Takeda Pharmaceutical Company Limited et al v. Actavis Laboratories FL, Inc. et al

Filing 60

MEMORANDUM OPINION providing claim construction for multiple terms in U.S. Patent Nos. 7,462,626 and 8,916,195. Within five day the parties shall submit a proposed order consistent with this Memorandum Opinion. Signed by Judge Richard G. Andrews on 6/6/2016. (nms)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE

TAKEDA PHARMACEUTICAL COMP ANY
LIMITED, TAKEDA PHARMACEUTICALS
INTERNATIONAL GMBH, TAKEDA
PHARMACEUTICALS USA, INC., TAKEDA
PHARMACEUTICALS AMERICA, INC., and
OREXIGEN THERAPEUTICS, INC.,
Civil Action No. 15-451-RGA

Plaintiffs,
v.
ACTAVIS LABORATORIES FL, INC.,
Defendant.

MEMORANDUM OPINION

Mary B. Graham, Esq., Stephen J. Kraftschik, Esq., MORRIS, NICHOLS, ARSHT & TUNNELL
LLP, Wilmington, DE; William F. Cavanaugh, Esq. (argued), Chad J. Peterman, Esq. (argued),
Irena Royzman, Esq., Andrew D. Cohen, Esq., Zhiqiang Liu, Esq., PATTERSON BELKNAP
WEBB & TYLER.LLP, New York, NY.
Attorneys for Plaintiffs.
Melanie K. Sharp, Esq., RobertM. Vrana, Esq., YOUNG CONAWAY STARGATT & TAYLOR,
LLP, Wilmington, DE; Thomas J. Melaro, Esq., Michael W. Johnson, Esq. (argued), Dan
Constantinescu, Esq., WILLKIE FARR & GALLAGHER LLP, New York, NY.
Attorneys for Defendant.

June_f,_,2016

AND~~;~
Presently before the Court is the issue of claim construction of multiple terms in U.S.
Patent Nos. 7,462,626 ("the '626 patent") and 8,916,195 ("the '195 patent"). The Court has
considered the Parties' Joint Claim Construction Brief. (D.I. 49). The Court heard oral
argument on May 24, 2016. (D.I. 55).

I.

BACKGROUND
The present claim construction dispute arises from Hatch-Waxman litigation involving

Contrave extended-release tablets, which is Plaintiffs' medication for weight management in
overweight or obese adults. (D.I. 49 at p. 1). Although Plaintiffs are asserting four patents
against Defendant in the underlying action, the present claim construction dispute only concerns
the '626 and '195 patents. (Id. at p. 6). Broadly speaking, both the '626 and '195 patents claim
methods of treating obesity by administering some combination of two active ingredients,
naltrexone and bupropion, in order to cause weight loss. (See, e.g., '626 patent, claim 1; '195
patent, claim 1).

II.

LEGAL STANDARD
"It' 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. A WH Corp., 415 F.3d 1303, 1312
(Fed. Cir. 2005) (en bane) (internal quotation marks omitted). "'[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.'"
Soft View 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.

2

WestView Instruments, Inc., 52 F.3d 967, 977-80 (Fed. Cir. 1995) (en bane), 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 (internal quotation marks omitted).

"[T]he 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 (citations and internal quotation marks omitted). "[T]he ordinary meaning of a

claim term is its meaning to [an] ordinary artisan after reading the entire patent." Id. at 1321
(internal quotation marks omitted). "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.
When a court relies solely upon the intrinsic evidence-the patent claims, the
specification, and the prosecution history-the court's construction is a determination oflaw.
See Teva Pharm. 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 (internal quotation marks
omitted). 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.

3

"A 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) (citation and internal quotation marks omitted).

III.

CONSTRUCTION OF DISPUTED TERMS
A.

The '626 and '195 patents

"administering" 1

1.

a.

Plaintif.fe 'proposed construction: "Delivering, or directing the delivery, into the
body"

b.

Defendant's proposed construction: "Delivering into the body"

c.

