Trials@uspto.gov
`571-272-7822
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` Paper No. 11
`
` Entered: September 9, 2019
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`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`NALOX-1 PHARMACEUTICALS, LLC,
`Petitioner,
`
`v.
`
`OPIANT PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
`
`Case IPR2019-00689
`Patent 9,468,747 B2
`____________
`
`
`Before ERICA A. FRANKLIN, ZHENYU YANG,
`and JACQUELINE T. HARLOW, Administrative Patent Judges.
`
`
`FRANKLIN, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314(a)
`
`
`
`
`
`
`
`
`
`
`571-272-7822
`
`
`
`
`
`
`
`
`
`
` Paper No. 11
`
` Entered: September 9, 2019
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`NALOX-1 PHARMACEUTICALS, LLC,
`Petitioner,
`
`v.
`
`OPIANT PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
`
`Case IPR2019-00689
`Patent 9,468,747 B2
`____________
`
`
`Before ERICA A. FRANKLIN, ZHENYU YANG,
`and JACQUELINE T. HARLOW, Administrative Patent Judges.
`
`
`FRANKLIN, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314(a)
`
`
`
`
`
`
`
`
`
`
`
`IPR2019-00689
`Patent 9,468,747 B2
`
`
`I. INTRODUCTION
`Nalox-1 Pharmaceuticals, LLC (“Petitioner”) filed a Petition seeking
`an inter partes review of claims 1–45 (“the challenged claims”) of U.S.
`Patent No. 9,468,747 B2 (“the ’747 patent,” Ex. 1001). Paper 1 (“Pet.”).
`Opiant Pharmaceuticals, Inc. (“Patent Owner”) filed a Preliminary Response
`to the Petition. Paper 6 (“Prelim. Resp.”).
`We have authority to determine whether to institute an inter partes
`review. 35 U.S.C. § 314. For the reasons provided below, we exercise our
`discretion under 35 U.S.C. § 314 to deny institution of an inter partes
`review.
`
`A. Related Proceedings
`The parties identify the following district court cases involving the
`’747 patent: Adapt Pharma Operations Ltd. v. Teva Pharmaceuticals USA,
`No. 2:16-cv-07721 (D.N.J.); Adapt Pharma Operations Ltd. v. Perrigo UK
`FINCO Limited Partnership, No. 2:18-cv-15287 (D.N.J.). Pet. 6; Paper 5, 2.
`Petitioner is not a party in either of those cases.
`In addition to the instant Petition, Petitioner challenges claims 1–45 of
`the ’747 patent in two other petitions concurrently filed in IPR2019-00688
`and IPR2019-00690. The ’747 patent is one of five patents listed in the
`Orange Book for intranasal naloxone sold under the brand name NARCAN.
`Pet. 1; Paper 9, 1. Petitioner has also filed petitions for inter partes review
`of claims of each of those other four patents. Paper 5, 1–2.
`B. The ’747 Patent
`Opioid overdose is a crisis in the United States. Ex. 1001, 6:43.
`Naloxone is an opioid receptor antagonist that was initially approved for use
`
`
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`2
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`IPR2019-00689
`Patent 9,468,747 B2
`
`by injection for the reversal of opioid overdose. Id. at 2:13–14. According
`to the Specification, administering naloxone via injection requires trained
`medical personnel and imposes the risk of exposure to blood borne
`pathogens through needlestick injury. Ex. 1001, 6:20–32. The ’747 patent
`discloses that “it ha[d] been suggested that in view of the growing opioid
`overdose crisis in the US, naloxone should be made available over-the-
`counter (OTC), which would require a device, such as a nasal spray device,
`that untrained consumers are able to use safely.” Id. at 6:42–46.
`The ’747 patent acknowledges that nasal administration of naloxone
`was known and used by numerous medical services and health departments.
`Ex. 1001, 2:29–6:13, see also id. at 4:39–42 (“Overdose education and nasal
`naloxone distribution (OEND) programs are community-based interventions
`that educate people at risk for overdose and potential bystanders on how to
`prevent, recognize and respond to an overdose.”). The Specification
`explains, however, that although some studies “reported that the nasal
`administration of naloxone is as effective as the intravenous route in opiate
`addicts,” other studies have “reported that naloxone administered
`intranasally displays a relative bioavailability of 4% only and concluded that
`the IN [intranasal] absorption is rapid but does not maintain measurable
`concentrations for more than an hour.” Id. at 2:47–55. The ’747 patent
`states
`
`Thus, there remains a need for durable, easy-to-use, needleless
`devices 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. The therapeutically effective dose should be
`sufficient to obviate the need for the untrained individual to
`3
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`IPR2019-00689
`Patent 9,468,747 B2
`
`administer either a second dose of opioid antagonist or an
`alternative medical intervention to the patient, and to stabilize the
`patient until professional medical care becomes available.
