MALLINCKRODT LLC et al v. WATSON LABORATORIES, INC.- FLORIDA et al

Filing 123

OPINION. Signed by Judge Katharine S. Hayden on 5/9/17. (sr, )

NOT FOR PUBLICATION
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY

MALLINCKRODT LLC, and
MALLINCKRODT, INC.,
Civil No.: 2:15-cv-3800 (KSH) (CLW)
Plaintiffs,
v.
OPINION
ACTAVIS LABORATORIES FL., INC.,
Defendant.
Katharine S. Hayden, U.S.D.J.
I.

BACKGROUND
Plaintiffs Mallinckrodt LLC and Mallinckrodt Inc. (collectively, “Mallinckrodt”) own

various patents covering an extended release drug product containing the active ingredients
acetaminophen and oxycodone, which Mallinckrodt sells under the trade name XARTEMIS®
XR. This case arises out of the filing of ANDA NO. 207113 by Actavis Laboratories Fl., Inc.
(“Actavis”) with the U.S. Food and Drug Administration seeking approval to market a generic
version of XARTEMIS® XR.
Mallinckrodt filed an amended complaint on November 2, 2015 (D.E. 37), alleging that
by submitting the above-referenced ANDA, Actavis infringed 11 patents held by Mallinckrodt
and/or co-plaintiff Depomed. 1 On May 25, 2016, the parties stipulated to the dismissal of all
claims and counterclaims pertaining to 7 of the 11 above-mentioned patents (D.E. 66). In
anticipation of a Markman hearing, the parties submitted a Joint Claim Construction and

1 On June 22, 2016, the parties stipulated to the dismissal of all claims and counterclaims as to Depomed
(D.E. 71).

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Prehearing Statement (D.E. 64), along with opening and responsive Markman briefs (D.E. 72,
73, 79, 80), identifying disputed claim terms in the remaining patents-in-suit—patent numbers
8,658,631 (the “’631 Patent”), 8,741,885 (the “’885 Patent”), 8,992,975 (the “’975 Patent”), and
9,050,335 (the “’335 Patent”)—and setting forth proposed constructions.
II.

LEGAL STANDARD
A. Claim Construction
“[T]he construction of a patent, including terms of art within its claim, is exclusively

within the province of the court.” Markman v. Westview Instruments, Inc., 517 U.S. 370, 372
(1996). To interpret a claim, the Court first looks to “intrinsic evidence of record, i.e., the patent
itself, including the claims, the specification and, if in evidence, the prosecution history. Such
intrinsic evidence is the most significant source of the legally operative meaning of disputed
claim language.” Vitronics Corp. v. Conceptronics, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)
(internal citation omitted).
Thus, “[c]laim construction begins with the language of the claims themselves.”
Imaginal Systematic, LLC v. Leggett & Platt, Inc., 805 F.3d 1102, 1108 (Fed. Cir. 2015) (citing
Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1116 (Fed. Cir.
2004)). Words of a claim should be given their customary meaning – that is, “the meaning that
the term would have to a person of ordinary skill in the art at the time of the invention.” Id.
(citing Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005) (en banc)). A court
must read the claims “in view of the specification, of which they are a part.” Phillips, at 1315.
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.” Vitronics Corp. v.
Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). However, a court should “avoid

