Fusion Pharmaceuticals, Inc. v. European Atomic Energy Community Euratom et al.

This case, IPR2023-00551, involved Fusion Pharmaceuticals, Inc. challenging a patent owned by the European Atomic Energy Community Euratom and Universität Heidelberg before the Patent Trial and Appeal Board (PTAB). Fusion Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company based in Canada, specializing in the development of targeted alpha-particle radiotherapies for cancer treatment. Notably, Fusion Pharmaceuticals was acquired by AstraZeneca in June 2024 for approximately $2.4 billion, underscoring the value of its radiopharmaceutical pipeline. The European Atomic Energy Community (Euratom) is an international organization established to foster the development of a civil nuclear industry in Europe, engaging in nuclear research and setting safety standards. Universität Heidelberg is a public research university in Germany, involved in this case as a patent owner, likely through its research activities.

The patent at issue is U.S. Patent No. 10,980,901, titled "Treatment of PMSA expressing cancers." This patent broadly covers methods for treating prostate-specific membrane antigen (PSMA)-expressing cancers by administering specific dosages of Actinium-225 (Ac-225) radiopharmaceuticals. While IPRs do not involve an "accused product" in the traditional infringement sense, the subject matter of the patent directly relates to Fusion's drug candidate, FPI-2265, an actinium-225-based targeted radiotherapy for PSMA-expressing cancers. The procedural posture of the case was an Inter Partes Review (IPR) filed by Fusion Pharmaceuticals at the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office. The PTAB is an administrative body within the USPTO that conducts trials regarding the patentability of claims in an issued patent, and its proceedings are managed through the Patent Trial and Appeal Case Tracking System (P-TACTS).

The case is particularly notable because it concluded in a settlement that transformed a patent dispute into a significant collaboration. Following the institution of the IPR in August 2023, Fusion Pharmaceuticals, Inc. entered into an exclusive worldwide license agreement with Heidelberg University and Euratom for the '901 patent. Under the terms of this agreement, Fusion gained exclusive rights to develop, manufacture, and commercialize compounds covered by the patent, including FPI-2265, for an upfront fee of €1.0 million, along with potential regulatory milestones and low single-digit royalties on future net sales. This resolution highlights the strategic use of IPRs in clearing intellectual property hurdles for promising therapeutic technologies, particularly in the rapidly evolving field of targeted alpha radiotherapies for oncology. The subsequent acquisition of Fusion by AstraZeneca further emphasizes the commercial and medical importance of the technologies involved in this patent dispute.

Key Legal Developments and Outcome for IPR2023-00551

The Inter Partes Review (IPR) proceeding, IPR2023-00551, was initiated by Fusion Pharmaceuticals, Inc. against the European Atomic Energy Community Euratom and Universität Heidelberg concerning U.S. Patent No. 10,980,901. This IPR ultimately concluded with a settlement between the parties.

Chronological Developments:

• 2023-02-13: Fusion Pharmaceuticals, Inc. filed the IPR petition, IPR2023-00551, challenging U.S. Patent No. 10,980,901.
• August 2023: The Patent Trial and Appeal Board (PTAB) instituted the IPR, agreeing to review the patentability of claims challenged in the petition.
• 2024-02-16: Fusion Pharmaceuticals, Inc., Heidelberg University, and Euratom announced an exclusive worldwide license agreement for compounds covered by U.S. Patent No. 10,980,901, including FPI-2265. Concurrent with this agreement, the parties signed an agreement to settle their dispute related to the IPR.
• Settlement and Termination: As a direct result of the settlement agreement, the IPR proceeding, IPR2023-00551, was terminated. While the exact termination date on the PTAB docket isn't specified in the provided search results, the public announcement of the settlement on February 16, 2024, indicates the effective end of the IPR dispute. The USPTO's Open Data Portal lists "Terminated-Settled" as a possible trial status for IPRs, confirming this type of resolution for such proceedings.

Outcome:

The IPR did not proceed to a final written decision. Instead, the parties reached a settlement. The settlement was part of a broader deal where Fusion Pharmaceuticals obtained an exclusive worldwide license to the patent at issue (US 10,980,901) from Heidelberg University and Euratom. This outcome allowed Fusion to continue the development and commercialization of its actinium-based PSMA targeted radiotherapy, FPI-2265, for prostate cancer, while resolving the patentability challenge raised in the IPR.

Fusion Pharmaceuticals, Inc. was represented by counsel from Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, and Foley & Lardner LLP in the IPR proceeding.

Here are the details for the counsel of record:

• Michael J. Flibbert

  • Role: Lead Counsel
  • Firm: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Washington, DC office.
  • Note: Mr. Flibbert has over 20 years of patent litigation experience, specializing in IPRs before the PTAB, district court litigations, and Federal Circuit appeals. He represents clients in pharmaceutical, biotechnology, chemistry, and materials science cases, and has specific experience with Hatch-Waxman Act litigations. He served as lead counsel for patent owner AstraZeneca in IPRs related to Zomig® Nasal Spray, leading to non-institution decisions.

• Stephen B. Maebius

  • Role: Of Counsel (Partner)
  • Firm: Foley & Lardner LLP, Washington, DC office.
  • Note: Mr. Maebius is a partner and intellectual property lawyer with over 30 years of experience. He leads teams handling various IP work, including IP due diligence, opinions, patent portfolio management, licensing, and litigation with parallel inter partes reviews. He previously served as a patent examiner in the Biotechnology Group of the U.S. Patent & Trademark Office. He also acted as lead counsel in the successful defense of six IPRs against a family of Orange Book-listed pharmaceutical patents.

• Eric J. Fues

  • Role: Counsel
  • Firm: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Washington, DC office.
  • Note: Mr. Fues has over 30 years of litigation experience, serving as lead counsel in high-stakes intellectual property disputes in federal court, the ITC, and on appeal to the Federal Circuit. He also has significant experience with pharmaceutical patent litigation under the Hatch-Waxman Act and in IPR proceedings before the PTAB.

The defendants in IPR2023-00551, European Atomic Energy Community Euratom and Universität Heidelberg, were represented by counsel from Finnegan, Henderson, Farabow, Garrett & Dunner LLP.

Here's a breakdown of the identified counsel:

Firm: Finnegan, Henderson, Farabow, Garrett & Dunner LLP

• Office Location: Washington, D.C. (Finnegan also has offices in Atlanta, Boston, London, Munich, Palo Alto, Reston, Seoul, Shanghai, Taipei, and Tokyo).
• Relevant Experience: Finnegan is a leading intellectual property law firm with a strong track record in complex patent litigation before the PTAB, as well as district and federal courts. They have a deep bench of technically sophisticated attorneys, with many holding advanced scientific degrees. The firm has extensive experience representing both petitioners and patent owners in post-grant review proceedings.