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Collegium Pharmaceutical, Inc. v. Teva Pharmaceuticals USA, Inc.

United States District Court, D. Delaware

September 11, 2019




         In these consolidated Hatch-Waxman patent litigation matters filed by Plaintiff Collegium Pharmaceutical, Inc. ("Plaintiff) against Defendant Teva Pharmaceuticals USA, Inc. ("Defendant"), Plaintiff alleges infringement of 13 patents: United States Patent Nos. 7, 771, 707 (the "707 patent"), 8, 449, 909 (the '"909 patent"), 8, 557, 291 (the '"291 patent"), 8, 758, 813 (the '"813 patent"), 8, 840, 928 (the '"928 patent"), 9, 044, 398 (the '"398 patent"), 9, 248, 195 (the '"195 patent"), 9, 592, 200 (the '"200 patent"), 9, 682, 075 (the '"075 patent"), 9, 737, 530 (the '"530 patent"), 9, 763, 883 (the '"883 patent"), 9, 968, 598 (the '"598 patent") and 10, 004, 729 (the "729 patent" and collectively with the other patents, "the asserted patents"). Presently before the Court is the matter of claim construction. The Court recommends that the District Court adopt the constructions set forth below.

         I. BACKGROUND

         Plaintiff filed a Complaint in Civil Action No. 18-300-LPS-CJB on February 22, 2018, in which it asserted that Defendant's submission of AND A No. 209431 to the United States Food and Drug Administration-a submission that sought approval to engage in the commercial manufacture, use, sale, offer for sale, or importation of Oxycodone Extended-Release Capsules, CII, 9 mg, 13.5 mg, 18 mg, and 36 mg-was an act of infringement of, inter alia, the first 11 of the asserted patents listed above. (D.I. 1; D.I. 84)[1] On November 30, 2018, Plaintiff filed a second Complaint in Civil Action No. 18-900-LPS-CJB, asserting infringement of the '598 patent and the 729 patent, which were issued after ANDA No. 209431 was filed. (Civil Action No. 18-1900-LPS-CJB, D.I. 1; D.I. 84) Both cases have been referred to the Court to hear and resolve all pretrial matters, up to and including case-dispositive motions. (D.I. 8; Civil Action No. 18-1900-LPS-CJB, D.I. 7) On January 29, 2019, at the parties' request, the Court consolidated the cases for all purposes. (D.I. 48)

         According to Plaintiff, the patented inventions "make attempts to abuse powerful pain medications more difficult or less rewarding, generally by protecting against unintended exposure of drugs such as opiates." (D.I. 54 at 1) The claims of the asserted patents purport to "involve new ways to dissolve [such drugs] in very small beads of wax that will release the drug over time when administered as intended, but that make it difficult to manipulate the formulation for purposes of abuse and misuse." (Id.; see also D.I. 1 at ¶¶ 33-34)

         The parties filed simultaneous opening claim construction briefs on February 22, 2019, and simultaneous responsive briefs on March 22, 2019. (D.I. 54; D.I. 55; D.I. 69; D.I. 71) The Court held a Markman hearing on April 12, 2019. (D.I. 83 (hereinafter, "Tr.")) Following the hearing, the parties submitted supplemental letter briefs relating to Defendant's use of deposition testimony at the claim construction hearing. This supplemental briefing was completed on April 29, 2019. (D.I. 85)


         It is well-understood that "[a] claim in a patent provides the metes and bounds of the right which the patent confers on the patentee to exclude others from making, using, or selling the protected invention." Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257 (Fed. Cir. 1989). Claim construction is a generally a question of law, although subsidiary fact finding is sometimes necessary. Teva Pharms. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 837-38 (2015).

         The Court should typically assign claim terms their "ordinary and customary meaning[, ]" which is "the meaning that the term[s] would have to a person of ordinary skill in the art ['POSITA'] in question at the time of the invention, i.e., as of the effective filing date of the patent application." Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005). However, when determining the ordinary meaning of claim terms, the Court should not extract and isolate those terms from the context of the patent; rather it should endeavor to reflect their "meaning to the ordinary artisan after reading the entire patent." Id. at 1321; see also Eon Corp. IP Holdings LLC v. Silver Spring Networks, Inc., 815 F.3d 1314, 1320 (Fed. Cir. 2016).

         In proceeding with claim construction, the Court should look first and foremost to the language of the claims themselves, because "[i]t 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, 415 F.3d at 1312 (internal quotation marks and citations omitted). For example, the context in which a term is used in a claim may be "highly instructive." Id. at 1314. In addition, "[o]ther claims of the patent in question, both asserted and unasserted, can ... be valuable" in discerning the meaning of a particular claim term. Id. This is "[b]ecause claim terms are normally used consistently throughout the patent, [and so] the usage of a term in one claim can often illuminate the meaning of the same term in other claims." Id. Moreover, "[differences among claims can also be a useful guide[, ]" as when "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.

         In addition to the words of the claims, the Court should look to other intrinsic evidence. For example, the Court should analyze the patent specification, which "may reveal a special definition given to a claim term . . . that differs from the meaning [that term] would otherwise possess" or may reveal an intentional disclaimer of claim scope. Id. at 1316. Even if the specification does not contain such revelations, it "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. at 1315 (internal quotation marks and citation omitted). That said, however, the specification "is not a substitute for, nor can it be used to rewrite, the chosen claim language." SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870, 875 (Fed. Cir. 2004). And a court should also consider the patent's prosecution history, if it is in evidence, because it "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[.]" Phillips, 415 F.3d at 1317.

         Extrinsic evidence, "including expert and inventor testimony, dictionaries, and learned treatises[, ]" can also "shed useful light on the relevant art[.]" Id. (internal quotation marks and citations omitted). Overall, while extrinsic evidence may be useful, it is "less significant than the intrinsic record in determining the legally operative meaning of claim language." Id. (internal quotation marks and citations omitted); accord Markman v. Westview Instruments, Inc., 52 F.3d 967, 981 (Fed. Cir. 1995).

         In utilizing these resources during claim construction, courts should keep in mind that "[t]he 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." Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998).


         The parties currently have disputes regarding six terms or sets of terms (hereinafter, "terms"). This Report and Recommendation addresses two of the terms: "homogeneous single phase" and "solidified solution." The other terms will be addressed in one or more forthcoming Report and Recommendations.

         A. "homogeneous single phase"

         The "homogeneous single phase" term appears in the asserted claims of the '200 patent, which all recite abuse-deterrent oral dosage forms. Independent claim 1 is representative; that claim is reproduced below, with the disputed term highlighted:

1. An abuse-deterrent oral dosage form comprising a plurality of microparticles, wherein each microparticle comprises a homog ...

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