UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ____________
`NALOX-1 PHARMACEUTICALS, LLC,
`Petitioner,
`v.
`OPIANT PHARMACEUTICALS, INC.
`Patent Owner
`____________
`
`IPR2019-00685, IPR2019-00686, and IPR2019-00687
`Patent No. 9,211,253 B2
` ____________
`
`PETITIONER’S NOTICE
`(As Authorized by the Board’s Order Dated June 11, 2019)
`
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ____________
`NALOX-1 PHARMACEUTICALS, LLC,
`Petitioner,
`v.
`OPIANT PHARMACEUTICALS, INC.
`Patent Owner
`____________
`
`IPR2019-00685, IPR2019-00686, and IPR2019-00687
`Patent No. 9,211,253 B2
` ____________
`
`PETITIONER’S NOTICE
`(As Authorized by the Board’s Order Dated June 11, 2019)
`
`
`
`Petitioner Nalox-1 Pharmaceuticals, a pharmaceutical company, is currently
`
`developing, and plans to seek FDA approval to market far in advance of the 2035
`
`patent expiration, a much needed generic version of Narcan® naloxone nasal spray.
`
`The ’253 patent is one of several related Orange Book patents listed for Narcan®
`
`that Petitioner has challenged to remove the barriers to an approved generic naloxone
`
`nasal spray. The ’253 patent claims are invalid, primarily in light of the teachings of
`
`Wyse, Davies, and Wang. Due to different statutory bases for invalidity, as well as
`
`substantive differences in these three primary references, Petitioner filed three
`
`separate, non-redundant, IPR Petitions. The Board should consider the Petitions in
`
`the following order, and for at least the following reasons, the Board should institute
`
`review for all three Petitions:
`
`Primary Reference
`Rank Petition
`1
`IPR2019-00685 Wyse
`2
`IPR2019-00687
`Davies
`3
`IPR2019-00686 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 ’253 patent and relies on Wyse,
`
`A.
`
`which is prior art because the ’253 patent is not entitled to a priority date of March
`
`14, 2014. The other Petitions do not rely on challenging the priority claim.
`
`Petition 1 relies on Wyse, which is prior art under § 102(a)(2). Petitions 2 and
`
`3, on the other hand, rely on primary references Davies and Wang, each of which is
`
`1
`
`
`
`prior art under § 102(a)(1). Patent Owner may seek to remove Wyse as prior art
`
`under an exception under § 102(b)(2), but will be unable to do so for Davies and
`
`Wang under the same exception, as Davies and Wang are prior art under § 102(a)(1)
`
`and can only be removed as prior art if an exception under a separate statutory
`
`section, § 102(b)(1), applies. Instituting each Petition will ensure that Patent Owner
`
`cannot eliminate all instituted Petitions, should it present evidence sufficient to
`
`qualify as an exception for only one category of prior art.
`
`In addition, Petitions 2 and 3 rely on a human translation of Wang, certified
`
`to be true and accurate, while, during prosecution, Patent Owner provided to the
`
`Office only a machine translation. Patent Owner may argue about the materiality of
`
`such differences, and may otherwise seek to disqualify or discredit Wang as prior
`
`art. For these reasons, the Petitions are not redundant.
`
`B.
`
`Differences of Disclosure Between Primary References Renders the
`Petitions Non-Redundant
`There are numerous differences in the disclosures of the three primary
`
`references, such that certain primary references anticipate certain claim limitations
`
`while others do not. For example, Petition 1 relies on Wyse, which Patent Owner
`
`argues teaches away from the use of benzalkonium chloride (BAC). Petition 1 relies
`
`on Wyse as a primary reference and the Declaration of Dr. Donovan to support the
`
`position that a POSA would not have considered Wyse to teach away from the use
`
`2
`
`
`
`of BAC. Petitions 2 and 3 do not rely Wyse for the teaching of BAC, but instead for
`
`its other teachings.
`
`In addition, Wyse and Davies each anticipates the “single-use, pre-primed
`
`device” limitation of claim 1, while Wang does not. Wyse and Wang each anticipates
`
`the “pH of 3.5-5.5” limitation of claim 1, while Davies does not. And Wyse
`
`anticipates the plasma concentration limitations of claims 25–29, while Davies and
`
`Wang do not. Different legal standards apply depending on whether a claim
`
`limitation is anticipated by a single reference, or obvious in view of multiple
`
`references. For this additional reason, the Petitions are not redundant.
`
`The following chart highlights the differences noted above, as well as
`
`additional information the Board may find useful in determining the disposition of
`
`the Petitions.
`
`Wyse
`§ 102(a)(2)
`Publication
`version
`Y
`Y
`
`Wang
`Davies
`§ 102(a)(1) § 102(a)(1)
`Machine
`translation
`N
`N
`
`Y
`N
`Y
`
`Statutory category of primary
`reference
`Was primary reference Cited By
`Patent Owner
`Relies on Wyse for teaching of BAC
`Anticipates “single-use, pre-primed
`device” limitation of claim 1
`Anticipates “pH 3.5-5.5” limitation of
`claim 1
`Anticipates plasma concentration
`limitations of claims 25-29
`The Petitions do not rely on substantially overlapping grounds or theories,
`
`Y
`
`Y
`
`N
`
`N
`
`Y
`
`N
`
`and the Petitioner respectfully requests that the Board institute each Petition.
`
`3
`
`
`
`Dated: June 17, 2019
`
`
`
`/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
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that on this 17th day of June 2019, the foregoing
`
`PETITIONER’S NOTICE was served via e-mail and Federal Express on June 17,
`
`2019 to the following counsel 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
`
`
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