United States District Court, D. Delaware
PURDUE PHARMA L.P., PURDUE PHARMACEUTICALS L.P., THE P.F. LABORATORIES, INC., RHODES TECHNOLOGIES, and GRUNENTHAL GMBH, Plaintiffs,
INTELLIPHARMACEUTICS INTERNATIONAL INC., INTELLIPHARMACEUTICS CORPORATION, and INTELLIPHARMACEUTICS LTD., Defendants.
B. Blumenfeld, Rodger D. Smith II, Megan E. Dellinger,
MORRIS, NICHOLS, ARSHT & TUNNELL LLP, Wilmington, DE.
Attorneys for Plaintiffs
J. Normile, Pablo D. Hendler (argued), Kelsey I. Nix, Gasper
J. LaRosa, Kenneth S. Canfield (argued), Sarah A. Geers,
Lisamarie LoGuidice, Christopher J. Harnett, Mital B. Patel,
JONES DAY, New York, NY. Attorneys for Plaintiffs Purdue
Pharma L.P., Purdue Pharmaceuticals L.P., The P.F.
Laboratories, Inc., and Rhodes Technologies
Jennifer H. Roscetti, Matthew J. Luneack, Nicholas J. Doyle,
FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP,
Washington, DC; Anthony C. Tridico, FINNEGAN EUROPE LLP,
London, UK. Attorneys for Plaintiff Grunenthal GmbH
C. Belgam, Eve H. Ormerod, SMITH, KATZENSTEIN & JENKSINS
LLP, Wilmington, DE; Shashank Upadhye, Joseph E. Cwik, Yixin
H. Tang (argued), Brent Batzer, Adam D. Sussman, Samuel J.
Ruggio, AMIN TALATI UPADHYE LLP, Chicago, IL. Attorneys for
ANDREWS, U.S. DISTRICT JUDGE.
before the Court is the issue of claim construction of
multiple terms in U.S. Patent Nos. 9, 060, 976 ("the
'976 patent"), 9, 073, 933 ("the '933
patent"), 9, 522, 919 ("the '919 patent"),
9, 492, 389 ("the '389 patent"), and 9, 492,
391 ("the '391 patent"). The Court has
considered the parties' joint claim construction brief.
(D.I. 85). The Court heard oral argument on June 22, 2018.
suit arises from Defendants' filing a New Drug
Application ("NDA"). Plaintiffs filed suit on April
7, 2017, alleging that the generic product that is the
subject of the NDA would infringe six of Plaintiffs'
patents. (D.I. 1). The patents-in-suit relate to
OxyContin®, an extended-release pain medication.
Plaintiffs have asserted the '976 and '933 patents in
another action, No. 15-1152, in which I issued a
Markman opinion. (Civ. Act. No. 15-1152, D.I. 120).
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) (en banc).
'"[T]here is no magic formula or catechism for
conducting claim construction.' Instead, the court is
free to attach the appropriate weight to appropriate sources
'in light of the statutes and policies that inform patent
law.'" SoftView LLC v. Apple Inc., 2013 WL
4758195, at *1 (D. Del. Sept. 4, 2013) (quoting
Phillips, 415 F.3d at 1324) (alteration in
original). When construing patent claims, a court considers
the literal language of the claim, the patent specification,
and the prosecution history. Markman v. Westview
Instruments, Inc., 52 F.3d 967, 979-80 (Fed. Cir. 1995)
(en banc), aff'd, 517 U.S. 370 (1996). Of these
sources, "the 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." Phillips, 415 F.3d at 1315.
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. "[T]he ordinary meaning of a
claim term is its meaning to [an] ordinary artisan after
reading the entire patent." Id. at 1321.
"In some cases, the ordinary meaning of claim language
as understood by a person of skill in the art may be readily
apparent even to lay judges, and claim construction in such
cases involves little more than the application of the widely
accepted meaning of commonly understood words."
Id. at 1314.
court relies solely upon the intrinsic evidence-the patent
claims, the specification, and the prosecution history-the
court's construction is a determination of law. See
Teva Pharms. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831,
841 (2015). The court may also make factual findings based
upon consideration of extrinsic evidence, which
"consists of all evidence external to the patent and
prosecution history, including expert and inventor testimony,
dictionaries, and learned treatises." Phillips,
415 F.3d at 1317-19. Extrinsic evidence may assist the court
in understanding the underlying technology, the meaning of
terms to one skilled in the art, and how the invention works.
Id. Extrinsic evidence, however, is less reliable
and less useful in claim construction than the patent and its
prosecution history. Id.
claim construction is persuasive, not because it follows a
certain rule, but because it defines terms in the context of
the whole patent." 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).
'976 patent is directed to an abuse deterrent dosage form
of OxyContin®. The sole claim of that patent reads as
extended release abuse deterrent dosage form comprising:
a. a core matrix comprising a blended mixture of:
(a) PEO having a molecular weight of from about 300, 000
daltons to about 5, 000, 000 daltons;
(b) magnesium stearate; and
(c) oxycodone or a pharmaceutically acceptable salt thereof;
wherein the core matrix is heated to melt at least a portion
of the PEO included in the core matrix during preparation of
the dosage form; and
b. PEG applied onto the core matrix;
wherein the dosage form provides extended release of the
patent, claim 1) (disputed term italicized).
'933 and '919 patents are directed to oxycodone
formulations having low amounts of 14-hydroxycodeinone and
8α, respectively. Claim 1 of the '933 and claim 1
of the '919 patent are representative. They read:
1. An oxycodone hydrochloride composition which
comprises at least 95% oxycodone hydrochloride,
8α, 14-dihydroxy-7, 8-dihydrocodeinone, and less than
25 ppm of 14-hydroxycodeinone.
('933 patent, claim 1) (disputed terms italicized).
1. An oxycodone HCl composition comprising oxycodone
HC1 and 8α, 14-dihydroxy-7, 8-dihydrocodeinone, wherein
the ratio of 8α, 14-dihydroxy-7,
8-dihydrocodeinone to oxycodone HCl is 0.04% or less as
measured by HPLC.
('919 patent, claim 1) (disputed terms italicized).
'389 and '391 patents are directed to cured
pharmaceutical dosage forms. Claim 1 of the '389 patent
and claim 20, which depends from claim 1, are representative.
They read as follows:
cured shaped pharmaceutical tablet comprising:
(1) at least a first compression shaped and then air cured
matrix, wherein said curing is without compression, by
heated air having a temperature of at least about 62° C.
for a duration of at least about 5 minutes, said matrix
comprising an opioid or a pharmaceutically acceptable salt
thereof in combination with at least one high molecular
weight polyethylene oxide having, based on rheological
measurements, an approximate molecular weight selected from
the group consisting of 4, 000, 000, 7, 000, 000, and a
combination thereof, and optionally further comprising at