Court's construction: "Delivering into the body"

The crux of the Parties' dispute here is straightforward: Defendant seeks to limit the term
"administering" to the actual act of delivering the drug into the patient's body, while Plaintiffs
want the term construed to include the act of a physician prescribing or otherwise directing a
patient to take the drug. (D.I. 49 at p. 8). Plaintiffs argue that their construction reflects the
ordinary meaning of "administering" in the context of prescription drugs and is supported by the
intrinsic record. (Id.). Specifically, Plaintiffs contend that the specifications and claims of the
two patents are written with the perspective of the healthcare provider in mind, because they are
method of treatment claims and some of the claims contemplate a "diagnosing" step. (Id. at pp.
9-10). Plaintiffs also assert that the specifications primarily contemplate oral administration,

1

The Parties' Joint Claim Construction Brief treats the term "administering" the same as used in both the '626
and '195 patents, even though they come from different patent families. (D.I. 49 at pp. 8-35). Likewise, at oral
argument, the Parties told the Court that the term was used consistently in the '626 and '19 5 patents and did not need
to be construed separately as to each patent. (D.I. 55 at 5, Tr. pp. 19-20). I agree with the Parties and will construe
the term accordingly.

4

which typically does not require a physical act from the physician. (Id. at p. 10). Lastly,
Plaintiffs maintain that extrinsic evidence, including dictionary definitions and case law,
demonstrates that their construction is consistent with the plain and ordinary meaning of the term
in the prescription drug context. (Id. at pp. 10-13).
Defendant argues that the specifications only refer to administering as being the specific
act of delivering the drug into the body and distinguish between such delivery and a physician's
prescribing activity. (Id. at pp. 14-17). For instance, Defendant points out that the specification
of the '626 patent describes "multiple techniques of administering a compound," all of which are
physical acts of delivering the compound into the body. (Id. at p. 16). Thus, Defendant asserts,
"Plaintiffs have identified no examples from the intrinsic records where 'administering' is used
to refer to activities such as prescribing, providing, managing, or supervising," all of which
Plaintiffs contend should be encompassed by the term. (Id. at p. 31 ). Defendant also points to
the' 195 patent specification's discussion of various resulting effects caused by a compound that
are described in terms of specific time intervals after "administration," which would not make
sense in relation to when a physician merely told a patient to ingest the compound. (Id. at p. 17).
Moreover, Defendant contends that Plaintiffs' record citations for the proposition that the patents
discuss the perspective of a physician say nothing about the perspective of the healthcare
provider with respect to the specific act of administering. (Id. at p. 18, 31 ). Finally, Defendant
argues that extrinsic evidence is unnecessary in light of the clear intrinsic record, but that, to the
extent the Court deems it necessary, Plaintiffs' proposed dictionary definition only provides
equivocal support for Plaintiffs' position. (Id. at pp. 20-25).
The Court will adopt Defendant's proposed construction.· I acknowledge that courts have
come to differing conclusions when considering whether the term "administer" extends to the

5

verbal directives or management activities of physicians in the medical treatment context. 2
However, these decisions construe the term in the context of different claims and specifications.
The use of administering in the specific claims and specifications of the '626 and '195 patents
adequately guides the inquiry presently before me. See Phillips, 415 F.3d at 1315 ("Usually, [the
specification] is dispositive; it is the single best guide to the meaning of a disputed term."
(internal quotation marks omitted)).
The specifications of both the '626 and '195 patents consistently refer to the term
"administering" solely to describe the physical act of delivering the drug into or onto the body.

(See, e.g., '626 patent, col. 23, 11. 47--49 ("Multiple techniques of administering a compound
exist in the art including, but not limited to, oral, injection, aerosol, parenteral, and topical
administration."); '195 patent, col. 11, 11. 30-31 ("The oral dosage form may be distributed,
provided to a patient for self-administration or administered to a patient.")). Plaintiffs have not
pointed to a single portion of either specification where some form of the word administer refers
to the verbal directives or treatment management activities of physicians. Indeed, those types of
activities, "distribut[ing], [and] provid[ing] to a patient for self-administration," are referred to
separately and apart from the term administer. (' 195 patent, col. 11, 11. 30-31 ). Moreover, many
of the references to administration in both specifications would simply not make sense if
administering were construed to also include directing the delivery into the body, as Plaintiffs