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importing limitations from the specification into the claims.” Phillips, 415 F.3d at 1323. Under
the doctrine of claim differentiation, a court should also endeavor not to read a limitation from a
dependent claim into an independent claim. Summit 6, LLC v. Samsung Electronics Co., Ltd.,
802 F.3d 1283, 1290 (Fed. Cir. 2015). A court may also look to the patent prosecution history to
help understand the claim language, but the history may not “‘enlarge, diminish, or vary’ the
limitations in the claims.” Markman, 52 F.3d at 980 (quoting Goodyear Dental Vulcanite Co. v.
Darvis, 102 U.S. 222, 227 (1880)).
Additionally, a court must adopt a term’s plain and ordinary meaning unless a patentee
“sets out a definition and acts as his own lexicographer,” or unequivocally “disavows” a certain
meaning in order to obtain the patent. Thorner v. Sony Computer Entm't Am. LLC, 669 F.3d
1362, 1365 (Fed.Cir.2012) (citation omitted); see also Omega Eng'g, Inc. v. Raytek Corp., 334
F.3d 1314, 1324 (Fed.Cir.2003). Absent lexicography or disavowal, courts “do not depart from
the plain meaning of the claims.” Luminara Worldwide, LLC v. Liown Elecs. Co., 814 F.3d
1343, 1353 (Fed.Cir.2016) (citation omitted). In other words, a patentee should ordinarily
receive the benefit of “the full scope of its plain language.” Home Diagnostics, Inc. v. LifeScan,
Inc., 381 F.3d 1352, 1358 (Fed.Cir.2004).
“Although courts are permitted to consider extrinsic evidence, like expert testimony,
dictionaries, and treatises, such evidence is generally of less significance than the intrinsic
record.” Summit 6, LLC, 802 F.3d at 1290 (citing Phillips, 415 F.3d at 1317). “Undue reliance
on external evidence poses the risk that it will be used to change the meaning of claims in
derogation of the [public record of intrinsic evidence], thereby undermining the public notice
function of patents.” (Phillips, 415 F.3d at 1319.) Accordingly, courts should only rely on
extrinsic evidence “when the claim language remains genuinely ambiguous after consideration of

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the intrinsic evidence.” Interactive Gift Exp., Inc. v. Compuserve Inc., 256 F.3d 1323, 1332
(Fed. Cir. 2001). “Extrinsic evidence may not be used ‘to contradict claim meaning that is
unambiguous in light of the intrinsic evidence.’” Summit 6, LLC, 802 F.3d at 1290 (quoting
Phillips, 415 F.3d at 1317).
In summary, the Court must first look to the language of the claim itself and determine
the terms’ meanings as they would be understood by a person of ordinary skill in the art
(“POSITA”). Philips, 415 F.3d at 1312-13. The Court may also look to the specification and
prosecution history. Id. at 1315, 1317. If the terms are still ambiguous, the Court may consult
extrinsic evidence such as dictionaries or expert testimony. Id. at 1317-18.
B. Indefiniteness
Section 112(b) of the Patent Act requires that “[t]he specification shall conclude with one
or more claims particularly pointing out and distinctly claiming the subject matter which the
inventor or a joint inventor regards as the invention.” 35 U.S.C. § 112(b). A claim is sufficiently
definite “[i]f one skilled in the art would understand the bounds of the claim when read in light
of the specification.” Exxon Research & Eng'g Co. v. United States, 265 F.3d 1371, 1375 (Fed.
Cir. 2001). “If the meaning of the claim is discernible, even though the task may be formidable
and the conclusion may be one over which reasonable persons will disagree, [courts] have held
the claim sufficiently clear to avoid invalidity on indefiniteness grounds.” Id.
A claim is indefinite when “an accused infringer shows by clear and convincing evidence
that a skilled artisan could not discern the boundaries of the claim based on the claim language,
the specification, and the prosecution history, as well as her knowledge of the relevant art area.”
Halliburton Energy Servs., Inc. v. M–I LLC, 514 F.3d 1244, 1249–50 (Fed. Cir. 2008).

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The “determination of claim indefiniteness is a legal conclusion that is drawn from the
court's performance of its duty as the construer of patent claims.” Exxon, 265 F.3d at 1376. The
Supreme Court has stated that “a patent is invalid for indefiniteness if its claims, read in light of
the specification delineating the patent, and the prosecution history, fail to inform, with
reasonable certainty, those skilled in the art about the scope of the invention.” Nautilus, Inc. v.
Biosig Instruments, Inc., 134 S.Ct. 2124 (2014).
III.

DISCUSSION
A. “AUC”

Claim Term
“AUC”

Mallinckrodt’s Construction
Actavis’s Construction
Plain and ordinary meaning. No
“Total exposure.”
construction necessary. In the
alternative, the term means “area
under the plasma concentration curve.”

The term “AUC” is recited in claims 1 and 22 of the ‘885 Patent and claims 8, 9, 10, and
18 of the ‘975 Patent. At oral argument, the parties agreed that “AUC” means “area under the
plasma concentration curve from time equals zero to infinity.” See Markman Hearing Tr., at p.
53:5–11. Accordingly, the Court adopts the parties’ agreed-upon construction of this claim term.
B. “in a fasted state”
Claim Term
“in a fasted state”

Mallinckrodt’s Construction
Plain and ordinary meaning. No
construction necessary.
In the alternative, the term means “in a
state following at least 10 hours
without food.”

