ADAPT PHARMA OPERATIONS LIMITED et al v. TEVA PHARMACEUTICALS USA, INC. et al

Filing 200

OPINION. Signed by Chief Judge Jose L. Linares on 4/22/2019. (sms)

NOT FOR PUBLICATION
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY

ADAPT PHARMA OPERATIONS LIMITED, Civil Action Nos.: 16-7721, 17-2877, 17-864,
17-5 100, 18-9880 (JLL)

eta!.,

Plaintiffs,

OPINION

V.

TEVA PHARMACEUTICALS USA. INC., et
a!.,
Defendants.

LINARES, Chief District Judge,

This matter comes before the Court by way of an application for claims construction by
Plaintiffs Adapt Pharrna Operations Limited, Adapt Pharrna, Inc., and Opiant Pharmaceuticals,
Inc. (“Adapt”) and Defendants Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals
Industries, Ltd. (“Teva”). Specifically, the parties seek construction of certain language contained
in Claim I of United States Patent Numbers 9,211,253 (“‘253 patent”) and 9,468,747 (“747

patent”), Claim 10 of the ‘253 patent and ‘747 patent, and Claim 29 of United States Patent No.
9,629,965 (“‘965 patent”).’ The Court has considered the parties’ written submissions. (ECF Nos.
65, 70, 160, 162), and the oral arguments advanced at the Mai*man hearing held on March 31,
2019. (ECFNo. 188).

The parties additionally sought the Court’s construction of the terms “about 0.2 mg of a stabilizing agent / about
0.2 mg disodium edetate / about 0.2% (w/v) disodium edetate as the stabilizing agent” found in Claims I and 3 of
the ‘253 patent, Claims 3 and 33 of the ‘747 patent, Claims 5 and 27 of United States Patent No. 9,561,177 (“177
patent”), and Claims 1 and 22 of the ‘965 patent. They have since resolved their dispute regarding these terms.
(ECFNo. 194).

I.
A.

BACKGROUND

The Patents

The subject patents deal with, and relate to, the administration of a nasal spray form of an
oploid receptor antagonist known as the drug “naloxone.” (‘253 patent at 1:8—12; 2:9_11).2
Naloxone is used to reverse opioid overdoses and for “adjunct” use to treat septic shock. (Id. at
13—15). The FDA has previously approved naloxone treatments in the form of injection. (Id. at
9—11). There is debate about the relative effectiveness of the nasal delivery method of naloxone
ingestion compared to various injection methods via IV, intramuscular injection, or subcutaneous
administration. (Id. at 2:43—6:4).
Adapt asserts that the patents cover its brand name drug Narcan®, which is a nasal spray
comprising 4mg of naloxone hydrochloride.
received

FDA approval

(ECF No. 65 at 6, ‘253 patent at 9:34). Adapt

for Narcan® on November

18,

2015

(NDA

No.

208411,

https://www.accessdata. fda.gov/scripts/cder/daf/index.cfln?event=overview.process&ApplNo=2
08411). Narcan is the first and only FDA approved nasal spray to combat opioid overdose. (ECF
No. 65 at 6). The patents-in-suit describe pre-primed “devices adapted for nasal delivery of a
pharmaceutical composition to a patient, comprising a therapeutically effective amount of an
opioid antagonist selected from naloxone and pharmaceutically acceptable salts,” in amounts
ranging from 2mg to 12mg of naloxone hydrochloride. (‘253 patent at 6:54—60). The patents-insuit also describe methods of treating an opioid overdose using this device, “comprising nasally

2

A copy of the ‘253 patent can be found at ECF No. 65-2. The Court cites only to the ‘253 patent except for issues
that refer specifically to one of the other patents-in-suit.

2

administering to a patient in need thereof’ the aforementioned therapeutically effective naloxone
hydrochloride dosage. (Id. at 6:61—67). Adapt markets Narcan® as a product that fills the need
for a “durable, easy-to-use, needleless device[] with storage-stable formulations that can enable
untrained individuals to quickly deliver a therapeutically effective dose of a rapid-acting opioid
antagonist to an opioid overdose patient.” (‘253 patent at 6:43—47).
B.