2
Compare Janssen Prods. L.P. v. Lupin Ltd., 2013 U.S. Dist. LEXIS 189016, at *36-38 (D.N.J. Oct. 9, 2013)
(construing "administering" such as to "recognize and encompass 'the activities of doctors and other medical
professionals who are involved in prescribing the claimed compounds or otherwise supervising [] care ... ."'),and
!ovate Health Scis., Inc. v. Bio-Engineered Supplements & Nutrition, Inc., 2008 WL 2359961, at *2-3 (E.D. Tex. June
5, 2008) (construing "administering/administered" to mean "delivering into a body, or the management or supervision
of the process whereby something is delivered into a body"), with AstraZeneca AB v. Hanmi USA, Inc., 2012 WL
6203602, at *4-6 (D.N.J. Dec. 12, 2012) (rejecting argument that "administration" should include '"the prescription
by a physician or other licensed healthcare professional, dispensing and ingestion"'), and Med. Research Inst. v. BioEngineered Supplements & Nutrition,. Inc., 2007 WL 128937, at *7 (E.D. Tex. Jan. 12, 2007) (construing
"administer/administration" to mean "delivering the formulation-in-question into a person's body").

6

propose. (See, e.g., '626 patent, col. 24, 11. 55-57 ("[O]ne may administer the compound in a
local rather than systemic manner, for example, via injection of the compound directly in the
renal or cardiac area .... "); '195 patent, col. 6, 11. 23-27 (observing that "immediate release"
includes "release of a drug from a dosage form in a relatively brief period of time after
administration"); id. col. 11, 1. 31 ("self-administration"); id. col. 12, 11. 34-36 ("The sustainedrelease dosage forms described herein may be administered one, two or more times per da~,
without or without a loading dose.")).
Defendant's proposed construction is also consistent with the language of the claims
themselves. (See, e.g., '195 patent, claim 11 ("orally administering daily about 32 mg of
naltrexone and about 360 mg ofbupropion .... ")). Being proceeded by the modifier "orally"
highlights the fact that administering, as used in claim 11 of the '195 patent, refers to the
physical means of delivering the medication into the patient's body. Accord AstraZeneca AB v.
Hanmi USA, Inc., 2012 WL 6203602, at *5 (D.N.J. Dec. 12, 2012). Plaintiffs' broad assertion
that the claims at issue inherently include the perspective of physicians because they sometimes
involve a diagnosing step is unconvincing, as it does not change the fact that administering is
only used with regard to the physical act of taking or receiving treatment. In fact, the '626
patent's disclosure that a prescribing physician can choose the "route of administration and
dosage" and "the manner of administration," reinforces the fact that administration in the context
of the patent refers to delivering the drug into the body, not the prescribing and distributing
activities of a physician which are separately referred to. ('626 patent col. 27, 11. 29-32; id. col.
28, 11. 21-25). Because the intrinsic evidence here-the claims themselves and the
specifications-provides consistent, clear guidance for how administration is used in the context
of the patents, I need not consider extrinsic evidence. See, e.g., Storage Tech. Corp. v. Cisco

7

Systems, Inc., 329 F.3d 823, 832 (Fed. Cir. 2003) ("Resort to extrinsic evidence is appropriate

only when an ambiguity remains after consulting the intrinsic evidence ofrecord."). 3
Ultimately, I conclude that Defendant's proposed construction comports with the literal
language of the claims and the use of the term throughout the specification, while Plaintiffs
stretch the term beyond the scope contemplated by the '626 and '195 patents. Accordingly, I
will construe "administering" to mean "delivering into the body."4
2.

"a weight loss effective amount of a first and second compound" ('626 patent only)
a.

Plaintiffa 'proposed construction: "A weight loss effective amount of a first and
second compound, in combination."

b.

Defendant's proposed construction: "A weight loss effective amount of a first
compound and a weight loss effective amount of a second compound."

