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United States District Court for the District of New Jersey
March 22, 2021, Decided; April 7, 2021, Filed
Civil Action No. 17-5319 (FLW) (DEA)
[*179] REDACTED & AMENDED OPINION
WOLFSON, [**2] Chief Judge:
This consolidated action was filed by Plaintiffs, Mitsubishi Tanabe Pharma Corp. ("MTPC"), Janssen Pharmaceuticals, Inc. ("JPI"), Janssen Pharmaceutica NV ("JNV"), Janssen Research and Development, LLC ("JRD"), and Cilag GmbH International ("Cilag")1 (collectively, "Plaintiffs") against Defendant Zydus Pharmaceuticals (U.S.A.) Inc. ("Zydus" or "Defendant") for patent infringement in violation of section 271(e)(2) of Title 35 of the United States Code. In response, Zydus has filed a counterclaim seeking a declaratory judgment against Plaintiffs that the patents-in-suit are invalid.
Defendant is alleged to infringe the following claims of the corresponding United States Patents held by Plaintiffs: (1) claims 12 and 20 of United States Patent Number 7,943,788 ("the '788 Patent"); (2) claim 22 of United States Patent Number 8,222,219 ("the '219 Patent"); and (3) claim 26 of United States Patent Number 8,785,403 ("the '403 Patent") (collectively, the "asserted claims").2 The patents-in-suit relate to the pharmaceutical composition and method of treatment encompassed by the drugs "Invokana" and "Invokamet" (together "the Invokana Products"), which are used to treat type 2 diabetes. Plaintiffs' infringement claims are based on Zydus's filing of Abbreviated New Drug Applications ("ANDA") with the Food and Drug Administration ("FDA") seeking approval to commercially manufacture and market generic versions [**3] of the Invokana Products prior to the expiration of the patents-in-suit.3 Zydus has stipulated that its submission of the ANDAs and any commercial manufacture, use, offer for sale, sale, or importation of the ANDA products before expiration of the patents-in-suit would infringe the asserted claims. As its defense, Zydus contends that (1) the asserted claims of patents-in-suit are invalid as obvious; and (2) claims 12 and 20 of the '788 Patent are invalid under the doctrine of obviousness-type double patenting.
The Court conducted a six-day bench trial,4 during which numerous experts testified as to the issues of obviousness and obviousness-type double patenting. In accordance [*180] with Federal Rule of Civil Procedure 52(a), the Court sets forth herein its findings of facts and conclusions of law. After consideration of all the evidence, the Court finds that the patents-in-suit are not invalid as obvious and that claims 12 and 20 of the '788 Patent are not invalid under the doctrine of obviousness-type double patenting. Based on Zydus's concession, the Court further concludes that the filed ANDAs infringe upon the patents-in-suit.
Full case includes Shepard's, Headnotes, Legal Analytics from Lex Machina, and more.
533 F. Supp. 3d 170 *; 2021 U.S. Dist. LEXIS 90174 **
MITSUBISHI TANABE PHARMA CORPORATION, JANSSEN PHARMACEUTICALS, INC., JANSSEN PHARAMCEUTICA NV, JANSSEN RESEARCH AND DEVELOPMENT, LLC, and CILAG GMBH INTERNATIONAL, Plaintiffs, v. SANDOZ, INC., et al., Defendants.
Subsequent History: Remanded by Mitsubishi Tanabe Pharma Corp. v. Zydus Pharms. USA Inc., 2021 U.S. App. LEXIS 40084 (Fed. Cir., Nov. 9, 2021)
Prior History: Mitsubishi Tanabe Pharma Corp. v. Sandoz Inc., 2020 U.S. Dist. LEXIS 104156, 2020 WL 3169372 (D.N.J., June 15, 2020)
compound, patent, inhibitors, dapagliflozin, diabetes, prior art, canagliflozin, ring, Products, invention, glucose, bioisosterism, biological, patents-in-suit, methyl, double patenting, nonobviousness, obviousness-type, invalid, modify, thiophene, metabolic, antidiabetic, expiration, chemistry, chlorine, modifications, medicinal, promising, replacing
Patent Law, Nonobviousness, Elements & Tests, Hindsight, Anticipation & Novelty, Invention, Claimed Invention as a Whole, Defenses, Patent Invalidity, Presumption of Validity, Grounds, Evidence, Prima Facie Obviousness, Inferences & Presumptions, Graham Test, Secondary Considerations, Ordinary Skill Standard, Prior Art, Accidental Anticipation & Inherency, Elements, Teaching Away From Invention, Predictability, Elements & Tests, Business & Corporate Compliance, Infringement Actions, Experimental Use & Testing, Double Patenting, Standards & Tests