United States District Court, D. Delaware
PAR PHARACEUTICAL, INC., PAR STERILE PRODUCTS, LLC, and ENDO PAR INNOVATION COMPANY, LLC, Plaintiffs,
HOSPIRA, INC., Defendant.
REPORT AND RCOMMENDATION
R. FALLON, UNITED STATES MAGISTRATE JUDGE.
patent infingement action fled by plaintiffs Par
Pharmaceutical, Inc., Pa Sterile Products, LLC, and Endo Par
Innovation Company, LLC ("Par") against defendant
Hospira, Inc. ('-Hospira"), Par alleges infingement
of United States Patent Nos. 9, 119, 876 ("the '876
patent") and 9, 295, 657 ("the '657
patent") (together, the "patents-in-suit").
(D.I. 1) Presently before the court is the matter of claim
This decision sets forth the court's recommendations of
constructions fr the disputed claim terms discussed in the
briefing and at the Markman hearing held on March
patents-in-suit, entitled "Epinephrine
Formulations," claim priority to U.S. Patent Application
No. 14/657, 990 ("the '990 application") and
have an efective fling date of March 13, 2015. The '657
patent is a continuation of the '876 patent, and it
shares the same inventors and specification. (D.I. 151, Exs.
1 & 2) The patents-in-suit are directed to a specific
epinephrine formulation with improved stability, as evidenced
by the limited amounts of certain impurities after eighteen
months of storage. In pharmaceutical compositions,
epinephrine acts to improve breathing, stimulate the heart,
raise dropping blood pressure, reverse hives, and reduce
swelling of the face, lips, and throat. ('876 patent,
col. 1:15-19) Epinephrine is used as an emergency treatment
for Type 1 allergic reactions, among other conditions.
(Id., col. 1:20-29)
13, 2017, Par filed suit against Hospira, alleging that
Hospira's ANDA product infringes the patents-in-suit, as
embodied by Par's Adrenalin® product. (D.I. 1) In
2012, the Food and Drug Administration ("FDA")
approved the Adrenalin® epinephrine injection formulation
of Par's predecessor, JHP Pharmaceuticals
("JHP"). However, the FDA asked JHP to investigate
improvements to the formulation and process to reduce the
levels of impurities in the Adrenalin® product.
Subsequent testing revealed the presence of Impurity A,
Impurity B, and Unknown C. The inventors developed a
procedure using gradient Hydrophobic Interaction Liquid
Chromatography ("HILIC") to isolate Impurity A, Impurity B,
and Unknown C. ('876 patent, col. 16:38-20:61, Figs. 1-4)
the claims of a patent presents a question of law, although
subsidiary fact finding is sometimes necessary. Teva
Pharms. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 837-38
(2015) (citing Markman v. Westview Instruments,
Inc., 52 F.3d 967, 977-78 (Fed. Cir. 1995),
aff'd, 517 U.S. 370, 388-90 (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) (internal quotation marks
omitted). "[T]here is no magic formula or catechism for
conducting claim construction." Id. at 1324.
Instead, the court may attach the appropriate weight to
appropriate sources "in light of the statutes and
policies that inform patent law." Id.
words of the claims "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."
Phillips, 415 F.3d 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); see also Eon Corp. IP
Holdings v. Silver Spring Networks, Inc., 815 F.3d 1314,
1320 (Fed. Cir. 2016). Claim terms are typically used
consistently throughout the patent, and "usage of a term
in one claim can often illuminate the meaning of the same
term in other claims." Phillips, 415 F.3d at
1314 (observing that "[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. . .").
intrinsic evidence, including 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). "[T]he 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 (citing CCS Fitness,
Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir.
2002)). 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." Liebel-Flarsheim Co. v. Medrad,
Inc., 358 F.3d 898, 906 (Fed. Cir. 2004) (internal
quotation marks omitted), aff'd, 481 F.3d 1371
(Fed. Cir. 2007). The specification "is not a substitute
for, nor can it be used to rewrite, the chosen claim
language." SuperGuide Corp. v. DirecTV Enters.,
Inc., 358 F.3d 870, 875 (Fed. Cir. 2004).
addition to the specification, a court "should also
consider the patent's prosecution history, if it is in
evidence." Markman, 52 F.3d at 980. The
prosecution history, which is also "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.
also may rely on "extrinsic evidence," which
"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. ("[C]onclusory, unsupported
assertions by experts as to the definition of a claim term
are not useful to a court."). 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." Mat 1318-19.
"[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