3

In any event, the extrinsic evidence Plaintiffs submit is unpersuasive and would not change my conclusion.
Plaintiffs attempt to establish the plain and ordinary meaning of administer by pinpointing one of the definitions of
administer from a 1994 edition ofMERRIAMWEBSTER'S COLLEGIATE DICTIONARY. It is not an art-specific dictionary,
and defines "administer" in numerous ways. (D.I. 49-1at76-79). The Federal Circuit has stated:
By design, general dictionaries collect the definitions of a term as used not only in a particular art
field, but in many different settings. In such circumstances, it is inevitable that the multiple
dictionary definitions for a term will extend beyond the construction of the patent [that] is confirmed
by the avowed understanding of the patentee, expressed by him, or on his behalf, when his
application for the original patent was pending.
Phillips, 415 F.3d at 1321-22 (alteration in original) (internal quotation marks omitted). Plaintiffs merely cherry pick
the most advantageous definition, out of numerous possibilities, for their current position: "to manage or supervise
the execution, use, or conduct of<- a trust fund>." (D.I. 49-1 at 79). However, another definition on the same page
refers specifically to medicine and fits more closely with the use of administering throughout the specifications here:
"to give remedially<- a dose of medicine>." (Id.). Accordingly, Plaintiffs' extrinsic evidence does not persuasively
establish the ordinary and customary meaning of the term in the relevant art.
4
My understanding from the Markman hearing is that Defendant may pursue non-infringement arguments based
upon a theory of divided infringement, because a physician often may not ultimately administer the compound under
this construction. (D.I. 55 at 5-6, Tr. pp. 20-23). Although the issue is not presently before the Court, I am dubious
as to whether Defendant's pursuit of such an argument will be successful in light of the Federal Circuit's en bane
decision inAkamai Techs., Inc. v. Limelight Networks, Inc., 797 F.3d 1020, 1022 (Fed. Cir. 2015) (en bane) ("We will
hold an entity responsible for others' performance of method steps ... where that entity directs or controls others'
performance ... .");see also Eli Lilly & Co. v. Teva Parenteral Meds., Inc., 126 F. Supp. 3d 1037, 1042-43 (S.D.
Ind. 2015) ("The physician, based upon the patented method, directs the manner and timing of the patient's
ingestion . . . . [Plaintiff] has shown, by a preponderance of the evidence that, in accordance with Defendants'
proposed labeling, the physician directs or controls the patient's administration of folic acid such that performance of
all the claimed steps, including the administration offolic acid, can be attributed to a single person, i.e. the physician."),
appeal docketed, No. 15-2067 (Fed. Cir. Sept. 25, 2015). However, that is properly a question for another day and
should not affect how this claim construction dispute is decided. Plaintiffs reach too far in an attempt to obviate the
need for such a later inquiry.

8

c.

Court's construction: "A weight loss effective amount of a first and second
compound, in combination."

This term only appears in claim 25 of the '626 patent, which reads as follows:
A method of treating overweight or obesity, comprising administering a weight loss
effective amount of a first and second compound to an individual who has been
diagnosed as suffering from overweight or obesity in order to treat said overweight
or obesity, wherein said first compound is bupropion, or a pharmaceutically
acceptable salt thereof, and said second compound is naltrexone, or a
pharmaceutically acceptable salt thereof, and wherein the weight loss activity of
said first and second compounds is enhanced compared to the administration of the
same amount of either compound alone.
('626 patent, claim 25 (emphasis added)). Plaintiffs argue, "The disputed term refers to the
combination of the first (bupropion) and second (naltrexone) compound being administered in a
weight loss effective amount, and not each of the compounds being present individually in a
weight loss effective amount." (D.I. 49 at p. 36). Plaintiffs further contend that the
specification's "repeated and consistent reference to the combination of naltrexone and
bupropion as affecting weight loss rather than the individual compounds affecting weight loss
supports [their] construction." (Id. at p. 37).
Defendant asserts that the use of the plural "compounds" in the latter portion of claim 25
"shows that when the applicants wanted to refer to the weight loss activity of the first compound
and second compound, in combination, they used the plural form 'compounds."' (Id. at pp. 3738). Moreover, Defendant contends that because "this limitation indicates that the weight loss
activity of the 'compounds'-i.e., in combination-is enhanced compared to the weight loss of
activity of each compound alone, [it] indicates that each compound alone also has weight loss
activity." (Id. at p. 38). Defendant further argues that the specification of the '626 patent
describes bupropion and naltrexone as each individually having weight loss effects. (Id. at pp.

38-39). Defendant also points to "the results from the study reported in example 8 disclosed in

