Trials@uspto.gov
`571-272-7822
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` Paper No. 10
`
` Entered: October 1, 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 IPR2019-00695
`Patent 9,629,965 B2
`____________
`
`
`
`
`Before ERICA A. FRANKLIN, ZHENYU YANG, and
`MICHAEL A. VALEK, Administrative Patent Judges.
`
`
`YANG, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`
`
`
`571-272-7822
`
`
`
`
`
`
`
`
`
`
` Paper No. 10
`
` Entered: October 1, 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 IPR2019-00695
`Patent 9,629,965 B2
`____________
`
`
`
`
`Before ERICA A. FRANKLIN, ZHENYU YANG, and
`MICHAEL A. VALEK, Administrative Patent Judges.
`
`
`YANG, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`
`
`
`
`IPR2019-00695
`Patent No. 9,629,965 B2
`
`
`INTRODUCTION
`Nalox-1 Pharmaceuticals, LLC (“Petitioner”) filed a Petition (Paper 1
`(“Pet.”)), seeking an inter partes review of claims 1–30 of U.S. Patent
`No. 9,629,965 B2 (“the ’965 patent,” Ex. 1001). Opiant Pharmaceuticals,
`Inc. (“Patent Owner”) filed a Preliminary Response. Paper 6 (“Prelim.
`Resp.”).
`For the reasons provided below, we exercise our discretion under
`35 U.S.C. § 314 to deny institution of an inter partes review.
`Related Proceedings
`Petitioner challenges claims 1–30 of the ’965 patent in two other
`concurrently filed petitions. In IPR2019-00694, Petitioner relies on Wyse1
`as the primary reference; and in IPR2019-00696, Petitioner relies on Davies2
`as the primary reference.
`The ’965 patent is one of five patents listed in the Orange Book for
`intranasal naloxone sold under the brand name NARCAN. Pet. 1; Paper 8,
`1. Petitioner also filed petitions for inter partes review, challenging the
`other four patents listed. Pet. 6; Paper 4, 1–2.
`According to the parties, Patent Owner asserted all five Orange-Book-
`listed patents in Adapt Pharma Operations Ltd. v. Teva Pharmaceuticals
`USA, Inc., Case 2:16-cv-07721 (D.N.J.) (consolidated, “the Teva Case”),
`and Adapt Pharma Operations Ltd. v. Perrigo UK FINCO Limited
`
`
`1 Wyse et al., U.S. Patent No. 9,192,570 B2, issued November 24, 2015
`(Ex. 1007).
`2 Davies et al., PCT Publication WO 00/62757, published October 26, 2000
`(Ex. 1009).
`
`2
`
`
`
`IPR2019-00695
`Patent No. 9,629,965 B2
`
`Partnership, Case 2:18-cv-15287 (D.N.J.). Pet. 6; Paper 4, 2. Petitioner is
`not involved in those actions. Pet. 6.
`Background of Technology and the ’965 Patent
`Opioid overdose is a crisis in the United States. Ex. 1001, 6:46.
`Naloxone is an opioid receptor antagonist that was initially approved for use
`by injection for the reversal of opioid overdose. Id. at 2:15–16. Naloxone
`hydrochloride injection prevents or reverses the effects of opioids,
`“including respiratory depression, sedation and hypotension.” Ex. 1044,3
`1300.
`
`According to the ’965 patent, administering naloxone via injection
`requires trained medical personnel and imposes the risk of exposure to blood
`borne pathogens through needlestick injury. Ex. 1001, 6:17–38. The
`’965 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
`6:45–49.
`The ’965 patent acknowledges that nasal administration of naloxone
`was known and used by numerous medical services and health departments.
`Ex. 1001, 2:32–6:16; see also id. at 4:42–45 (“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.”). It points out, however,
`
`
`3 Physicians’ Desk Reference 2003, entry for NARCAN (Naloxone
`Hydrochloride Injection, USP).
`
`3
`
`
`
`IPR2019-00695
`Patent No. 9,629,965 B2
`
`although some studies “reported that the nasal administration of naloxone is
`as effective as the intravenous route in opiate addicts,” others “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 2:50–58.
