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Purdue Pharma, L.P. v. Collegium Pharmaceutical, Inc.

United States District Court, D. Massachusetts

November 21, 2017

COLLEGIUM PHARMACEUTICAL, INC., Defendant. Term Plaintiffs' construction Defendant's construction Patent Number Plaintiffs' construction Defendant's construction Term Plaintiffs' construction Defendant's construction Term Plaintiffs' construction Defendant's construction Term Plaintiffs' construction Defendant's construction Plaintiffs' construction Defendant's construction



         This is a patent dispute concerning a pharmaceutical product: abuse-deterrent, extended-release oxycodone. Plaintiffs Purdue Pharma L.P.; The P.F. Laboratories, Inc.; Purdue Pharmaceuticals L.P.; and Rhodes Technologies (collectively, “Purdue”) have brought suit against Collegium Pharmaceutical, Inc. The amended complaint asserts claims for infringement pursuant to 35 U.S.C. §§ 271(a), (b), (c), and (e)(2)(A) arising out of three related patents.

         The case is at the claim-construction stage. The parties have submitted proposed constructions for seven terms, five of which are in dispute: (1) “irritant, ” (2) “effective amount of an irritant to impart an irritating sensation, ” (3) “an effective amount of an irritant to impart a burning sensation, ” (4) effective amount to discourage an abuser from tampering with the dosage form, ” and (5) “removing 8α, 14-dihydroxy-7, 8-dihydrocodeinone.”

         I. Background

         A. Factual Background

         Purdue Pharma L.P. is the owner of the three patents at issue, all of which relate to abuse-deterrent and low-toxicity versions of the pain medication oxycodone. Purdue Pharma L.P. sells oxycodone in the United States under the OxyContin brand name. (First Am. Compl. (“FAC”) ¶¶ 2, 12-14). The P.F. Laboratories, Inc. owns a patent that describes processes for producing oxycodone with low levels of toxicity, which plaintiffs refer to as the “low-toxicity patent.” (Id. ¶ 3, 12). Purdue Pharmaceuticals L.P. also owns the low-toxicity patent and manufactures extended-release oxycodone pain-relief medication under the OxyContin brand name. (Id. ¶ 4, 12). Rhodes Technologies owns the low-toxicity patent and manufactures the active pharmaceutical ingredient used in OxyContin. (Id. ¶ 5, 12).

         Collegium Pharmaceutical, Inc. recently filed a new drug application (“NDA”) with the Food and Drug Administration to manufacture, use, sell, or import a product that plaintiffs allege infringes on their patents. (Id. ¶¶ 6, 15, 18-22).

         The dispute concerns pharmaceutical products designed to deter abuse of addictive pain medications, such as oxycodone, as well as methods for reducing toxicity in oxycodone pharmaceuticals. (Id. ¶ 12-14). Oxycodone is an opioid, first developed in Germany in 1916, first used as a drug in 1917, and first introduced to the United States market in 1939. (See Def. CC at 1; Pl. Summ. Judg. Opp. at 4). Purdue developed an extended release (“ER”) version of oxycodone, known as OxyContin, in 1995. (Pl. Summ. Judg. Opp. at 4).

         Opioid drugs are often used to treat pain, but are also subject to abuse. (Id.). The FDA approved an abuse-deterring version of OxyContin in 2010. (Id. at 5). The drug incorporated two features to deter abuse: (1) a harder tablet, to resist crushing, and (2) a gelling agent, to impede snorting and injecting of any powder resulting from successful crushing. (Id.). Those features are the subject of two of the patents at issue. In April 2013, the FDA granted abuse-deterrent OxyContin the first abuse-deterrent labeling. The FDA also declined to approve generic versions of original OxyContin because they lacked the new formulation's abuse-deterring features. (Id.).

         Collegium recently developed a version of oxycodone, called XTAMPZA ER, which also contains abuse-deterring features. (Def. Summ. Judg. Br. at 4-5). XTAMPZA ER utilizes a “hydrophobic matrix of fatty acid and waxes” to “reduce[] the potential for dose dumping” and to “create[] barriers to abuse via oral ingestion, insufflation, or injection.” (Id. at 5). The FDA approved XTAMPZA ER and made it the first and only ER opioid without a warning on its label related to crushing or chewing and the potential exposure to a fatal dose. (Id.). However, the XTAMPZA ER label includes a “Drug Abuse and Dependence” section warning that “abuse of Xtampza ER by injection and by the nasal route of administration, as well as by the oral route is still possible.” (Pl. Summ. Judg. Opp. at 6).