Actavis’s Construction
“Not having ingested food for
at least 1 hour prior to
administration of each dose of
the composition.”

The term “in a fasted state” is recited in claims 1 and 22 of the ‘885 Patent and claim 1 of
the ‘335 Patent.
The specification for the ’885 Patent states in relevant part:

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A fasted state may be defined as not having ingested food for at least
10 hours prior to administration of the composition. In some
embodiments, the subject may have fasted for at least 10 hours prior
to the first dose and refrains from ingesting food for at least one hour
prior to administration of subsequent doses. In other embodiments,
the fasted subject may not have ingested food for at least 1 hour, 2
hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours,
or 10 hours prior to administration of each dose of the composition.
’885 Patent, col. 37, ll. 42–57 (emphasis added).
The specification for the ‘335 Patent states in relevant part:
In general, a fasted state is defined as not having ingested food for
at least 10 hours prior to administration of the composition. In some
embodiments, the pharmaceutical composition may be administered
to a subject who has fasted for at least 10 hours prior to the first dose
and who fasts for at least one hour prior to administration of
subsequent doses. In other embodiments, the pharmaceutical
composition may be administered to a subject who has fasted for at
least 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8
hours, 9 hours or 10 hours prior to administration of each dose.
‘335 Patent, col. 67, l. 63–col. 68, l. 14. (emphasis added).
Actavis argues that by virtue of the above language in the ’885 and ’335 Patents, the
patentees explicitly defined the “fasted state” as not having ingested food for anywhere between
at least one to ten hours before administration of each dose. Accordingly, Actavis asks the Court
to construe the claim term “fasted state” to mean “not having ingested food for at least 1 hour
prior to administration of each dose of the composition.” By contrast, Mallinckrodt argues that
the term “fasted state” has a plain and ordinary meaning that need not be construed. In the
alternative, Mallinckrodt argues that the ’885 and ’335 Patents expressly define the term as “not
having ingested food for at least 10 hours prior to administration of the composition.”
With respect to Mallinckrodt’s proposed alternative construction, Actavis counters that a
definition of “fasted state” that is marked by at least 10 hours of fasting would exclude
embodiments described in the specification where a “fasted subject” had not “ingested food for

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anywhere between at least one to ten hours before administration.” See Actavis Opening Br., at
p. 8. Actavis further argues that Mallinckrodt’s construction contradicts other disclosures in the
’885 and ’335 Patent specifications. For example, the patents describe a study where the
composition was administered “under fasted conditions (10 hours for the first dose on Days 1
and 5; at least 1 hour for all other doses.” ’885 Patent, col. 126, ll. 1–20; ’335 Patent, col. 97,
ll. 97–34 (emphasis added).
Mallinckrodt counters that although the specifications disclose embodiments where a
“fasted subject” has not ingested food for anywhere between at least one to ten hours before
administration of each dose, “nothing about the specification shows that the inventors intended to
include language regarding a ‘fasting subject’ in the original definition of ‘fasted state.’”
Mallinckrodt Resp. Br., at p. 9. In other words, Mallinckrodt argues, “a subject can fast for a
period of five hours, but not be ‘in a fasted state.’” Id. at 10. By contrast, Actavis argues that a
POSITA would understand the terms “the subject may have fasted,” the “fasted subject,” “fasted
condition,” and “fasted state” all refer to the same concept. See Actavis Resp. Br., at p. 5.
Where a patentee acts as its own lexicographer and assigns a specific definition to a term,
“the patentee’s lexicography must govern the claim construction analysis.” Braintree Labs., Inc.
v. Novel Labs., Inc., 749 F.3d 1349, 1356 (Fed. Cir. 2014). Consistent with the language in the
relevant specifications, the Court construes the phrase “fasted state” to mean “not having
ingested food for at least 10 hours prior to administration of the composition.” Although the
specifications disclose embodiments where the composition is administered to a “fasted subject”
or “a subject who has fasted” for less than 10 hours, nothing in the specifications suggests that a
“fasted subject” or “a subject who has fasted” is necessarily in a “fasted state.” Additionally,
although the patents describe a study where the composition was administered under “fasted

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conditions” of less than 10 hours, nothing in the specifications suggests that a subject who
ingests a dose under “fasted conditions” is necessarily in a “fasted state.” Thus, contrary to
Actavis’s proposed construction, the Court finds that a subject can fast for a period of less than
10 hours but not be in a “fasted state” as that term is used in the disputed claims terms, and for
that reason, construing “fasted state” to mean “not having ingested food for at least 10 hours
prior to administration of the composition” does not exclude any disclosed embodiments, as
Actavis suggests.
C. “in a fed state”
Claim Term
“in a fed state”

Mallinckrodt’s Construction
Plain and ordinary meaning. No
construction necessary.

