United States District Court, D. Delaware
E. Farnan, RICHARDS, LAYTON & FINGER, Wilmington, DE A.
Neal Seth, Lawrence M. Sung, Teresa Summers, and Alexander B.
Owczarczak, WILEY REIN LLP, Washington, DC Attorneys for
W. Poff, YOUNG, CONWAY, STARGATT & TAYLOR, Wilmington, DE
Jeffrey R. Gargano, Kevin P. Shortsle, and Zachary D. Miller,
MORGAN, LEWIS & BOCKIUS LLP, Chicago, IL Attorneys for
U.S DISTRICT JUDGE.
Horatio Washington Depot Technologies, LLC
("Horatio") sued Defendants TOLMAR, Inc., TOLMAR
Pharmaceuticals, Inc., and TOLMAR Therapeutics, Inc.
(together, "Tolmar"), alleging that Tolmar
infringes Horatio's U.S. Patent Nos. 5, 932, 547
("the '547 patent"), 6, 124, 261 ("the
'261 patent"), and 6, 235, 712 ("the '712
patent"). (D.I. 1) The patents-in-suit describe stable
non-aqueous formulations that include a peptide and a polar
aprotic solvent. (See '547 patent, Abstract)
These formulations may be used, for example, to treat
prostatic cancer. ('547 patent, 2:29-46)
before the Court are the parties' disputes over the
meaning of certain terms in the asserted claims. The parties
submitted technology tutorials (D.I. 67, 68) and claim
construction briefs (D.I. 62, 66, 70, 72). Tolmar also filed
objections to Horatio's technology tutorial. (D.I. 69)
The Court held a claim construction hearing on October 22,
2018. (D.I. 79 ("Tr."))
ultimate question of the proper construction of a patent
presents an issue 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) (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 [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).
"[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)
(internal quotation marks omitted).
CONSTRUCTION OF DISPUTED TERMS
three patents-in-suit are entitled "Non-Aqueous Polar
Aprotic Peptide Formulations." The asserted claims
relate to "stable non-aqueous formulation[s]"
comprising a "peptide compound," such as
luteinizing hormone-releasing hormone (LHRH), and a
"polar aprotic solvent," methods for preparing
these formulations, and methods for treating prostatic cancer
using these formulations. ('547 patent, cl. 1; '261
patent, cl. 3, 4; '712 patent, cl. 1, 8) According to the
specification, using non-aqueous polar aprotic solvents
results in more physically and chemically stable peptide
formulations than "standard" formulations, which
"consist of dilute aqueous solutions." ('547
patent, 4:14-36) The specification states that this increased
stability "mak[es] possible the delivery of peptides in
long term implantable devices that would not otherwise be
feasible." ('547 patent, 4:48-56)
plain and ordinary meaning
"solution having a non-water-based solvent
"solution having a non-water-based solvent
parties agree that "stable" is expressly defined in
the specification (see '547 patent, 3:12-13,
5:4-7) and agree that the use of the term in the preamble is
limiting, but they disagree as to the meaning of
"non-aqueous formulation." (See D.I. 62 at
14; D.I. 66 at 3) The dispute centers on whether a
"formulation" can be, as Horatio contends, a depot,
suspension, or dispersion or whether, as Tolmar ...