`Id. at 6:52–61.
`According to the Specification, the disclosed invention relates to
`devices adapted for nasal delivery of “a therapeutically effective amount of
`an opioid antagonist selected from naloxone and pharmaceutically
`acceptable salts thereof, wherein the device is pre-primed, and wherein the
`therapeutically effective amount, is equivalent to about 2 mg to about 12 mg
`of naloxone hydrochloride.” Id. at 6:63–7:2.
`C. Illustrative Claims
`Claims 1 and 30 of the ’747 patent, reproduced below, are the only
`independent claims challenged, and are illustrative of the claimed subject
`matter.
` 1. A method of treatment of opioid overdose or a symptom
`thereof, comprising nasally administering to a patient in need
`thereof a dose of naloxone hydrochloride using a single-use, pre-
`primed device adapted for nasal delivery of a pharmaceutical
`composition to a patient by one actuation of said device into one
`nostril of said patient, having a single reservoir comprising a
`pharmaceutical composition which is an aqueous solution of
`about 100 µL comprising:
` about 4 mg naloxone hydrochloride or a hydrate thereof;
` between about 0.2 mg and about 1.2 mg of an isotonicity agent;
` between about 0.005 mg and about 0.015 mg of a compound
` which is at least one of a preservative, a cationic surfactant,
` and a permeation enhancer;
` between about 0.1 mg and about 0.5 mg of a stabilizing agent;
` and
` an amount of an acid sufficient to achieve a pH of 3.5-5.5.
`
`
`
`
`4
`
`
`
`IPR2019-00689
`Patent 9,468,747 B2
`
` 30. A pharmaceutical formulation for intranasal adminis-
`tration comprising, in an aqueous solution of not more than about
`140 µL:
` about 4 mg naloxone hydrochloride or a hydrate thereof;
` between about 0.2 mg and about 1.2 mg of an isotonicity agent;
` between about 0.005 mg and about 0.015 mg of a compound
` which is at least one of a preservative, a cationic surfactant,
` and a permeation enhancer;
` between about 0.1 mg and about 0.5 mg of a stabilizing agent;
` an amount of an acid sufficient to achieve a pH of 3.5-5.5.
`
`
`D. Asserted Grounds of Unpatentability
`Petitioner challenges the patentability of claims 1–45 under 35 U.S.C.
`§ 103 on the following grounds:
`
`Claims
`
`References
`Wang,1 Djupesland,2 HPE,3 Bahal,4 and
`1–7, 16, 30–33
`Kushwaha5
`10–15, 17–29, 34–39 Wang, Djupesland, HPE, Bahal, Kushwaha, and
`Wyse6
`
`
`1 Wang et al., Chinese Patent Publication No. CN 1575795 A, published
`February 9, 2005 (“Wang”) (Ex. 1008).
`2 Djupesland, Nasal Drug Delivery Devices: Characteristics and
`Performance in a Clinical Perspective - A Review, 3 DRUG DELIV. &
`TRANSL. RES. 42–62 (2013) (“Djupesland”) (Ex. 1010).
`3 Handbook of Pharmaceutical Excipients, 56–60, 64–66, 78–81, 220–22,
`242–44, 270–72, 441–45, 517–22, 596–98 (Rowe et al. eds., 6th ed. 2009)
`(“HPE”) (Ex. 1012).
`4 Bahal et al., U.S. Patent No. 5,866,154, issued February 2, 1999 (“Bahal”)
`(Ex. 1014).
`5 Kushwaha et al., Advances in Nasal Trans-Mucosal Drug Delivery, 01(07)
`J. APPLIED PHARM. Sci. 21–28 (2011) (“Kushawaha”) (Ex. 1013).
`6 U.S. Patent No. 9,192,570, issued November 24, 2015 (“Wyse”)
`(Ex. 1007).
`
`5
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`IPR2019-00689
`Patent 9,468,747 B2
`
`
`Claims
`
`40–45
`
`8–9
`
`References
`Wang, Djupesland, HPE, Bahal, Kushwaha, and
`Wyse or Wermeling 20137, or Pharmacologist
`POSA knowledge
`Wang, Djupesland, HPE, Bahal, Kushwaha, and
`the ’291 patent
`
`Petitioner also relies on the Declarations of Maureen D. Donovan,
`Ph.D. (Ex. 1002) and Günther Hochhaus, Ph.D. (Ex. 1003).
