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Sanofi-Aventis U.S., LLC v. Dr. Reddy's Labs., Inc.

United States Court of Appeals for the Federal Circuit

August 14, 2019, Decided

2018-1804, 2018-1808, 2018-1809

Opinion

 [*1370]  Lourie, Circuit Judge.

Plaintiffs-Appellants (collectively, "Sanofi") appeal from the judgment of the U.S. District Court for the District of New Jersey holding, after a bench trial, claims 7, 11, 14-16, and 26 of U.S. Patent 8,927,592 (the "'592 patent") invalid as obvious. Sanofi-Aventis U.S. LLC v. Fresenius Kabi USA, LLC, No. 14-7869 (D.N.J. Dec. 19, 2017) ("Decision"). Defendants-Cross-Appellants (collectively, "Fresenius") cross-appeal from the same judgment holding claims 1 and 2 of U.S. Patent 5,847,170 (the "'170 patent") not invalid as obvious. Because there was no case or controversy with respect to claims 7, 11, 14-16, [**3]  and 26 of the '592 patent when the district court issued its decision, we vacate the court's decision concerning those claims. We affirm the court's judgment that the '170 patent is not invalid as obvious.

Background

Sanofi owns the '170 and '592 patents, respectively claiming the compound cabazitaxel and methods of using it. Sanofi markets cabazitaxel under the trade name  [*1371]  Jevtana® to treat certain drug-resistant prostate cancers. Both the '170 and '592 patents are listed in the Orange Book1 as covering cabazitaxel.

Cabazitaxel belongs to a family of compounds called taxanes and is the third and most recent taxane drug to gain approval by the Food and Drug Administration ("FDA"). The other two are paclitaxel, approved in 1992, and docetaxel, approved in 1996. The chemical structures of docetaxel and cabazitaxel are depicted below:

As annotated above, cabazitaxel differs from docetaxel in the substitution of two methoxy groups for hydroxyl groups. The carbon atoms to which the right and left methoxy groups are bound are referred to as C7 and C10, respectively. A fully numbered cabazitaxel is depicted in Appendix A, and the carbon positions are numbered in the same way in docetaxel.2

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933 F.3d 1367 *; 2019 U.S. App. LEXIS 24141 **; 2019 U.S.P.Q.2D (BNA) 301908; 2019 WL 3807979

SANOFI-AVENTIS U.S., LLC, SANOFI MATURE IP, SANOFI, Plaintiffs-Appellants v. DR. REDDY'S LABORATORIES, INC., DR. REDDY'S LABORATORIES, LTD., SANDOZ, INC., Defendants-Appellees, FRESENIUS KABI USA, LLC, ACCORD HEALTHCARE, INC., APOTEX CORP., APOTEX INC., ACTAVIS LLC, ACTAVIS ELIZABETH LLC, MYLAN LABORATORIES LIMITED, Defendants-Cross-Appellants

Prior History:  [**1] Appeals from the United States District Court for the District of New Jersey in Nos. 3:14-cv-07869-MAS-LHG, 3:14-cv-08079-MAS-LHG, 3:14-cv-08082-MAS-LHG, 3:15-cv-00287-MAS-LHG, 3:15-cv-00290-MAS-LHG, 3:15-cv-00776-MAS-LHG, 3:15-cv-01835-MAS-LHG, 3:15-cv-02520-MAS-LHG, 3:15-cv-02522-MAS-LHG, 3:15-cv-02631-MAS-LHG, 3:15-cv-03107-MAS-LHG, 3:15-cv-03392-MAS-LHG, 3:16-cv-02259-MAS-LHG, 3:16-cv-05678-MAS-LHG, Judge Michael A. Shipp.

Disposition: AFFIRMED-IN-PART AND VACATED-IN-PART.

CORE TERMS

substitutions, district court, disclaimed, taxanes, docetaxel, methoxy, compound, cabazitaxel, patent, cell, resistant, skilled, case or controversy, lipophilicity, invalid, paclitaxel, artisan, references, analogs, prior art, drug-resistant, investigated, preclusion, positions, modify, hypothetical, motivation, methylthiomethoxy, modification, teaching

Patent Law, Jurisdiction & Review, Standards of Review, De Novo Review, Infringement Actions, Defenses, Patent Invalidity, Remedies, Declaratory Judgments, Constitutional Law, The Judiciary, Case or Controversy, Advisory Opinions, Standing, Elements, Civil Procedure, Preliminary Considerations, Justiciability, Mootness, Claims & Specifications, Claims, Subject Matter Jurisdiction, Appeals, Clearly Erroneous Review, Evidence, Burdens of Proof, Inferences & Presumptions, Presumptions, Rebuttal of Presumptions, Patent Invalidity, Presumption of Validity, Nonobviousness, Elements & Tests, Ordinary Skill Standard, Prior Art, Nonobviousness