Actavis’s Construction
“Having consumed food
within about 30 minutes prior
to administration of the
composition. The food may
be a high fat meal, a low fat
meal, a high calorie meal, or a
low calorie meal.”

The term “in a fed state” is recited in claims 1 and 22 of the ‘885 Patent and claim 16 of
the ‘335 Patent.
The specifications for the ‘885 Patent and ‘335 Patent both state in relevant part:
In general, a fed state is defined as having consumed food within
about 30 min prior to administration of the composition. The food
may be a high fat meal, a low fat meal, a high calorie meal, or a low
calorie meal.
‘885 Patent, col. 37, ll. 44–48; ‘335 Patent, col. 67, l. 65–col. 68, l. 1.
Actavis argues that the Court should adopt the above excerpt in its entirety as a definition
for the term “in a fed state.” See Actavis Opening Br., at p. 9. By contrast, Mallinckrodt argues
that the Court should afford the term its plain and ordinary meaning, which, according to
Mallinckrodt, the ‘885 and ‘335 Patents define as “having consumed food within about 30 min
prior to administration of the composition.” See Mallinckrodt Opening Br., at pp. 18–19. Thus,
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while the parties generally agree that a “fed state” is characterized by the consumption of food
within about 30 minutes prior to drug administration, the parties disagree on whether construction
of the phrase requires an explicit definition of the word “food.”
According to Actavis, “food with different fat and calorie content will affect the delivery
and absorption of a particular drug, and to evaluate fully the effect from food, a [POSITA] would
administer different types of food to subjects, each of whom is considered to be in a ‘fed state.’”
Actavis Resp. Br., at p. 8 (citing Lipman Decl., at ¶ 40). Thus, Actavis argues, “it is important to
specify, as the patentees did, the types of food suitable for such studies involving a particular drug.”
Id. (citing Lipman Resp. Decl., at ¶ 16). Mallinckrodt counters that to define the word “food” as
Actavis proposes would provide minimal guidance, since the proposed definition is only a partial
description of the types of food that a subject may consume (i.e. “[T]he food may be . . .”). See
Mallinckrodt Resp. Br., at p. 13. Mallinckrodt adds that “food” is a simple, non-technical word,
the meaning of which is readily apparent, even to laypersons. Id.
The Court adopts the first sentence of Actavis’s proposal and construes the term “in a fed
state” to mean “having consumed food within about 30 minutes prior to administration of the
compound.” There is no disagreement among the parties as to this portion of the term’s meaning.
However, the Court declines to further define the word “food” when construing this term. As
noted above, Actavis asks the Court to include in its construction of “in a fed state” language
indicating that “[t]he food may be a high fat meal, a low fat meal, a high calorie meal, or a low
calorie meal.” But, as Actavis’s own expert concedes, this is only a “partial description of the
types of food that a subject may consume.” See Lipman Dep. At 44:18–46:1. The Court finds that
incorporating a “partial description” of types of foods into the definition of “in a fed state[,]” as
Actavis proposes, would only give rise to ambiguity, not clarity.

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D. “wherein the composition is in the form of a tablet and a single dose comprises two
tablets”
Claim Term
Mallinckrodt’s Construction
“wherein the
Plain and ordinary meaning. No
composition is in the construction necessary. Definite.
form of a tablet and
a single dose
comprises two
tablets”

Actavis’s Construction
This term is indefinite
because it does not inform a
person of ordinary skill with
reasonable certainty of what
is claimed.

