JFB-SRF

Opinion

REPORT AND RECOMMENDATION

I. INTRODUCTION

Presently before the court in this patent infringement action brought under the Hatch-Waxman Act is defendant Hospira, Inc.'s ("Hospira") motion to dismiss pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure. (D.I. 11) For the following reasons, I recommend that the court deny Hospira's motion to [*2]  dismiss.

II. BACKGROUND

On July 13, 2017, plaintiffs Par Pharmaceutical, Inc., Par Sterile Products, LLC, and Endo Par Innovation Company, LLC (collectively, "Par") filed a complaint for patent infringement under the Hatch-Waxman Act against Hospira. (D.I. 1) The action relates to Abbreviated New Drug Application ("ANDA") No. 208908, which was filed by Hospira with the U.S. Food and Drug Administration ("FDA") seeking approval to market generic versions of Par's Adrenalin(R) epinephrine injection, 1 mg/mL ("the Hospira ANDA Product") prior to the expiration of the patents-in-suit. (D.I. 1 at ¶ 24) The Adrenalin(R) product is a clear, colorless, sterile parenteral solution containing the active ingredient L-epinephrine, which is intended for intramuscular or subcutaneous administration, and is indicated for emergency treatment of allergic reactions, including anaphylaxis. (Id. at IT 13) Par is the holder of New Drug Application ("NDA") No. 204200 for Adrenalin(R) brand epinephrine injection 1 mg/mL. (Id. at ¶ 13) Par's Adrenalin(R) products are indicated for emergency treatment of allergic reactions, including anaphylaxis. (Id. at ¶ 13)

The complaint alleges infringement of U.S. Patent Nos. 9,119,876 ("the '876 patent") and 9,295,657 ("the '657 patent") (together, [*3]  the "patents-in-suit"). (Id. at ¶ 1) The '876 patent, entitled "Epinephrine Formulations," was issued on September 1, 2015 to Par Pharmaceutical, Inc. as assignee. (Id. at ¶ 9) The '876 patent claims are directed to compositions comprising epinephrine, a tonicity regulating agent, a pH raising agent, an antioxidant comprising sodium bisulfite and/or sodium metabisulfite, a pH lowering agent, and a transition metal complexing agent, in certain ranges. (Id. at ¶ 21) The '657 patent, which is also entitled "Epinephrine Formulations," was issued on March 29, 2016 to Par Pharmaceutical, Inc. as assignee. (Id. at ¶ 11) Plaintiffs own and have exclusive rights to the patents-in-suit, including all rights to sue for infringement. (Id. at ¶¶ 9, 11) The '657 patent covers methods of using the inventive formulations to treat Type 1 allergic reactions, including anaphylaxis, by administering the composition claimed in the '876 patent. (Id. at ¶ 22)

III. LEGAL STANDARD

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2018 U.S. Dist. LEXIS 114588 *

PAR PHARMACEUTICAL, INC., PAR STERILE PRODUCTS, LLC, and ENDO PAR INNOVATION COMPANY, LLC, Plaintiffs, v. HOSPIRA, INC., Defendant.

Subsequent History: Request denied by Par Pharm., Inc. v. Hospira, Inc., 2018 U.S. Dist. LEXIS 140169 (D. Del., Aug. 14, 2018)

Magistrate's recommendation at Par Pharm., Inc. v. Hospira, Inc., 2019 U.S. Dist. LEXIS 77349 (D. Del., Apr. 30, 2019)

Sanctions disallowed by, Objection overruled by, Decision reached on appeal by Par Pharm., Inc. v. Hospira, Inc., 2019 U.S. Dist. LEXIS 92817 (D. Del., June 3, 2019)

Motion denied by, Request denied by Par Pharm., Inc. v. Hospira, Inc., 2019 U.S. Dist. LEXIS 95045 (D. Del., June 6, 2019)

Motion denied by, Without prejudice Par Pharm., Inc. v. Hospira, Inc., 2019 U.S. Dist. LEXIS 103828 (D. Del., June 21, 2019)

CORE TERMS

infringement, Recommendation, patent, patents-in-suit, literal, epinephrine, ingredients