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Lundbeck v. Apotex Inc.

United States District Court, D. Delaware

July 16, 2019

H. LUNDBECK A/S, et al., Plaintiffs,
v.
APOTEX INC., et al, Defendants.

          Jack B. Blumenfeld and Megan E. Dellinger, MORRIS, NICHOLS, ARSHT & TUNNELL LLP, Wilmington, DE George F. Pappas, Einar Stole, Christopher N. Sipes, Brianne Bharkhda, Priscilla G. Dodson, Alaina Whitt, and Allison Schmitt, COVINGTON & BURLING LLP, Washington, DC Yiye Fu, COVINGTON & BURLING LLP, Palo Alto, CA Attorneys for Plaintiffs

          Kelly E. Farnan and Nicole K. Pedi, RICHARDS, LAYTON & FINGER, P.A., Wilmington, DE Bradley C. Graveline, SHEPPARD MULLIN RICHTER & HAMPTON LLP, Chicago, IL Jesse A. Salen, SHEPPARD MULLIN RICHTER & HAMPTON LLP, San Diego, CA April E. Weisbruch, SHEPPARD MULLIN RICHTER & HAMPTON LLP, Washington, DC Attorneys for Alembic Pharmaceuticals Limited, Alembic Global Holdings S/A, and Alembic Pharmaceuticals, Inc.

          Adam W. Poff and Pilar G. Kraman, YOUNG CON A WAY STARGATT & TAYLOR, LLP, Wilmington, DE Dennies Varughese, Robert C. Millonig, Daniel J. Ritterbeck, and Stephanie M. Nguyen, STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C, Washington, DC Attorneys for Alkem Laboratories Ltd.

          Karen L. Pascale and Robert M. Vrana, YOUNG CONAWAY STARGATT & TAYLOR LLP, Wilmington, DE William L. Mentlik, Tedd W.Van Burskirk, Aaron S. Eckenthal, LERNER, DAVID, LITTENBERG, KRUMHOLZ & MENTLIK, LLP, Westfield, N.J. Attorneys for Cipla Limited and Cipla USA Inc.

          Kenneth L. Dorsney, MORRIS JAMES LLP, Wilmington, DE Richard T. Ruzich, Stephen R. Auten, Ian Scott, and Philip Y. Kouyoumdjian, TAFT STETTINIUS & HOLLISTER LLP, Chicago IL Attorneys for Apotex Corp., Apotex Inc. and Apotex Research Private Limited.

          Kenneth L. Dorsney, MORRIS JAMES LLP, Wilmington, DE Howard S. Suh and Nicholas P. Chiara, HOLLAND & KNIGHT LLP, New York, NY Attorneys for Apicore U.S. LLC.

          Geoffrey Grivner, BUCHANAN INGERSOLL & ROONEY PC, Wilmington, DE Matthew L. Fedowitz, Erin M. Dunston, and Mythili Markowski, BUCHANAN INGERSOLL & ROONEY PC, Alexandria, VA Phillip L. Hirschhorn, BUCHANAN INGERSOLL & ROONEY PC, New York, NY Attorneys for MSN Private Laboratories Limited, MSN Pharmaceuticals, Inc., and MSN Pharmachem Private Limited.

          Kelly E. Farnan and Sara M. Metzler, RICHARDS, LAYTON & FINGER, P.A., Wilmington, DE B. Jefferson Boggs, MERCHANT & GOULD PC, Alexandria, VA Christopher J. Sorenson, MERCHANT & GOULD PC, Minneapolis, MN Attorneys for Macleods Pharmaceuticals Ltd. and Macleods Pharma USA, Inc.

          Dominick T. Gattuso, HEYMAN ENERIO GATTUSO & HIRZEL LLC, Wilmington, DE Laura A. Lydigsen, Joshua E. Ney, and Judy K. He, BRINKS GILSON & LIONE, Chicago, IL Attorneys for Sandoz Inc. and Lek Pharmaceuticals d.d.

          John C. Phillips Jr., David A Bilson, and Megan C. Haney, PHILLIPS GOLDMAN MCLAUGHLIN & HALL, P.A., Wilmington, DE Paul A. Braier, P. Branko Pejic, and Michael J. Fink, GREENBLUM & BERNSTEIN, P.L.C., Reston, VA Attorneys for Unichem Laboratories, Limited.

          Arthur G. Conolly III, CONNOLY GALLAGHER LLP, Wilmington, DE H. Keeto Sabharwal, Ceric C.Y. Tan, and Yun Wei, PILLSBURY WINTRHOP SHAW PITTMAN LLP, Washington, DC Attorneys for Torrent Pharmaceuticals Limited and Torrent Pharma Inc.

          John C. Phillips Jr, David A. Bilson, and Megan C. Haney, PHILLIPS GOLDMAN MCLAUGHLIN & HALL, P.A, Wilmington, DE Marc R. Wezowski, Don J. Mizerk, and David A. Gerasimow, HUSCH BLACKWELL LLP, Chicago, IL Thomas P. Heneghan, HUSCH BLACKWELL LLP, Madison, WI Daisy Manning, HUSCH BLACKWELL LLP, St. Louis, MO Attorneys for Sigmapharm Laboratories, LLC.

          MEMORANDUM OPINION

          STARK, U.S. District Judge

         Plaintiffs brought this suit against Defendants asserting infringement of U.S. Patent Nos. 8, 772684 (the '"684 patent"), 8, 969, 355 (the '"355 patent"), 9, 227, 946 (the '"946 patent"), and 9, 861, 630 (the '"630 patent") (the "Crystalline Form Patents"), among others. Presently before the Court is the issue of claim construction. The parties[1] submitted technology tutorials (D.I. 213, 214), objections to such technology tutorials (D.I. 229, 231), claim construction briefs (D.I. 200, 201, 230, 232, 251, 253), exhibits (D.I. 201-1, 202-1, 230, 232, 251, 253), and expert declarations (D.I. 203, 204, 205, 206, 233). The Court held a claim construction hearing on May 29, 2019, at which both sides presented oral argument. (D.I. 263 ("Tr."))

         I. LEGAL STANDARDS

         The ultimate question of the proper construction of a patent is a question of law. See Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 837 (2015) (citing Mar kman 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 normally used consistently throughout the patent." Id. (internal citation omitted).

         It is likewise true that "[differences among claims can also be a useful guide .... For example, the presence of a dependent claim that adds a particular limitation gives rise to a presumption that the limitation in question is not present in the independent claim." Id. at 1314-15 (internal citation omitted). This "presumption is especially strong when the limitation in dispute is the only meaningful difference between an independent and dependent claim, and one party is urging that the limitation in the dependent claim ...


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