This phrase appears in claims 8 and 23 of the ‘335 Patent.
This term appears in dependent claims which, pursuant to 35 U.S.C. § 112(d), must
“contain a reference to a claim previously set forth and then specify a further limitation of the
subject matter claimed.” Accordingly, Actavis argues that:
[w]ithout first indicating in the claims from which claims 8 and 23
depend, what a “single dose” is or what it means in the independent
claims, there is no antecedent basis for “single dose,” and it is
improper to refer to, and further limit, this term in the dependent
claims.
Thus, Actavis concludes, the term is indefinite.
Pursuant to Section 2173.05(e) (“Lack of Antecedent Basis”) of the Manual of Patent
Examining Procedure (“MPEP”), published by the United States Patent and Trademark Office:
A claim is indefinite when it contains words or phrases whose
meaning is unclear. In re Packard, 751 F.3d 1307, 1314 (Fed. Cir.
2014). The lack of clarity could arise where a claim refers to “said
lever” or “the lever,” where the claim contains no earlier recitation
or limitation of a lever and where it would be unclear as to what
element the limitation was making reference. Similarly, if two
different levers are recited earlier in the claim, the recitation of “said
lever” in the same or subsequent claim would be unclear where it is
uncertain which of the two levers was intended. A claim which
refers to “said aluminum lever,” but recites only “a lever” earlier in
the claim, is indefinite because it is uncertain as to the lever to which
reference is made . . . .

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As an initial matter, the Court finds Actavis’s “antecedent basis” argument to be misplaced.
Consistent with § 2173.05(e) of the MPEP, an antecedent basis issue might potentially arise if
claims 8 and 23 referred to “said single dose” or “the single dose” in the absence of an earlier
recitation of the phrase. However, the dependent claims here simply refer to “a single dose” and
do not implicate an earlier use of the phrase “single dose” in the relevant independent claims.
Moreover, “the failure to provide explicit antecedent basis for terms does not always render
a claim indefinite. If the scope of a claim would be reasonably ascertainable by those skilled in
the art, then the claim is not indefinite.” See MPEP § 2173.05(e). Thus, the issue is not whether
the phrase “single dose” appears or is defined in the independent claims, but whether the meaning
of the disputed claim term as a whole would be reasonably ascertainable by a POSITA.
Although Actavis asserts that the concept of a “dose” is improperly introduced in a
dependent claim for the first time, Actavis does not actually argue that the meaning of the phrase
“single dose” is not reasonably clear. See Markman Hearing Tr., at 36:18–21 (Actavis’s counsel:
“our argument . . . is not that we don’t understand that a single dose comprises two tablet. It is
that there’s not a sufficient antecedent basis in the end of claim 1, for the term single dose”).
As explained above, the Court finds that Actavis’s “antecedent basis” argument is without
merit and, in any event, that the phrase “wherein the composition is in the form of a tablet and a
single dose comprises two tablets” has a plain and ordinary meaning that does not require
construction.
E. “wherein the bioavailability of the acetaminophen and the oxycodone or the
pharmaceutically acceptable salt thereof is not affected by the absence of food in a
subject’s gastrointestinal tract”
Claim Term
Mallinckrodt’s Construction
“wherein the
Plain and ordinary meaning. No
bioavailability of the construction necessary.
acetaminophen and
the oxycodone or the
11

Actavis’s Construction
“Wherein the rate and extent
of the absorption and
availability at the site of
action of the acetaminophen

pharmaceutically
acceptable salt
thereof is not
affected by the
absence of food in a
subject’s
gastrointestinal
tract”

In the alternative, “wherein the rate
and extent of the absorption and
availability at the site of action of the
acetaminophen and the oxycodone or
the pharmaceutically acceptable salt
thereof is not substantially affected by
the absence of food in a subject’s
gastrointestinal tract”

and the oxycodone or the
pharmaceutically acceptable
salt thereof is the same
regardless of whether the
subject is in a fed or a fasted
state”

