Case 2:16-cv-07721-JLL-JAD Document 200 Filed 04/24/19 Page 1 of 14 PageID: 3188
`
`NOT FOR PUBLICATION
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`ADAPT PHARMA OPERATIONS LIMITED, Civil Action Nos.: 16-7721, 17-2877, 17-864,
`eta!.,
`17-5 100, 18-9880 (JLL)
`
`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).
`
`Opiant Exhibit 2025
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00690
`Page 1
`
`

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`A.
`
`The Patents
`
`I.
`
`BACKGROUND
`
`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.
`
`(ECF No. 65 at 6, ‘253 patent at 9:34). Adapt
`
`received FDA approval
`
`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
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`ranging from 2mg to 12mg of naloxone hydrochloride.
`
`(‘253 patent at 6:54—60). The patents-in-
`
`suit 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
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`Opiant Exhibit 2025
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00690
`Page 2
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`

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`administering to a patient in need thereof’ the aforementioned therapeutically effective naloxone
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`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
`
`“delivery time”
`
`Claim 10 of the ‘253 patent, Claim
`10 of the ‘747 patent, and Claim 29
`of the ‘965 patent
`pharmaceutical Claim 1 of the ‘253 patent and
`a
`comprising
`reservoir
`single
`“a
`composition which is an aqueous solution of about 100 Claim I of the ‘747 patent
`jiL”3
`
`Appears In
`
`Adapt proposes that this Court construe the above terms in the following manner:
`
`Disputed Term
`
`Plaintiffs’ Proposed Construction
`
`“delivery time”
`
`“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.”
`pharmaceutical Requires no construction
`comprising
`reservoir
`single
`“a
`a
`composition which is an aqueous solution of about 100
`jiL”
`
`(ECF No. 65 at 13, 15).
`
`tL stands for microliter, which is one millionth of a liter and is numerically represented as 1 10 C’ m
`3
`
`Opiant Exhibit 2025
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00690
`Page 3
`
`

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`Teva proposes the following constructions for the disputed terms:
`
`Disputed Term
`
`“delivery time”
`
`Defendant’s Proposed
`Construction
`
`Indefinite
`
`“a
`
`single
`
`reservoir
`
`comprising
`
`a
`
`pharmaceutical
`
`composition which is an aqueous solution of about 100
`4L”
`
`“a single device reservoir filled with
`approximately 100 1iL of an aqueous
`
`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
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`Opiant Exhibit 2025
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00690
`Page 4
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`

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`the meaning that the term would have to a person of ordinary skill in the art in question at the time
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`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
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`Opiant Exhibit 2025
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00690
`Page 5
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`

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`“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
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`Opiant Exhibit 2025
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00690
`Page 6
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`

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`Case 2:16-cv-07721-JLL-JAD Document 200 Filed 04/24/19 Page 7 of 14 PageID: 3194
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`“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
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`Opiant Exhibit 2025
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00690
`Page 7
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`

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`Case 2:16-cv-07721-JLL-JAD Document 200 Filed 04/24/19 Page 8 of 14 PageID: 3195
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`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$, at *16 (D. Del. Sept. 6.2011) (collecting cases). There are
`
`a number of factors present here that push the Court to defer a ruling on indefiniteness. First, the
`
`parties do not agree on, nor have they proposed, any qualifications or characteristics of a person
`
`of ordinary skill in the art. See Research Frontiers, Inc. v. F Ink Corp., No. 13-1231, 2016 WL
`
`1169580, at *20 (D. Del. Mar. 24, 2016) (declining to take up E Ink’s indefiniteness challenge
`
`where the parties “clearly disagree[d] as to what qualifications a person skilled in the relevant art
`
`would have, .
`
`.
`
`. [a]nd there [was] scant information in the record about what is the relevant level
`
`of skill in the art”). Additionally, the Court has not heard expert testimony or read expert reports
`
`concerning the distribution and administration of Narcan® nasal spray to those in need, as expert
`
`discovery is still ongoing. See Fttrdtte Pharm. Prods., L.P. v. Actavis Etftabeth, LLC. No. 12-
`
`$
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`Opiant Exhibit 2025
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00690
`Page 8
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`

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`Case 2:16-cv-07721-JLL-JAD Document 200 Filed 04/24/19 Page 9 of 14 PageID: 3196
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`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
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`Opiant Exhibit 2025
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00690
`Page 9
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`

