Litigation

Bicara Therapeutics Inc v. Johns Hopkins University

pending

PGR2026-00025

Filed
2026-02-10

Patents at issue (1)

Plaintiffs (1)

Defendants (1)

Summary

Bicara Therapeutics Inc initiated a Post-Grant Review challenging US patent 12295968, asserting a §112 invalidity challenge on all nine claims for lack of written description, enablement, and indefiniteness.

Case overview & background

Plain-language overview of the case: parties, accused product, patents at issue, and why the suit matters.

Bicara Therapeutics Inc., a clinical-stage biopharmaceutical company focused on developing bifunctional therapies for solid tumors, has initiated a Post-Grant Review (PGR) against Johns Hopkins University. Johns Hopkins University is a prominent research institution known for its extensive research across various fields, including biomedical sciences, and it actively engages in intellectual property protection and licensing of its inventions. The specific technology at issue is US patent 12295968, which is described as a cancer fusion protein patent.

The case, PGR2026-00025, is currently pending before the United States Patent and Trademark Office (USPTO) Patent Trial and Appeal Board (PTAB). Bicara Therapeutics is challenging all nine claims of US patent 12295968, asserting invalidity under 35 U.S.C. §112 for lack of written description, enablement, and indefiniteness. In a Post-Grant Review, the focus is on the patentability of the claims themselves, rather than an accused infringing product or service. Therefore, there is no "accused product, service, or technology" in the context of an infringement claim, but rather the patent claims themselves are under scrutiny for validity.

This PGR proceeding is notable as it involves a challenge to a university-owned patent by a biopharmaceutical company, which highlights the increasing scrutiny of foundational patents in the biotechnology and pharmaceutical sectors. The PTAB has shown a tendency to favor the institution of PGR petitions due to their short filing window and proximity to the original examination, making them a significant avenue for challenging patent validity early in a patent's life. The outcome could have implications for Johns Hopkins University's patent monetization strategies and for Bicara Therapeutics in potentially clearing pathways for its own therapeutic developments in cancer treatment.

Key legal developments & outcome

Major rulings, motions, claim construction, settlements, and the present posture or final disposition.

The case in question, PGR2026-00025, is a Post-Grant Review (PGR) proceeding before the United States Patent and Trademark Office's (USPTO) Patent Trial and Appeal Board (PTAB), not a district court patent infringement litigation. Bicara Therapeutics Inc. initiated this PGR to challenge U.S. Patent No. 12,295,968, owned by Johns Hopkins University.

As of May 29, 2026, the key legal developments and current posture are as follows:

  • Filing of Post-Grant Review (PGR) Petition (2026-02-10): Bicara Therapeutics Inc. filed a Post-Grant Review petition challenging all nine claims of U.S. Patent No. 12,295,968. The challenge asserts invalidity under 35 U.S.C. § 112 for lack of written description, enablement, and indefiniteness. The patent broadly discloses genera of targeting moieties and fusion proteins, including fusion antibodies.
  • Status of PGR: The PGR (PGR2026-00025) is currently pending before the PTAB. An institution decision is typically rendered within six months of the petition's filing. Given the filing date of February 10, 2026, an institution decision is anticipated by approximately August 2026.
  • Parallel Litigation: No direct parallel patent infringement litigation involving U.S. Patent No. 12,295,968 between Bicara Therapeutics Inc. and Johns Hopkins University in a U.S. district court has been identified through public records searches.
    • Separately, Bicara Therapeutics has been involved in other intellectual property disputes. For instance, in October 2024, Bicara Therapeutics and its former parent company, Biocon, faced a lawsuit from Y-Trap alleging intellectual property theft. Y-Trap claimed Biocon used confidential information to file patents around a novel immunotherapy approach and then launched Bicara to commercialize the technology. This suit, however, appears to be an IP theft and inventorship dispute rather than a patent infringement claim on U.S. Patent No. 12,295,968.
    • Johns Hopkins University has also been involved in other patent-related litigation, such as a breach of contract and declaratory judgment action filed by Merck Sharp & Dohme LLC in November 2022 concerning "Pembro Patents" related to Keytruda. This litigation does not involve U.S. Patent No. 12,295,968.