This phrase is recited in claims 13 and 29 of the ‘885 Patent.
At the heart of the parties’ disagreement over this claim term is the phrase “not affected
by the absence of food in a subject’s gastrointestinal tract[,]” which Actavis ask the Court to
construe to mean “the same regardless of whether the subject is in a fed or fasted state.”
Specifically, Actavis argues that the patentees use of the phrase “not affected” in claims 13 and
29 of ’885 Patent indicates to a POSITA that “there is no difference in the pharmacokinetic
parameters recited in these claims—i.e. they are the same.” See Actavis Opening Br., at p. 11
(emphasis added). By contrast, Mallinckrodt argues that the clause “is not affected by the
absence of food in a subject’s gastrointestinal tract” means that “there is no substantial
difference between the bioavailability of acetaminophen and oxycodone when administered to a
subject in either a fed state or a fasted state,” which Mallinckrodt asserts is easily understood by
a POSITA. See Mallinckrodt Opening Br., at p. 24 (emphasis added). Mallinckrodt further
argues that Actavis’s proposed construction, which would require an identical absorption rate in
the fed and fasted states, is an impermissible attempt to narrow the claims. See id.
In support of its proposed alternative construction, Mallinckrodt highlights a section of
the specification entitled, “The Pharmacokinetic Profiles are not Affected by the Fed or Fasted
State of the Subject,” which Mallinckrodt argues provides objective guidance as to the meaning
of the phrase “not affected.” See Mallinckrodt Resp. Br., at p. 18 (emphasis added).
Specifically, that section of the specification states in relevant part:
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Because non-opioid GR dosage forms of the prior art, as well as
prior art extended release opioid formulation, demonstrate food
effects, Applicants expected to likewise see a food effect with the
pharmaceutical compositions of the present invention. Here,
however, Applicants have surprisingly discovered that the
pharmacokinetic profiles of the oxycodone and acetaminophen, and
the hydrocodone and acetaminophen, are not substantially affected
by the fed or fasted state of a human subject ingesting the
composition. This means that there is no substantial difference in
the quantity of drug absorbed or the rate of drug absorption when
the oxycodone/acetaminophen compositions are administered in the
fed versus the fasted state.
’885 Patent, at col. 90, ll. 45–55 (emphasis added).
The ’885 Patent’s specification further states:
[T]he pharmacokinetic parameters of the compositions of the
invention are similar when the composition is administered in the
fed and fasted states. Benefits of a dosage form, which substantially
eliminates the effect of food, include an increase in convenience,
thereby increasing patient compliance, as the patient does not need
to ensure that they are taking a dose either with or without food.
’885 Patent, at col. 90, ll. 62 – col. 91 l. 2 (emphasis added).
Finally, the same section of the specification describes an embodiment of the invention in
which the administration of the composition to a human subject in a fasted state is bioequivalent
to administration of the composition to a human subject in a fed state, and further defines the
conditions that are required in order to establish bioequivalence (i.e. “(1) a 90% Confidence
Interval (CI) for AUC which is between 80% and 125%, and (2) a 90% CI for Cmax, which is 80%
and 125%”). See ’885 Patent, at col. 91 ll. 4–16.
When interpreted in context of the above-referenced sections of the specification, the
Court construes the phrase “not affected” to mean “not substantially affected” and finds that, in
context of the specification, this disputed claim term is reasonably understood to mean that there
is “no substantial difference” in the composition’s bioavailability in the fed and fasted states,
thereby claiming a composition that “substantially eliminates the effect of food.” Vitronics
13

Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996) (the specification “is the single
best guide to the meaning of a disputed term”). Thus, the Court adopts Mallinckrodt’s
alternative proposed construction and construes this disputed claim term in full to mean “wherein
the rate and extent of the absorption and availability at the site of action of the acetaminophen
and the oxycodone or the pharmaceutically acceptable salt thereof is not substantially affected by
the absence of food in a subject’s gastrointestinal tract.”
F. “multiple doses”
Claim Term
“multiple doses”

Mallinckrodt’s Construction
Plain and ordinary meaning. No
construction necessary.

Actavis’s Construction
“More than one dose.”

The term “multiple doses” appears in claim 17 of the ‘631 Patent and claims 13, 16, and
17 of the ‘975 Patent. At oral argument, the parties came to an agreement that “multiple doses”
means “more than one dose.” See Markman Hearing Tr., at p. 53:14–18. Accordingly, the Court
adopts the parties’ agreed-upon construction of this claim term.
G. “oral administration of” and “orally administered to”
Claim Term
“oral administration
of a single dose of
the composition to a
subject”

Mallinckrodt’s Construction
Plain and ordinary meaning. No
construction necessary.