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`Case 2:16-cv-07721-JLL-JAD Document 200 Filed 04/24/19 Page 10 of 14 PageID: 3197
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`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
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`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00690
`Page 10
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`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
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`Opiant Exhibit 2025
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00690
`Page 11
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`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
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`claim at issue and instead used the word “comprising.” This deliberate word choice should not be
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`ignored. See Tex. Dig. Svs., Inc., v. Tetegenix, Inc., 308 F.3d 1193, 1202 (Fed. Cir. 2002) (“The
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`terms used in the claims bear a ‘heavy presumption’ that they mean what they say and have the
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`ordinary meaning that would be attributed to those words by persons skilled in the relevant art.”).
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`The dependent claims in the patent lend support to the use of “comprising” over “filled.”
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`Most persuasively, Claim 5 of both the ‘253 and ‘747 patents reads: “wherein the volume of said
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`reservoir is not more than about 140 jiL.” (‘253 patent at 50:63—64; ‘747 patent at 53:40—41).
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`Claim 5 thus imposes an upper limit on the volume of the reservoir in the device. Given that the
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`Court “must not interpret an independent claim in a way that is inconsistent with a claim that
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`depends from it,” construing the claim as having an upper limit of 100 j.iL would violate one of
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`the maxims of claim construction. Wright Med. Tech., Inc. v. Osteonics Corp., 122 F.3d 1440,
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`1445 (Fed. Cir. 1997).
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`Additionally, Claim 6 of the ‘253 and ‘747 patents states that “wherein about 100 tL of
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`said aqueous solution in said reservoir is delivered to said patient in one actuation.” (‘253 patent
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`at 50:65—67; ‘747 patent at 53:42—44). Elsewhere, the ‘253 patent specification also infonns us
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`that “[t]o emit 100 tL, a volume of 125 jiL is filled in the device.” (‘253 patent at 16:51—52).
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`Thus, Teva’s argument that the “text of the claim makes clear that the 100 jiL is the amount in the
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`device reservoir,” (ECF No. 70 at 9), is simply inconsistent with the dependent claims in the ‘253
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`and ‘747 patents.
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`It is evident from reading Claim 6 in conjunction with the patent specification
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`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00690
`Page 12
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`Case 2:16-cv-07721-JLL-JAD Document 200 Filed 04/24/19 Page 13 of 14 PageID: 3200
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`that the device is designed to deliver 100 tL of the aqueous phanTiaceutical composition to the
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`patient, and that in order to do so, the reservoir must be filled with a volume greater than 100 iL.
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`See Trs. of Columbia Univ. in the City ofN.Y v. Symantec Corp., 811 F.3d 1359, 1362, 1370 (Fed.
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`Cir. 2016) (confirming that the patent specification “is the ‘single best guide to the meaning of a
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`disputed term,” and holding that “construing the independent claim to exclude material covered
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`by the dependent claim would be inconsistent” (quoting Vitronics Corp., 90 F.3d at 1582)).
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`In explaining that a volume of 125 jiL is filled in the device for it to emit 100 jiL of the
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`aqueous composition to the patient, the ‘253 patent references the “Pfeiffer/Aptar single-dose
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`device.” (‘253 patent at 16:52—53). This device is mentioned as the preferred embodiment in the
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`patent. (‘253 patent at 16:19—20; 49:53—61). The Court “nonnallydo[es] not interpret claim terms
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`in a way that excludes embodiments disclosed in the specification,” and the Court has seen no
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`evidence indicating that this should be one of the rare instances where it should. Oatey Co. v. IFS
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`Corp., 514 F.3d 1271, 1276—77 (Fed. Cir. 2008). Thus, the Court finds that the claim term “a
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`single reservoir comprising a pharmaceutical composition which is an aqueous solution of about
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`100 tL” requires no further construction, as “comprised” is a tenn of art that a person of ordinary
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`skill in the art would understand, and the use of which is supported by the intrinsic evidence.
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`IV.
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`CONCLUSION
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`For the aforementioned reasons,
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`this Court declines to address Teva’s indefiniteness
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`challenge at this juncture and concludes that the claim term “a single reservoir comprising a
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`pharmaceutical composition which is an aqueous solution of about 100 jiL” requires no further
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`construction. An appropriate Order accompanies this Opinion.
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`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00690
`Page 13
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`Case 2:16-cv-07721-JLL-JAD Document 200 Filed 04/24/19 Page 14 of 14 PageID: 3201
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`DATED: Apri1Z 2019
`
`L. LINARES
`Judge, United States District Court
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`14
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`Opiant Exhibit 2025
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00690
`Page 14
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`