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BTG Int'l Ltd. v. Amneal Pharms. LLC

United States District Court for the District of New Jersey

October 25, 2018, Decided; October 26, 2018, Filed

Civ. No. 15-cv-5909 (KM)(JBC); Civ. No. 16-cv-2449 (KM)(JBC); Civ. No. 17-cv-6435 (KM)(JBC)

Opinion

 [*358]  CONSOLIDATED OPINION

(Amended)

These are consolidated Hatch-Waxman actions for infringement of United States Patent No. 8,822,438 ("the '438 patent") brought by Janssen Biotech, Inc.; Janssen Oncology, Inc.; Janssen Research & Development, LLC (collectively, "Janssen"); and BTG International Ltd. ("BIG"). Janssen and BTG co-own the '438 patent. The '438 patent contains twenty claims covering methods for the treatment of prostate [**6]  cancer by administering various dosages of abiraterone acetate and prednisone in combination. Patent exclusivity for these medications individually is not at issue.

The defendants are Amerigen Pharmaceuticals, Inc.; Amerigen Pharmaceuticals Ltd. (collectively, "Amerigen"); Amneal Pharmaceuticals LLC; Amneal Pharmaceuticals of New York, LLC (collectively, "Amneal"); Dr. Reddy's Laboratories, Inc.; Dr. Reddy's Laboratories, Ltd. (collectively "DRL"); Mylan Pharmaceuticals Inc.; Mylan, Inc. (collectively, "Mylan"); Teva Pharmaceuticals USA, Inc. ("Teva"); West-Ward Pharmaceutical Corporation, and Hikma Pharmaceuticals, LLC ("West-Ward/Hikman"); Wockhardt Bio AG; Wockhardt USA LLC; and Wockhardt Ltd. (collectively, "Wockhardt"). The defendants are generic drug companies who seek to engage in the commercial manufacture, use, offer for sale, or sale of a generic version of the plaintiffs' branded drug, ZYTIGA®.

Plaintiffs allege infringement of claims 4, 8, 11, 19 and 20, all of which rely on claim 1 of the '438 patent, based on the defendants' filing of Abbreviated New Drug Applications ("ANDAs"). If defendants' ANDAs are approved, defendants will allegedly induce infringement of the asserted claims [**7]  of the '438 patent under 35 U.S.C. § 271(b) and contribute to infringement of the asserted claims under 35 U.S.C. § 271(c). Defendants deny infringement and claim that the patent claims are invalid for obviousness and for lack of a written description.

On November 3, 2017, defendants moved for summary judgment as to the induced and contributory infringement claims. (DE 364). The Court held a hearing on that motion on February 9, 2018. Because it appeared that there were issues of fact to be tried in any event, and that the issues on summary judgment would subsumed in those to be tried, the motion was terminated without prejudice to reassertion of all contentions therein following trial. (DE 483).

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352 F. Supp. 3d 352 *; 2018 U.S. Dist. LEXIS 183854 **; 2018 WL 5734626

BTG INTERNATIONAL LIMITED, et al., Plaintiffs, v. AMNEAL PHARMACEUTICALS LLC, et al., Defendants.BTG INTERNATIONAL LIMITED, et al., Plaintiffs v. AMERIGEN PHARMACEUTICALS, INC., and AMERIGEN PHARMACEUTICALS LTD., Defendants.BTG INTERNATIONAL LIMITED, et al., Plaintiffs, v. TEVA PHARMACEUTICALS USA, INC., Defendant.

Subsequent History: As Amended October 31, 2018.

Appeal dismissed by, As moot BTG Int'l Ltd. v. Amneal Pharms. LLC, 2019 U.S. App. LEXIS 14241 (Fed. Cir., May 14, 2019)

Prior History: BTG Int'l Ltd. v. Actavis Labs. Fl, Inc., 2016 U.S. Dist. LEXIS 157586 (D.N.J., Nov. 10, 2016)

CORE TERMS

abiraterone, prednisone, infringement, label, patent, prostate cancer, patients, acetate, Indications, defendants', effects, prior art, therapy, induced, invention, administered, cancer, Phase, mCRPC, dose, ketoconazole, steroids, inhibitor, Pharmaceuticals, metastatic, glucocorticoid, levels, anti-cancer, clinical, Usage