GlaxoSmithKline LLC et al v. Glenmark Generics Inc. USA
MEMORANDUM ORDER re (346 in 1:14-cv-00878-LPS-CJB) REPORT AND RECOMMENDATION is ADOPTED to the extent and as explained herein re Defendants' motion for summary judgment as related to invalidity is DENIED (248 in 1:14-cv-00878-LPS-CJB). Signed by Judge Leonard P. Stark on 5/25/17. 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., USA, :
GLAXOSMITHKLINE LLC and SMITHKLINE
BEECHAM (CORK) LIMITED,
C.A. No. 14-878-LPS-CJB
TEVA PHARMACEUTICALS USA, INC.,
WHEREAS, Magistrate Judge Burke issued a 47-page Report and Recommendation (the
"Report") (D.I. 346) 1, 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. 248)2 ;
All references to the docket_ index (D.1.) are to the Teva action, C.A. No. 14-878.
Defendants filed a "Combined Motion for Summary Judgment and to Exclude Certain
Expert Testimony" (DJ. 248), in which they, inter alia, moved for summary judgment on
multiple issues. The Report- and, accordingly, this Order- solely relates to the portions of
Defendants' motion raising invalidity arguments.
WHEREAS, on May 12, 2017, Plaintiffs GlaxoSmithKline LLC and SmithK.line
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
WBEREAS, 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"));
WHEREAS, 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)(l); Fed. R. Civ. P. 72(b)(3);
NOW 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 patent-in-suit). 3
GSK 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 Obj s at 6-9)
Regarding 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
Defendants also argue that GSK's expert, Dr. McCullough, only first disputed the length
of treatment in the Kelly study during his deposition, having failed to raise this issue in his expert
report. (Defs Objs at 3) While Defendants are correct that Dr. McCullough's expert report does
not explicitly raise this issue, Defendants are not entitled to any relief. Defendants did not raise a
concern about the timing of Dr. McCullough's length of treatment opinion in the summary
judgment briefing·or oral argument. (See GSK Resp at 7) Nor have Defendants attempted to
show that they have been unfairly prejudiced by GSK's actions or that such prejudice could not
be cured by consequences short of striking Dr. McCullough's opinion on this issue.
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)
With 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, ifthe
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). 4
GSK also argues that the Report is, in part, an improper advisory opinion because it
reaches the parties' arguments on inherency and enablement after finding a genuine dispute of
material fact with regard to whether Kelly contains all elements of the claims, in particular the
six-month maintenance period. (GSK Objs at 1-2) The Court disagrees. Moreover, even ifGSK
were correct, it would mean, at most, that the Report constitutes slightly premature assistance to
the Court in deciding a legal dispute that will have to be addressed no later than when the jury is
instructed. The Court has discretion to decide this legal issue now and to allow its
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 6-7)
Neither party identified much pertinent caselaw, so the Report turned to In re
Montgomery, 677 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 Montgome1y 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
determinations to guide both its jury instructions and its evidentiary decisions at trial.
disclosure in Montgomery].")
A 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." lmpax Labs., Inc. v. Aventis Pharm., Inc., 468 F.3d 1366, 1383 (Fed. Cir. 2006); see
Novo Nordisk Pharm., 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.
The Court will address the implications of its adoption of the Report, including
what issues relating to anticipation will be tried before the jury, during the pretrial conference to
be held tomorrow.
HON. LEbNARD P. STARK
UNITED STATES DISTRICT JUDGE
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