`
`II. DISCRETIONARY DENIAL
`Institution of inter partes review is discretionary. See 35 U.S.C.
`§ 314(a); SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1356 (2018) (explaining
`that section “314(a) invests the Director with discretion on the question
`whether to institute review”) (emphasis omitted). When determining whether
`to exercise our discretion under § 314(a), we consider, among other factors,
`whether a petitioner has filed multiple other petitions challenging the same
`patent.
`As explained above, in addition to the instant Petition, Petitioner has
`concurrently filed two other petitions challenging the same claims of the
`’747 patent as here. In the instant Petition, Petitioner relies upon Wang as
`the primary reference. See Pet. 3. Thus, in some instances, we refer to the
`instant Petition as the “Wang Petition.” In IPR2019-00688, Petitioner relies
`upon Wyse as the primary reference. See IPR2019-00688, Paper 1 (the
`“Wyse Petition”). In IPR2019-00690, Petitioner relies upon Davies as the
`
`7 Wermeling, A Response to the Opioid Overdose Epidemic: Naloxone
`Nasal Spray, 3 DRUG DELIV. & TRANSL. RES. 63–74 (2013) (“Wermeling”)
`(Ex. 1016).
`
`6
`
`
`
`
`
`IPR2019-00689
`Patent 9,468,747 B2
`
`primary reference. See IPR2019-00690, Paper 1 (the “Davies Petition”).
`Recently, we granted the Wyse Petition and instituted an inter partes review
`of claims 1–45 of the ’747 patent in IPR2019-00688. See IPR2019-00688,
`Paper 11. Patent Owner argues that we should exercise discretion to deny
`institution of the Wang Petition because it is redundant of the Wyse Petition
`in IPR2019-00688. See Prelim. Resp. 6–8. For the reasons that follow, we
`agree with Patent Owner.
`Our discretionary determination whether to institute review takes into
`consideration guidance in the Trial Practice Guide Update (July 2019),
`available at https://www.uspto.gov/TrialPracticeGuide3 (referenced in
`Office Patent Trial Practice Guide, July 2019 Update, 84 Fed. Reg. 33,926
`(July 16, 2019)) (“TPG July 2019 Update”). The TPG July 2019 Update
`addresses situations where Petitioner has concurrently filed parallel petitions
`challenging the same patent. The TPG July 2019 Update states:
`Based on the Board’s prior experience, one petition should be
`sufficient to challenge the claims of a patent in most situations.
`Two or more petitions filed against the same patent at or about
`the same time (e.g., before the first preliminary response by the
`patent owner) may place a substantial and unnecessary burden
`on the Board and the patent owner and could raise fairness,
`timing, and efficiency concerns. See 35 U.S.C. § 316(b). In
`addition, multiple petitions by a petitioner are not necessary in
`the vast majority of cases.
`TGP July 2019 Update 26.8 The TGP July 2019 Update acknowledges that
`“there may be circumstances in which more than one petition may be
`
`
`8 This is consistent with the guidance previously provided in the August
`2018 update to the Trial Practice Guide Update (August 2018), available at
`7
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`IPR2019-00689
`Patent 9,468,747 B2
`
`necessary, including, for example, when the patent owner has asserted a
`large number of claims in litigation or when there is a dispute about priority
`date requiring arguments under multiple prior art references,” but
`characterizes such circumstances as “rare.” Id.
`
`Additionally, the TPG July 2019 Update states:
`To aid the Board in determining whether more than one petition
`is necessary, if a petitioner files two or more petitions
`challenging the same patent, then the petitioner should, in its
`petitions or in a separate paper filed with the petitions, identify:
`(1) a ranking of the petitions in the order in which it wishes the
`Board to consider the merits, if the Board uses its discretion to
`institute any of the petitions, and (2) a succinct explanation of the
`differences between the petitions, why the issues addressed by
`the differences are material, and why the Board should exercise
`its discretion to institute additional petitions if it identifies one
`petition that satisfies petitioner’s burden under 35 U.S.C.
`§ 314(a).
`
`
`Id. at 27 (footnote omitted). Pursuant to that guidance, we issued an order
`requiring Petitioner to provide a Notice identifying such ranking of the
`Wang, Wyse, and Davies petitions, along with an explanation of the
`differences between them. Paper 8, 4. We also gave Patent Owner an
`opportunity to respond. Id. at 5.
