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Novartis Pharmaceuticals Corp. v. Accord Healthcare Inc.

United States District Court, D. Delaware

June 5, 2019

NOVARTIS PHARMACEUTICALS CORPORATION, Plaintiff,
v.
ACCORD HEALTHCARE INC., et al., Defendants.

          Michael P. Kelly, Daniel M. Silver, and Benjamin A. Smyth, McCARTER & ENGLISH, LLP, Wilmington, DE, Jane M. Love, Robert Trenchard, and Paul E. Torchia, GIBSON, DUNN & CRUTCHER LLP, New York, NY Andrew P. Blythe, GIBSON, DUNN & CRUTCHER LLP, Los Angeles, CA Attorneys for Plaintiff

          John C. Phillips, Jr. and Megan C. Haney, PHILLIPS, GOLDMAN, MCLAUGHLIN & HALL, P.A., Wilmington, DE Michael J. Gaertner, David B. Abramowitz, Carolyn A. Blessing, Emily L. Savas, and Jonathan B. Turpin, LOCKE LORD LLP, Chicago, IL Attorneys for Attorneys for Zydus Pharmaceuticals (USA), Cadila Healthcare Limited

          Neal C Belgam and Eve H. Ormerod, SMITH, KATZENSTEIN & JENKINS LLP, Wilmington, DE Alan Pollack and Louis H. Weinstein, BUDD LARNER, P.C, Short Hills, N.J. Attorneys for Accord Healthcare, Inc., Dr. Reddy's Laboratories, Inc., Dr. Reddy's Laboratories, Ltd., Torrent Pharmaceuticals Ltd., and Torrent Pharma Inc.

          Kenneth L. Dorsney, MORRIS JAMES LLP, Wilmington, DE Timothy H. Kratz and George J. Barry III, KRATZ & BARRY LLP, Atlanta, GA Attorneys for Aurobindo Pharma Limited, Aurobindo Pharma USA, Inc.

          Kenneth L. Dorsney, MORRIS JAMES LLP, Wilmington, DE Howard S. Sun, HOLLAND & KNIGHT LLP, Attorneys for Hetero USA Inc., Hetero Labs Limited, Hetero Labs Limited Unit-V, Prinston Pharmaceutical Inc.

          Kelly E. Farnan and Sara M. Metzler, RICHARDS, LAYTON & FINGER, PA., Wilmington, DE Attorneys for Breckenridge Pharmaceutical, Inc., Standard Chemical & Pharmaceutical Co. Ltd.

          Stamatios Stamoulis and Richard C. Weinblatt, STAMOULIS & WEINBLATT, LLP, Wilmington, DE Mieke Malmberg, SKIERMONT DERBY LLP, Los Angeles, CA Paul Skiermont, Sarah Spires, and Steven J. Udick, SKIERMONT DERBY LLP, Dallas, TX Attorneys for HEC Pharm Co. and HEC Pharm USA Inc.

          Fredrick L. Cottrell, III, Jason J. Rawnsley, and Alexandra M. Ewing, RICHARDS, LAYTON & FINGER, PA., Wilmington, DE Shannon M. Bloodworm and Brandon M. White, PERKINS COIE LLP, Washington, DC Bryan D. Beel, PERKINS COIE LLP, Portland, OR Michael R. Laing, PERKINS COIE LLP, Madison, WI Attorneys for Mylan Pharmaceuticals Inc.

          Kenneth L. Dorsney, MORRIS JAMES LLP, Wilmington, DE Stephen R. Auten, Richard T. Ruzich, Roshan P. Shrestha, TAFT STETTINIUS & HOLLISTER LLP, Chicago, IL Attorneys for Alkem Laboratories, Ltd.

          MEMORANDUM OPINION

          STARK, U.S. District Judge

         Plaintiff Novartis Pharmaceuticals Corp. ("Novartis" or "Plaintiff') filed suit against 25 generic pharmaceutical companies ("Defendants") on June 16, 2018, alleging infringement of U.S. Patent No. 9, 187, 405 ("the '405 patent"). (D.I. 1) The '405 patent "relates [to] uses of an SIP receptor modulator ... for the treatment or prevention of neo-angiogenesis associated with a demyelinating disease, e.g. multiple sclerosis." ('405 patent at Abstract) The parties dispute the significance of the preambles to the three independent claims of the '405 patent, as well as the meaning of the term "daily dosage." The Patent Trial and Appeal Board ("PTAB") issued a final written decision on a petition for inter par tes review ("IPR") challenging the validity of claims 1-6 of the '405 patent, on July 11, 2018. (D.I. 430-17 Ex. 43) The PTAB's decision construed the disputed terms using the standard of "broadest reasonable interpretation" ("BRI"). The parties completed claim construction briefing on April 16, 2019 (D.I. 426, 429, 479, 484) and the Court held a claim construction hearing on April 23, 2019 (D.I. 498) ("Tr.").

         LEGAL STANDARDS

         The ultimate question of the proper construction of a patent is a question of law. See TevaPharm. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 837 (2015) (citing Markman v. Westview Instruments, Inc., 517 U.S. 370, 388-91 (1996)). "It is a bedrock principle of patent law that the claims of a patent define the invention to which the patentee is entitled the right to exclude." Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (citation and internal quotation marks omitted). "[T]here is no magic formula or catechism for conducting claim construction." Id. at 1324. Instead, the court is free to attach the appropriate weight to appropriate sources "in light of the statutes and policies that inform patent law." Id.

         "[T]he words of a claim are generally given their ordinary and customary meaning.... [which is] the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application." Id. at 1312-13 (internal citations and quotation marks omitted). "[T]he ordinary meaning of a claim term is its meaning to the ordinary artisan after reading the entire patent." Id. at 1321 (internal quotation marks omitted). The patent "specification is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term." Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996).

         While "the claims themselves provide substantial guidance as to the meaning of particular claim terms," the context of the surrounding words of the claim also must be considered. Phillips, 415 F.3d at 1314. Furthermore, "[o]ther claims of the patent in question, both asserted and unasserted, can also be valuable sources of enlightenment.... [b]ecause claim terms are ...


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