9

the specification [as] demonstrat[ing] that bupropion and naltrexone reduced food intake in rats
when administered alone." (Id.). Lastly, Defendant maintains, "Plaintiffs assertion that the
specification refers to the alleged invention as the combination of two compounds does not
preclude the individual compounds in the combination from being present in a weight loss
effective amount." (Id. at p. 41).
Plaintiffs respond by arguing that "the term 'amount' is singular, and refers to a single
weight loss amount of what follows, not multiple weight loss effective amounts." (Id. at p. 42).
Indeed, Plaintiffs contend, "[i]f the patentees intended for each compound to be present in a
weight loss effective amount, then the claim would have been drafted in the plural to read
'weight loss effective amounts of a first and second compound."' (Id. at pp. 42-43). Plaintiffs
also argue that because the wherein clause of claim 25 only discusses enhanced "weight loss
activity," as opposed to a "weight loss effective amount," there is no requirement in claim 25 that
each individual compound have a non-zero weight loss activity. (Id. at p. 43). Moreover,
Plaintiffs point to portions of the prosecution history where the patentee "(1) expressly state[ d]
that naltrexone is not an effective weight loss drug in humans and (2) disclosed[ d] a clinical
study of humans which shows that naltrexone is not an effective weight loss drug alone." (Id. at
pp. 44-45 (citing D.I. 49-1 at 112)). Plaintiffs also note that they did their own clinical studies
on humans, which demonstrated that naltrexone alone was less effective than a placebo, as
demonstrated by the number of individuals losing 5% or more of their body weight. (Id. at p. 45
(citing D.I. 49-1 at 118-19)).
The Court will adopt Plaintiffs' construction. First, I think that as a matter of
straightforward grammatical construction claim 25 refers to a singular "amount," i.e., the
combination. The combination is composed of two compounds, "a first and second compound."

10

The adjective "weight loss effective" modifies the singular noun "amount," and does not
separately modify each component compound that makes up the amount. Second, this
straightforward reading of claim 25 finds ample support in the specification of the '626 patent.
The specification consistently focuses on the fact that a specific composition causes weight loss,
the composition being a combination of two or more compounds. (See, e.g., '626 patent, col. 3,
11. 33-34 ("The present invention provides a multi-faceted combination therapy approach to the
problem of weight loss."); id. col. 8, 11. 33-35 ("[A]n individual is given a pharmaceutical
composition comprising a combination of two or more compounds to affect weight loss.")). In
fact, a full reading of the '626 patent makes clear that the invention itself is a method of treating
obesity with the combination of naltrexone and bupropion, because they have a synergistic effect
when used in combination. (See, e.g., '626 patent col. 3, 11. 44-47 ("The present inventors have
discovered that a combination of two or more of the compounds disclosed herein results in a
synergistic effect that affects weight loss more quickly and on a more permanent basis.")).
Third, even assuming arguendo that the specification clearly disclosed that naltrexone
alone can serve as an effective weight loss agent, 5 it would not change the result. Defendant's

5

Defendant's case for this point is, at best, only an implication that can be drawn from the specification, and, at
worst, inconsistent with other more explicit aspects of the intrinsic record. Defendant relies on the following passage
to suggest that the specification clearly contemplates each compound being individually present in a weight loss
effective amount: "[A] combination of two or more of the compounds disclosed herein results in a synergistic effect
that affects weight loss more quickly and on a more permanent basis." (D.I. 49 at p. 38 (citing '626 patent, col. 3, 11.
44--47)). Defendant suggests that this "passage clearly compares the weight loss effect of the combination of the two
compounds with the effect of each compound alone." (Id.). While that implication can be drawn, the passage does
not actually address the purported weight loss effects of either compound alone. Defendant's reliance on the study
from example 8 in the specification, which shows that naltrexone alone reduced food intake in mice, is likewise thin
evidence that naltrexone alone is an effective weight loss compound for humans. On the other hand, these intrinsic
references are directly contradicted by disclosures of clinical studies made by the patentee during prosecution, which
directly state that naltrexone alone is not an effective weight loss agent in humans. (See, e.g., D.I. 49-1 at 112 (''Despite
some early evidence in animal models that naltrexone could cause weight loss, clinical studies indicate that it is a poor
weight-loss drug in humans."); id. at 118-19 (reporting clinical trial results where only 15% of users of naltrexone
alone lost at least 5% of their body weight, while 20% of the placebo group lost more than 5% of their body weight")).
At best, the intrinsic evidence Defendant cites implies that naltrexone or bupropion alone can theoretically cause
weight loss. These portions of the intrinsic record, contradicted by more explicit intrinsic evidence stating that
naltrexone alone is not an effective weight loss agent in humans, provide a rather thin basis to conclude that naltrexone

11

argument that the specification "does not preclude the individual compounds in the combination
from being present in a weight loss effective amount" misses the mark. (D.I. 49 at p. 41). The
point is that nothing in the specification requfres each compound to be present individually in a
weight .loss effective amount. Defendant's entire argument rests on the faulty premise that if a
compound alone can cause weight loss, any amount of the compound will automatically be "a
weight loss effective amount." Yet even ifnaltrexone and bupropion alone can cause some
"weight loss activity," it does not automatically follow that the patent requires each compound to
be present individually in "weight loss effective amounts." All that claim 25 requires, read in
light of the specification, is that the combination ofnaltrexone and bupropion be present in a
weight loss effective amount.
Accordingly, I construe the term "a weight loss effective amount of a first and second
compound" to mean "a weight loss effective amount of a first and second compound, in
combination."
3.