`
`
`https://go.usa.gov/xU7GP (referenced in Office Patent Trial Practice Guide,
`August 2018 Update, 83 Fed. Reg. 39,989 (August 13, 2018)) (“TGP August
`2018 Update”). The TPG August 2018 Update explains that “[t]here may be
`other reasons besides the ‘follow-on’ petition context where the ‘effect . . .
`on the economy, the integrity of the patent system, the efficient
`administration of the Office, and the ability of the Office to timely complete
`proceedings,’ 35 U.S.C. § 316(b), favors denying a petition,” including
`“other proceedings related to the same patent . . . at the Office.” Id. at 10.
`8
`
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`
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`IPR2019-00689
`Patent 9,468,747 B2
`
`Thereafter, Petitioner filed its Notice asserting that we should consider
`
`the Wyse Petition first. Paper 9, 1. Petitioner, however, urges that “[d]ue to
`different statutory bases for invalidity, as well as substantive differences in
`the[] three primary references,” we “should institute review for all three
`Petitions.” Id. In its Response to Petitioner’s Notice, Patent Owner
`disagrees, and maintains that “if the Board institutes anything, it should
`institute only the Wyse Petition.” Paper 10, 1.
`
`Based upon our review, Petitioner’s evidence and arguments in the
`present proceeding largely resemble what is set forth in the Wyse Petition.
`In both cases, Petitioner relies on Djupesland, HPE, and the ’291 patent as
`secondary references for essentially the same disclosures. Petitioner also
`relies on the same two expert declarations to support both petitions.
`Although the instant Petition relies on Wang as the primary reference,
`instead of Wyse, we do not find Petitioner has demonstrated that this or
`other differences between the petitions are material. According to
`Petitioner, “[t]here are numerous differences in the disclosures” of Wyse and
`Wang. Paper 9, 2. As Patent Owner correctly asserts, however, the two
`petitions present similar arguments, and that “in many cases, they exhibit
`word-by-word sameness,” on limitations such as the volume of the nasal
`spray, the naloxone dose, and the choice of excipients. See Paper 9, 2;
`compare Pet. 13–22 with Wyse Pet. 15–23. For example, in both petitions,
`for the “about 4 mg naloxone” limitation of claim 1, Petitioner relies on the
`same evidence, including data from Table 4 of Wyse, to argue “[a] POSA
`. . . would have been motivated to deliver a naloxone dose of about 4–6 mg.”
`Compare Pet. 18 with Wyse Pet. 19–20. Thus, even for those grounds in the
`
`
`
`9
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`
`
`IPR2019-00689
`Patent 9,468,747 B2
`
`Wang Petition that do not expressly include Wyse in the stated combination
`of references, Petitioner still relies on Wyse as evidence for its argument that
`a 4 mg dose would have been obvious.
`Petitioner argues that the Wyse Petition relies on “the Declaration of
`Dr. Donovan to support the position that a POSA would not have considered
`Wyse to teach away from the use of BAC [i.e., benzalkonium chloride],”
`whereas the present Petition “do[es] not rely [on] Wyse for the teaching of
`BAC, but instead for its other teachings.” Paper 9, 2–3. We are not
`persuaded by this argument either.
`“A reference must be considered for everything that it teaches.” See In
`re Applied Materials, Inc., 692 F.3d 1289, 1298 (Fed. Cir. 2012). Here,
`Patent Owner identifies the same statements in Wyse regarding the use of
`BAC in a naloxone intranasal formulation to support its teaching away
`argument as it does in the Wyse Petition. Compare Prelim. Resp. 49–54
`with IPR2019-00688 Prelim. Resp. 50–56. Thus, whether Wyse teaches
`away from the claimed invention is squarely at issue in both cases. Indeed,
`it is apparent that Petitioner acknowledges the relevance of Wyse in this case
`by relying on the same declaration testimony of Dr. Donovan to support the
`position that a person of ordinary skill in the art would not have considered
`Wyse to teach away from using BAC with naloxone here, just as it does in
`the Wyse Petition.9 Compare Pet. 60–61 with Wyse Pet. 59–60.
`
`
`9 Both this Petition and the Wyse Petition also rely on the same secondary
`reference (HPE) to support Petitioner’s argument that an ordinary artisan
`would have been motivated to include BAC as a preservative. See Pet. 32;
`Wyse Pet. 33–34.