         Oxycodone contains a substance known as alpha, beta-unsaturated ketone (“ABUK”), that may damage human DNA. Pl. CC at 15 (citing Byrn Decl. Exs. 14-15). Purdue has also patented an oxycodone-based product that contains a low level of ABUK, as well as a method for removing a source of ABUK in the manufacturing process, by removing a toxin that the parties refer to as 8α. In 2016, three related Purdue-owned patents for low-ABUK oxycodone products were invalidated on obviousness grounds. See Purdue Pharma L.P. v. Epic Pharma, LLC, 811 F.3d 1345, 1348 (Fed. Cir. 2016).

         B. Patents at Issue

         Purdue Pharma L.P., is the named assignee on two patents related to abuse-deterring oxycodone: U.S. Patent Nos. 8, 652, 497 (“the '497 patent”) and 9, 155, 717 (“the '717 Patent”). FAC, Exs. B-C. Plaintiffs are the named assignees of the 8α-removing, low-ABUK patent: U.S. Patent No. 9, 073, 933 (“the '933 Patent”).

         1. The '497 Patent

         The '497 patent is entitled “Pharmaceutical Formulation Containing Irritant.” It was issued on February 18, 2014. ('497 Patent). It names Richard Sackler as the inventor and Purdue Pharma L.P. as the assignee. (Id.).

         The '497 patent is generally directed to “provide an oral dosage form of an opioid analgesic which is subject to less parenteral . . . intranasal . . . [and] oral abuse than other dosage forms.” (Id. col. 2 ll. 14-22). The patent is also directed to preventing abuse of drugs other than opioid analgesics that may be the subject of abuse. (Id. col. 5 ll. 35-40). At the time the patent was issued, a number of other techniques were known for deterring opioid abuse. (Id. col. 1 ll. 28-41, 55-67; Id. col. 1 ll. 1-4). In certain embodiments, the patent provides an opioid product that includes “an aversive agent such as an irritant to discourage from tampering with the dosage form and thereafter inhaling, injecting, or swallowing the tampered dosage form. Preferably, the irritant is released when the dosage form is tampered with and provides a burning or irritating effect to the abuser upon inhalation, injection, and/or swallowing of the tampered dosage form.” (Id. col. 2 ll. 52-59).

         2. The '717 Patent

         The '717 patent is entitled “Pharmaceutical Formulation Containing Irritant.” It was issued on October 13, 2015. ('717 Patent). It names Sackler as the inventor and Purdue Pharma L.P. as the assignee. (Id.). The '717 patent shares a specification with the '497 patent.

         3.The '933 Patent

         The '933 patent is entitled “Oxycodone Hydrocholoride Having less than 25 PPM 14-Hyrdroxycodeinone.” It was issued on July 7, 2015. ('933 Patent). It names Robert Chapman, Lonn S. Rider, Qi Hong, Donald Kyle, and Robert Kupper as the inventors and Purdue Pharma L.P., The P.F. Laboratories, Inc., Purdue Pharmaceuticals L.P., and Rhodes Technologies as the assignees. (Id.).

         The '933 patent is generally directed to a process for reducing the amount of 14-hyrdroxycodeinone in an oxycodone hydrochloride composition as compared to existing formulations. (Id. col. 2 ll. 20-23). Specifically, the patent is directed at producing oxycodone hydrochloride compositions with less than 25 ppm of 14-hyrdroxycodeinone in an oxycodone hydrochloride composition. (Id. col. 2 ll. 30-34). Methods for reducing the amount of 14-hyrdroxycodeinone in an oxycodone hydrochloride composition were known in the prior art. (Id. col.1, ll. 47-col. 2 ll. 2). At the time of the patent, existing procedures for reducing toxicity in oxycodone hydrochloride produced levels greater than 100 ppm. (Id. col. 2 ll. 12-19).

         II. Legal Standard

         The construction of claim terms is a question of law, which may in some cases rely on underlying factual determinations. Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 835, 837-38 (2015); Markman v. Westview Instruments, 517 U.S. 370, 372 (1996) (“[T]he construction of a patent, including terms of art within its claim, is exclusively within the province of the court.”).

