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AstraZeneca LP v. Sigmapharm Laboratories, LLC

United States District Court, D. Delaware

February 17, 2017

ASTRAZENECA LP, ASTRAZENECA AB, ASTRAZENECA UK LIMITED, and ASTRAZENECA PHARMACEUTICALS LP, Plaintiffs,
v.
SIGMAPHARM LABORATORIES, LLC, et al, Defendants.

          Michael P. Kelly, Esq., MCCARTER & ENGLISH LLP, Wilmington, DE; Daniel M. Silver, Esq., MCCARTER & ENGLISH LLP, Wilmington, DE; Benjamin A. Smyth, Esq., MCCARTER & ENGLISH LLP, Wilmington, DE; Charles E. Lipsey, Esq., FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP, Reston, VA; Ryan P. O'Quinn, Esq., FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP, Reston, VA; Mark J. Feldstein, Esq. (argued), FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP, Washington, DC; Jill K. MacAlpine, Esq. (argued), FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP, Washington, DC; Cora R. Holt, Esq., FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP, Washington, DC. Attorneys for Plaintiffs.

          David E. Moore, Esq., POTTER ANDERSON & CORROON LLP, Wilmington, DE; Bindu A. Palapura, Esq., POTTER ANDERSON & CORROON LLP, Wilmington, DE; Stephanie E. O'Byrne, Esq., POTTER ANDERSON & CORROON LLP, Wilmington, DE; Natalie C. Clayton, Esq. (argued), ALSTON & BIRD LLP, New York, NY; Stephen Yang, Esq., ALSTON & BIRD LLP, New York, NY; Yi Wen Wu, Esq., ALSTON & BIRD LLP, New York, NY. Attorneys for Defendant Watson Laboratories Inc.

          Karen L. Pascale, Esq., YOUNG CONAWAY STARGATT & TAYLOR, LLP, Wilmington, DE; Anne Shea Gaza, Esq., YOUNG CONAWAY STARGATT & TAYLOR, LLP, Wilmington, DE; Robert M. Vrana, Esq., YOUNG CONAWAY STARGATT & TAYLOR, LLP, Wilmington, DE; Maureen Rurka, Esq., WINSTON & STRAWN LLP, Chicago, IL; John R. McNair, Esq., WINSTON & STRAWN LLP, Chicago, IL; Loren G. Rene, Esq., WINSTON & STRAWN LLP, Chicago, IL. Attorneys for Defendants Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals of New York, LLC

          James M. Lennon, Esq., YOUNG CONAWAY STARGATT & TAYLOR, LLP, Wilmington, DE; Gregory J. Brodzik, Esq., YOUNG CONAWAY STARGATT & TAYLOR, LLP, Wilmington, DE; James H. Wallace, Jr., Esq., WILEY REIN LLP, Washington, DC; Mark A. Pacella, Esq., WILEY REIN LLP, Washington, DC; Wesley E. Weeks, Esq., WILEY REIN LLP, Washington, DC; Brian H. Pandya, Esq., WILEY REIN LLP, Washington, DC. Attorneys for Defendant Mylan Pharmaceuticals Inc.

          R. Touhey Myer, Esq., CAESAR RIVISE PC, Wilmington, DE; Robert S. Silver, Esq., CAESAR RIVISE PC, Philadelphia, PA; Salvatore Guerriero, Esq., CAESAR RIVISE PC, Philadelphia, PA; Pei-Ru Wey, Esq., CAESAR RIVISE PC, Philadelphia, PA; Lynne M. Terrebonne, Esq., CAESAR RIVISE PC, Philadelphia, PA. Attorneys for Defendants InvaGen Pharmaceuticals, Inc. and Sigmapharm Laboratories LLC.

          Kelly E. Farnan, Esq., RICHARDS, LAYTON & FINGER PA, Wilmington, DE; Christine Dealey Haynes, Esq., RICHARDS, LAYTON & FINGER PA, Wilmington, DE; Steven E. Feldman, Esq., HAHN LOESER & PARKS LLP, Chicago, IL; Sherry L. Rollo, Esq. (argued), HAHN LOESER & PARKS LLP, Chicago, IL; Daniel R. Cherry, Esq., HAHN LOESER & PARKS LLP, Chicago, IL. Attorneys for Defendant Prinston Pharmaceutical Inc.

          MEMORANDUM OPINION

          ANDREWS, U.S. DISTRICT JUDGE.

         Presently before the Court is the issue of claim construction of multiple terms in U.S. Patent Nos. 6, 525, 060 ("the '060 patent") and 7, 265, 124 ("the '124 patent").[1] The Court has considered the Parties' Joint Claim Construction Brief. (Civ. Act. No. 15-1000-RGA, D.I. 149). The Court heard oral argument on February 14, 2017.

         I. BACKGROUND

         This litigation arises from each of the Defendants filing an Abbreviated New Drug Application ("ANDA") before expiration of several of AstraZeneca's patents. (D.I. 149 at 11). On October 30, 2015, Plaintiffs filed suit against each Defendant alleging that the generic products that are the subjects of the ANDA filings would infringe five of AstraZeneca's patents. (D.I. I).[2] The patents-in-suit claim chemical compounds as well as processes for making the compounds and methods for therapeutic treatments using the compounds.

         II. LEGAL STANDARD

         "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) (en banc) (internal quotation marks omitted). '"[T]here is no magic formula or catechism for conducting claim construction.' Instead, the court is free to attach the appropriate weight to appropriate sources 'in light of the statutes and policies that inform patent law."' SoftView LLC v. Apple Inc., 2013 WL 4758195, at *1 (D. Del. Sept. 4, 2013) (quoting Phillips, 415 F.3d at 1324) (alteration in original). When construing patent claims, a court considers the literal language of the claim, the patent specification, and the prosecution history. Markman v. Westview Instruments, Inc., 52 F.3d 967, 977-80 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996). Of these sources, "the 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." Phillips, 415 F.3d at 1315 (internal quotation marks omitted).

         "[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 (citations and internal quotation marks omitted). "[T]he ordinary meaning of a claim term is its meaning to [an] ordinary artisan after reading the entire patent." Id. at 1321 (internal quotation marks omitted). "In some cases, the ordinary meaning of claim language as understood by a person of skill in the art may be readily apparent even to lay judges, and claim construction in such cases involves little more than the application of the widely accepted meaning of commonly understood words." Id. at 1314.

         When a court relies solely upon the intrinsic evidence-the patent claims, the specification, and the prosecution history-the court's construction is a determination of law. See Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 841 (2015). The court may also make factual findings based upon consideration of extrinsic evidence, which "consists of all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises." Phillips, 415 F.3d at 1317-19 (internal quotation marks omitted). Extrinsic evidence may assist the court in understanding the underlying technology, the meaning of terms to one skilled in the art, and how the invention works. Id. Extrinsic evidence, however, is less reliable and less useful in claim construction than the patent and its prosecution history. Id.

         "A claim construction is persuasive, not because it follows a certain rule, but because it defines terms in the context of the whole patent." Renlshaw PLC v. Marposs Societa 'per Azioni,158 F.3d 1243, 1250 (Fed. Cir. 1998). It follows that "a claim interpretation that would exclude the inventor's device is rarely the correct interpretation." Osram GMBH v. Int'l Trade Comm ...


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