Disputed Term and

Proposed Construction

The parties have asked the Court to construe the following terms:
Disputed Term

Patent Claims that the Term
Appears

“delivery time”

“a single reservoir comprising a pharmaceutical
composition which is an aqueous solution of about 100
jiL”3

In

Claim 10 of the ‘253 patent, Claim
10 of the ‘747 patent, and Claim 29
of the ‘965 patent
Claim 1 of the ‘253 patent and
Claim I of the ‘747 patent

Adapt proposes that this Court construe the above terms in the following manner:
Disputed Term

Plaintiffs’

“delivery time”

“a single reservoir comprising a pharmaceutical
composition which is an aqueous solution of about 100
jiL”

Proposed Construction

“the amount of time that elapses
between a determination made by a
healthcare professional, or an
untrained
individual
that
an
individual is in need of nasal
delivery of an opioid antagonist and
completion of the delivery.”
Requires no construction

(ECF No. 65 at 13, 15).

tL stands for microliter, which is one millionth of a liter and is numerically represented as 1 10

3

C’

m

Teva proposes the following constructions for the disputed terms:

Disputed Term

Defendant’s Proposed
Construction
Indefinite

“delivery time”
“a

single

composition

reservoir

which

is

comprising
an

aqueous

a

pharmaceutical

solution

of

about 100

4L”

“a

single

filled with
100 1iL of an aqueous

device reservoir

approximately

phannaceutical composition.”

(ECF No.70

at

8,21).
II.

LEGAL STANDARD

A court’s analysis of a patent infringement claim is two-fold. Tate Access floors, Inc. v.
Interface Architectural Res., Inc., 279 F.3d 1357. 1365 (Fed. Cir. 2002). The court must first
define the meaning and scope of the patent claims as a matter of law. Markman v. Wesiview
Instrttrnel?ts, Inc., 52 F.3d 967, 978 (Fed. Cir. 1995) (en bane), aff’d, 517 U.S. 370 (1996). The
court then engages in a comparison of the claims as construed to the alleged infringing product or
method. Tate, 279 F.3d at 1365. At this stage, the Court must only engage in the first step.
Claim construction is a matter of law to be determined solely by the court. Phillips v. A WH
Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005), cert. denied, 546 U.S. 1170 (2006). “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.” Id. at 1312 (quoting Innova/Pure Water, Inc. v. Safliri Water
Filtration Sys., Inc., 381 F.3d 1111, 1115 (Fed. Cir. 2004)). In construing the terms of a patent, a
court should look first to the language of the claim itself. Vitronics Corp. v. Conceptronic, Inc.,
90 F.3d 1576, 1582 (Fed. Cir. 1996). The tenns in the claim “are generally given their ordinary
and customary meaning.” Id. at 1582. “[TJhe ordinary and customary meaning of a claim term is
4

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.” Phillips, 415 f.3d at
1313. A court “must look at the ordinary meaning in the context of the written description and the
prosecution history.” Medrad, Inc. v. MRI Devices Coip., 401 F.3d 1313, 1319 (fed. Cir. 2005)
(quotingDeliarini Sports, Inc.

i

Worth, 239 F.3d 1314, 1324 (Fed. Cir. 2001)). The court should

turn to “those sources available to the public that show what a person of skill in the art would have
understood disputed claim language to mean.” Innova/Pitre, 381 F.3d at 1116.
To this end, the court should first examine the intrinsic record—the patent itself, including
the claims, the specification and, if in evidence, the prosecution history. Vitronics, 90 F.3d at 1582
(citing Markrnan, 52 F.3d at 979). The specification “acts as a dictionary when it expressly defines
terms used in the claims or when it defines terms by implication.” Id. Indeed, the Federal Circuit

has explained that the specification is “usually

.

.

.

dispositive

.

.

.

