Aquestive Therapeutics, Inc. v. Iono Pharma, LLC

Aquestive Therapeutics, Inc. v. Iono Pharma, LLC, IPR2025-00874, involves a challenge to the validity of U.S. Patent No. 11,021,437 at the Patent Trial and Appeal Board (PTAB). Aquestive Therapeutics is a specialty pharmaceutical company focused on developing and commercializing medicines using innovative delivery technologies, including oral films, for conditions such as neurological disorders and severe allergic reactions. Their pipeline includes Anaphylm™ (dibutepinephrine) sublingual film, a no-needle, no-device epinephrine product candidate for anaphylaxis. Iono Pharma, LLC, the patent owner, is described as a "deadpooled" company founded in 2015 that develops drug delivery technologies, particularly for pediatric diseases, and has been seeking funding for novel epinephrine prodrugs, including "Epi Relief Strips™." Given Iono Pharma's description, it operates more as a patent holding or research entity rather than a fully operational pharmaceutical manufacturer, potentially functioning as a Patent Assertion Entity (PAE).

The sole patent at issue, US Patent No. 11,021,437, titled "Pharmaceutical formulation for sublingual or buccal delivery of epinephrine or a pro-drug thereof," describes pharmaceutical compositions, often in the form of rapidly dissolving films, designed for the sublingual or buccal administration of epinephrine or an epinephrine prodrug to treat anaphylaxis. This patent's focus on non-invasive epinephrine delivery via oral films directly overlaps with Aquestive's Anaphylm™ product candidate, suggesting that Aquestive initiated the IPR to clear a path for its own product by challenging the validity of Iono Pharma's patent.

The case's procedural posture is an Inter Partes Review (IPR) at the Patent Trial and Appeal Board. Aquestive Therapeutics filed the petition challenging claims 1-3 of the '437 patent as obvious. However, the PTAB exercised its discretion and denied institution of the IPR. This denial is particularly notable in the current climate of PTAB proceedings, where discretionary denials have become more frequent, often influenced by factors such as "settled expectations" of the patent owner or the existence of parallel district court litigation, making it more challenging for petitioners to successfully initiate an IPR. The denial means Aquestive cannot use the PTAB to challenge the patent's validity and may have to address any potential infringement claims in a district court setting, which typically involves a higher burden of proof for invalidity.

PTAB Inter Partes Review IPR2025-00874: Aquestive Therapeutics, Inc. v. Iono Pharma, LLC

The case presented, IPR2025-00874, is an Inter Partes Review (IPR) proceeding before the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO), not a district court patent infringement litigation. As such, many of the typical milestones of patent infringement litigation—such as filing a complaint and answer, pre-trial motions to dismiss or transfer, Markman hearings for claim construction in a judicial setting, discovery milestones, trial, verdict, and appeals to the Federal Circuit from a district court judgment—do not apply directly to this PTAB proceeding.

The primary legal developments in this case are confined to the IPR process, which was initiated to challenge the validity of a patent.

Key Legal Developments and Outcome:

• Filing of IPR Petition (2025-05-16): Aquestive Therapeutics, Inc. filed an IPR petition, IPR2025-00874, challenging the validity of claims 1-3 of U.S. Patent No. 11,021,437. The petition alleged that these claims were unpatentable as obvious, citing "Truelove art for prodrug half-life combined with Almoazen film delivery." The '437 patent is owned by Iono Pharma, LLC.

• Patent Owner Preliminary Response and Discretionary Denial Request (2025-08-18 & 2025-09-18): Iono Pharma, LLC, as the Patent Owner, likely filed a preliminary response to the petition, and a request for discretionary denial of institution, as indicated by the "PO DD Request" (Patent Owner Discretionary Denial Request) and "PO Preliminary Response" entries in the docket.

• Institution Decision (2025-10-03): The Patent Trial and Appeal Board issued a decision on the institution of the IPR. The Board exercised its discretion and denied institution of the IPR. The status of the IPR is noted as "Discretionary Denial" or "Not Instituted - Procedural." While the specific reasons for the discretionary denial in this IPR are not detailed in the provided search results, such denials often occur under the PTAB's application of Fintiv factors, which consider the status of parallel district court litigation, among other things.