"having reduced adverse effects" ('915 patent only).
a.

Plaintiffs' proposed construction: The proposed phrase from the preamble is not
limiting.

b.

Defendant's proposed construction: The proposed phrase from the preamble is
limiting.

c.

Court's construction: The proposed phrase from the preamble is not limiting.

The sole dispute with regard to this term arises from claim 11 of the '195 patent.
Specifically, the parties dispute whether "having reduced adverse effects," which appears in the
preamble of claim 11, should be construed as a limitation. 6 Claim 11 reads as follows:

alone can be used in weight loss effective amounts. In any event, these portions of the specification do not come close
to affirmatively requiring that each compound individually be present in a weight loss effective amount.
6
The preamble of claim 1 also contains the language, "having reduced adverse effects." (' 195 patent, claim 1).
In claim 1, however, the preamble is augmented by an express limitation in the body of the claim, which does not

12

A method of treating overweight or obesity having reduced adverse effects
comprising orally administering daily about 32 mg of naltrexone and about 360 mg
of bupropion, or pharmaceutically acceptable salts thereof, to a person in need
thereof, wherein the bupropion or pharmaceutically acceptable salt thereof is
administered as a sustained-release formulation, wherein the naltrexone or
pharmaceutically acceptable salt thereof is administered as a sustained-release
formulation, and wherein said sustained-release formulation of naltrexone has an in
vitro naltrexone dissolution profile in a dissolution test of USP Apparatus 2 Paddle
Method at 100 rpm in a dissolution medium of water at 37° C of:
a) between 39% and 70% of naltrexone released in one hour;
b) between 62% and 90% of naltrexone released in two hours; and
c) at least 99% in 8 hours;
wherein about 16 mg of said sustained-release formulation of naltrexone or a
pharmaceutically acceptable salt thereof is administered twice daily, and about 180
mg of said sustained-release formulation of bupropion or a pharmaceutically
acceptable salt thereof is administered twice daily.
(' 195 patent, claim 11 ).
"Whether to treat a preamble term as a claim limitation is determined on the facts of
each case in light of the claim as a whole and the invention described in the patent." Am. Med.
Sys., Inc. v. Biolitec, Inc., 618 F.3d 1354, 1358 (Fed. Cir. 2010) (internal quotation marks

omitted). "Generally, the preamble does not limit the claims." Allen Eng'g Corp. v. Bartell
Indus., Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). "[A] preamble limits the invention if it

recites essential structure or steps, or if it is necessary to give life, meaning, and vitality to the
claim." CatalinaMktg. Int'!, Inc. v. Coo/savings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002)
(internal quotation marks omitted). "Conversely, a preamble is not limiting where a patentee

appear in claim 11: "whereby at least one adverse effect ... is reduced." (Id.). Plaintiffs appear to concede that the
preamble is limiting in claim 1, "because the preamble reflects express limitations found later in the body of the
claim .... " (D.I. 49 at p. 49). While of little practical significance to this case, I think that the preambles in both
claim 1 and claim 11 are not limiting, because, as discussed more fully below, they merely state the intended purpose
or result of the claimed method. The reduction of at least one adverse effect is still a material limitation in claim 1,
but only because it is expressly included as a limitation in the body of the claim. See, e.g., Storage Tech. C01p. v.
Cisco Sys., Inc., 329 F.3d 823, 830-31 (Fed. Cir. 2003) (holding that district court erred by limiting the scope of a
claim based on language in the preamble where any claim in the patent that actually required what was set forth in the
preamble also included "an explicit ... limitation in the body of the claim" saying so).