[and] the single best guide to

the meaning ofadisputed term.” Phillips, 415 F.3d at 1315 (quoting Vitronics, 90 F.3d at 1582).
It is “entirely appropriate for a court, when conducting claim construction, to rely heavily on the
written description for guidance as to the meaning of the claims.” Id. at 1317. The specification
is also an important guide in claims construction as it may contain “an intentional disclaimer, or
disavowal, of claim scope by the inventor.” Id. at 13 16.
Additionally, the court should consult the patent’s prosecution history as it “provides
evidence of how the PTO and the inventor understood the patent.” Id. at 1317. Courts should be
circumspect in reviewing a prosecution history as it represents “an ongoing negotiation between
the PTO and the applicant, rather than the final product of that negotiation.” Id. A district court
may also examine extrinsic evidence: “all evidence external to the patent and prosecution history.”
Markman, 52 f.3d at 980; see also Phillips, 415 F.3d at 1317 (stating that the Federal Circuit
5

“ha[s] authorized district courts to rely on extrinsic evidence”).

Such evidence consists of

testimony by the inventor or by experts. dictionaries, and treatises. Markmcm, 52 F.3d at 980. In
particular, a court may find reference to technical dictionaries useful “in determining the meaning
of particular terminology.” See Phi/tips, 415 F.3d at 1318.

However, extrinsic evidence is

generally thought to be less reliable than the patent and prosecution history, id. at 1318—19; in
essence, it is “less significant than the intrinsic record in determining ihe legally operative
meaning of claim language,” C.R. Bard, Inc. v. US. Surgical Corp., 388 F.3d $58, $62 (Fed. Cir.
2004) (quoting Vanderlctnde Inthts. Nederland B V v. liii ‘1 Trade Comm

‘ii,

366 F.3d 1311, 13 18

(Fed. Cir. 2004)).
Finally, a party may challenge the definiteness of a disputed tenm Should the Court find
the term indefinite the claim is rendered invalid. tVcttttittts, Inc. v. Biosig Instruments, Inc., 572
U.S. 898, 901—02 (2014). “A lack of definiteness renders invalid ‘the patent or any claim in suit.”
Natttthts, 572 U.S. at 902 (quoting 35 U.S.C.

§ 282, ¶2(3)). The Federal Circuit recently confirmed

that “[i]ndefiniteness must be proven by clear and convincing evidence.” Sonix Tech. Co.

i’.

Ptib/’ns Int’l, Ltd., 844 f.3d 1370, 1377 (Fed. Cir. 2017). The “indefiniteness analysis involves
general claim construction principles.” Sonix, 844 F.3d at 1378.
III.

ANALYSIS

A. Indefiniteness

Teva advances an indefiniteness challenge with respect to “delivery time.” Teva asserts
that “tying delivering time to a subjective ‘detennination made by a healthcare professional or an
untrained individual,’

.

.

.

fail[s] to provide any reasonable certainty as to the scope of the claims.

(ECF No. 70 at 21). Teva also argues that the purported end point of the “delivery time,”—
6

“completion of delivery”— is similarly ambiguous. (ECF No. 70 at 21). As to the determination
made by a healthcare professional or untrained individual, Teva argues that such a determination
is the “formation of a mental impression,” and that the patent “provides no guidance whatsoever
as to how to detenriine when such an event has occurred,” nor could it, as the thought process
occurs in the observing individual’s head. (ECF No. 70 at 2 1—22). For example, Teva argued at
the Markrnan hearing that “there is no definition in the specification of what the determination is.
You can

imagine

that the detenriination could be a period of evaluation. You could imagine that

while they are evaluating, they are preparing the device to deliver.” (ECF No. 193 (“Tr.”) at
10:16—20). This ambiguity is exacerbated, Teva argues, by the difference between a medical
professional’s ability to determine the symptoms of an overdose as opposed to a layperson’s. (ECF
No. 70 at 22). Regarding the “completion of delivery,” Teva argues that is unclear “whether
delivery is complete when the nasal spray leaves the medical device, when the spray reaches the
nasal mucosa, when the naloxone enters the blood stream, or when the naloxone is actually
delivered to the opioid receptors.” (ECF No. 70 at 22).
Adapt contends that the inventors of the device “acted as their own lexicographers and
expressly defined ‘delivery time’

.

.

.

