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. STARK UNITED STATES DISTRICT JUDGE
Magistrate Judge Burke issued a 47-page Report and
Recommendation (the "Report") (D.I.
346), dated May 2, 2017, recommending that the
Court deny the invalidity portions of Defendants Teva
Pharmaceuticals USA, Inc. and Glenmark Pharmaceuticals Inc.,
USA's (collectively, "Defendants" or
"Defs") motion for summary judgment (D.I.
on May 12, 2017, Plaintiffs GlaxoSmithKline LLC and
SmithKline Beecham (Cork) Limited (collectively,
"GSK") as well as Defendants objected to the Report
(D.I. 353 ("Defendants Objections" or "Defs
Objs"); D.I. 355 ("GSK Objections" or
"GSK Objs")); WHEREAS, on May 22, 2017, both sides
responded to the opposing Objections (D.I. 366 ("GSK
Response" or "GSK Resp"); D.I. 367
("Defendants Response" or "Defs Resp"));
the Court has considered the parties' objections and
responses 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);
THEREFORE, IT IS HEREBY ORDERED that:
Defendants' Objections (D.I. 353) are OVERRULED,
GSK's Objections (D.I. 355) are OVERRULED, Judge
Burke's Report (D.I. 346) is ADOPTED to the extent and as
explained below, and Defendants' Motion for Summary
Judgment as related to invalidity (D.I. 248) is DENIED.
Defendants object to the Report's conclusion that the
record reveals a genuine dispute of material fact with regard
to whether prior art reference Kelly expressly discloses
treatment with carvedilol for more than six months. (Defs
Objs at 1-2) The Court agrees with the Report. While Kelly
discloses a "long-term study" with "6 and 18
months of follow-up, " the Report correctly observed
that "Kelly never expressly states that the patient is
to actually receive carvedilol for all of that time."
(Report at 16, 17) Defendants point to the first sentence of
the Kelly abstract, which mentions "[s]ustained oral
treatment;" however, as GSK notes, "sustained"
may be viewed in that sentence as not referring to the
protocol for the study but, rather, as referring to other
studies that had already occurred. (GSK Response at 4) Thus,
at trial, both sides will be given the opportunity to present
evidence on the disputed factual issue of whether Kelly
discloses treatment for more than six months (which is an
element of the asserted claims of the
objects to the Report's findings on inherent
anticipation, arguing that the Report misstates the law by
(1) incorrectly concluding that whether the asserted claims
constitute an unpatentable newly discovered result of a known
process, rather than a patentable new use of a known process,
depends on whether there is a manipulative difference in the
steps of the methods in the prior art and the method claimed
in the patent, and (2) disregarding the "intent"
limitation in the asserted claims. (GSK Objs at 6-9)
the first issue, the Report thoroughly examined the existing
caselaw on inherent anticipation, concluding that the proper
test for determining whether a use is patentably
"new" is to compare "the methods disclosed in
the prior art" to those disclosed in the patent to
determine if "they teach the same physical steps"
or whether there is a "manipulative difference" in
the disclosed steps. (Report at 23, 29) The Report properly
considered and rejected GSK's proposed alternative test -
that a claimed method is patentable even if it is the same as
the method of the prior art, so long as "the use is
different and not present in the prior art."
(Id. at 24) The Court agrees with the Report's
conclusions of law on inherent anticipation, including that
there is not "an exception for the later discovery of
life-saving inherent results of a known method."
(Id. at 34)
regard to the second inherent anticipation issue raised in
GSK's Objections, the Report correctly concluded that a
patentee may not circumvent the doctrine of inherent
anticipation simply by adding an "intent"
limitation to a claim. (See Report at 36) That is,
if the only distinction between the prior art and the
asserted claim is an express intent limitation in the
asserted claim - and there is no manipulative difference in
the physical steps in the asserted claims as compared to
those in the prior art - then the asserted claim is
anticipated. See Rapoport v. Dement, 254 F.3d 1053,
1061 (Fed. Cir. 2001) (finding no inherent anticipation where
intent for administering buspirone as part of asserted claims
- to treat sleep apnea -resulted in manipulative difference
from method disclosed in prior art - which was to treat
anxiety; dosing regime for anxiety was three times daily
while regime for sleep apnea was larger dose once a day at
time of sleep); see also Perricone v. Medicis Pharm.
Corp., 432 F.3d 1368, 1371, 1378 n.* (Fed. Cir. 2005)
(affirming district court's finding of inherent
anticipation, even when preamble reciting purpose of claimed
method was construed as limiting, because prior art reference
disclosed same steps as those in claims, and reversing
district court's finding of anticipation where claimed
method differed from prior art).
Finally, Defendants object to the Report's conclusion
that the record reveals a genuine dispute of material fact as
to whether the study disclosed in Kelly - a planned but not
yet initiated trial - is enabling of the asserted claims.
(Defs Objs at 5-6) Defendants assert that there is no legal
or factual basis for this conclusion because: (1) the study
in Kelly is not "too theoretical" to be enabling,
and (2) enablement under 35 U.S.C. § 102 does not
require a clinical trial to be underway. (Id. at
party identified much pertinent caselaw, so the Report turned
to In re Montgomery, 611 F.3d 1375 (Fed. Cir. 2012),
and found by analogy that here a factual dispute exists as to
whether the disclosure in Kelly is "too
theoretical" to be enabling (Report at 43). Dicta in
Montgomery differentiated between a mere
"invitation to investigate" or "abstract
theory, " both of which may not be sufficiently enabling
for anticipation, and the reference at issue in
Montgomery, which disclosed "an advanced stage
of testing designed to secure regulatory approval." 677
F.3d at 1382. Similarly here, the Report found the fact that
the Kelly trial had not yet started was not dispositive, but
the fact that the trial was not so far along as to be
designed to secure regulatory approval supported the
conclusion that a material dispute of fact underlies the
legal issue of enablement. (Report at 44-45) ("On the
one hand, the disclosure in Kelly can be seen as being more
concrete than the exemplary 'invitation to
investigate' set out by the Montgomery Court, in
that the planned multicentre trial in Kelly was focused on
the use of particular drugs . . ., in particular dosage
levels . . ., to treat particular symptoms . . . of patients
who have a particular condition. . .. Yet on the other hand,
the disclosure in Kelly regards a planned but not yet started
trial, and so in that sense, can be seen as more
'abstract' than [the disclosure in
reasonable jury, taking the evidence in the light most
favorable to Teva, might find that Kelly meets the standard
for enablement under § 102, as that standard does not
require actual performance or advanced studies, but only
requires that the prior art reference "describe the
claimed invention sufficiently to enable a person of ordinary
skill in the art to carry out the invention."
ImpaxLabs., Inc. v. Aventis Pharm., Inc., 468 F.3d
1366, 1383 (Fed. Cir. 2006); see Novo NordiskPharm., Inc.
v. Bio-Tech. Gen. Corp., 424 F.3d 1347, 1355 (Fed. Cir.
2005). Alternatively, a reasonable jury, taking the evidence
in the light most favorable to GSK, might instead find that
Kelly does not meet the standard for enablement under §
102, for reasons including Kelly's brevity and that the
study had not yet even begun.
Court will address the implications of its adoption of the
Report, including what issues relating to anticipation will
be tried before the jury, ...