`
`10
`
`
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`
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`IPR2019-00689
`Patent 9,468,747 B2
`
`Petitioner asserts that Wyse “anticipates” certain limitations, “while
`Wang does not.” Paper 9, 3. According to Petitioner, “[d]ifferent legal
`standards apply depending on whether a claim limitation is anticipated by a
`single reference, or obvious in view of multiple references.” Id. A prior art
`reference may be asserted as anticipating a claim, not merely a claim
`limitation. Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir.
`1983) (“Anticipation requires the presence in a single prior art disclosure of
`all elements of a claimed invention arranged as in the claim.”). Petitioner
`does not allege Wyse anticipates any challenged claims. Instead, both the
`instant Petition and the Wyse Petition challenge claims 1–45 of the ’747
`patent as obvious under 35 U.S.C. § 103 over various combinations of
`multiple references. See Pet. 3; Wyse Pet. 3. Thus, the same legal standard
`applies to both petitions, and Petitioner’s argument otherwise is erroneous.
`Petitioner points out that Wyse is prior art under § 102(a)(2), whereas
`Wang is prior art under § 102(a)(1). Paper 9, 1–2. According to Petitioner,
`“Patent Owner may seek to remove Wyse as prior art under an exception
`under § 102(b)(2), but will be unable to so for . . . Wang under the same
`exception.” Id. at 2. Patent Owner, however, has stipulated that for
`purposes of these proceedings, it will not dispute that Wyse is prior art.
`Paper 10, 1. Thus, Petitioner’s argument seeking to justify instituting a
`second inter partes review here, based upon a potential challenge to the prior
`art status of Wyse, is moot.
`Petitioner also notes that the instant Petition relies on a human
`translation of Wang, in contrast to a machine translated version relied upon
`during prosecution. Paper 9, 2. Petitioner, however, does not identify any
`
`
`
`11
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`IPR2019-00689
`Patent 9,468,747 B2
`
`differences between the translations. Nor does Petitioner explain how
`“Patent Owner may argue about the materiality of such differences,” or how
`Patent Owner “may otherwise seek to disqualify or discredit Wang as prior
`art.” See id. Moreover, Patent Owner has stipulated that for purposes of
`these proceedings, it will not dispute that Wang is prior art. Paper 10, 1.
`Thus, Petitioner’s assertion that the Wang translation relied upon in the
`instant Petition instituting a second inter partes review here is not well-
`taken.
`We acknowledge that the instant Petition relies on other secondary
`references in addition to those asserted in the Wyse Petition. Petitioner,
`however, does not identify, and we do not discern, any differences relating
`to those references that materially distinguish the arguments here from those
`in the Wyse Petition. See generally Paper 9, 1–3.
`Therefore, having considered the parties’ arguments and evidence in
`both IPR2019-00688 and in the current record, we agree with Patent Owner
`that the instant Petition “largely duplicates” the Wyse Petition, “merely
`adding grounds that make the same arguments with more complicated
`combinations of more references.” Prelim. Resp. 1. Because we institute an
`inter partes review of all claims of the ’747 patent on all grounds presented
`in the Wyse Petition (see IPR2019-00688, Paper 11), we exercise our
`discretion under 35 U.S.C. § 314(a) to deny instituting an inter partes review
`of the challenged claims based upon the instant Petition.
`
`
`
`
`12
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`IPR2019-00689
`Patent 9,468,747 B2
`
`
`III. CONCLUSION
`For the foregoing reasons, based on the circumstances of this case, we
`exercise discretion under 35 U.S.C. § 314 and deny the Petition requesting
`institution of an inter partes review of claims 1–45 of the ’747 patent.
`
`
`ORDER
`
`Accordingly, it is
`ORDERED that Petitioner’s request for an inter partes review of
`claims 1–45 of the ’747 patent in this case is denied.
`
`
`
`
`
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`13
`
`
`
`IPR2019-00689
`Patent 9,468,747 B2
`
`PETITIONER:
`Yelee Y. Kim
`Janine A. Carlan
`Richard Berman
`Bradford Frese
`Christopher Yaen
`ARENT FOX LLP
`Yelee.Kim@arentfox.com
`Janine.Carlan@arentfox.com
`Richard.Berman@arentfox.com
`Bradford.Frese@arentfox.com
`Christopher.Yaen@arentfox.com
`
`
`PATENT OWNER:
`
`Robert F. Green
`Jessica Tyrus Mackay
`GREEN, GRIFFITH & BORG-BREEN, LLP
`rgreen@greengriffith.com
`jmackay@greengriffith.com
`
`
`
`
`
`14
`
`
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