13

defines a structurally complete invention in the claim body and uses the preamble only to state a
purpose or intended use for the invention." Id. (internal quotation marks omitted).
''No litmus test defines when a preamble limits claim scope. Some guideposts, however,
have emerged from various cases discussing the preamble's effect on claim scope." Id. (citation
omitted). For instance, "when reciting additional structure or steps underscored as important by
the specification, the preamble may operate as a claim limitation." Id. "Moreover, clear reliance
on the preamble during prosecution to distinguish the claimed invention from the prior art
transforms the preamble into a claim limitation because such reliance indicates use of the
preamble to define, in part, the claimed invention." Id. "Without such reliance, however, a
preamble generally is not limiting when the claim body describes a structurally complete
. invention such that deletion of the preamble phrase does not affect the structure or steps of the
claimed invention." Id. at 809. "Thus, preamble language merely extolling benefits or features
of the claimed invention does not limit the claim scope without clear reliance on those benefits or
features as patentably significant." Id. In method claims, statements of intended result or
purpose in a preamble are generally not considered to be claim limitations where the "method
[is] performed in the same way regardless whether or not the [intended result actually
ensues] .... " Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1375 (Fed.
Cir. 2001).
Plaintiffs argue that the preamble in claim 11 is "merely a statement of the asserted
benefits of the invention" and that "the steps of the method are performed the same regardless
whether the patient experiences reduced adverse effects." (D.I. 49 at p. 48). Plaintiffs also
contrast claim 11 with claim 1, which has the same preamble but also expressly includes a
limitation in the body of the claim requiring that at least one adverse effect be reduced. (Id. at p.

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49). Thus, according to Plaintiffs, claim 11 reflects a deliberate choice not to require reduced
adverse effects as a claim limitation. (Id.). Defendant argues that the preamble must be
construed as a limitation "because it is clear from the specification and the prosecution history
that [having reduced adverse affects] is an integral part of the alleged invention and material to
the patentability of the claim." (Id.). Specifically, Defendant contends that the specification of
the '195 patent "repeatedly discloses embodiments of the invention having one or more reduced
adverse effects." (Id. at p. 50). Defendant also asserts that during prosecution the patentee
repeatedly tried to distinguish the prior art in order to overcome the examiner's obviousness
rejections by arguing that its specific dosage method for co-administering naltrexone and
bupropion led to the unexpected result of having reduced adverse effects, which was not
previously disclosed by the prior art. (Id. at pp. 50-53 (citing D.I. 49-1 at 134-36)).
Plaintiffs respond by pointing out that the prosecution history statements Defendant relies
on occurred before claim 11 (formerly claim 79 of the '773 application) was introduced by a
later amendment. (D.I. 49 at p. 58). Instead, Plaintiffs argue that, as to claim 11 in particular,
the patentee relied on the specified dissolution profile in order to overcome the examiner's
obviousness objection. (Id.). According to Plaintiffs, the patentee only generally referenced that
it "previously provided arguments regarding unexpected results" and "argued generally that the
Patent Office's discounting of those results was improper." (Id.).
The Court concludes that the proposed phrase from the preamble is not limiting. Claim

11 of the '195 patent sets forth a detailed method, which provides specific dosages of both
naltrexone and bupropion, designates that each compound should be in a sustained-release
formulation, and provides a specific dissolution profile for the naltrexone. (' 195 patent, claim

11 ). Claim 11 describes all the steps required to completely and adequately carry out the

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invented method and the language "having reduced adverse effects" in the preamble is merely a
statement of the intended result of the method of treatment. See Catalina Mktg., 289 F.3d at 808.
Although the intended result of the method is ''underscored as important by the specification,"
the preamble is not limiting because it does not "recit[ e] additional structure or steps," but
instead "merely extoll[s] benefits or features of the claimed invention." 7 Id.
In Bristol-Myers, the Federal Circuit considered similar arguments that the preambles of
various method of treatment claims should be construed as limiting. See Bristol-Myers Squibb

Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1374-76 (Fed. Cir. 2001). The Federal Circuit
emphasized that the asserted preamble phrases merely expressed a purpose or intended result of
the specific method steps outlined in the body of the claims. See id. For instance, with regard to
the preamble phrase "an antineoplastically effective amount," the court concluded:
That expression of intended result essentially duplicates the dosage amounts recited
in the claims that are also described in the specification as "antineoplastically
effective." '803 patent, col. 5, 11. 4~4 ("It has also been surprisingly discovered
that lower taxol dosages ... [can] still be antineoplastically effective."). The
express dosage amounts are material claim 'limitations; the statement of the
intended result of administering those amounts does not change those amounts or
otherwise limit the claim.

