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GlaxoSmithKline LLC v. Glenmark Pharmaceuticals Inc., USA

United States District Court, D. Delaware

February 17, 2017

GLAXOSMITHKLINE LLC and SMITHKLINE BEECHAM CORK LIMITED Plaintiffs,
v.
GLENMARK PHARMACEUTICALS, INC., USA, Defendant. GLAXOSMITHKLINE LLC and SMITHKLINE BEECHAM CORK LIMITED Plaintiffs,
v.
TEVA PHARMACEUTICALS USA, INC. Defendant.

          MEMORANDUM ORDER

          HON. LEONARD P. STABK, UNITED STATES DISTRICT JUDGE

         WHEREAS, Magistrate Judge Burke issued a 45-page Report and Recommendation (the "Claim Construction Report") (C.A. No. 14-877 D.I. 133; C.A. No. 14-878 D.I. 165), dated June 3, 2016, recommending that the Court adopt certain claim constructions for disputed terms in U.S. Patent No. RE40, 000 (the "'000 Patent");

         WHEREAS, on June 20, 2016, Plaintiffs GlaxoSmithKline LLC and SmithKline Beecham (Cork) Limited ("Plaintiffs"), objected to the Claim Construction Report ("Plaintiffs' Objections") (C.A. No. 14-877 D.I. 141; C.A. No. 14-878 D.I. 175), and specifically objected to the Claim Construction Report's constructions of the terms "maintenance dosages, " "administering, " and "maintenance period;"

         WHEREAS, on June 20, 2016, Defendant Teva Pharmaceuticals USA, Inc. ("Teva"), objected to the Claim Construction Report ("Teva's Objections") (C.A. No. 14-878 D.I. 174), I and specifically object to the Claim Construction Report's constructions of "administering" and "decreasing mortality;"

         WHEREAS, on July 8, 2016, Defendants Glenmark Pharmaceutical Inc., USA, and Teva Pharmaceuticals USA, Inc. ("Defendants"), responded to the Plaintiffs' Objections (C.A. No. 14-877 D.I. 153; C.A. No. 14-878 D.I. 189) ("Defendants' Response to Plaintiffs' Objections");

         WHEREAS, on July 8, 2016, Plaintiffs responded to the Teva's Objections (C.A. No. 14-; 878 D.I. 188) ("Plaintiffs' Response to Teva's Objections");

         WHEREAS, the Court has considered the parties' claim construction disputes addressed by the Claim Construction Report de novo, see St. Clair Intellectual Prop. Consultants, Inc. v. Matsushita Elec. Indus. Co., Ltd., 691 F.Supp.2d 538, 541-42 (D. Del. 2010); 28 U.S.C. § 636(b)(1); Fed.R.Civ.P. 72(b)(3);

         NOW THEREFORE, IT IS HEREBY ORDERED that:

         1. Plaintiffs' Objections (C.A. No. 14-877 D.I. 141) to Judge Burke's construction of "maintenance" dosages are SUSTAINED and the Court construes the term as "dosages in the therapeutic amount." | j 2. Plaintiffs' Objections (C.A. No. 14-877 D.I. 141) to Judge Burke's constructions of "administering" and "maintenance period" are OVERRULED and the constructions set forth in Judge Burke's Claim Construction Report are ADOPTED.

         3. Teva's Objections (C.A. No. 14-878 D.I. 174) to Judge Burke's construction:of "administering" and "decreasing mortality" are OVERRULED and the constructions set forth in ! Judge Burke's claim construction report are ADOPTED.

