United States District Court, D. Massachusetts
PURDUE PHARMA L.P.; THE P.F. LABORATORIES, INC.; PURDUE PHARMACEUTICALS, L.P.; and RHODES TECHNOLOGIES, Plaintiffs,
COLLEGIUM PHARMACEUTICAL, INC., Defendant. Term Plaintiffs' construction Defendant's construction Patent Number Plaintiffs' construction Defendant's construction Term Plaintiffs' construction Defendant's construction Term Plaintiffs' construction Defendant's construction Term Plaintiffs' construction Defendant's construction Plaintiffs' construction Defendant's construction
MEMORANDUM AND ORDER ON CLAIM CONSTRUCTION
DENNIS SAYLOR IV, UNITED STATES DISTRICT JUDGE.
a patent dispute concerning a pharmaceutical product:
abuse-deterrent, extended-release oxycodone. Plaintiffs
Purdue Pharma L.P.; The P.F. Laboratories, Inc.; Purdue
Pharmaceuticals L.P.; and Rhodes Technologies (collectively,
“Purdue”) have brought suit against Collegium
Pharmaceutical, Inc. The amended complaint asserts claims for
infringement pursuant to 35 U.S.C. §§ 271(a), (b),
(c), and (e)(2)(A) arising out of three related patents.
case is at the claim-construction stage. The parties have
submitted proposed constructions for seven terms, five of
which are in dispute: (1) “irritant, ” (2)
“effective amount of an irritant to impart an
irritating sensation, ” (3) “an effective amount
of an irritant to impart a burning sensation, ” (4)
effective amount to discourage an abuser from tampering with
the dosage form, ” and (5) “removing 8α,
Pharma L.P. is the owner of the three patents at issue, all
of which relate to abuse-deterrent and low-toxicity versions
of the pain medication oxycodone. Purdue Pharma L.P. sells
oxycodone in the United States under the OxyContin brand
name. (First Am. Compl. (“FAC”) ¶¶ 2,
12-14). The P.F. Laboratories, Inc. owns a patent that
describes processes for producing oxycodone with low levels
of toxicity, which plaintiffs refer to as the
“low-toxicity patent.” (Id. ¶ 3,
12). Purdue Pharmaceuticals L.P. also owns the low-toxicity
patent and manufactures extended-release oxycodone
pain-relief medication under the OxyContin brand name.
(Id. ¶ 4, 12). Rhodes Technologies owns the
low-toxicity patent and manufactures the active
pharmaceutical ingredient used in OxyContin. (Id.
¶ 5, 12).
Pharmaceutical, Inc. recently filed a new drug application
(“NDA”) with the Food and Drug Administration to
manufacture, use, sell, or import a product that plaintiffs
allege infringes on their patents. (Id. ¶¶
6, 15, 18-22).
dispute concerns pharmaceutical products designed to deter
abuse of addictive pain medications, such as oxycodone, as
well as methods for reducing toxicity in oxycodone
pharmaceuticals. (Id. ¶ 12-14). Oxycodone is an
opioid, first developed in Germany in 1916, first used as a
drug in 1917, and first introduced to the United States
market in 1939. (See Def. CC at 1; Pl. Summ. Judg.
Opp. at 4). Purdue developed an extended release
(“ER”) version of oxycodone, known as OxyContin,
in 1995. (Pl. Summ. Judg. Opp. at 4).
drugs are often used to treat pain, but are also subject to
abuse. (Id.). The FDA approved an abuse-deterring
version of OxyContin in 2010. (Id. at 5). The drug
incorporated two features to deter abuse: (1) a harder
tablet, to resist crushing, and (2) a gelling agent, to
impede snorting and injecting of any powder resulting from
successful crushing. (Id.). Those features are the
subject of two of the patents at issue. In April 2013, the
FDA granted abuse-deterrent OxyContin the first
abuse-deterrent labeling. The FDA also declined to approve
generic versions of original OxyContin because they lacked
the new formulation's abuse-deterring features.
recently developed a version of oxycodone, called XTAMPZA ER,
which also contains abuse-deterring features. (Def. Summ.
