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Purdue Pharma L.P. v. Amneal Pharmaceuticals LLC

United States District Court, D. Delaware

February 16, 2017

PURDUE PHARMA L.P., PURDUE PHARMACEUTICALS L.P., THE P.F. LABORATORIES, INC., RHODES TECHNOLOGIES, and GRUNENTHAL GMBH, Plaintiffs,
v.
AMNEAL PHARMACEUTICALS, LLC, Defendant. PURDUE PHARMA L.P., PURDUE PHARMACEUTICALS L.P., THE P.F. LABORATORIES, INC., RHODES TECHNOLOGIES, and GRUNENTHAL GMBH, Plaintiffs,
v.
ABHAI, LLC and KVK-TECH, INC., Defendants.

          Jack B. Blumenfeld, Esq., MORRIS NICHOLS ARSHT & TUNNELL LLP, Wilmington, DE; Rodger D. Smith II, Esq., MORRIS NICHOLS ARSHT & TUNNELL LLP, Wilmington, DE. Attorneys for Plaintiffs

          John J. Normile, Esq., JONES DAY, New York, NY; Pablo D. Hendler, Esq. (argued), JONES DAY, New York, NY; Kelsey I. Nix, Esq., JONES DAY, New York, NY; Gasper J. LaRosa, Esq., JONES DAY, New York, NY; Kenneth S. Canfield, Esq., JONES DAY, New York, NY; Sarah A. Geers, Esq., JONES DAY, New York, NY; Lisamarie LoGiudice, Esq., JONES DAY, New York, NY; Jason G. Winchester, Esq., JONES DAY, Chicago, IL. Attorneys for Plaintiffs Purdue Pharma L.P ., Purdue Pharmaceuticals L.P ., The P .F. Laboratories, Inc., and Rhodes Technologies

          Jennifer H. Roscetti, Esq. (argued), FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP, Washington, DC; Matthew J. Luneack, Esq., FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP, Washington, DC; Erin M. Sommers, Esq., FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP, Washington, DC. Attorneys for Plaintiff Grunenthal GmbH

          Anne Shea Gaza, Esq., YOUNG CONAWAY STARGATT & TAYLOR, LLP, Wilmington, DE; Samantha G. Wilson, Esq., YOUNG CONAWAY STARGATT & TAYLOR, LLP, Wilmington, DE; Michael V. Ciresi, Esq., CIRESI CONLIN LLP, Minneapolis, MN; Jan M. Conlin, Esq., CIRESI CONLIN LLP, Minneapolis, MN; Katie Crosby Lehman, Esq., CIRESI CONLIN LLP, Minneapolis, MN; James C. Joslin, Esq., CIRESI CONLIN LLP, Minneapolis, MN; Melissa A. Goodman, Esq., CIRESI CONLIN LLP, Minneapolis, MN; Stuart D. Sender, Esq., BUDD LARNER, PC, Short Hills, NJ; James Barabas, Esq., BUDD LARNER, PC, Short Hills, NJ; Michael W. Choi, Esq., BUDD LARNER, PC, Short Hills, NJ; Barbara L. Mullin, Esq. (argued), AKIN GUMP STRAUSS HAUER & FELD LLP, Philadelphia, PA; Matthew A. Pearson, Esq., AKIN GUMP STRAUSS HAUER & FELD LLP, Philadelphia, PA; Angela Verrecchio, Esq., AKIN GUMP STRAUSS HAUER & FELD LLP, Philadelphia, PA; Jonathan J. Underwood, Esq., AKIN GUMP STRAUSS HAUER & FELD LLP, Philadelphia, PA. Attorneys for Defendant Amneal Pharmaceuticals LLC

          David S. Eagle, Esq., KLEHR HARRISON HARVEY BRANZBURG LLP, Wilmington, DE; Sally E. Veghte, Esq., KLEHR HARRISON HARVEY BRANZBURG LLP, Wilmington, DE; Chad A. Landmon, Esq., AXINN, VELTROP & HARKRIDER LLP, Hartford, CT; Edward M. Mathias, Esq. (argued), AXINN, VELTROP & HARKRIDER LLP, Hartford, CT; Dan Feng Mei, Esq., AXINN, VELTROP & HARKRIDER LLP, New York, NY. Attorneys for Defendants Abhai, LLC and KVK-TECH, 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. 8, 808, 741 ("the '741 patent"), 8, 894, 987 ("the '987 patent"), 8, 894, 988 ("the '988 patent"), 8, 309, 060 ("the '060 patent"), and 9, 073, 933 ("the '933 patent"). The Court has considered the Parties' Joint Claim Construction Brief. (Civ. Act. No. 15-1152-RGA-SRF, D.I. 117; Civ. Act. No. 16-25-RGA-SRF, D.I. 87).[1] The Court heard oral argument on February 10, 2017.

         I. BACKGROUND

         This suit arises from Defendant Amneal's filing an Abbreviated New Drug Application ("AND A").[2] Plaintiff filed suit against Defendant Amneal on December 15, 2015, alleging that the generic product that is the subject of the AND A filing would infringe a number of Plaintiffs' patents. (D.I. 1). The patents-in-suit claim analgesic compounds with abuse deterrent properties, processes for making such compounds, and methods of treating pain using such 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." Renishaw 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 'n, 505 F.3d 1351, 1358 (Fed. Cir. 2007) (citation and internal quotation marks omitted).

         III. CONSTRUCTION OF DISPUTED TERMS

         The '741 patent is directed to methods of pain treatment using tamper resistant oral dosage forms. Claim 1 is representative and reads as follows:

1. A method of treating pain comprising administering to a patient in need thereof a convection cured shaped tablet comprising an extended release matrix comprising a composition, wherein said tablet comprises:
(1) at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 4, 000, 000, and
(2) oxycodone or a pharmaceutically acceptable salt, and wherein said tablet is prepared by a process comprising the steps of:
(a) combining at least (1) and (2) to form a blend;
(b) shaping said blend to form a shaped tablet; and
(c) convection curing said shaped tablet by subjecting the shaped tablet to a temperature from about 60 to about 90° C. for a time of from about 15 minutes to about 10 hours, wherein said [sic]
wherein said convection cured shaped tablet comprises:
(i) 5, 7.5, 10, 15, 20, or 30 mg of said oxycodone or pharmaceutically acceptable salt and at least 79% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of'4, 000, 000;
(ii) 40 mg of said oxycodone or pharmaceutically acceptable salt and at least 72% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 4, 000, 000;
(iii) 60 mg of said oxycodone or pharmaceutically acceptable salt and at least 57% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 4, 000, 000; or
(iv) 80 mg of said oxycodone or pharmaceutically acceptable salt and at least 54% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 4, 000, 000.

('741 patent, claim 1) (disputed terms italicized).

         The '987 patent is directed to tamper resistant oral dosage formulations of analgesics and processes for making such analgesics. Claim 1 is representative and reads as follows:

1. A process of preparing a solid oral extended release pharmaceutical dosage form, comprising at least the steps of:
(a) combining at least (1) at least one polyethylene oxide and (2) at least one active agent comprising oxycodone ...

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