United States District Court, D. Delaware
COSMO TECHNOLOGIES LIMITED, VALEANT PHARMACEUTICALS INTERNATIONAL, and VALEANT PHARMACEUTICALS LUXEMBOURG S.AR.L, Plaintiffs,
LUPIN LTD. and LUPIN PHARMACEUTICALS, INC., Defendants. COSMO TECHNOLOGIES LIMITED, VALEANT PHARMACEUTICALS INTERNATIONAL, and VALEANT PHARMACEUTICALS LUXEMBOURG S.A R.L., Plaintiffs,
MYLAN PHARMACEUTICALS INC., Defendant.
B. Blumenfeld and Maryellen Noreika, MORRIS, NICHOLS, ARSHT
& TUNNELL LLP, Wilmington, DE Melanie R. Rupert, David M.
Conca, and Nicholas A. Tymoczko, PAUL HASTINGS LLP, New York,
NY Attorneys for Plaintiffs.
B. Rath and James S. Green Jr., LANDIS RATH & COBB LLP,
Wilmington, DE William R. Zimmerman, Andrew E. Morrell, and
Andrea L. Cheek, KNOBBE, MARTENS, OLSON & BEAR, LLP,
Washington, DC Carol Pitzel Cruz, KNOBBE, MARTENS, OLSON
& BEAR, LLP, Seattle, WA Sheila N. Swaroop and Stephanie
Johnson, KNOBBE, MARTENS, OLSON & BEAR, LLP, Irvine, CA
Loni L. Morrow, KNOBBE, MARTENS, OLSON & BEAR, LLP, San
Diego, CA Attorneys for Defendants Lupin Ltd. and Lupin
M. Lennon and Robert M. Vrana, YOUNG CONAWAY STARGATT &
TAYLOR, LLP, Wilmington, DE Deepro R. Mukerjee, Lance
Soderstrom, and Stephanie M. Roberts, ALSTON & BIRD LLP,
New York, NY Joseph M. Janusz, ALSTON & BIRD LLP,
Charlotte, NC Attorneys for Defendant Mylan Pharmaceuticals,
U.S. District Judge
Cosmo Technologies Limited, Valeant Pharmaceuticals
International, and . Valeant Pharmaceuticals Luxembourg S.a
r.l. (collectively, "Cosmo") filed suit against
Defendants Lupin Ltd. and Lupin Pharmaceuticals, Inc.
(collectively, "Lupin") and separately, Defendant
Mylan Pharmaceuticals Inc. ("Mylan"), alleging
infringement of U.S. Patent Nos. 7, 410, 651; RE 43, 799; 8,
784, 888; and 9, 320, 716. The patents describe and claim
controlled-release pharmaceutical compositions containing
budesonide, which are used to treat ulcerative colitis.
before the Court is the issue of claim construction. The
Court previously construed terms of the patents in suit in
related litigation. See Cosmo Techs. Ltd. v. Actavis
Labs. FL, Inc., 2016 WL 4697953 (D. Del. Sept. 7, 2016).
The parties submitted technology tutorials (see C.A.
No. 15-669-LPS D.I. 91, 95; C.A. No. 16-152-LPS D.I. 39) and
briefs (see D.I. 92, 96, 102, 105; C.A. No.
16-152-LPS D.I. 40, 56). The parties elected to forgo a claim
construction hearing. (See D.I. 113)
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. AWHCorp., 415 F.3d 1303, 1312 (Fed. Cir. 2005)
(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."
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) (quotingLiebel-Flarsheim Co. v. Medrad,
Inc., 358 F.3d 898, 906 (Fed. Cir. 2004)) (internal
quotation marks omitted).
addition to the specification, a court "should also
consider the patent's prosecution history, if it is in
evidence." Markman 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 PTO [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.
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
' j 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.3datl583).
"[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
i 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)).
CONSTRUCTION OF DISPUTED TERMS
Lipophilic, Amphiphilic, and Hydrophilic
"having an affinity for lipids and a poor affinity
towards aqueous fluids"
"having an affinity for lipids and a poor affinity for
aqueous fluids and not characterized as hydrophilic or
"having an affinity for lipids and a poor affinity
towards aqueous fluids"
"having an affinity for lipids and an affinity ...