Judg. Br. at 4-5). XTAMPZA ER utilizes a “hydrophobic
matrix of fatty acid and waxes” to “reduce the
potential for dose dumping” and to “create
barriers to abuse via oral ingestion, insufflation, or
injection.” (Id. at 5). The FDA approved
XTAMPZA ER and made it the first and only ER opioid without a
warning on its label related to crushing or chewing and the
potential exposure to a fatal dose. (Id.). However,
the XTAMPZA ER label includes a “Drug Abuse and
Dependence” section warning that “abuse of
Xtampza ER by injection and by the nasal route of
administration, as well as by the oral route is still
possible.” (Pl. Summ. Judg. Opp. at 6).
contains a substance known as alpha, beta-unsaturated ketone
(“ABUK”), that may damage human DNA. Pl. CC at 15
(citing Byrn Decl. Exs. 14-15). Purdue has also patented an
oxycodone-based product that contains a low level of ABUK, as
well as a method for removing a source of ABUK in the
manufacturing process, by removing a toxin that the parties
refer to as 8α. In 2016, three related Purdue-owned
patents for low-ABUK oxycodone products were invalidated on
obviousness grounds. See Purdue Pharma L.P. v. Epic
Pharma, LLC, 811 F.3d 1345, 1348 (Fed. Cir. 2016).
Patents at Issue
Pharma L.P., is the named assignee on two patents related to
abuse-deterring oxycodone: U.S. Patent Nos. 8, 652, 497
(“the '497 patent”) and 9, 155, 717
(“the '717 Patent”). FAC, Exs. B-C.
Plaintiffs are the named assignees of the 8α-removing,
low-ABUK patent: U.S. Patent No. 9, 073, 933 (“the
The '497 Patent
'497 patent is entitled “Pharmaceutical Formulation
Containing Irritant.” It was issued on February 18,
2014. ('497 Patent). It names Richard Sackler as the
inventor and Purdue Pharma L.P. as the assignee.
'497 patent is generally directed to “provide an
oral dosage form of an opioid analgesic which is subject to
less parenteral . . . intranasal . . . [and] oral abuse than
other dosage forms.” (Id. col. 2 ll. 14-22).
The patent is also directed to preventing abuse of drugs
other than opioid analgesics that may be the subject of
abuse. (Id. col. 5 ll. 35-40). At the time the
patent was issued, a number of other techniques were known
for deterring opioid abuse. (Id. col. 1 ll. 28-41,
55-67; Id. col. 1 ll. 1-4). In certain embodiments,
the patent provides an opioid product that includes “an
aversive agent such as an irritant to discourage from
tampering with the dosage form and thereafter inhaling,
injecting, or swallowing the tampered dosage form.
Preferably, the irritant is released when the dosage form is
tampered with and provides a burning or irritating effect to
the abuser upon inhalation, injection, and/or swallowing of
the tampered dosage form.” (Id. col. 2 ll.
The '717 Patent
'717 patent is entitled “Pharmaceutical Formulation
Containing Irritant.” It was issued on October 13,
2015. ('717 Patent). It names Sackler as the inventor and
Purdue Pharma L.P. as the assignee. (Id.). The
'717 patent shares a specification with the '497
'933 patent is entitled “Oxycodone Hydrocholoride
Having less than 25 PPM 14-Hyrdroxycodeinone.” It was
issued on July 7, 2015. ('933 Patent). It names Robert
Chapman, Lonn S. Rider, Qi Hong, Donald Kyle, and Robert
Kupper as the inventors and Purdue Pharma L.P., The P.F.
Laboratories, Inc., Purdue Pharmaceuticals L.P., and Rhodes
Technologies as the assignees. (Id.).
'933 patent is generally directed to a process for
reducing the amount of 14-hyrdroxycodeinone in an oxycodone
hydrochloride composition as compared to existing
formulations. (Id. col. 2 ll. 20-23). Specifically,
the patent is directed at producing oxycodone hydrochloride
compositions with less than 25 ppm of 14-hyrdroxycodeinone in
an oxycodone hydrochloride composition. (Id. col. 2
ll. 30-34). Methods for reducing the amount of
14-hyrdroxycodeinone in an oxycodone hydrochloride
composition were known in the prior art. (Id. col.1,
ll. 47-col. 2 ll. 2). At the time of the patent, existing
procedures for reducing toxicity in oxycodone hydrochloride
produced levels greater than 100 ppm. (Id. col. 2
construction of claim terms is a question of law, which may
in some cases rely on underlying factual determinations.
Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S.Ct.
831, 835, 837-38 (2015); Markman v. Westview
Instruments, 517 U.S. 370, 372 (1996) (“[T]he
construction of a patent, including terms of art within its
claim, is exclusively within the province of the
Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir.
