United States District Court, D. Delaware
VALEANT PHARMACEUTICALS INTERNATIONAL, SALIX PHARMACEUTICALS LTD. and COSMO TECHNOLOGIES LIMITED, Plaintiff,
ACTAVIS LABORATORIES FL., INC., ACTAVIS PHARMA, INC., TEVA PHARMACEUTICALS USA, INC. and TEVA PHARMACEUTICAL INDUSTRIES LTD., Defendants.
B. Blumenfeld and Michael Flynn, MORRIS, NICHOLS, ARSHT &
TUNNELL LLP, Wilmington, DE Thomas P. Steindler, William
Rose, and Christopher M. Bruno, McDERMOTT WILL & EMERY,
LLP, Washington, D.C. Counsel for Plaintiffs Valeant
Pharmaceuticals International and Salix Pharmaceuticals Gray
Frischling and Yite John Liu, IRELL & MANELLA, LLP, Los
Angeles, CA Counsel for Plaintiff Cosmo Technologies
C. Phillips, Jr. and David A. Bilson, PHILLIPS, GOLDMAN,
MCLAUGHLIN & HALL, P.A., Wilmington, DE Elizabeth J.
Holland, GOODWIN PROCTER, LLP, New York, NY Samuel Sherry,
John T. Bennett, and Christie Larochelle, GOODWIN PROCTER,
LLP, Boston, MA Counsel for Defendants Actavis Laboratories
FL, Inc., Actavis Pharma, Inc., Teva Pharmaceuticals USA,
Inc., and Teva Pharmaceuticals Industries Limited
U.S. DISTRICT JUDGE
Valeant Pharmaceuticals International, Salix Pharmaceuticals
Ltd., and Cosmo Technology Ltd. ("Plaintiffs")
filed suit against Actavis Laboratories FL, Inc., Actavis
Pharma Inc., Teva Pharmaceuticals USA Inc., and Teva
Pharmaceutical Industries, Ltd. ("Defendants") on
August 22, 2018, alleging infringement of U.S. Patent Nos.
10, 052, 286 (the '"286 patent"), 10, 064, 878
(the "'878 patent"), 10, 105, 374 (the
"'374 Patent"), 10, 143, 698 (the
"'698 Patent"), 10, 154, 964 (the
"'964 Patent"), and 10, 172, 799 (the
"'799 Patent") (collectively "the
patents-in-suit"). (D.I. 1) These patents may be grouped
into the "Villa I patents" (the '374, '878,
and '698 patents) claiming priority to a 1999
and the "Villa II patents" (the '286, '964,
and '799 patents) claiming priority to a 2011
application. (D.I. 143 at 1 n.1) The Villa I and Villa II
patents claim "controlled release budesonide
formulations with a tablet core inside a gastro-resistant
coating." (Id. at 6) Closely-related patents
were the subject of litigation in Cosmo Technologies
Limited et al. v. Alvogen Pine Brook LLC, CA. Nos.
16-164-LPS, 15-193-LPS (D. Del. 2017) ("Uceris
I'). (Id. at 2) "All six patents [currently
in-suit] share the same set of inventors and the same
assignee, and their specifications contain identical
disclosures of Cosmo's multi-matrix budesonide
formulation" as the patents-in-suit in Uceris I
(Id. at 8)
parties dispute whether the terms "matrix,"
"mixture," and "compressed blend" require
a homogenous system, and whether the term "controls the
release kinetics" excludes contribution from
"physically discrete elements." Significantly, the
parties contest the persuasiveness of the Court's
Uceris I decision (construing similar terms) and
certain post-allowance prosecution statements made by
applicants following the Court's decision in Uceris
I, finding non-infringement.
claim construction briefing was submitted on June 17, 2019,
an amended version was filed on June 27, 2019 (D.L 143)
("CC"), and the Court held a claim construction
hearing on July 2, 2019 (D.I. 147) ("Tr.").
ultimate question of the proper construction of a patent is a
question of law. See Teva Pharm. USA, Inc. v. Sandoz,
Inc., 135 S.Ct. 831, 837 (2015) (citing Markman v.
Westview Instruments, Inc., 517 U.S. 370, 388-91
(1996)). "It is a bedrock principle of patent law that
the claims of a patent define the invention to which the
patentee is entitled the right to exclude." Phillips
v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005)
(citation and internal quotation marks omitted).
"[T]here is no magic formula or catechism for conducting
claim construction." Id. at 1324. Instead, the
court is free to attach the appropriate weight to appropriate
sources "in light of the statutes and policies that
inform patent law." Id.
words of a claim are generally given their ordinary and
customary meaning.., . [which is] the meaning that the term
would have to a person of ordinary skill in the art in
question at the time of the invention, i.e., as of the
effective filing date of the patent application."
Id. at 1312-13 (internal citations and quotation
marks omitted). "[T]he ordinary meaning of a claim term
is its meaning to the ordinary artisan after reading the
entire patent." Id. at 1321 (internal quotation
marks omitted). The patent "specification is always
highly relevant to the claim construction analysis. Usually,
it is dispositive; it is the single best guide to the meaning
of a disputed term." Vitronics Corp. v.
Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996).
"the claims themselves provide substantial guidance as
to the meaning of particular claim terms," the context
of the surrounding words of the claim also must be
considered. Phillips, 415 F.3d at 1314. Furthermore,
"[o]ther claims of the patent in question, both asserted
and unasserted, can also be valuable sources of
enlightenment.... [b]ecause claim terms are normally used
consistently throughout the patent." Id.
(internal citation omitted).
likewise true that "[differences among claims can also
be a useful guide .... For example, the presence of a
dependent claim that adds a particular limitation gives rise
to a presumption that the limitation in question is not
present in the independent claim." Id. at
1314-15 (internal citation omitted). This "presumption
is especially strong when the limitation in dispute is the
only meaningful difference between an independent and
dependent claim, and one party is urging that the limitation
in the dependent claim should be read into the independent
claim." SunRace Roots Enter. Co., Ltd. v. SRAM
Corp., 336 F.3d 1298, 1303 (Fed. Cir. 2003).
also possible that "the specification may reveal a
special definition given to a claim term by the patentee that
differs from the meaning it would otherwise possess. In such
cases, the inventor's lexicography governs."
Phillips, 415 F.3d at 1316. It bears emphasis that
"[e]ven when the specification describes only a single
embodiment, the claims of the patent will not be read
restrictively unless the patentee has demonstrated a clear
intention to limit the claim scope using words or expressions
of manifest exclusion or restriction." Hill-Rom
Servs., Inc. v. Stryker Corp., 755 F.3d 1367, 1372 (Fed.
Cir. 2014) (quoting Liebel-Flarsheim Co. v. Medrad,
Inc., 358 F.3d 898, 906 (Fed. Cir. 2004)) (alteration in
original) (internal quotation marks omitted).
addition to the specification, a court "should also
consider the patent's prosecution history, if it is in
evidence." Marbnan v. Westview Instruments,
Inc., 52 F.3d 967, 980 (Fed. Cir. 1995),
aff'd, 517 U.S. 370 (1996). The prosecution
history, which is "intrinsic evidence,"
"consists of the complete record of the proceedings
before the [Patent and Trademark Office] and includes the
prior art cited during the examination of the patent."
Phillips, 415 F.3d at 1317. "[T]he prosecution
history can often inform the meaning of the claim language by
demonstrating how the inventor understood the invention and
whether the inventor limited the invention in the course of
prosecution, making the claim scope narrower than it would
otherwise be." Id.
some cases, ... the district court will need to look beyond
the patent's intrinsic evidence and to consult extrinsic
evidence in order to understand, for example, the background
science or the meaning of a term in the relevant art during
the relevant time period." Teva, 135 S.Ct. at
841. "Extrinsic evidence consists of all evidence
external to the patent and prosecution history, including
expert and inventor testimony, dictionaries, and learned
treatises." Markman, 52 F.3d at 980. For
instance, technical dictionaries can assist the court in
determining the meaning of a term to those of skill in the
relevant art because such dictionaries "endeavor to
collect the accepted meanings of terms used in various fields
of science and technology." Phillips, 415 F.3d
at 1318. In addition, expert testimony can be useful "to
ensure that the court's understanding of the technical
aspects of the patent is consistent with that of a person of
skill in the art, or to establish that a particular term in
the patent or the prior art has a particular meaning in the
pertinent field." Id. Nonetheless, courts must
not lose sight of the fact that "expert reports and
testimony [are] generated at the time of and for the purpose
of litigation and thus can suffer from bias that is not
present in intrinsic evidence." Id. Overall,
while extrinsic evidence "may be useful to the
court," it is "less reliable" than intrinsic
evidence, and its consideration "is unlikely to result
in a reliable interpretation of patent claim scope unless
considered in the context of the intrinsic evidence."
Id. at 1318-19. Where the intrinsic record
unambiguously describes the scope of the patented invention,
reliance on any extrinsic evidence is improper. See
Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d
1298, 1308 (Fed. Cir. 1999) (citing Vitronics, 90
F.3d at 1583).
"[t]he construction that stays true to the claim
language and most naturally aligns with the patent's
description of the invention will be, in the end, the correct
construction." Renishaw PLC v. Marposs Societa
'per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998).
It follows that "a claim interpretation that would
exclude the inventor's device is rarely the correct
interpretation." Osram GmbH v. Int'l Trade
Comm'n, 505 F.3d 1351, 1358 (Fed. Cir. 2007)
(quoting Modine Mfg. Co. v. U.S. Int'l Trade Comm
'n, 75 F.3d 1545, 1550 (Fed. Cir. 1996)).
OF DISPUTED TERMS
Plaintiffs "a structure for
controlling the release of an active ingredient that
does not have layers"
Defendants "a homogeneous
structure in all its volume"
Court "a homogeneous structure
in all its volume"