Millennium Pharm., Inc. v. Sandoz Inc.
| Decision Date | 17 July 2017 |
| Docket Number | 2016-1762, 2016-1109, 2016-1008, 2016-1283, 2016-1010, 2016-1009, 2016-1110,2015-2066 |
| Citation | 862 F.3d 1356 |
| Parties | 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 |
| Court | U.S. Court of Appeals — Federal Circuit |
William F. Lee , Wilmer Cutler Pickering Hale and Dorr LLP, Boston, MA, argued for plaintiff-appellant. Also represented by Mark Christopher Fleming, Lisa Jon Pirozzolo, Jason H. Liss, Anna E. Lumelsky, Tasha Joy Bahal, Emily R. Whelan ; Robert M. Galvin , Palo Alto, CA.
Thomas J. Meloro , Willkie Farr & Gallagher LLP, New York, NY, argued for all defendants-appellees. Defendant-appellee Hospira, Inc. also represented by Michael Johnson .
George C. Lombardi , Winston & Strawn LLP, Chicago, IL, for defendant-appellee Sandoz Inc. Also represented by Kathleen Bridget Barry, Maureen L. Rurka .
Paul Braier , Greenblum & Bernstein, P.L.C., Reston, VA, for defendant-appellee Accord Healthcare, Inc. Also represented by Peter Branko Pejic .
Gary Edward Hood , Polsinelli PC, Chicago, IL, for defendant-appellee Actavis LLC. Also represented by Mark Thomas Deming, Khurram Naik ; Robyn Ast-Gmoser , St. Louis, MO.
Tung On Kong , Rhodes Attorneys at Law P.C., San Francisco, CA, for defendants-appellees Mylan Laboratories Limited, Agila Specialties Inc. Also represented by Elham Firouzi Steiner , Wilson, Sonsini, Goodrich & Rosati, PC, San Diego, CA.
Louis Harry Weinstein , Budd Larner, P.C., Short Hills, NJ, for defendants-appellees Dr. Reddy's Laboratories, Ltd., Dr. Reddy's Laboratories, Inc. Also represented by Ellen Tchorni Lowenthal, Stuart D. Sender .
Rachel C. Hughey , Merchant & Gould P.C., Minneapolis, MN, for defendants-appellees Sun Pharmaceutical Industries Limited, Sun Pharma Global FZE. Also represented by Aaron M. Johnson, Christopher J. Sorenson .
William A. Rakoczy , Rakoczy Molino Mazzochi Siwik LLP, Chicago, IL, for defendants-appellees Apotex Corp., Apotex Inc. Also represented by Peter James Curtin, Thomas Ehrich, Luke Timothy Shannon .
Mark David Schuman , Carlson, Caspers, Vandenburgh, Lindquist & Schuman, P.A., Minneapolis, MN, for defendant-appellee Teva Pharmaceuticals USA, Inc. Also represented by Jennell Christine Bilek, Samuel T. Lockner, Alexandra Jane Olson, Todd S. Werner .
Jay Philip Lessler , Blank Rome LLP, New York, NY, for defendants-appellees Glenmark Pharmaceuticals Ltd., Glenmark Generics Ltd., Glenmark Generics Inc., USA. Also represented by Christopher K. Hu, Paul M. Zagar ; David Anthony Dorey , Wilmington, DE.
Kevin Michael Nelson , Duane Morris LLP, Chicago, IL, for defendants-appellees Wockhardt Bio AG, Wockhardt USA LLC. Also represented by Patrick Gallagher .
Before Newman, Mayer, and O'Malley, Circuit Judges.
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 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 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.
The '446 Patent describes the chemical compound D-mannitol N-(2-pyrazine)carbonyl-L-phenylalanine-L-leucine boronate. The compound is described as a boronate ester of bortezomib
(a boronic acid) and D-mannitol (a hydroxy compound ) and has the following chemical structure, with Millennium's highlight of the bonds between the bortezomib moiety and the D-mannitol moiety:
Millennium Br. 13. The lyophilized compound is claimed in Claim 20:
20. The lyophilized compound D-mannitol N-(2-pyrazine)carbonyl-L-phenylalanine-L-leucine boronate.
Other asserted claims include the new compound as a lyophilized cake, the method of preparation of the new compound, and its reconstitution with a pharmaceutically acceptable carrier. Dist. Ct. Op. *2.
and its properties as a proteasome inhibitor were previously known and are described in United States Patent No. 5,780,454 ("the Adams Patent"). However, despite its known efficacy against various cancers, bortezomib never achieved FDA approval and market status because of its instability, its rapid degradation in liquid formulations, and its insolubility. The record states that these problems remained unsolved despite extensive research effort by the inventor Dr. Adams and others at Millennium and its predecessor company. Dr. Adams' team attempted to develop a stable liquid formulation of bortezomib, but after evaluating approximately 20 different formulations, the team failed to develop a formulation that was stable enough for transportation, storage, and administration to patients under conditions of clinical use and distribution.
The inventor of the '446 Patent was associated with the National Cancer Institute and the University of Kansas, and was consulted by Dr. Adams after years of unsuccessful attempts to solve formulation and stability problems with bortezomib
. Despite preparing approximately twenty-five different liquid formulations, these efforts encountered the same stability and solubility problems as had other researchers attempting to solve this problem.
After failing to develop a viable liquid formulation, researchers began work on a lyophilized formulation for injection. The process of lyophilization
(freeze-drying) is not intended to change the chemical structure of the active pharmaceutical ingredient. After experimenting with multiple variables that affect the lyophilization process, including solvents and bulking agents, researchers produced a promising lyophilized formulation using mannitol, a known bulking agent. It was discovered that the reason for the dramatic improvement in dissolution and stability for this formulation was the formation of a new chemical compound during lyophilization : the claimed ester of bortezomib and mannitol. The mannitol ester of bortezomib acts as a "prodrug," a compound that converts to or releases the active pharmaceutical ingredient upon administration to a patient. This discovery is described and claimed in the '446 Patent.
The ensuing drug product (Velcade
®) became Millennium Br. 1.
After the Sandoz defendants each filed an ANDA seeking FDA approval for the commercial manufacture, use, and sale of generic counterparts of Velcade®>, Millennium filed patent infringement suits alleging that the products infringe at least claims 20, 31, 49, and 53 of the '446 Patent. The defendants stipulated to infringement of all asserted claims, and raised the defense of patent invalidity based on obviousness.
The district court held that the claims were obvious because they were the inherent result of an allegedly obvious process, viz ., lyophilizing bortezomib in the presence of the bulking agent mannitol. Millennium argued that a person of ordinary skill would avoid lyophilization
in developing a formulation involving bortezomib because "bortezomib was known to be unstable even in the dry state as a freestanding solid compound." Dist. Ct. Op. *6. The court was not persuaded by this argument and in-stead relied on the testimony of Sandoz's witness, Dr. Repta, to find that, as of the '446 Patent's priority date, lyophilization"was well-known in the field of formulation" and that it was considered an obvious alternative "when a liquid formulation provided limited success." Id.
The district court did not find that the prior art taught or suggested that the claimed new compound would be formed, or taught or suggested making the claimed new compound by any method, or taught or suggested that this new compound would have the properties of stability, solubility, and dissociability that it exhibited. No reference taught or suggested reacting bortezomib
with mannitol, and no reference hinted that such an esterification reaction might occur during lyophilization. No reference taught or suggested that the product of such lyophilization would be a new chemical compound that would solve the problems that had inhibited development of bortezomib in oncology. However, the district court concluded that...
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