“oral administration
of multiple doses of
the composition to a
subject”
“oral administration
of the composition”
“wherein upon oral
administration of
two solid oral
14

Actavis’s Construction
This phrase appears in
connection with specifically
claimed pharmacokinetic
properties. Thus, the proper
construction of this language
requires that “oral
administration of” the
claimed composition to a
subject always results in the
claimed pharmacokinetic
properties, regardless of
whether the subject is in the
fed or fasted state.

dosage forms of the
composition in
multiple doses”
“wherein upon oral
administration of
two solid oral
dosage forms of the
composition”
“orally administered
to a subject in need
thereof”
The “oral administration of” term appears in claims 2 and 4 of the ‘631 Patent and claims
1, 8, 13, 16, 17, 23, and 30 of the ‘975 Patent. The “orally administered to” term appears in
claims 1 and 22 of the ‘885 Patent and claim 31 of the ‘335 Patent.
Each of the disputed “oral administration” terms appear in the context of administering
the claimed composition to a subject, who then exhibits specific pharmacokinetic properties.
Actavis argues that the absence of any reference to a specific food state (i.e. fasted or fed) in a
given “oral administration” term creates ambiguity as to whether the pharmacokinetic properties
exhibited by the claimed compositions must be met by a subject who is in the fed state, the fasted
state, either, or both. See Actavis Resp. Br., at p. 14. Accordingly, Actavis argues that where the
phrase “oral administration” is used and the food state of the subject is not specified, “this means
that the specifically claims parameters must be met when the subject is in both the fed and fasted
states.” Id. Thus, Actavis requests the court to construe these terms to mean that oral
administration of the claimed compositions to a subject “always results in the claimed
pharmacokinetic properties, regardless of whether the subject is in the fed or fasted state.” By
contrast, Mallinckrodt argues that the disputed “oral administration” terms have a plain and
ordinary meaning and that no construction is necessary.
15

Actavis offers two general arguments in support of its proposed construction. First,
Actavis argues that “[e]ven though the claim language itself does not specify a fed or fasted
state, the specifications demonstrate that the patentees knew how to specify an individual food
state when they intended to.” Actavis Moving Br., at p. 15. Thus, Actavis argues, “[b]y not so
specifying in the claims, the claims require both the fed and fasted food states.” Id.
The Court finds this first argument unavailing. By stating that the patentees knew how to
specify an individual food state when they intended to, Actavis is implicitly suggesting that
patentees’ lack of indication of a food state in the disputed “oral administration” terms was also
intentional. Accordingly, to construe these terms to mean that, once administered, the claimed
compositions “always result[] in the claimed pharmacokinetic properties, regardless of whether
the subject is in the fed or fasted state[,]” as Actavis requests, would be to import limitations into
the claims from the specifications absent a clear intention to do so. See Abbott Labs. v. Sandoz,
Inc., 566 F.3d 1282, 1288 (Fed. Cir. 2009) (“When consulting the specification to clarify the
meaning of the claim terms, courts must take care not to import limitations into the claims from
the specification”); Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 906 (Fed. Cir. 2004)
(“the claims of the patent will not be read restrictively unless the patentee has demonstrated a
clear intention to limit the claim scope using the words or expressions of manifest exclusion or
restriction”).
Second, Actavis argues that during the patent prosecution, inventor Dr. Ralph Healey
emphasized that the claimed composition can be administered “without regard to food.” Actavis
Moving Br., at p. 15. Thus, by claiming that the composition can be administered without regard
to food, Actavis argues that the patentees were indicating that “oral administration” of the
composition is not specific to one, but encompasses both, food states. With respect to this

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argument, the Court finds that Dr. Healey’s indication that the claimed composition can be
administered “without regard to food” is consistent with—not contradictory to—the absence of
any reference to food state in the disputed “oral administration” terms.
Accordingly, the Court finds that no construction is necessary for these terms.
H. “% by weight”; “% of the total amount”; “% of the amount of”
Claim Term
“% by weight”

Mallinckrodt’s Construction
Plain and ordinary meaning. No
construction necessary.

“% of the total amount
of [oxycodone or salt
thereof/acetaminophen”

Actavis’s Construction
This term is indefinite
because it does not inform a
person of ordinary skill with
reasonable certainty of what
is claimed.

