ITM Isotope Technologies Munich SE v. The Johns Hopkins University

ITM Isotope Technologies Munich SE, a radiopharmaceutical biotech company specializing in developing precision therapeutics and diagnostics for challenging tumors, initiated a Post-Grant Review (PGR) against The Johns Hopkins University. The Johns Hopkins University, a renowned research institution, actively manages and licenses intellectual property generated by its researchers, often focusing on advancements in cancer treatment. The patent central to this PGR is U.S. Patent No. 11,938,201. While a direct abstract for this specific U.S. patent was not explicitly provided in search results, related international patent applications describe the technology as concerning "imaging and radiotherapeutics agents targeting fibroblast-activation protein-α (FAP-α) and their use in imaging and treating FAP-α related diseases and disorders." This technology operates within the high-value domain of precision oncology and theranostics, an area of significant strategic importance to ITM.

The proceeding was conducted before the Patent Trial and Appeal Board (PTAB), an administrative tribunal of the U.S. Patent and Trademark Office. A PGR is a specific type of PTAB trial that allows a third party to challenge the patentability (validity) of claims in a newly issued patent on broad grounds, including novelty, obviousness, written description, enablement, indefiniteness, or eligible subject matter, provided the petition is filed within nine months of the patent's grant. This venue is often sought as a potentially faster and less expensive alternative to challenging patent validity in federal district court. The case, identified as PGR2025-00012, was filed on December 24, 2024, and concluded with a settlement on October 16, 2025. The PTAB panel adjudicating this matter included Administrative Patent Judges Jeffrey N. Fredman and James A. Worth.

This case is notable due to the significant commercial landscape of radiopharmaceuticals for cancer treatment, a rapidly expanding sector of precision medicine. The swift settlement, occurring less than a year after the petition was filed, suggests that the parties reached a mutually agreeable resolution relatively early in the PTAB process, prior to a final written decision. Furthermore, U.S. Patent No. 11,938,201 appears to be part of a broader intellectual property dispute, as it is identified as a benefit-claiming patent for U.S. Patent No. 12,115,233 (which is also subject to another PGR, PGR2025-00065). Additionally, the '201 patent was involved in an Inter Partes Review (IPR2025-00808) initiated by GE Healthcare Ltd. that was procedurally terminated, indicating ongoing challenges to the underlying technology by multiple industry players.

The Post-Grant Review (PGR) proceeding, ITM Isotope Technologies Munich SE v. The Johns Hopkins University, Case No. PGR2025-00012, concerned U.S. Patent No. 11,938,201. The case, filed at the Patent Trial and Appeal Board (PTAB) on December 24, 2024, concluded in a settlement and was terminated on October 16, 2025.

Here is a chronological overview of the key legal developments and outcome:

• Patent Issuance: U.S. Patent No. 11,938,201 was issued on March 6, 2024.
• PGR Petition Filing (2024-12-24): ITM Isotope Technologies Munich SE initiated the Post-Grant Review by filing a petition challenging the patentability of U.S. Patent No. 11,938,201. The petition was filed within nine months of the patent's issuance, a requirement for PGR eligibility.
• Patent Owner's Preliminary Response and Discretionary Denial Request (2025-04-28): The Johns Hopkins University, as the Patent Owner, filed its preliminary response along with a brief requesting discretionary denial of the PGR institution.
• Petitioner's Objections to Evidence (2025-05-08): ITM Isotope Technologies Munich SE filed objections to evidence presented by The Johns Hopkins University in support of its preliminary response and discretionary denial arguments.
• Director's Decision on Discretionary Denial (2025-06-25): The Acting Director of the United States Patent and Trademark Office issued a decision denying the Patent Owner's request for discretionary denial of institution. The Director noted that the petition was filed early in the patent's life, which favors robust patent rights and weighs against discretionary denial. Consequently, the petition was referred back to the Board for a merits-based institution decision.
• PGR Institution Decision (2025-07-16): The PTAB instituted the Post-Grant Review proceeding, meaning the Board determined that the petition met the threshold requirements to proceed to trial. For PGRs, the threshold for institution is typically a determination that it is "more likely than not that at least one of the claims challenged in the petition is unpatentable."
• Parallel IPR Termination (2025-07-23): A separate inter partes review (IPR) proceeding, IPR2025-00808, filed by GE Healthcare Ltd. against the same patent (11938201) and Patent Owner (The Johns Hopkins University), was procedurally terminated. This termination occurred shortly after the institution of PGR2025-00012.
• Settlement and Termination (2025-10-16): The PGR proceeding was resolved through a settlement agreement between ITM Isotope Technologies Munich SE and The Johns Hopkins University. As a result of the settlement, the PTAB terminated the case on October 16, 2025.

Parallel PTAB Proceedings:
Beyond the PGR2025-00012, The Johns Hopkins University was also involved in another PGR proceeding initiated by ITM Isotope Technologies Munich SE, specifically PGR2025-00065, filed on July 15, 2025, which challenged U.S. Patent No. 12,115,233. This patent is identified as related to the '201 patent at issue in PGR2025-00012.

The plaintiff, ITM Isotope Technologies Munich SE, was represented by counsel from the firm Sterne, Kessler, Goldstein & Fox PLLC.

The counsel identified for ITM Isotope Technologies Munich SE in this Post-Grant Review (PGR) proceeding (PGR2025-00012) is:

• Name: David Kohn
• Role: Petitioner Counsel (presumably lead counsel, given the "et al." implying others may be involved but he is listed first).
• Firm: Sterne, Kessler, Goldstein & Fox PLLC
• Office Location: Washington, DC
• Notable Experience: While the specific search results for this case did not detail his experience, Sterne, Kessler, Goldstein & Fox PLLC is a well-known intellectual property law firm frequently involved in PTAB proceedings. Another document related to a different PGR case (PGR2025-00059) involving The Johns Hopkins University, mentions Sterne, Kessler, Goldstein & Fox PLLC as representing the Patent Owner, Eldora L. Ellison, in that separate matter. This indicates the firm's regular involvement in patent litigation, particularly before the PTAB.

The Johns Hopkins University was represented by attorneys from Sterne, Kessler, Goldstein & Fox PLLC in PGR2025-00012. This firm also represented Johns Hopkins in a related PGR proceeding (PGR2025-00059) involving a patent that claims benefit from the patent at issue in PGR2025-00012.

The identified counsel are:

• Eldora L. Ellison (Lead Counsel)

  • Firm: Sterne, Kessler, Goldstein & Fox PLLC, Washington, DC.
  • Note: Ms. Ellison is a Director at Sterne Kessler and co-chair of the firm's PTAB practice. She focuses on post-grant proceedings and appeals, with experience in biotechnology and pharmaceutical patent litigation.

• Olga A. Partington (Back-up Counsel)

  • Firm: Sterne, Kessler, Goldstein & Fox PLLC, Washington, DC.
  • Note: Ms. Partington is a Director at Sterne Kessler, specializing in PTAB trials and patent prosecution, particularly in the biotechnology and pharmaceutical fields.

• Christina E. Dashe (Back-up Counsel)

  • Firm: Sterne, Kessler, Goldstein & Fox PLLC, Washington, DC.
  • Note: Ms. Dashe is a Director at Sterne Kessler whose practice focuses on patent litigation, including PTAB proceedings, in various technology areas such as biotechnology and pharmaceuticals. She has been noted for her work in design patent cases.