Id. at 1375 (emphasis added); see also id. at 1376 (concluding that preamble phrase "for treating
a cancer patient to effect regression of a taxol-sensitive tumor, said method being associated with

reduced hematologic toxiciry" was "only a statement of purpose and intended result" and did
"not result in a manipulative difference in the steps of the claim." (emphasis added)). The
preamble phrase at issue here, "having reduced adverse effects," likewise only describes the

7

This point is further underscored by juxtaposing claim 11 with claim 1. Claim 1, despite having a preamble
identical to that of claim 11, includes an express limitation in the body of the claim requiring the reduction of at least
one adverse effect. ('195 patent, claim 1 ("whereby at least one adverse effect ... is reduced.")). Claim 1 demonstrates
that the patentee knew how to make "reduced adverse effects" an express claim limitation, but deliberately chose not
to in drafting claim 11. That choice should be given meaning. See Phillips, 415 F.3d at 1314.

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intended result of administering the specific dosage amounts laid out in the body of claim 11 and
does not result in a manipulative difference in the steps of the claim. Thus, as in Bristol-Myers,
entirely deleting this language from the preamble of claim 11 would not change the way the
method of claim 11 is performed in any way. In other words, the "method [is] performed in the
same way regardless whether or not the [intended result actually ensues] .... " Bristol-Myers,
246 F.3d at 1375.
Lastly, Defendant's argument based on statements the patentee made during prosecution
is unconvincing. The patentee's statements during prosecution regarding unexpected results
("having reduced adverse effects") that Defendant cites began well before claim 11 ever existed:
the prosecution statements were first made on February 2, 2011, while the amendment that added
claim 11 (then claim 79 of the '773 application) was introduced on December 2, 2013. (D.I. 491 at 134-37; D.I. 49-2 at 5-6, 15). On May 21, 2014, in response to an obviousness rejection of
then claim 79, the patentee argued that the prior art failed to disclose any specific formulations of
naltrexone falling within the claimed dissolution profile specified in claims 59 and 79. (D.I. 49-2
at 40-41). In addition, referencing twenty-one different claims that had been rejected on
obviousness grounds, the patentee also broadly reiterated its continuing objection to the
examiner's rejection of these claims for what it perceived as the examiner's failure to take into
account the unexpected results of reduced adverse effects. (Id. at 41-44). Indeed, the
prosecution history reveals that the patentee broadly objected to the examiner's purported failure
to take into account unexpected results at all stages of the prosecution, both before and after the
introduction of then claim 79, but the patentee never argued that reduced adverse effects were a
differentiating factor unique to then claim 79. (D.I. 49-1 at 134-36; D.I. 49-2 at 12-14, 41-44).
The patentee's broad, consistent references to the entire' 195 patent's unexpected results during

17

prosecution do not provide adequate grounds to conclude that it relied upon the preamble of
claim 11 to overcome the examiner's specific rejection of claim 11. 8
Accordingly, I conclude that the phrase "having reduced adverse effects" in the preamble
of claim 11 is not limiting.

IV.

CONCLUSION
Within five days the parties shall submit a proposed order consistent with this

Memorandum Opinion.

8

In any event, I think there is a fundamental difference between arguing that a preamble of a specific claim
renders that claim not anticipated by a prior art reference and touting the unexpected results of all claimed methods as
a secondary consideration of nonobviousness during prosecution. Where a patentee relies on a preamble during
prosecution essentially as an extra element allowing that specific claim to avoid anticipation, it makes sense that the
preamble should be treated as a claim limitation, "because such reliance indicates use of the preamble to define, in
part, the claimed invention." Catalina Mktg., 289 F .3d at 808. While unexpected results are a secondary consideration
of nonobviousness, they do not define the claimed invention in any real respect-they merely state one of the intended
results or purposes of the claimed invention. Cf Genetics Inst., LLC v. Novartis Vaccines and Diagnostics, Inc., 655
F.3d 1291, 1307-08 (Fed. Cir. 2011) (treating unexpected results as a secondary consideration ofnonobviousness and
observing that "evidence of unexpected results may be used to rebut a case of prima facie obviousness even if that
evidence was obtained after the patent's filing or issue date."). Accordingly, even ifthe patentee specifically relied
on unexpected results with regard to claim 11-which I do not think it did here-I would be hesitant to conclude that
such reliance should render claim 11 's preamble limiting.

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