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Bristol-Myers Squibb Co. v. Aurobindo Pharma USA Inc.

United States District Court, D. Delaware

October 18, 2018

BRISTOL-MYERS SQUIBB COMPANY and PFIZER INC., Plaintiffs and Counterclaim-Defendants
AUROBINDO PHARMA USA INC. and AUROBINDO PHARMA LTD., Defendants and Counterclaim-Plaintiffs.

          Joseph J. Farnan, Brian E. Farnan, Michael J. Farnan, FARNAN LLP, Wilmington, DE Amy K. Wigmore, Gregory H. Lantiere, Heather M. Petruzzi, Tracey C. Allen, Jeffrey T. Hanston, WILMER CUTLER PICKERING HALE & DALE LLP, Washington, DC Kevin S. Prussia, Andrew J. Danford, Timothy A. Cook, Kevin M. Yukerwich, WILMER CUTLER PICKERING HALE & DALE LLP, Boston, MA Attorneys for Plaintiffs Bristol-Myers Squibb Company and Pfizer, Inc.

          Arthur G. Connolly, III, CONNOLLY GALLAGHER LLP, Wilmington, DE Attorney for Defendants Aurobindo Pharma USA Inc. and Aurobindo Pharma Ltd. Neal C. Belgam, Eve H. Ormerod, SMITH, KATZENSTEIN & JENKINS LLP, Wilmington, DE Attorneys for Defendant InvaGen Pharmaceuticals Inc.

          Stamatios Stamaulis, Richard C. Weinblatt, STAMOULIS & WEINBLATT LLC, Wilmington DE Attorneys for Defendant Mylan Pharmaceuticals Inc.

          Karen L. Pascale, Robert M. Vrana, YOUNG CONAWAY STARGATT & TAYLOR LLP, Wilmington, DE Attorneys for Defendants Sunshine Lake Pharma Co., Ltd. and HEC Pharm USA Inc.

          John C. Phillips, Jr. David A. Bilson, PHILLIPS, GOLDMAN, MCLAUGHLIN & HALL, P.A., Wilmington, DE Attorneys for Defendants Unichem Laboratories, Ltd., Impax Laboratories LLC, Sigmapharm Laboratories LLC, and Zydus Pharmaceuticals (USA) Inc.

          David Ellis Moore, Bindu Palapura, Stephanie E. O'Byrne, POTTER ANDERSON & CORROON, LLP, Wilmington, DE Attorneys for Defendants Dr. Reddy's Laboratories Ltd. And Dr. Reddy's Laboratories Inc.

          Sean M. Brennecke, KLEHR HARRISON HARVEY BRANZBURG LLP, Wilmington, DE Attorney for Defendant Indoco Remedies Ltd. Dominick T. Gattuso, HEYMAN ENERIO GATTUSO & HIRZEL LLP, Wilmington, DE Attorney for Defendant Sandoz Inc.


          STARK, U.S. District Judge

         This is a patent infringement case arising under the Hatch Waxman Act. Plaintiffs Bristol-Myers Squibb Co. and Pfizer Inc. (collectively, "Plaintiffs") sued multiple Defendants who seek to market a generic form of Plaintiffs' Eliquis (apixaban) drug product before the expiration of U.S. Patent Nos. 9, 326, 945 ('"945 patent") and 6, 967, 208 ('"208 patent").[1] (See generally D.I. 124)

         Presently before the Court are the parties' disputes over the meaning of certain terms in the asserted claims. Some defendants[2] have also filed a motion to strike an article relied upon by Plaintiffs. (See D.I. 258, 259, 271) The parties submitted technology tutorials (D.I. 202, 203), comments to the opposing side's technology tutorial (D.I. 235, 236), claim construction briefs (D.I. 204, 206, 243, 245), and supporting declarations (D.I. 205, 207, 208, 209, 244, 246, 247). The Court held a claim construction hearing on September 6, 2018. (See D.I. 296) ("Tr.")


         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 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) (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 should be read into the independent claim." SunRace Roots Enter. Co., Ltd. v. SRAM Corp., 336 F.3d 1298, 1303 (Fed. Cir. 2003).

         It is also possible that "the specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess. In such cases, the inventor's lexicography governs." Phillips, 415 F.3d at 1316. It bears emphasis that "[e]ven when the specification describes only a single embodiment, the claims of the patent will not be read restrictively unless the patentee has demonstrated a clear intention to limit the claim scope using words or expressions of manifest exclusion or restriction." Hill-Rom Servs., Inc. v. Stryker Corp., 755 F.3d 1367, 1372 (Fed. Cir. 2014) (quoting Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 906 (Fed. Cir. 2004)) (internal quotation marks omitted).

         In addition to the specification, a court "should also consider the patent's prosecution history, if it is in evidence." Markman v. Westview Instruments, Inc., 52 F.3d 967, 980 (Fed. Cir. 1995), aff'd, 517 U.S. 370 (1996). The prosecution history, which is "intrinsic evidence," "consists of the complete record of the proceedings before the PTO [Patent and Trademark Office] and includes the prior art cited during the examination of the patent." Phillips, 415 F.3d at 1317. "[T]he prosecution history can often inform the meaning of the claim language by demonstrating how the inventor understood the invention and whether the inventor limited the invention in the course of prosecution, making the claim scope narrower than it would otherwise be." Id.

         In some cases, "the district court will need to look beyond the patent's intrinsic evidence and to consult extrinsic evidence in order to understand, for example, the background science or the meaning of a term in the relevant art during the relevant time period." Teva, 135 S.Ct. at 841. Extrinsic evidence "consists of all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises." Markman, 52 F.3d at 980. For instance, technical dictionaries can assist the court in determining the meaning of a term to those of skill in the relevant art because such dictionaries "endeavor to collect the accepted meanings of terms used in various fields of science and technology." Phillips, 415 F.3d at 1318. In addition, expert testimony can be useful "to ensure that the court's understanding of the technical aspects of the patent is consistent with that of a person of skill in the art, or to establish that a particular term in the patent or the prior art has a particular meaning in the pertinent field." Id. Nonetheless, courts must not lose sight of the fact that "expert reports and testimony [are] generated at the time of and for the purpose of litigation and thus can suffer from bias that is not present in intrinsic evidence." Id. Overall, while extrinsic evidence "may be useful" to the court, it is "less reliable" than intrinsic evidence, and its consideration "is unlikely to result in a reliable interpretation of patent claim scope unless ...

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