United States District Court, D. Delaware
REPORT AND RECOMMENDATION
CHRISTOPHER J. BURKE, UNITED STATES MAGISTRATE JUDGE
these consolidated Hatch-Waxman patent litigation matters
filed by Plaintiff Collegium Pharmaceutical, Inc.
("Plaintiff) against Defendant Teva Pharmaceuticals USA,
Inc. ("Defendant"), Plaintiff alleges infringement
of 13 patents: United States Patent Nos. 7, 771, 707 (the
"707 patent"), 8, 449, 909 (the '"909
patent"), 8, 557, 291 (the '"291 patent"),
8, 758, 813 (the '"813 patent"), 8, 840, 928
(the '"928 patent"), 9, 044, 398 (the
'"398 patent"), 9, 248, 195 (the '"195
patent"), 9, 592, 200 (the '"200 patent"),
9, 682, 075 (the '"075 patent"), 9, 737, 530
(the '"530 patent"), 9, 763, 883 (the
'"883 patent"), 9, 968, 598 (the '"598
patent") and 10, 004, 729 (the "729 patent"
and collectively with the other patents, "the asserted
patents"). Presently before the Court is the matter of
claim construction. The Court recommends that the District
Court adopt the constructions set forth below.
filed a Complaint in Civil Action No. 18-300-LPS-CJB on
February 22, 2018, in which it asserted that Defendant's
submission of AND A No. 209431 to the United States Food and
Drug Administration-a submission that sought approval to
engage in the commercial manufacture, use, sale, offer for
sale, or importation of Oxycodone Extended-Release Capsules,
CII, 9 mg, 13.5 mg, 18 mg, and 36 mg-was an act of
infringement of, inter alia, the first 11 of the
asserted patents listed above. (D.I. 1; D.I.
November 30, 2018, Plaintiff filed a second Complaint in
Civil Action No. 18-900-LPS-CJB, asserting infringement of
the '598 patent and the 729 patent, which were issued
after ANDA No. 209431 was filed. (Civil Action No.
18-1900-LPS-CJB, D.I. 1; D.I. 84) Both cases have been
referred to the Court to hear and resolve all pretrial
matters, up to and including case-dispositive motions. (D.I.
8; Civil Action No. 18-1900-LPS-CJB, D.I. 7) On January 29,
2019, at the parties' request, the Court consolidated the
cases for all purposes. (D.I. 48)
to Plaintiff, the patented inventions "make attempts to
abuse powerful pain medications more difficult or less
rewarding, generally by protecting against unintended
exposure of drugs such as opiates." (D.I. 54 at 1) The
claims of the asserted patents purport to "involve new
ways to dissolve [such drugs] in very small beads of wax that
will release the drug over time when administered as
intended, but that make it difficult to manipulate the
formulation for purposes of abuse and misuse." (Id.;
see also D.I. 1 at ¶¶ 33-34)
parties filed simultaneous opening claim construction briefs
on February 22, 2019, and simultaneous responsive briefs on
March 22, 2019. (D.I. 54; D.I. 55; D.I. 69; D.I. 71) The
Court held a Markman hearing on April 12, 2019.
(D.I. 83 (hereinafter, "Tr.")) Following the
hearing, the parties submitted supplemental letter briefs
relating to Defendant's use of deposition testimony at
the claim construction hearing. This supplemental briefing
was completed on April 29, 2019. (D.I. 85)
STANDARD OF REVIEW
well-understood that "[a] claim in a patent provides the
metes and bounds of the right which the patent confers on the
patentee to exclude others from making, using, or selling the
protected invention." Corning Glass Works v.
Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257 (Fed.
Cir. 1989). Claim construction is a generally 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).
Court should typically assign claim terms their
"ordinary and customary meaning[, ]" which is
"the meaning that the term[s] would have to a person of
ordinary skill in the art ['POSITA'] in question at
the time of the invention, i.e., as of the effective filing
date of the patent application." Phillips v. AWH
Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005). However,
when determining the ordinary meaning of claim terms, the
Court should not extract and isolate those terms from the
context of the patent; rather it should endeavor to reflect
their "meaning to the ordinary artisan after reading the
entire patent." Id. at 1321; see also Eon
Corp. IP Holdings LLC v. Silver Spring Networks, Inc.,
815 F.3d 1314, 1320 (Fed. Cir. 2016).
proceeding with claim construction, the Court should look
first and foremost to the language of the claims themselves,
because "[i]t 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, 415 F.3d at 1312 (internal quotation marks
and citations omitted). For example, the context in which a
term is used in a claim may be "highly
instructive." Id. at 1314. In addition,
"[o]ther claims of the patent in question, both asserted
and unasserted, can ... be valuable" in discerning the
meaning of a particular claim term. Id. This is
"[b]ecause claim terms are normally used consistently
throughout the patent, [and so] the usage of a term in one
claim can often illuminate the meaning of the same term in
other claims." Id. Moreover, "[differences
among claims can also be a useful guide[, ]" as when
"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.
addition to the words of the claims, the Court should look to
other intrinsic evidence. For example, the Court should
analyze the patent specification, which "may reveal a
special definition given to a claim term . . . that differs
from the meaning [that term] would otherwise possess" or
may reveal an intentional disclaimer of claim scope.
Id. at 1316. Even if the specification does not
contain such revelations, it "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." Id. at 1315 (internal quotation
marks and citation omitted). That said, however, 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). And a court should also consider
the patent's prosecution history, if it is in evidence,
because it "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[.]" Phillips, 415
F.3d at 1317.
evidence, "including expert and inventor testimony,
dictionaries, and learned treatises[, ]" can also
"shed useful light on the relevant art[.]"
Id. (internal quotation marks and citations
omitted). Overall, while extrinsic evidence may be useful, it
is "less significant than the intrinsic record in
determining the legally operative meaning of claim
language." Id. (internal quotation marks and
citations omitted); accord Markman v. Westview
Instruments, Inc., 52 F.3d 967, 981 (Fed. Cir. 1995).
utilizing these resources during claim construction, courts
should keep in mind that "[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).
parties currently have disputes regarding six terms or sets
of terms (hereinafter, "terms"). This Report and
Recommendation addresses two of the terms: "homogeneous
single phase" and "solidified solution." The
other terms will be addressed in one or more forthcoming
Report and Recommendations.
"homogeneous single phase"
"homogeneous single phase" term appears in the
asserted claims of the '200 patent, which all recite
abuse-deterrent oral dosage forms. Independent claim 1 is
representative; that claim is reproduced below, with the
disputed term highlighted:
1. An abuse-deterrent oral dosage form comprising a plurality
of microparticles, wherein each microparticle comprises a