GlaxoSmithKline LLC et al v. Glenmark Generics Inc. USA
MEMORANDUM ORDER re (165 in 1:14-cv-00878-LPS-CJB, 133 in 1:14-cv-00877-LPS-CJB) REPORT AND RECOMMENDATION re claim construction. Signed by Judge Leonard P. Stark on 2/17/17. Associated Cases: 1:14-cv-00877-LPS-CJB, 1:14-cv-00878-LPS-CJB (ntl)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
GLAXOSMITHKLINE LLC and SMITHKLINE
BEECHAM (CORK) LIMITED)
C.A. No. 14-877-LPS-CJB
GLENMARK PHARMACEUTICALS, INC.,
GLAXOSMITHKLINE LUC and SMITHKLINE
BEECHAM (CORK) LIMITED) ·
C.A. No. 14-878-LPS-CJB
TEVA PHARMACEUTICALS USA, INC.
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 SmithK.line
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),
and specifically object to the Claim Construction Report's constructions of "administering" Iand
WHEREAS, on July 8, 2016,_ Defendants Glenmark Pharmaceutical Inc., USA, and Teva
Pharmaceuticals USA, Inc. ("Defendants"), responded to the Plaintiffs' Objections (C.A. Nb. 14.
877 D.I. 153; C.A. No. 14-878 D.I. 189) ("Defendants' Response to Plaintiffs; Objections"j;
WHEREAS, on July 8, 2016, Plaintiffs responded to the Teva's Objections· (C.A. No. 14878 D.I. 188) ("Plaintiffs' Response to Teva'sObjections");
WHEREAS, the Court has considered the parties' claim construction disputes addressed
by the Claim Construction Report de novo, see St. Clair Intellectual Prop. Consultants, lnc. v.
Matsushita Elec. Indus. Co., Ltd., 691 F. Supp. 2d 538, 541-42 (D. Del. 2010); 28 U.S.C.
§ 636(b)(l); Fed. R. Civ. P. 72(b)(3);
NOW THEREFORE, IT .IS HEREBY ORDERED that:
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 tetm as "dosages in the
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.·
Teva's Objections (C.A. No. 14-878D.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.
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
in which the patient's tolerance of the drug is monitored." (Claim Construction Report at 33)
Plaintiffs objectto this construction on the grounds that the claims do not require a "monitoring
period" prior to the administration ofa 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 Bvrke'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 ofthis amount). Rather, the patent consistently uses
This term appears in all claims of the· '000 patent.
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
Plaintiffs next object to Judge Burke's construction of"administering," which
was: "[p]rescribing, 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 opposedto requiring the physician to take direct
action to deliver the dosage into the person's body), the claims do require that the patient
ultimately consume the drug. (Claim Construction Report at35-37) 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)
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 .
Plaintiffs further objected to Judge Burke's construction of"maintenance dosages" on the
ground that it "improperly imports as an additional limitation a 'monitoring' period for" the.
drug(s) the claims require to be administered with carvedilol (i.e. an ACE inhibitor, a diuretic, or
digoxin). (Plaintiffs' Objections at 6) Given that the Court's construction does not require either
· up-titration or a monitoring period, the Court assumes this aspect of the parties' dispute is moot.
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
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
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
Teva objects in particular to the inclusion of the word "dispensing" in the construction,
arguing that it leads to the conclusion that the claim maybe practiced by the filling of a
prescription by a pharmacist. (Teva's Objections at 10) The Court agrees with Teva that
"administering" here does not include an individual who has "no connection to the treatment of a
... patient" and merely fills a prescription at the direction of a physician. However, as the Claim
Construction Report makes clear, that is not "dispensing;" the term instead refers to situations in
which the individual responsible for a patient's treatment provides the medication to the patient.
(See Claim Construction.Report at 35-36 (explaining that "administering" could encompass
circumstances "where a medical professional is 'prescribing' or 'dispensing' the dosage to a
patient and leaving it to the patient to take the drug on her own") (internal citations omitted))
The key point, as Judge Burke makes clear, is that the claims encompass scenarios in which a
physician directly. places a drug into a patient's body, scenarios in which a phys_ician prescribes a
drug for a patient to take elsewhere, and alternatives in between. (Id.)
This term appears in all claims of the '000 patent.
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 said
maintenance 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. Plaintiffs correctly point out that the Report's construction implies "you
would not know whether the claimed method was being practiced until you saw how long the
patient lives" (Plaintiffs' Objections at 10), but whether Plaintiffs like this result or not it is the
result of how they drafted their claims.
Teva's additional objection is to Judge Burke's conclusion that "decreasing
mortality" is a claim limitation. 5 (Claim Construction Report at 9, 17) The Court agrees with
Judge Burke, who explained that "decreasing mortality" recites the objective of the claimed
method (to treat congestive heart failure) and distinguishes it from the use of the same method to
treat other illnesses (or mere symptoms of heart failure). (Id. at 14-15); see Jansen v. Rexall
Sundown, Inc., 342 F.3d 1329, 1332-33 (Fed. Cir. 2003); see also Sanofi v. Glenmark Pharms. ·
Inc., 2015 WL 5092631, at *6 (D. Del. Aug. 28, 2015). Further, the term, as used in its broader
context ("decreasing mortality caused by congestive heart failure in a patient in need thereof')
provides antecedent basis for the term "said patient," and clarifies that "said patient" refers to a
This term appears in all claims of the '000 patent.
patient having a risk of mortality due to congestive heart failure. (See Claim Construction Report ·
at 15) Finally, as Judge Burke explained, the patentees relied on the "decreasing mortality"
limitations to persuade the PTO that the claimed invention was patentable. (See id. at 15-16)
Regardless of whether the PTO ultimately relied on these statements in its patentability
determination, the Court must hold the patentee to its unambiguous statements about claim
scope. See Fenner Investments, Ltd. v. Cellco P'ship, 778 F.3d 1320, 1325 (Fed. Cir. 2015)
("[T]he interested public has the right to rely on the inventor's statements made during ·
prosecution, without attempting to decipher whether the examiner relied on them, or how much
weight they were given").
Given the detailed reasoning provided in the Claim Construction Report, and
· given that the· parties have not raised any arguments that are not adequately addressed therein, the
Court finds it unnecessary to address Plaintiffs' Objections (C.A. No. 14-877 at D.I. 141) or
Teva's Objections (C.A. No. No. 14-878 D.I. 174) any further.
HON. LE NARD P. STA
UNITED STATES DISTRICT JUDGE
February 17, 2017
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