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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`NALOX-1 PHARMACEUTICALS, LLC,
`Petitioner,
`v.
`ADAPT PHARMA LIMITED, and
`OPIANT PHARMACEUTICALS, INC.
`Patent Owner
`____________
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`IPR2019-00691, IPR2019-00692, and IPR2019-00693
`Patent No. 9,561,177 B2
` ____________
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`PETITIONER’S NOTICE
`(As Authorized by the Board’s Order Dated July 30, 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 ’177 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 ’177 patent claims are invalid, primarily in light of the
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`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:
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`Primary Reference
`Rank Petition
`1
`IPR2019-00691 Wyse
`2
`IPR2019-00693
`Davies
`3
`IPR2019-00692 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 ’177 patent and relies on Wyse,
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`A.
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`which is prior art because the ’177 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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`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 Davies each anticipates the “pre-primed device”
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`limitation of independent claims 1, 12, and 22, while Wang does not. Wyse and
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`Wang each anticipate the “pH between about 3.5 and about 5.5” limitation of claims
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`3 and 25, while Davies does not. And Wyse anticipates the plasma concentration
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`limitations of claims 10, 11, 16, 22, and 28, while Davies and Wang do not. Different
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`legal standards apply depending on whether a claim limitation is anticipated by a
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`single reference, or obvious in view of multiple references. For this additional
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`reason, 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.
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`Wang
`Davies
`Wyse
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`Statutory category of primary reference § 102(a)(2) § 102(a)(1) § 102(a)(1)
`Machine
`Was primary reference cited
`Y
`Y
`translation
`Relies on Wyse for teaching of BAC
`Y
`N
`N
`Anticipates “pre-primed device”
`Y
`Y
`N
`limitation (claims 1, 12, 22)
`Anticipates “pH between about 3.5 and
`about 5.5” (claims 3, 25)
`Anticipates plasma concentration
`limitations (claims 10, 11, 16, 22, 28)
`The Petitions do not rely on substantially overlapping grounds or theories,
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`Y
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`Y
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`N
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`N
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`Y
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`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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`Dated: August 5, 2019
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`/s/ Yelee Y. Kim
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`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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`CERTIFICATE OF SERVICE
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`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:
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`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
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`/s/ Yelee Y. Kim
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`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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