United States District Court, D. Delaware
PURDUE PHARMA L.P., PURDUE PHARMACEUTICALS L.P., THE P.F. LABORATORIES, INC., and RHODES TECHNOLOGIES, Plaintiffs,
AMNEAL PHARMACEUTICALS, LLC, Defendant.
B. Blumenfeld, Rodger D. Smith II, MORRIS, NICHOLS, ARSHT
& TUNNELL LLP, Wilmington, DE; John J. Normile, Pablo D.
Hendler (argued), Kelsey I. Nix, Gasper J. LaRosa, Kenneth S.
Canfield, Sarah A. Geers, Lisamarie LoGiudice, JONES DAY, New
York, NY; Jason G. Winchester, JONES DAY, Chicago, IL.
Attorneys for Plaintiffs
Shea Gaza, Samantha G. Wilson, YOUNG CONAWAY STARGATT &
TAYLOR, LLP, Wilmington, DE; Michael V. Ciresi, Jan M.
Conlin, Katie Crosby Lehman (argued), Melissa A. Goodman,
CIRESI CONLIN LLP, Minneapolis, MN; Barbara L. Mullin,
Matthew A. Pearson, Angela Verrecchio, Jonathan J. Underwood,
AKIN GUMP STRAUSS HAUER & FELD LLP, Philadelphia, PA.
Attorneys for Defendant
ANDREWS, U.S. DISTRICT JUDGE
before the Court is the issue of claim construction of
multiple terms in U.S. Patent Nos. 9, 492, 392 ("the
'392 patent"), 9, 492, 393 ("the '393
patent"), and 9, 522, 919 ("the '919
patent"). The Court has considered the parties'
joint claim construction brief. (D.I. 48). The Court heard
oral argument on February 14, 2018. (D.I. 80
suit arises from Defendant's filing an Abbreviated New
Drug Application ("ANDA"). Plaintiffs filed suit on
March 1, 2017, alleging that the generic product that is the
subject of the ANDA filing would infringe a number of
Plaintiffs' patents. (D.I. 1). The patents-in-suit relate
to OxyContin®, an extended-release pain medication. They
are from two of the same patent families asserted by
Plaintiffs in an earlier related action, in which I issued a
Markman opinion. (No. 15-1152, D.I. 120). More
specifically, the '392 and '393 patents are related
to and have the same specification as U.S. Patent Nos. 8,
808, 741 ("the '741 patent"), 8, 894, 987
("the '987 patent), and 8, 894, 988 ("the
'988 patent"). (D.I. 48 at 9). The '919 patent
is related to and has the same specification as U.S. Patent
No. 9, 073, 933 ("the '933 patent").
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)
'392 and '393 patents relate to a tamper resistant
dosage form of OxyContin®. Claim 1 of the '392 patent
is representative and reads as follows:
1. A 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
oxycodone 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 least
one low molecular weight polyethylene oxide having, based on
rheological measurements, an approximate molecular weight of
less than 1, 000, 000;
(2) optionally a second air cured matrix comprising oxycodone
or a pharmaceutically acceptable salt thereof in combination
with at least one low molecular weight polyethylene oxide
having, based on rheological measurements, an ...