Research Firm Alleges Dana-Farber and Others Infringed Copyrights by Modifying Diagnostic Tests
Boston, MA, September 4, 2025 — A Washington-based biomedical research company, MMAS Research, has filed a lawsuit against the Dana-Farber Cancer Institute, Harvard Medical School, the Karolinska Institute, and the Mayo Clinic, alleging that these institutions made unauthorized modifications to its proprietary diagnostic tests. The complaint, lodged in the U.S. District Court for the District of Massachusetts, claims that the defendants’ actions infringed on MMAS Research’s copyrights and potentially compromised the safety of clinical trial participants.
Details of the Lawsuit
According to the filing, MMAS Research, a leader in developing diagnostic tools for cancer research, accuses the defendant institutions of altering its copyrighted tests without permission. The tests, designed to ensure accurate diagnosis and monitoring of cancer in clinical trials, were allegedly modified in ways that deviated from their validated protocols, raising concerns about reliability and patient outcomes. Steve Trubow, Solutions Architect at MMAS Research, emphasized the patient-centric focus of the lawsuit, stating, “These tests need to benefit the patients, not Harvard, Dana-Farber, Karolinska Institute, and Mayo Clinic, they should benefit the patient.”
The lawsuit contends that the unauthorized changes not only violated intellectual property rights but also posed risks to trial participants by potentially undermining the tests’ efficacy. While specific details of the modifications remain under seal pending discovery, the complaint alleges that the institutions used the altered tests in clinical research without MMAS Research’s approval, breaching licensing agreements.
Context of Dana-Farber’s Recent Challenges
The allegations come at a time when Dana-Farber, a Harvard-affiliated cancer research powerhouse, is grappling with reputational challenges. In 2024, the institute faced scrutiny after British molecular biologist Sholto David flagged data manipulation in 58 studies, leading to the retraction of seven papers and corrections to 31 others. The affected papers, authored by senior researchers including former President and CEO Laurie Glimcher, involved duplicated or manipulated images, sparking a broader debate about research integrity. Although unrelated to the MMAS lawsuit, these incidents have heightened scrutiny of Dana-Farber’s practices, potentially amplifying the impact of the current allegations.
Broader Implications for Biomedical Research
The lawsuit raises critical questions about intellectual property rights in collaborative medical research. Academic institutions and research firms often share proprietary tools under strict licensing agreements, and unauthorized modifications can lead to legal disputes and safety concerns. MMAS Research’s complaint underscores the need for clear guidelines on the use of diagnostic tools in clinical trials, particularly when multiple institutions are involved.
Legal experts suggest that the case could set a precedent for how intellectual property disputes are resolved in biomedical research. “This lawsuit highlights the tension between innovation and compliance,” said intellectual property attorney Sarah Klein. “Institutions must balance the drive to advance research with respect for proprietary rights, especially when patient safety is at stake.”
Institutional Responses
Dana-Farber, Harvard, the Karolinska Institute, and the Mayo Clinic have yet to issue detailed public responses to the lawsuit. A Dana-Farber spokesperson stated, “We are reviewing the allegations and will respond appropriately in court,” emphasizing the institute’s commitment to ethical research practices. The other defendants have similarly declined to comment pending legal proceedings.
MMAS Research has called for an injunction to halt the use of the modified tests and is seeking unspecified damages for copyright infringement. The firm also demands that the institutions provide full transparency on how the tests were altered and used in clinical trials.
Looking Ahead
The case is expected to proceed to discovery, where MMAS Research will seek evidence of the extent and impact of the alleged modifications. If the court finds in favor of the plaintiff, it could lead to significant financial penalties and stricter oversight of diagnostic tool usage in research settings. For Dana-Farber, already navigating fallout from the 2024 misconduct scandal, the lawsuit adds another layer of complexity to its efforts to restore public and industry trust.
As the biomedical research community watches closely, the outcome of this case could influence how institutions collaborate on proprietary technologies, balancing innovation with accountability to ensure patient safety and intellectual property protections.
For more information, contact MMAS Research at info@mmasresearch.com or Dana-Farber Cancer Institute at media@dfci.harvard.edu.