`The ’965 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
`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 6:55–64.
`According to the ’965 patent, its 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 6:66–7:5.
`Illustrative Claims
`Among the challenged claims, claims 1 and 20 are independent, and
`are reproduced below:
`intranasal
`for
`formulation
`A
`pharmaceutical
`1.
`administration comprising, in an aqueous solution of not more
`than about 140 μL:
`about 4 mg naloxone hydrochloride;
`about 0.74 mg NaCl;
`about 0.01 mg benzalkonium chloride;
`
`4
`
`
`
`IPR2019-00695
`Patent No. 9,629,965 B2
`
`
`about 0.2 mg disodium edetate; and
`an amount of hydrochloric acid sufficient to achieve a pH
`of 3.5–5.5.
`20. 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
`comprises per 100 μL of aqueous solution:
`
`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
`preservative;
`
`between about 0.1 mg and about 0.5 mg of a stabilizing
`agent; and
`
`an amount of acid sufficient to achieve a pH of 3.5–5.5.
`Asserted Grounds of Unpatentability
`Petitioner asserts the following grounds of unpatentability:
`Claim(s)
`Basis
`References
`1, 2, 9–12, 17,
`§ 103 Wang,4 Djupesland,5 HPE,6 Bahal,7 and
`20–26
`Kushwaha8
`3–5, 13–16,
`Wang, Djupesland, HPE, Bahal,
`18, 19, 29–30
`Kushwaha, and Wyse
`
`§ 103
`
`
`4 Wang et al., Chinese Patent Publication No. CN 1575795 A, published
`February 9, 2005 (Ex. 1008).
`5 Djupesland, Nasal Drug Delivery Device: Characteristics and
`Performance in a Clinical Perspective - A Review, 3 DRUG DELIV. &
`TRANSL. RES. 42–62 (2013) (Ex. 1010).
`6 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)
`(Ex. 1012).
`7 Bahal et al., U.S. Patent No. 5,866,154, issued February 2, 1999
`(Ex. 1014).
`8 Kushwaha et al., Advances in Nasal Trans-Mucosal Drug Delivery, 01(07)
`J. APPLIED PHARM. Sci. 21–28 (2011) (Ex. 1013).
`5
`
`
`
`IPR2019-00695
`Patent No. 9,629,965 B2
`
`
`Claim(s)
`6–8
`
`Basis
`§ 103
`
`References
`Wang, Djupesland, HPE, Bahal,
`Kushwaha, and Wyse or Wermeling 20139
`Wang, Djupesland, HPE, Bahal,
`Kushwaha, and the ’291 patent10
`In support of its patentability challenge, Petitioner relies on the
`Declarations of Maureen D. Donovan, Ph.D. (Ex. 1002) and Günther
`Hochhaus, Ph.D. (Ex. 1003).
`
`27, 28
`
`§ 103
`
`DISCUSSION
`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 IPR petitions challenging the same claims. In
`IPR2019-00694, we institute an inter partes review of claims 1–30 on the
`grounds presented in the Wyse Petition. See IPR2019-00694, Paper 10.
`Here, however, we agree with Patent Owner that it is appropriate that we
`exercise discretion to deny institution of this Petition because it is redundant
`of the Wyse Petition. See Prelim. Resp. 6–8.
`
`
`9 Wermeling, A Response to the Opioid Overdose Epidemic: Naloxone
`Nasal Spray, 3 DRUG DELIV. & TRANSL. RES. 63–74 (2013) (Ex. 1016).
`10 Wermeling, U.S. Patent No. 8,198,291 B2, issued June 12, 2012
`(Ex. 1015).
`
`6
`
`
`
`IPR2019-00695
`Patent No. 9,629,965 B2
`
`
`Although “there may be circumstances in which more than one
`petition may be necessary,” “one petition should be sufficient to challenge
`the claims of a patent in most situations.” Office Patent Trial Practice
`Guide, July 2019 Update (“TPG July 2019 Update”),11 26. According to the
`TGP July 2019 Update, “[t]wo 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.” Id. (citing 35 U.S.C. § 316(b)).
`The TGP 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).