[and that] Teva cannot point to anything in the inventors’

easily-understood definition of ‘delivery time’ that would make it difficult for a [person of ordinary
skill in the art] to discern with reasonable certainty what is meant by that tenTh”4 (ECF No. 65 at
13—14). Adapt believes that the process of making the determination to administer the naloxone
is not part of the “delivery time” and that “the people administering the drug—whether trained or

The parties have not come to an agreement on who a person of ordinary skill in the art might be in this context, nor
has either party proposed their own definition for a person of ordinary skill in the art.

7

untrained—know when they set out to administer the drug, and anyone else trying to ‘measure’
‘delivery time’ from that starting point could simply ask them, or tell them to start a stopwatch, or
to look at the clock and later report the time.” (ECF No. 162 at 11).

In other words, “the

determination, however long it may take to make that determination, is made prior to the delivery
time commencing.” (Tr. at 21:23—25). Adapt also argues that the “completion of the delivery” is
clear, in that a person of ordinary skill in the art would understand that term to mean the completion
of nasal deliver, i.e., “when the pharmaceutical composition has been sprayed into the nose.” (ECF
No. 162 at 11).
Adapt also urges this Court to consider Teva’s indefiniteness argument at trial, arguing that
it would be premature at the claims construction stage. (ECF No. 65 at 8). This Court agrees. It
is not uncommon for courts to defer ruling on an indefiniteness challenge at the claims construction
stage where such a ruling would be better suited for trial. See A/con Resectrch, Ltd. v. Barr Labs.
Inc., No. 09-0318, 2011 WL 390187$, at *16 (D. Del. Sept. 6.2011) (collecting cases). There are
a number of factors present here that push the Court to defer a ruling on indefiniteness. First, the
parties do not agree on, nor have they proposed, any qualifications or characteristics of a person
of ordinary skill in the art. See Research Frontiers, Inc. v. F Ink Corp., No. 13-1231, 2016 WL
1169580, at *20 (D. Del. Mar. 24, 2016) (declining to take up E Ink’s indefiniteness challenge
where the parties “clearly disagree[d] as to what qualifications a person skilled in the relevant art
would have,

.

.

.

[a]nd there [was] scant information in the record about what is the relevant level

of skill in the art”). Additionally, the Court has not heard expert testimony or read expert reports
concerning the distribution and administration of Narcan® nasal spray to those in need, as expert
discovery is still ongoing. See Fttrdtte Pharm. Prods., L.P. v. Actavis Etftabeth, LLC. No. 12$

5311, 2014 WL 2624787, at *6 (D.N.J. June 11,2014), aff’d 627 F. App’x 931 (Fed. Cir. 2016)
(concluding that a finding of indefiniteness would be premature in part due to the lack of expert
testimony in the record); see also McGinley v. Franklin Sports, Inc., 262 F.3d 1339, 1362 (Fed.
Cir. 2001) (“Mere attorney argument is no substitute for evidence of record”); WesternGeco L.L.C.
v. ION Geophysical Co;p., 876 F. Supp. 2d 857, 875 (S.D. Tex. 2012) (“Defendants’ unsupported
attorney argument fails to prove indefiniteness by clear and convincing evidence.”); Cacace v.
Meyer Mktg. (Macau Commercial Offshore,) Co., 812 F. Supp. 2d 547, 561 (S.D.N.Y. 2011)
(finding attorney argument in support of indefiniteness insufficient to establish invalidity).
Moreover, where, as here, the indefiniteness challenge has to do with a method of
measurement—in this case, the measurement of time between the determination that someone
needs Narcan® and the completion of that delivery—there must be “clear and convincing evidence
that the method of measurement is in fact outcome-determinative in the infringement analysis.”
Takeda fharm. Co. v. Zydtts Pharm. USA, Inc., 743 F.3d 1359, 1367 n.4 (Fed. Cir. 2014). And
inconsistent results from a method of measurement alone would not necessarily render a claim
indefinite. Id. at 1367 n.3. Thus, because the indefiniteness argument in this claim construction
is “potentially dispositive, require[s] a high burden of proof, and may more profitably be
considered in connection with patent validity,” the Court declines to rule on the indefiniteness of
“delivery time” at the claims construction stage. Fresenius Kabi USA, LLC v. Fera Pharm., LLC,
No. 15-3654, 2016 WL 5109142, at *9 (D.N.J. Sept. 20, 2016).
B. Claim Construction
The Court now turns its attention to the remaining disputed term.