In summary, the sole identified proceeding concerning U.S. Patent No. 12,295,968 is the active Post-Grant Review before the PTAB, which is awaiting an institution decision.

Plaintiff representatives

Counsel of record for the plaintiff(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).

Based on the available information from the PTAB docket for PGR2026-00025, Bicara Therapeutics Inc. is represented by the following counsel:

  • Linnea P. Cipriano - Lead Counsel
    • Firm: Goodwin Procter LLP
    • Goodwin Procter is a global law firm with a significant intellectual property practice. Ms. Cipriano's specific patent litigation experience is not detailed in the provided snippets, but Goodwin Procter is generally active in life sciences and technology patent matters.
  • Christie Larochelle - Counsel
    • Firm: Goodwin Procter LLP
    • Similar to Ms. Cipriano, specific experience for Ms. Larochelle is not detailed in the snippets, but she is part of the Goodwin Procter team representing Bicara.
  • Thomas McTigue - Counsel
    • Firm: Goodwin Procter LLP
    • Mr. McTigue is also listed as part of the Goodwin Procter team for Bicara. His specific experience isn't detailed here.

It's important to note that the PTAB docket lists these attorneys and their firm as representing Bicara Therapeutics Inc.. The provided information does not specify roles beyond general "attorney" for Larochelle and McTigue, so "Counsel" is used as a general designation. Lead counsel is inferred for Cipriano as she is listed first. Firm office locations are not specified in the docket snippet.

Defendant representatives

Counsel of record for the defendant(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).

Johns Hopkins University is represented in PGR2026-00025 by attorneys from Finnegan, Henderson, Farabow, Garrett & Dunner LLP, a prominent intellectual property law firm. Johns Hopkins University's Office of General Counsel is responsible for hiring and managing outside counsel to represent the university.

The following counsel are representing Johns Hopkins University:

  • William B. Raich - Lead Counsel
    • Firm: Finnegan, Henderson, Farabow, Garrett & Dunner LLP (Washington, DC office likely, given firm's structure and typical practice areas).
    • Experience Note: Mr. Raich heads Finnegan's biotechnology and pharmaceutical department and specializes in representing innovative companies developing biologics and pharmaceuticals. Finnegan has a proven track record in complex patent litigation before the PTAB, as well as district and federal courts, particularly in ANDA and trade secrets cases. The firm has extensive experience with post-grant review proceedings.
  • John Livingstone - Counsel
    • Firm: Finnegan, Henderson, Farabow, Garrett & Dunner LLP (Washington, DC office likely).
    • Experience Note: Mr. Livingstone is noted for thoroughly engaging in matters and persisting until optimal results are achieved.
  • Mark Feldstein - Counsel
    • Firm: Finnegan, Henderson, Farabow, Garrett & Dunner LLP (Washington, DC office likely).
    • Experience Note: Mr. Feldstein is described as brilliant, direct, and formidable in his practice.
  • David Weingarten - Counsel
    • Firm: Finnegan, Henderson, Farabow, Garrett & Dunner LLP (Washington, DC office likely).
    • Experience Note: Mr. Weingarten is recognized for his deep understanding of science and ability to challenge even seasoned experts.

It's important to note that the PTAB docket does not explicitly assign "Lead Counsel" roles, but William B. Raich is listed as the head of the firm's biotechnology and pharmaceutical department, which aligns with the subject matter of the patent at issue, suggesting a leadership role. Finnegan has multiple offices, including Washington, DC, Atlanta, Boston, Palo Alto, and Reston in the US. Given the nature of PTAB proceedings, the Washington D.C. office is a common location for counsel.