“% of the [oxycodone
or salt
thereof/acetaminophen”
The term “% by weight” appears in claims 3 and 13 of the ‘631 Patent, the term “% of the
total amount” appears in claim 1 of the ‘631 Patent, and the term “% of the amount of” appears
in claim 6 of the ‘631 Patent.
When appearing in the ‘631 Patent, each of these terms is generally used in reference to
the amount of oxycodone or acetaminophen released from the composition, at various points in
time, in an in vitro dissolution test. Mallinckrodt argues that “[it] is clear from the language of
the claims that these terms provide straightforward quantitative values for the amount of
acetaminophen and oxycodone released from the tablets as the percentage of the total weight of
the pharmaceutical composition.” See Mallinckrodt’s Opening Br., at p. 38. By contrast,
Actavis argues that “the term ‘total amount’ could refer to the amount of drug as measured by
weight or concentration.” Actavis Resp. Br., at p. 20 (emphasis added). Thus, according to
Actavis, because “it is presumed that different words used in different claims result in a
difference in meaning and scope for each of the claims,” see Actavis Resp. Br., at p. 20 (citing
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Clearstream Waste Water Sys., Inc. v. Hydro-Action, Inc., 206 F.3d 1440, 1446 (Fed. Cir.
2000)), these disputed terms do not inform a POSITA with reasonable certainty of what is
claimed and are therefore indefinite.
Although the doctrine of claim differentiation creates a presumption that different words
in different claims have different meanings, the doctrine does not create a per se rule. See Tate
Access Floors, Inc. v. Maxcess Techs., Inc., 222 F.3d 958, 967–69 (Fed. Cir. 2000). Rather,
where inventors use terms interchangeably in the specification and the intrinsic evidence
demonstrates that the terms should have the same meaning, courts have held that the clear
intention of the inventors overrides the claim differentiation doctrine. Id. Thus, the question for
the Court is not whether the disputed terms as used could have different meanings—in this case,
“total amount” or “%” as measured by weight or concentration—but whether the meanings of
the disputed terms as used are not discernable. “If the meaning of the claim is discernible, even
though the task may be formidable and the conclusion may be one over which reasonable
persons will disagree, [courts] have held the claim sufficiently clear to avoid invalidity on
indefiniteness grounds.” Exxon Research & Eng'g Co. v. United States, 265 F.3d 1371, 1375
(Fed. Cir. 2001). Moreover, “the burden of proving indefiniteness remains on the party
challenging validity and . . . they must establish it by clear and convincing evidence.” Dow
Chem. Co. v. Nova Chemicals Corp. (Canada), 809 F.3d 1223, 1227 (Fed. Cir. 2015).
Mallinckrodt argues that the claims of the ‘631 Patent in which these disputed terms
appear provide “significant context and certainty” as to their meanings. Mallinckrodt Moving
Br., at p. 36. For example, claims 1 sets forth the “total amount” of acetaminophen and
oxycodone in the composition by weight in milligrams, “about 325 mg to about 650 mg” and
“about 7.5 mg to about 10 mg” respectively, and then further sets forth the percentage of the

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“total amount” of those compositions released during an in vitro dissolution test. Claim 6, which
depends on claim 1, similarly refers to the percentage of the compositions (which are set forth in
claim 1 by weight in milligrams) being released in an in vitro dissolution test. And claims 3 and
13 expressly refer to release of the compositions in an in vitro dissolution test in terms of total
amount “by weight.”
The Court finds that the intrinsic evidence and context in which the terms are used
support Mallinckrodt’s position that “% by weight”, “% of the amount of”, and “% of” refer to
the amount of acetaminophen and oxycodone released from the tablets as the percentage of the
total weight of the pharmaceutical composition. Each of the disputed claims terms either
expressly indicates that the percentage of composition being released in an in vitro dissolution
test is “by weight,” or appears in or depends upon a claim that expressly sets forth the “total
amount” of the compositions by weight in milligrams. Although the Court acknowledges
Actavis’s position that the “total amount” or “%” of composition released could theoretically be
measured in terms of concentration as opposed to weight, as the party challenging validity,
Actavis bears the burden of proving indefiniteness by clear and convincing evidence. In light of
the context in which the disputed terms are used, the Court finds that Actavis cannot meet its
burden and the terms are not indefinite.
IV.

CONCLUSION
For the foregoing reasons, the Court adopts the various constructions of the disputed

claim terms as set forth above. An appropriate order will be entered.
Dated: May 9, 2017

s/ Katharine S. Hayden___________
Katharine S. Hayden, U.S.D.J.

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