United States District Court, D. Delaware
B. Matterer and Richard K. Herrmann, MORRIS JAMES LLP,
Wilmington, DE Mitchell G. Stockwell, Anil H. Patel, and
Joshua H. Lee, KILPATRICK TOWNSEND & STOCKTON LLP,
Atlanta, GA Taylor H. Ludlam, KILPATRICK TOWNSEND &
STOCKTON LLP, Raleigh, NC Attorneys for Plaintiff.
B. Blumenfeld, Karen Jacobs, Jennifer Ying, and Stephen J.
Kraftschik, MORRIS, NICHOLS, ARSHT & TUNNELL LLP,
Wilmington, DE David E. De Lorenzi, George Gould, Estelle
Tsevdos, Wendy R. Stein, and Ankit D. Patel, GIBBONS P.C.,
Newark, N.J. Attorneys for Defendant.
U.S. District Judge:
Cipla Ltd. ("Cipla") brought this patent
infringement suit against Defendant Sunovion Pharmaceuticals,
Inc. ("Sunovion"), alleging that Sunovion's
Xopenex HFA® aerosol inhaler infringes Cipla's U.S.
Reissued Patent No. RE43, 984 (the '"984
Reissue"). The asserted patent describes and claims
optically pure salbutamol salts of tartaric acid obtained by
resolving a racemic or otherwise optically impure mixture of
salbutamol enantiomers with tartaric acid. Presently before
the Court is the issue of claim construction. The parties
submitted technology tutorials (see D.I. 89, 93),
claim construction briefs (see D.I. 90, 94, 119,
146, 149), and expert declarations (see D.I. 92, 96,
135-137). The Court held a claim construction hearing on May
1, 2017, at which both sides presented oral argument and
expert testimony. (See D.I. 233
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) (quoting Liebel-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
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 l583).
"[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 GmbHv. 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
Cipla "R-salbutamol salt of L-tartaric acid"
Sunovion "A 1:1 ratio of (R)-salbutamol cation and