2005) (en banc), the Federal Circuit clarified the
proper approach to claim construction and set forth
principles for determining the hierarchy and weight of the
definitional sources that give a patent its meaning. The
guiding principle of construction is “the meaning that
the term would have to a person of ordinary skill in the art
in question at the time of . . . the effective filing date of
the patent application.” Id. at 1313. Courts
thus seek clarification of meaning in “the words of the
claims themselves, the remainder of the specification, the
prosecution history, and extrinsic evidence concerning
relevant scientific principles, the meaning of technical
terms, and the state of the art.” Id. at 1314
(quoting Innova/Pure Water, Inc. v. Safari Water
Filtration Sys., Inc., 381 F.3d 1111, 1116 (Fed. Cir.
The Words of the Claim
claim construction analysis normally begins with the claims
The claims of a patent “define the invention to which
the patentee is entitled the right to exclude.”
Phillips, 415 F.3d at 1312 (citing Innova,
381 F.3d at 1115).
may construe a claim term to have its plain meaning when such
a construction resolves a dispute between the parties.
See O2 Micro Int'l Ltd. v. Beyond Innovation Tech.
Co., 521 F.3d 1351, 1361 (Fed. Cir. 2008); see also
U.S. Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554,
1568 (Fed. Cir. 1997) (“Claim construction is a matter
of resolution of disputed meanings and technical scope, to
clarify and when necessary to explain what the patentee
covered by the claims, . . . [but] is not an obligatory
exercise in redundancy.”).
instances, it is the arrangement of the disputed term in the
claims that is dispositive. “This court's cases
provide numerous . . . examples in which the use of a term
within the claim provides a firm basis for construing the
term.” Phillips, 415 F.3d at 1314. For
example, because claim terms are normally used consistently
throughout the patent, the meaning of a term in one claim is
likely the meaning of that same term in another. Id.
In addition, “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 1315.
claims, of course, do not stand alone.” Id.
“Rather, they are part of a fully integrated written
instrument, consisting principally of a specification that
concludes with the claims.” Id. (citations and
quotations omitted). For that reason, the specification must
always be consulted to determine a claim's intended
meaning. 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.” Id. (quoting Vitronics
Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.
general, the scope and outer boundary of claims is set by the
patentee's description of his invention.” On
Demand Mach. Corp. v. Ingram Indus., Inc., 442 F.3d
1331, 1338 (Fed. Cir. 2006); see also Phillips, 415
F.3d at 1315-17 (“[T]he interpretation to be given a
term can only be determined and confirmed with a full
understanding of what the inventors actually invented and
intended to envelop with the claim.” (quoting
Renishaw PLC v. Marposs Societa' per Azioni, 158
F.3d 1243, 1250 (Fed. Cir. 1998))). “[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.” Phillips, 415 F.3d
at 1316. It may also reveal “an intentional disclaimer,
or disavowal, of claim scope by the inventor.”
Id. Therefore, the claims are to be construed in a
way that makes them consistent with, and no broader than, the
invention disclosed in the specification. On Demand,
442 F.3d at 1340 (“[C]laims cannot be of broader scope
than the invention that is set forth in the
specification.”); Phillips, 415 F.3d at 1316
(“[C]laims must be construed so as to be consistent
with the specification, of which they are a part.”
(quoting Merck & Co. v. Teva Pharm. USA, Inc.,
347 F.3d 1367, 1371 (Fed. Cir. 2003))).
courts must be careful to “us[e] the specification
[only] to interpret the meaning of a claim” and not to
“import limitations from the specification into the
claim.” Id. at 1323. A patent's
“claims, not specification embodiments, define the
scope of patent protection.” Kara Tech. Inc. v.
Stamps.com Inc., 582 F.3d 1341, 1348 (Fed. Cir. 2009);
see also Martek Biosciences Corp. v. Nutrinova,
Inc., 579 F.3d 1363, 1381 (Fed. Cir. 2009)
(“[E]mbodiments appearing in the written description
will not be used to limit claim language that has broader
effect.”). “In particular, [the Federal Circuit]
ha[s] expressly rejected the contention that if a patent
describes only a single embodiment, the claims of the patent
must be construed as being limited to that embodiment.”
Phillips, 415 F.3d at 1323. This is “because
persons of ordinary skill in the art rarely would confine
their definitions of terms to the exact representations
depicted in the embodiments.” Id.
this distinction “can be a difficult one to apply in
practice[, ] . . . the line between construing terms and
importing limitations can be discerned with reasonable
certainty and predictability if the court's focus remains
on understanding how a person of ordinary skill in the art
would understand the claim terms.” Id.
“The 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.” Id. at 1316 (quoting
Renishaw, 158 F.3d at 1250).