9

a. “a single reservoir comprising a pharmaceutical composition which is an
aqueous solution of about 100 iL”

The term “a single reservoir comprising a pharmaceutical composition which is an aqueous
solution of about 100 iiL” appears in Claim 1 of the ‘253 and ‘747 patents. (‘253 patent at 2 1:8—
9,50:39—40; ‘747 patent5 at 22:12—13, 53:13—15).
Teva construes the term to mean “a single device reservoir filled with approximately 100
iL of an aqcieous pharmaceutical composition.” (ECF No. 70 at 8). Teva’s issue with the term is
that in Adapt’s infringement contentions, “Adapt treats the 100 tL as if it referred to the amount
of the pharmaceutical composition delivered to the patient rather than the amount present in the
reservoir of the device,” when the “text of the claim makes clear that the 100 tL is the amount in
the device reservoir.” (ECF No. 70 at 9). Teva points to the dependent claims of the ‘253 and
‘747 patents, as well as the specifications of those patents, as support for its proposed construction.
It argues that because Claim 6 of the ‘253 patent, which depends from Claim 1, “specifies that
‘about 100 tL of said aqueous solution in said reservoir is delivered to said patient in one
actuation,” Adapt “knew how to draft claims regarding the amount of drug administered to a
patient when it wanted to do so.” (ECF No. 70 at 10). Teva also points to the ‘253 patent
specification language, which tracks the language of Claim 1, as evidence that the claim covers a
reservoir limited to containing 100 tL of the drug. (ECF No. 70 at 10).
Adapt proposes that this tenri requires no construction and that the plain and ordinary
meaning of the claim language controls. (ECF No. 65 at 15). Adapt believes that Teva’s proposed
constructions reads improper limitations into the claim in three ways. First, Teva unnecessarily

The ‘747 patent can be found at ECF No. 65-3.

10

adds the limitation of “device” to a “a single device reservoir.” (ECF No. 65 at 16). Second,
Adapt contends that replacing “comprising” with “filled with” replaces a “broad, open-ended tenTi
of art that means that an embodiment of the claims must contain certain elements but can also
include other things,” with a “narrow, closed-ended term that would unduly limit the scope of the
claims.” (ECF No. 65 at 16). Third, Adapt argues that replacing “about” with “approximately” is
an exercise in redundancy. (ECF No. 65 at 16—17).
Teva has abandoned two of its challenged changes. As to whether the claim reads “a single
reservoir” or “a single device reservoir,” the parties agree that the reservoir is part of the device.
(Tr. at 58:24—25). Teva’s counsel Mr. Rozendaal also admitted that he does not “think it matters
whether we call it a device reservoir or just a reservoir.” (Tr. at 59:2—3). Teva has also conceded
that “approximately” and “about” are synonymous. (ECF No. 160 at 12). Thus, the Court sees no
need to unnecessarily address these revisions and will leave these claims terms as Adapt has
written them. See K-2 Corp.

V.

Solomon S.A., 191 f.3d 1356, 1364 (fed. Cir. 1999) (“Courts do

not rewrite claims; instead, we give effect to the terms chosen by the patentee.”).
The remaining dispute centers around the volume of the pharmaceutical composition in the
reservoir and the makeup of the solution in the reservoir.

Adapt suggests that the word

comprising’s plain and ordinary meaning governs. “Comprising” is an “open-ended term

.

.