`At our request (Paper 7), Petitioner filed its Notice, stating we should
`consider the Wyse Petition first, the Davies Petition second, and the instant
`Petition the last. Paper 8, 1. Petitioner, however, asserts that “[d]ue to
`different statutory bases for invalidity, as well as substantive differences in
`
`
`11 84 Fed. Reg. 33,926 (July 16, 2019), available at
`https://www.uspto.gov/TrialPracticeGuide3.
`7
`
`
`
`IPR2019-00695
`Patent No. 9,629,965 B2
`
`the[] three primary references,” we “should institute review for all three
`Petitions.” Id. We are not persuaded.
`Petitioner’s arguments in this Petition are substantially similar to
`those in the Wyse Petition. In both cases, Petitioner relies on HPE,
`Djupesland, 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.
`The two petitions differ mainly in the primary reference Petitioner
`relies on for its obviousness combinations. In the Wyse Petition, Petitioner
`relies on Wyse, whereas here, Petitioner relies on Wang. Petitioner contends
`that “[t]here are numerous differences in the disclosures” of Wyse and
`Wang. Id. at 2. But as Patent Owner points out, the two petitions present
`similar arguments, including in many cases, “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. 15–24. 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. 20. Thus, even for those grounds in this 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],”
`
`8
`
`
`
`IPR2019-00695
`Patent No. 9,629,965 B2
`
`whereas the present Petition “do[es] not rely [on] Wyse for the teaching of
`BAC, but instead for its other teachings.” Paper 8, 2. 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. 48–54,
`with IPR2019-00694 Prelim. Resp. 50–56. Thus, Petitioner cannot escape
`the alleged teaching away in Wyse, which is squarely at issue in this
`proceeding as in the Wyse Petition, merely by “not rely[ing on] Wyse for the
`teaching of BAC.” In fact, Petitioner recognizes this and relies on the same
`“Declaration of Dr. Donovan to support the position that a POSA would not
`have considered Wyse to teach away from the use of BAC” here, just as it
`does in the Wyse Petition.12 Compare Pet. 55–58, with Wyse Pet. 51–54.
`Petitioner asserts that Wyse “anticipates” certain limitations, “while
`Wang does not.” Paper 8, 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 anticipates, however, not a claim limitation, but the claimed
`invention. Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir.
`1983) (“Anticipation requires the presence in a single prior art disclosure of
`
`
`12 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–
`34; Wyse Pet. 33–35.
`
`9
`
`
`
`IPR2019-00695
`Patent No. 9,629,965 B2
`
`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 1–30 of the ’965
`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 8, 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 9, 1. As a result, Petitioner’s argument based on the prior-art status of
`Wyse to justify instituting a second inter partes review here as a precaution
`is moot.
`Petitioner also points out that the Petition relies on a human
`translation of Wang, in contrast to a machine translated version provided
`during prosecution. Paper 8, 2. Petitioner, however, does not point to any
`differences between the translations. Petitioner also does not explain, nor is
`it apparent to us, 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. In any event, Patent Owner also has
`stipulated that for purposes of these proceedings, it will not dispute that
`Wang is prior art. Paper 9, 1. Thus, we are not persuaded that a new
`translation of Wang would justify instituting a second inter partes review
`here.
`
`10
`
`
`
`IPR2019-00695
`Patent No. 9,629,965 B2
`
`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 substantively distinguish the arguments here from
`those in the Wyse Petition. See generally Paper 8, 1–3.
`In sum, having considered the parties’ arguments and evidence in both
`IPR2019-00694 and the present proceeding, we agree with Patent Owner
`that the present 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 ’965 patent on all grounds presented
`in the Wyse Petition (see IPR2019-00694, Paper 10), we exercise our
`discretion under 35 U.S.C. § 314 to deny instituting review of the Petition
`here.
`
`ORDER
`
`Accordingly, it is
`ORDERED that Petitioner’s request for an inter partes review of
`claims 1–30 of the ’965 patent is denied and no inter partes review is
`instituted.
`
`
`
`
`
`
`
`
`
`
`11
`
`
`
`IPR2019-00695
`Patent No. 9,629,965 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
`
`
`
`12
`
`
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