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Millennium Pharms., Inc. v. Sandoz Inc.

United States Court of Appeals for the Federal Circuit

July 17, 2017, Decided

2015-2066, 2016-1008, 2016-1009, 2016-1010, 2016-1109, 2016-1110, 2016-1283, 2016-1762

Opinion

 [*1360]  [***1331]   Newman, Circuit Judge.

Millennium Pharmaceuticals, Inc. is the exclusive licensee of U.S. Patent No. 6,713,446 ("the '446 Patent"), issued March 30, 2004 and assigned to the United States. Millennium developed the patented product for treatment of oncology disease, particularly multiple myeloma and mantle cell lymphoma. The product has the brand  [*1361]  name Velcade®. Appellees in Appeal Nos. 15-2066, 16-1008, 16-1009, 16-1010, 16-1110, 16-1283, and 16-1762 (collectively, "Sandoz") all filed abbreviated new drug applications ("ANDAs"), admitting infringement and seeking to invalidate various claims of the '446 Patent. Based on the litigation that ensued, the district court held that claims 20, 31, 49, and 53 of the '446 Patent were invalid,1 leading to this appeal.

Millennium filed a notice of appeal in Appeal No. 16-1109 after the district court [**4]  entered final judgment against Millennium in separate cases arising from ANDAs filed by Apotex and Teva, based on collateral estoppel arising from the district court's judgment of invalidity of claims 20, 31, 49, and 53 of the '446 Patent in the Sandoz-Millennium action. We consolidated the appeals in the Sandoz, Apotex, and Teva actions.

On review of the record and the applicable law, we conclude that the district court erred in the Sandoz litigation and that invalidity was not established. We reverse and enter judgment in favor of Millennium in the Sandoz litigation. We also vacate the district court's judgment in the action between Millennium, Teva, and Apotex based on our decision in the Sandoz litigation and remand that action for further proceedings.

I. Background

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862 F.3d 1356 *; 2017 U.S. App. LEXIS 12702 **; 123 U.S.P.Q.2D (BNA) 1329 ***; 2017 WL 3013204

MILLENNIUM PHARMACEUTICALS, INC., Plaintiff-Appellant v. SANDOZ INC., ACCORD HEALTHCARE, INC., ACTAVIS LLC, MYLAN LABORATORIES LIMITED, AGILA SPECIALTIES INC., DR. REDDY'S LABORATORIES, LTD., DR. REDDY'S LABORATORIES, INC., SUN PHARMACEUTICAL INDUSTRIES LIMITED, SUN PHARMA GLOBAL FZE, APOTEX CORP., APOTEX INC., TEVA PHARMACEUTICALS USA, INC., GLENMARK PHARMACEUTICALS LTD., GLENMARK GENERICS LTD., GLENMARK GENERICS INC., USA, HOSPIRA, INC., WOCKHARDT BIO AG, WOCKHARDT USA LLC, Defendants-Appellees

Prior History:  [**1] Appeals from the United States District Court for the District of Delaware in Nos. 1:12-cv-01011-GMS, 1:12-cv-01490-GMS, 1:12-cv-01750-GMS, 1:13-cv-01874-GMS, 1:14-cv-01156-GMS, 1:15-cv-00040-GMS, 1:15-cv-00539-GMS, 1:15-cv-00540-GMS, 1:15-cv-00804-GMS, 1:16-cv-00034-GMS, Judge Gregory M. Sleet.

Millennium Pharms., Inc. v. Sandoz Inc., 2015 U.S. Dist. LEXIS 110099 (D. Del., Aug. 20, 2015)

Disposition: REVERSED-IN-PART AND REMANDED-IN-PART; VACATED-IN-PART AND REMANDED-IN-PART.

CORE TERMS

bortezomib, mannitol, compound, lyophilization, district court, Patent, prior art, stability, skill, teach, invention, ordinary person, properties, bulking, no reference, invalidity, unexpected, solubility, boronic, solve, pharmaceutical, chemical, suggests, objective indicia, dissociability, nonobviousness, long-felt, glycerol, chemical compound, infringement

Evidence, Burdens of Proof, Clear & Convincing Proof, Patent Law, Jurisdiction & Review, Standards of Review, De Novo Review, Nonobviousness, Evidence, Fact & Law Issues, Elements & Tests, Predictability, Prior Art, Teaching Away From Invention, Anticipation & Novelty, Accidental Anticipation & Inherency, Elements & Tests, Hindsight, Ordinary Skill Standard, Graham Test, Graham Test, Secondary Considerations