.

of

art used in claim language which means that the named elements are essential, but other elements
may be added and still form a construct within the scope of the claim.” Genentech, Inc. e. Chiron

Corp., 112 f.3d 495, 501 (Fed. Cir. 1997). Teva suggests replacing “comprising” with “filled,” a
term that is defined in the ‘253 patent. The patent defines that term as follows: “[t]he term ‘filled,’
as used herein, refers to an association between a device and a pharmaceutical composition, for
11

example, when a pharmaceutical composition described herein comprising a therapeutically
effective amount of an opioid antagonist is present within a reservoir that fonns a part of a device
described herein.” (‘253 patent at 9:15—21). Adapt, however, chose not to use this word in the
claim at issue and instead used the word “comprising.” This deliberate word choice should not be
ignored. See Tex. Dig. Svs., Inc., v. Tetegenix, Inc., 308 F.3d 1193, 1202 (Fed. Cir. 2002) (“The
terms used in the claims bear a ‘heavy presumption’ that they mean what they say and have the
ordinary meaning that would be attributed to those words by persons skilled in the relevant art.”).
The dependent claims in the patent lend support to the use of “comprising” over “filled.”
Most persuasively, Claim 5 of both the ‘253 and ‘747 patents reads: “wherein the volume of said
reservoir is not more than about 140 jiL.” (‘253 patent at 50:63—64; ‘747 patent at 53:40—41).
Claim 5 thus imposes an upper limit on the volume of the reservoir in the device. Given that the
Court “must not interpret an independent claim in a way that is inconsistent with a claim that
depends from it,” construing the claim as having an upper limit of 100 j.iL would violate one of
the maxims of claim construction. Wright Med. Tech., Inc. v. Osteonics Corp., 122 F.3d 1440,
1445 (Fed. Cir. 1997).
Additionally, Claim 6 of the ‘253 and ‘747 patents states that “wherein about 100 tL of
said aqueous solution in said reservoir is delivered to said patient in one actuation.” (‘253 patent
at 50:65—67; ‘747 patent at 53:42—44). Elsewhere, the ‘253 patent specification also infonns us
that “[t]o emit 100 tL, a volume of 125 jiL is filled in the device.” (‘253 patent at 16:51—52).
Thus, Teva’s argument that the “text of the claim makes clear that the 100 jiL is the amount in the
device reservoir,” (ECF No. 70 at 9), is simply inconsistent with the dependent claims in the ‘253
and ‘747 patents. It is evident from reading Claim 6 in conjunction with the patent specification
12

that the device is designed to deliver 100 tL of the aqueous phanTiaceutical composition to the
patient, and that in order to do so, the reservoir must be filled with a volume greater than 100 iL.
See Trs. of Columbia Univ. in the City ofN.Y v. Symantec Corp., 811 F.3d 1359, 1362, 1370 (Fed.
Cir. 2016) (confirming that the patent specification “is the ‘single best guide to the meaning of a
disputed term,” and holding that “construing the independent claim to exclude material covered
by the dependent claim would be inconsistent” (quoting Vitronics Corp., 90 F.3d at 1582)).
In explaining that a volume of 125 jiL is filled in the device for it to emit 100 jiL of the
aqueous composition to the patient, the ‘253 patent references the “Pfeiffer/Aptar single-dose
device.” (‘253 patent at 16:52—53). This device is mentioned as the preferred embodiment in the
patent. (‘253 patent at 16:19—20; 49:53—61). The Court “nonnallydo[es] not interpret claim terms

in a way that excludes embodiments disclosed in the specification,” and the Court has seen no
evidence indicating that this should be one of the rare instances where it should. Oatey Co. v. IFS
Corp., 514 F.3d 1271, 1276—77 (Fed. Cir. 2008). Thus, the Court finds that the claim term “a
single reservoir comprising a pharmaceutical composition which is an aqueous solution of about
100 tL” requires no further construction, as “comprised” is a tenn of art that a person of ordinary
skill in the art would understand, and the use of which is supported by the intrinsic evidence.

IV.

CONCLUSION

For the aforementioned reasons, this Court declines to address Teva’s indefiniteness
challenge at this juncture and concludes that the claim term “a single reservoir comprising a
pharmaceutical composition which is an aqueous solution of about 100 jiL” requires no further
construction. An appropriate Order accompanies this Opinion.
13

DATED: Apri1Z 2019

L. LINARES
Judge, United States District Court

14