United States District Court, D. Delaware
GLAXOSMITHKLINE LLC and SMITHKLINE BEECHAM CORK LIMITED Plaintiffs,
GLENMARK PHARMACEUTICALS, INC., USA, Defendant. GLAXOSMITHKLINE LLC and SMITHKLINE BEECHAM CORK LIMITED Plaintiffs,
TEVA PHARMACEUTICALS USA, INC. Defendant.
LEONARD P. STABK, UNITED STATES DISTRICT JUDGE
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");
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
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
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'
on July 8, 2016, Plaintiffs responded to the Teva's
Objections (C.A. No. 14-; 878 D.I. 188)
("Plaintiffs' Response to Teva's
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);
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 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.
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.
Plaintiffs first object to Judge Burke's construction of
"maintenance dosages, "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.
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)
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.
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." (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. ...