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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.
`____________
`
`IPR2019-00688, IPR2019-00689, and IPR2019-00690
`Patent No. 9,468,747 B2
` ____________
`
`PETITIONER’S NOTICE
`(As Authorized by the Board’s Order Dated August 1, 2019)
`
`
`
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`
`
`Petitioner Nalox-1 Pharmaceuticals, a pharmaceutical company, is currently
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`developing, and plans to seek FDA approval to market a much needed generic
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`version of Narcan® naloxone nasal spray far in advance of the 2035 patent
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`expiration. The ’747 patent is one of several related Orange Book patents listed for
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`Narcan® that Petitioner has challenged to remove the barriers to an approved generic
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`naloxone nasal spray. The ’747 patent claims are invalid, primarily in light of the
`
`teachings of Wyse, Davies, and Wang. Due to different statutory bases for invalidity,
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`as well as substantive differences in these three primary references, Petitioner filed
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`three separate, non-redundant, IPR Petitions. The Board should consider the
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`Petitions in the following order, and for at least the following reasons, the Board
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`should institute review for all three Petitions:
`
`Primary Reference
`Rank Petition
`1
`IPR2019-00688 Wyse
`2
`IPR2019-00690
`Davies
`3
`IPR2019-00689 Wang
`Statutory Bases for Invalidity and Different Version of Wang Used
`in Petitions Render the Petitions Non-Redundant
`Petition 1 challenges the priority claim of the ’747 patent and relies on Wyse,
`
`
`A.
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`which is prior art because the ’747 patent is not entitled to a priority date of March
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`14, 2014. The other Petitions do not rely on challenging the priority claim.
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`Petition 1 relies on Wyse, which is prior art under § 102(a)(2). Petitions 2 and
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`3, on the other hand, rely on primary references Davies and Wang, each of which is
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`
`
`1
`
`
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`prior art under § 102(a)(1). Patent Owner may seek to remove Wyse as prior art
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`under an exception under § 102(b)(2), but will be unable to do so for Davies and
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`Wang under the same exception, as Davies and Wang are prior art under § 102(a)(1)
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`and can only be removed as prior art if an exception under a separate statutory
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`section, § 102(b)(1), applies. Instituting each Petition will ensure that Patent Owner
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`cannot eliminate all instituted Petitions, should it present evidence sufficient to
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`qualify as an exception for only one category of prior art.
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`In addition, Petitions 2 and 3 rely on a human translation of Wang, certified
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`to be true and accurate, while, during prosecution, Patent Owner provided to the
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`Office only a machine translation. Patent Owner may argue about the materiality of
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`such differences, and may otherwise seek to disqualify or discredit Wang as prior
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`art. For these reasons, the Petitions are not redundant.
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`B. Differences of Disclosure Between Primary References Renders the
`Petitions Non-Redundant
`There are numerous differences in the disclosures of the three primary
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`references, such that certain primary references anticipate certain claim limitations
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`while others do not. For example, Petition 1 relies on Wyse, which Patent Owner
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`argues teaches away from the use of benzalkonium chloride (BAC). Petition 1 relies
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`on Wyse as a primary reference and the Declaration of Dr. Donovan to support the
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`position that a POSA would not have considered Wyse to teach away from the use
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`
`
`2
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`
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`of BAC. Petitions 2 and 3 do not rely Wyse for the teaching of BAC, but instead for
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`its other teachings.
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`In addition, Wyse and Wang each anticipate the “pH of 3.5-5.5” limitation of
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`claims 1 and 30, while Davies does not. Wyse and Davies each anticipates the
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`“single-use, pre-primed device” limitation of claim 1, while Wang does not. And
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`Wyse anticipates the “between about 0.2 mg and about 1.2 mg of an isotonicity
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`agent” of claims 1 and 30, and the plasma concentration limitations of claims 15,
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`25-29, and 34-45, while Davies and Wang do not. Different legal standards apply
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`depending on whether a claim limitation is anticipated by a single reference, or
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`obvious in view of multiple references. Therefore, the Petitions are not redundant.
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`The following highlights these differences, as well as additional information
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`the Board may find useful in determining the disposition of the Petitions.
`
`Wang
`Davies
`Wyse
`§102(a)(2) §102(a)(1) §102(a)(1)
`Machine
`Y
`Y
`translation
`Y
`N
`N
`Y
`N
`Y
`Y
`Y
`N
`
`
`Statutory category of primary reference
`Was primary reference cited
`Relies on Wyse for teaching of BAC
`Anticipates “pH of 3.5-5.5” (claims 1, 30)
`Anticipates “single-use, pre-primed
`device” limitation (claim 1)
`Anticipates “about 0.2 mg and about 1.2
`of an isotonicity agent” (claims 1, 30)
`Anticipates plasma concentration
`limitations (claims 15, 25-29, 34-45)
`The Petitions do not rely on substantially overlapping grounds or theories,
`
`Y
`
`Y
`
`N
`
`N
`
`N
`
`N
`
`
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`and the Petitioner respectfully requests that the Board institute each Petition.
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`
`
`3
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`
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`Dated: August 5, 2019
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`
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`
`
`/s/ Yelee Y. Kim
`
`Dr. Yelee Y. Kim
`Reg. No. 60,088
`ARENT FOX LLP
`1717 K Street NW
`Washington D.C. 20006
`Telephone: (202) 857-6000
`Fax: (202) 857-6395
`yelee.kim@arentfox.com
`
`Attorney for Petitioner
`
`
`
`4
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`CERTIFICATE OF SERVICE
`
`The undersigned certifies that on this 5th day of August 2019, the foregoing
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`
`
`PETITIONER’S NOTICE was served via electronic mail on the following counsel
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`of record for Patent Owner:
`
`Robert F. Green
`Jessica Tyrus Mackay
`Green, Griffith & Borg-Breen LLP
`676 North Michigan Avenue
`Suite 3900
`Chicago, IL 60611
`rgreen@greengriffith.com
`jmackay@greengriffith.com
`
`
`
`
`
`
`
`/s/ Yelee Y. Kim
`
`Dr. Yelee Y. Kim
`Reg. No. 60,088
`ARENT FOX LLP
`1717 K Street NW
`Washington D.C. 20006
`Telephone: (202) 857-6000
`Fax: (202) 857-6395
`yelee.kim@arentfox.com
`
`Attorney for Petitioner
`
`4
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