PTAB

IPR2025-00465

Padagis US LLC v. Neurelis Inc

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Administration Of Benzodiazepine Compositions
  • Brief Description: The ’414 patent discloses pharmaceutical solutions for the intranasal administration of benzodiazepine drugs, such as diazepam. The invention is a formulation "consisting of" specific components, including diazepam, tocopherols, a combination of ethanol and benzyl alcohol, and an alkyl glycoside to enhance solubility and bioavailability for treating conditions like seizures.

3. Grounds for Unpatentability

Ground 1: Obviousness over Gwozdz and Meezan - Claims 1-18 are obvious over Gwozdz in view of Meezan.

  • Prior Art Relied Upon: Gwozdz (WO 2009/120933) and Meezan (Application # 2006/0046962).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Gwozdz disclosed all elements of the claimed invention except for the specific alkyl glycoside. Gwozdz taught pharmaceutical solutions for nasal administration containing a benzodiazepine (specifically diazepam), tocopherols (e.g., alpha-tocopherol) in an amount of 30-99% (w/w), and a combination of alcohols including ethanol and benzyl alcohol in an amount of 1-70% (w/w). Meezan taught the use of alkyl glycosides, including the claimed n-dodecyl beta-D-maltoside, as absorption enhancers to increase the bioavailability of drugs administered intranasally. Petitioner contended that the overlapping concentration ranges disclosed in Gwozdz rendered the claimed ranges prima facie obvious. For the dependent claims, Petitioner argued the specific concentrations and components were either directly taught by Gwozdz or would have been arrived at through routine optimization by a person of ordinary skill in the art (POSITA).
    • Motivation to Combine: A POSITA, starting with Gwozdz's formulation for nasally delivering poorly soluble diazepam, would be motivated to improve its performance. Gwozdz itself suggested adding other excipients like "penetration enhancers" to improve efficacy. Petitioner asserted a POSITA would have looked to references like Meezan, which taught that alkyl glycosides were well-known and effective absorption enhancers for intranasal formulations. The goal of increasing absorption and bioavailability for a rapid-onset seizure treatment would provide a clear motivation to incorporate Meezan's enhancer into Gwozdz's base formulation.
    • Expectation of Success: A POSITA would have had a reasonable expectation of success in combining the references. Gwozdz demonstrated a stable and effective solvent system for diazepam, solving the core solubility problem. Meezan showed that alkyl glycosides successfully enhanced nasal absorption for other drugs and were compatible with alcohol-based solvent systems. Therefore, combining a known enhancer with a known solubilized drug formulation was a predictable path to an improved product.
    • Key Aspects: Petitioner heavily relied on the legal doctrine of collateral estoppel, arguing that the Patent Owner was precluded from contesting the key issues of this ground. A prior Final Written Decision (FWD) in IPR2019-00451, which invalidated claims of a parent patent (’876 patent), allegedly resolved the same core issues: the proper priority date of the patent family, the availability of Gwozdz as prior art, and the obviousness of combining Gwozdz with Meezan. Petitioner asserted the claims of the ’414 patent are not materially different from those previously invalidated.

4. Key Claim Construction Positions

  • "vitamin E": For claim 10, which recites a solution consisting of "vitamin E," Petitioner contended the term should be construed according to the patent's express definition at col. 30, ll. 7-10. This definition encompasses "any of the natural or synthetic tocopherols, tocotrienols, any isomers thereof, any esters thereof, any analogs or derivatives thereof, or any combinations thereof." This construction was used to map Gwozdz's disclosure of "tocopherols" and "tocols or vitamin E" to the claimed element.

5. Key Technical Contentions (Beyond Claim Construction)

  • Priority Date Entitlement: Petitioner’s central technical contention was that the ’414 patent was not entitled to the March 28, 2008, priority date of its provisional application (’558 provisional). The petition argued that the ’558 provisional failed to provide adequate written description support for the "alkyl glycoside" and "n-dodecyl beta-D-maltoside" limitation, as this component was essential to the invention but was not mentioned until a later-filed application (’439 application) on March 27, 2009.
  • Relevance: Establishing the later priority date was critical, as it made Gwozdz (which has a priority date of March 28, 2008) available as prior art under pre-AIA 35 U.S.C. §102(e). This issue was also decided against the Patent Owner in the related IPR2019-00451.

6. Arguments Regarding Discretionary Denial

  • §325(d): Petitioner argued against discretionary denial under §325(d), asserting that the Examiner committed a material error during prosecution. Specifically, the Examiner incorrectly determined that the ’414 patent was entitled to the 2008 priority date of the ’558 provisional. This error led the Examiner to improperly disqualify Gwozdz as prior art, meaning the obviousness combination presented in the petition was never substantively considered on its merits.
  • Fintiv Factors: To avoid discretionary denial under Fintiv, Petitioner stipulated that if the Board institutes the inter partes review (IPR), it will not pursue in a parallel district court proceeding the same grounds raised in the petition or any grounds that could have reasonably been raised.

7. Relief Requested

  • Petitioner requested institution of an IPR and cancellation of claims 1-18 of Patent 11,241,414 as unpatentable.