         In Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc), the Federal Circuit clarified the proper approach to claim construction and set forth principles for determining the hierarchy and weight of the definitional sources that give a patent its meaning. The guiding principle of construction is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of . . . the effective filing date of the patent application.” Id. at 1313. Courts thus seek clarification of meaning in “the words of the claims themselves, the remainder of the specification, the prosecution history, and extrinsic evidence concerning relevant scientific principles, the meaning of technical terms, and the state of the art.” Id. at 1314 (quoting Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1116 (Fed. Cir. 2004)).

         A. The Words of the Claim

         The claim construction analysis normally begins with the claims themselves.[1] The claims of a patent “define the invention to which the patentee is entitled the right to exclude.” Phillips, 415 F.3d at 1312 (citing Innova, 381 F.3d at 1115).

         A court may construe a claim term to have its plain meaning when such a construction resolves a dispute between the parties. See O2 Micro Int'l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351, 1361 (Fed. Cir. 2008); see also U.S. Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554, 1568 (Fed. Cir. 1997) (“Claim construction is a matter of resolution of disputed meanings and technical scope, to clarify and when necessary to explain what the patentee covered by the claims, . . . [but] is not an obligatory exercise in redundancy.”).

         In some instances, it is the arrangement of the disputed term in the claims that is dispositive. “This court's cases provide numerous . . . examples in which the use of a term within the claim provides a firm basis for construing the term.” Phillips, 415 F.3d at 1314. For example, because claim terms are normally used consistently throughout the patent, the meaning of a term in one claim is likely the meaning of that same term in another. Id. In addition, “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 1315.

         B. The Specification

         “The claims, of course, do not stand alone.” Id. “Rather, they are part of a fully integrated written instrument, consisting principally of a specification that concludes with the claims.” Id. (citations and quotations omitted). For that reason, the specification must always be consulted to determine a claim's intended meaning. 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.” Id. (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)).

         “In general, the scope and outer boundary of claims is set by the patentee's description of his invention.” On Demand Mach. Corp. v. Ingram Indus., Inc., 442 F.3d 1331, 1338 (Fed. Cir. 2006); see also Phillips, 415 F.3d at 1315-17 (“[T]he interpretation to be given a term can only be determined and confirmed with a full understanding of what the inventors actually invented and intended to envelop with the claim.” (quoting Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998))). “[T]he specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess.” Phillips, 415 F.3d at 1316. It may also reveal “an intentional disclaimer, or disavowal, of claim scope by the inventor.” Id. Therefore, the claims are to be construed in a way that makes them consistent with, and no broader than, the invention disclosed in the specification. On Demand, 442 F.3d at 1340 (“[C]laims cannot be of broader scope than the invention that is set forth in the specification.”); Phillips, 415 F.3d at 1316 (“[C]laims must be construed so as to be consistent with the specification, of which they are a part.” (quoting Merck & Co. v. Teva Pharm. USA, Inc., 347 F.3d 1367, 1371 (Fed. Cir. 2003))).

         Nevertheless, courts must be careful to “us[e] the specification [only] to interpret the meaning of a claim” and not to “import[] limitations from the specification into the claim.” Id. at 1323. A patent's “claims, not specification embodiments, define the scope of patent protection.” Kara Tech. Inc. v. Inc., 582 F.3d 1341, 1348 (Fed. Cir. 2009); see also Martek Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363, 1381 (Fed. Cir. 2009) (“[E]mbodiments appearing in the written description will not be used to limit claim language that has broader effect.”). “In particular, [the Federal Circuit] ha[s] expressly rejected the contention that if a patent describes only a single embodiment, the claims of the patent must be construed as being limited to that embodiment.” Phillips, 415 F.3d at 1323. This is “because persons of ordinary skill in the art rarely would confine their definitions of terms to the exact representations depicted in the embodiments.” Id.

         Although this distinction “can be a difficult one to apply in practice[, ] . . . the line between construing terms and importing limitations can be discerned with reasonable certainty and predictability if the court's focus remains on understanding how a person of ordinary skill in the art would understand the claim terms.” Id. “The construction that stays true to the claim language and most naturally aligns with the patent's description of the invention will be, in the end, the correct construction.” Id. at 1316 (quoting Renishaw, 158 F.3d at 1250).

         C. The ...

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