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Purdue Pharma L.P. v. Intellipharmaceutics International Inc.

United States District Court, D. Delaware

July 6, 2018


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

          John J. Normile, Pablo D. Hendler (argued), Kelsey I. Nix, Gasper J. LaRosa, Kenneth S. Canfield (argued), Sarah A. Geers, Lisamarie LoGuidice, Christopher J. Harnett, Mital B. Patel, JONES DAY, New York, NY. Attorneys for Plaintiffs Purdue Pharma L.P., Purdue Pharmaceuticals L.P., The P.F. Laboratories, Inc., and Rhodes Technologies

          Jennifer H. Roscetti, Matthew J. Luneack, Nicholas J. Doyle, FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP, Washington, DC; Anthony C. Tridico, FINNEGAN EUROPE LLP, London, UK. Attorneys for Plaintiff Grunenthal GmbH

          Neal C. Belgam, Eve H. Ormerod, SMITH, KATZENSTEIN & JENKSINS LLP, Wilmington, DE; Shashank Upadhye, Joseph E. Cwik, Yixin H. Tang (argued), Brent Batzer, Adam D. Sussman, Samuel J. Ruggio, AMIN TALATI UPADHYE LLP, Chicago, IL. Attorneys for Defendants



         Presently before the Court is the issue of claim construction of multiple terms in U.S. Patent Nos. 9, 060, 976 ("the '976 patent"), 9, 073, 933 ("the '933 patent"), 9, 522, 919 ("the '919 patent"), 9, 492, 389 ("the '389 patent"), and 9, 492, 391 ("the '391 patent"). The Court has considered the parties' joint claim construction brief. (D.I. 85). The Court heard oral argument on June 22, 2018. (D.I. 128).

         I. BACKGROUND

         This suit arises from Defendants' filing a New Drug Application ("NDA"). Plaintiffs filed suit on April 7, 2017, alleging that the generic product that is the subject of the NDA would infringe six of Plaintiffs' patents. (D.I. 1). The patents-in-suit relate to OxyContin®, an extended-release pain medication. Plaintiffs have asserted the '976 and '933 patents in another action, No. 15-1152, in which I issued a Markman opinion. (Civ. Act. No. 15-1152, D.I. 120).


         "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). '"[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, 979-80 (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.

         "[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. "[T]he ordinary meaning of a claim term is its meaning to [an] ordinary artisan after reading the entire patent." Id. at 1321. "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 Pharms. 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. 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).


         The '976 patent is directed to an abuse deterrent dosage form of OxyContin®. The sole claim of that patent reads as follows:

         1. An extended release abuse deterrent dosage form comprising:

a. a core matrix comprising a blended mixture of:
(a) PEO having a molecular weight of from about 300, 000 daltons to about 5, 000, 000 daltons;
(b) magnesium stearate; and
(c) oxycodone or a pharmaceutically acceptable salt thereof; wherein the core matrix is heated to melt at least a portion of the PEO included in the core matrix during preparation of the dosage form; and
b. PEG applied onto the core matrix;
wherein the dosage form provides extended release of the drug.

         ('976 patent, claim 1) (disputed term italicized).[1]

         The '933 and '919 patents are directed to oxycodone formulations having low amounts of 14-hydroxycodeinone and 8α, respectively. Claim 1 of the '933 and claim 1 of the '919 patent are representative. They read:

1. An oxycodone hydrochloride composition which comprises at least 95% oxycodone hydrochloride, 8α, 14-dihydroxy-7, 8-dihydrocodeinone, and less than 25 ppm of 14-hydroxycodeinone.

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

1. An oxycodone HCl composition comprising oxycodone HC1 and 8α, 14-dihydroxy-7, 8-dihydrocodeinone, wherein the ratio of 8α, 14-dihydroxy-7, 8-dihydrocodeinone to oxycodone HCl is 0.04% or less as measured by HPLC.

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

         The '389 and '391 patents are directed to cured pharmaceutical dosage forms. Claim 1 of the '389 patent and claim 20, which depends from claim 1, are representative. They read as follows:

         1. A cured shaped pharmaceutical tablet comprising:

(1) at least a first compression shaped and then air cured matrix, wherein said curing is without compression, by heated air having a temperature of at least about 62° C. for a duration of at least about 5 minutes, said matrix comprising an opioid or a pharmaceutically acceptable salt thereof in combination with at least one high molecular weight polyethylene oxide having, based on rheological measurements, an approximate molecular weight selected from the group consisting of 4, 000, 000, 7, 000, 000, and a combination thereof, and optionally further comprising at ...

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