Absence of Identified Parallel District Court Patent Infringement Litigation:

Searches for district court patent infringement litigation involving Aquestive Therapeutics, Inc. and Iono Pharma, LLC, specifically concerning U.S. Patent No. 11,021,437, did not yield any direct results. While discretionary denials in IPRs frequently relate to co-pending district court litigation, no such corresponding patent infringement case between these specific parties and for this patent was found to be publicly reported in the provided search results. Therefore, events such as the filing of a complaint, answer, counterclaims, Markman hearings, discovery, trial, verdict, or appeals in a district court setting are not applicable to the IPR itself, and no related district court patent infringement litigation involving these parties and patent has been identified.

Aquestive Therapeutics, Inc. has been involved in other legal matters, including a securities fraud class action lawsuit (e.g., Modica v. Aquestive Therapeutics, Inc., No. 3:26-cv-02317 (D.N.J.), filed March 5, 2026) related to its Anaphylm drug application and FDA approval, and a past patent infringement settlement concerning SUBOXONE® Sublingual Film with different parties (Par Pharmaceuticals and IntelGenx in 2018). However, these cases are unrelated to IPR2025-00874 and the '437 patent.

Aquestive Therapeutics, Inc. is represented by Hoffmann & Baron, LLP, with the following attorneys of record in IPR2025-00874:

• Daniel A. Scola, Jr. - Partner and Managing Partner.

  • Firm: Hoffmann & Baron, LLP, with offices in Syosset, NY, Parsippany, NJ, and Washington D.C. He specifically manages the chemical, pharmaceutical/biochemical, and medical device practice group in the New Jersey office.
  • Experience: Mr. Scola has extensive experience in polymers, pharmaceuticals, and medical devices, specializing in building IP portfolios and designing strategies to protect and enhance company value. He extensively practices in Post Grant Proceedings at the USPTO, including Inter Partes Review (IPR) and Post Grant Review (PGR), and has argued Post Grant Proceedings at the appellate level before the U.S. Court of Appeals for the Federal Circuit. He was previously Counsel for patents and trademarks and Assistant Corporate Secretary at The Warner-Lambert Co.

• Michael I. Chakansky - Partner.

  • Firm: Hoffmann & Baron, LLP, with offices in Syosset, NY, Parsippany, NJ, and Washington D.C.
  • Experience: Mr. Chakansky is an experienced patent attorney with diverse experience in all aspects of intellectual property, including patent litigation, licensing, prosecution, and post-grant proceedings. He is admitted to practice before the U.S. Court of Appeals for the Federal Circuit and is registered with the USPTO.

• John T. Gallagher - Partner.

  • Firm: Hoffmann & Baron, LLP, based out of the Syosset, NY office.
  • Experience: Mr. Gallagher's practice focuses on patent infringement, antitrust, trade secret, and unfair competition disputes. He serves as lead trial counsel in federal district courts, before the U.S. International Trade Commission, and in post-grant review proceedings before the U.S. Patent and Trademark Office. He has also been lead appellate counsel in matters before the U.S. Court of Appeals for the Federal Circuit.

Here is the counsel of record representing Iono Pharma, LLC, the defendant in IPR2025-00874:

Desmarais LLP

• Yung-Hoon Ha

  • Role: Counsel
  • Firm & Office Location: Desmarais LLP (office location likely New York, NY, given the firm's primary presence).
  • Relevant Patent Litigation Experience: Yung-Hoon Ha is a partner at Desmarais LLP and has significant experience in patent litigation. The firm generally specializes in high-stakes intellectual property disputes, often representing clients in the pharmaceutical and technology sectors.

• Laura Avena

  • Role: Counsel
  • Firm & Office Location: Desmarais LLP (office location likely New York, NY).
  • Relevant Patent Litigation Experience: Laura Avena is an attorney at Desmarais LLP, a firm known for its work in patent litigation.