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Aquestive Therapeutics, Inc. formerly Monosol RX, LLC v. Neurelis, Inc.

Docket IPR2019-00450, Patent Trial and Appeal Board (Jan. 29, 2019)
Jamie Wisz, Jon Tornquist, Zhenyu Yang, presiding
Case TypeInter Partes Review
Patent
9763876
Orange Book Patent
9763876
Patent Owner Neurelis, Inc.
Petitioner Aquestive Therapeutics, Inc. formerly Monosol RX, LLC
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Aquestive Therapeutics, Inc. formerly Monosol RX, LLC v. Neurelis, Inc.

Docket IPR2019-00449, Patent Trial and Appeal Board (Jan. 28, 2019)
Jamie Wisz, Jon Tornquist, Zhenyu Yang, presiding
Case TypeInter Partes Review
Patent
9763876
Orange Book Patent
9763876
Patent Owner Neurelis, Inc.
Petitioner Aquestive Therapeutics, Inc. formerly Monosol RX, LLC
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Aquestive Therapeutics, Inc. formerly Monosol RX, LLC v. Neurelis, Inc.

Docket IPR2019-00451, Patent Trial and Appeal Board (Jan. 29, 2019)
Jamie Wisz, Jon Tornquist, Zhenyu Yang, presiding
Case TypeInter Partes Review
Patent
9763876
Orange Book Patent
9763876
Patent Owner Neurelis, Inc.
Petitioner Aquestive Therapeutics, Inc. formerly Monosol RX, LLC
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44 Termination Decision Document: Termination Decision Document

Document IPR2019-00451, No. 44 Termination Decision Document - Termination Decision Document (P.T.A.B. Aug. 6, 2020)
First, Patent Owner, with supporting testimony from Dr. Gizurarson, asserts that “the formulation of a benzodiazepine for intranasal administration is a difficult and complex science requiring a higher skill set and knowledge than a POSA with a bachelor’s degree ‘with several years of experience.’” Id. at 15 (citing Ex. 2012 ¶¶ 28–29).
Specifically, according to Patent Owner and Dr. Gizurarson, “the POSA would be working against physiological constraints of active ingredient uptake due to the nasal anatomy, as well as the very low solubility of benzodiazepines in formulating the pharmaceutical composition disclosed in the ’876 patent.” Id. at 15–16 (citing Ex. 2012 ¶¶ 28–29).
In order to satisfy the written description requirement, the blaze marks directing the skilled artisan to that tree must be in the originally filed disclosure.”); Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996) (“In the absence of such blazemarks, simply describing a large genus of compounds
Motivation to combine/reasonable expectation of success Petitioner argues that, since neither Gwozdz nor Meezan ’962 provide specific dosing regimens for benzodiazepines/diazepam, one of ordinary skill in the art would look to the similar reference of Cartt ’784, titled “Nasal Administration of Benzodiazepines,” for these teachings.
On this record, and upon review of Petitioner’s arguments and supporting evidence, we determine that Petitioner sufficiently explains why one of ordinary skill in the art would have looked to Cartt ’784’s disclosure when seeking dosing regimens for the compositions disclosed in Gwozdz and Meezan ’962, and would have had a reasonable expectation of success in achieving the claimed invention.
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43 Hearing Transcript: Hearing Transcript

Document IPR2019-00451, No. 43 Hearing Transcript - Hearing Transcript (P.T.A.B. May. 27, 2020)

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36 Order: Order Trial Hearing

Document IPR2019-00451, No. 36 Order - Order Trial Hearing (P.T.A.B. Apr. 23, 2020)

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12 Refund Approval: Notice of Refund

Document IPR2019-00449, No. 12 Refund Approval - Notice of Refund (P.T.A.B. Nov. 18, 2019)

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10 Refund Approval: Notice of Refund

Document IPR2019-00450, No. 10 Refund Approval - Notice of Refund (P.T.A.B. Nov. 18, 2019)

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