         4. Plaintiffs first object to Judge Burke's construction of "maintenance dosages, "[1]which Judge Burke construed as "[d]osages to maintain the therapeutic effect following a period i in which the patient's tolerance of the drug is monitored." (Claim Construction Report at 33) ! Plaintiffs object to this construction on the grounds that the claims do not require a "monitoring period" prior to the administration of a maintenance dose. (Plaintiffs' Objections at 5) The Court agrees with Plaintiffs on this point. As Judge Burke explained, the term "maintenance dosage" refers to dosages used to maintain therapeutic effect - in contrast to, for example, low "starting" dosages administered to check a patient's tolerance before "up-titrating" to the maintenance dose. (Claim Construction Report at 29) The Court agrees with Judge Burke that the patent uses the term "maintenance dose" to draw this distinction, and also with Judge Burke's conclusion that the claim term "maintenance" does not require up-titration (i.e., it is within the scope of the claims that the initial dose used with a patient becomes the dose that patient ultimately continues to receive throughout the maintenance period). (Id. 29-30) Although the intrinsic and extrinsic record suggest that, as a practical matter, physicians typically monitor patients' tolerance at the beginning of their course of treatment (id. 31-32), the record does not support viewing an initial or early dosage in an amount that turns out to be the "maintenance dosage" amount as excluded from the meaning of "maintenance dosage" (even if the physician is closely monitoring the patient's tolerance of this amount). Rather, the patent consistently uses the term "maintenance" dosage in contrast to dosages of less than the final, therapeutic amount. See '000 pat. col. 5:16-44; 7:6-21. Thus, the Court understands "maintenance dosage" to mean "dosages in the therapeutic amount given during the maintenance period, " and adopts this as the construction of the disputed term.[2]

         5. Plaintiffs next object to Judge Burke's construction of "administering, " which was: "[prescribing, dispensing, giving or taking (such that what is prescribed, dispensed, given or taken is actually taken into the patient's body)." (Claim Construction Report at 37) Plaintiffs argue that the parenthetical portion of the construction is "unnecessary" and "likely to confuse the jury." (Plaintiffs' Objections at 6-7) But this language is needed to make clear that, while "administering" encompasses situations in which a physician prescribes or dispenses a dosage that the patient later takes on his or her own (as opposed to requiring the physician to take direct f i action to deliver the dosage into the person's body), the claims do require that the patient I ultimately consume the drug. (Claim Construction Report at 35-37) In Other words, this language makes clear that the method claims of the '000 patent cannot be practiced simply by "writing a prescription or filling a pill bottle at a pharmacy." (See Defendants' Response to Plaintiffs' Objections at 9)

         6. Teva also objects to Judge Burke's construction of "administering." Teva contends that the construction should not include the terms "prescribing" and "dispensing, " arguing that the specification makes clear that the term refers to the "physical delivery of the drug into the patient's body." (Teva's Objections at 9-10) In Teva's view, the specification communicates this limitation by using the word "administration" or "administer[ing]" solely to refer to the process of delivering drug into a patient's body. (Id.) While the term "administer" does include transmitting drug into the patient's body, the term does not - as used in the '000 patent - require a physician to be directly involved in that process. (See Claim Construction Report at 34-36) Judge Burke's use of the phrase "prescribing, dispensing, giving or taking" properly clarifies this point.[3]

         7. Plaintiffs' final objection is to Judge Burke's construction of "maintenance period" as "[p]eriod of time over which the maintenance dose is taken into the patient's body."[4] (Claim Construction Report at 26) Plaintiffs argue that this term should be construed in the broader context of the phrase "said maintenance period is greater than six months, " and should j be given the meaning: "[w]ith the intent that the patient be on the maintenance dosage for more than six months." (Plaintiffs' Objections at 8, 10) According to Plaintiffs, their proposed construction properly includes within the scope of the claims the treatment of patients who die or opt to switch medications before completing a six-month course of treatment. (Id. at 8-10) For the reasons set forth in the Claim Construction Report, the Court disagrees with Plaintiffs. (See Claim Construction Report at 22-26) Most importantly, the claims themselves require "administering a therapeutically acceptable amount of carvediol... wherein the administering comprises administering ... maintenance dosages for a maintenance period ... and saidmaintenance period is greater than six months." '000 pat. at 8:30-40 (emphasis added). This language unambiguously requires that the maintenance period - which the Plaintiffs do not dispute is the period over which the maintenance dose is taken into the patient's body - must last for at least six months. ...


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