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Medication and Copyright Headaches

A New Lawsuit on Alleged Medication Adherence Scale Infringement

Longtime readers of the blog may remember several cases we have reported on in the past involving MMAS Research LLC (“Plaintiff” or “MMAS”), a Washington-based research company, filing lawsuits against educational institutions for alleged misconduct related to the Morisky Medication Adherence Scale. In this case, MMAS has filed a lawsuit against several additional educational institutions for allegedly breaching licensing agreements and disclosing its proprietary scoring and coding methodology, which it claims constitutes copyright infringement and misappropriation of a protected trade secret.

In November 2020 MMAS entered into a license agreement with the University of Leeds (“Defendant” or “Leeds”) for the use of MMAS’s Morisky Widget software (the “Software”). MMAS developed the Software to administer, score, and interpret the MMAS-4 and MMAS-8, also known as the Morisky Medication Adherence Scale, which is a standardized self-report questionnaire used to assess a patient’s adherence to prescribed medications. According to MMAS, the license agreement allowed the licensee to share the Software with third parties only with MMAS’s express permission and after MMAS-conducted training for any individuals using the Software.

Photo by NanSan/stock.adobe.com

MMAS alleges that in February 2021, Leeds breached the license by failing to use the Software at the start of a UK-based medical study known as ROSET. MMAS contends the license required the Software to be used from the baseline phase of the study. It further alleges that after the license was terminated, Leeds continued to use and misrepresent MMAS’s coding methodology in an article published on the National Library of Medicine website. MMAS claims that these actions not only violated the license agreement but also breached the study protocol, potentially constituting professional misconduct and posing risks to study participants.

In addition to its claims against Leeds, MMAS brings allegations against University College London (“UCL”), Michigan State University (“MSU”), Betsi Cadwaladr University Health Board (“BCUHB”), and East and North Hertfordshire NHS Trust (“ENHNT”).

Concerning UCL, MMAS alleges the university shared the Software with the University of Peshawar and the Institute of Omics and Health Research without written authorization, in connection with a research study conducted in Pakistan. MMAS further asserts that UCL failed to provide the required disclosure of how the Software was used, which violates the license terms.

Against MSU, MMAS raises similar claims of unauthorized use and sharing of the Software, specifically with BCUHB, in connection with another study conducted by both universities. MMAS alleges MSU also misused the Software’s scoring and coding methodology. BCUHB and ENHNT were also named as defendants for using the Software without proper licensing.

MMAS claims to be the sole copyright holder of the Software, holding a valid registration since 2019. Notably, some of the license agreements with these educational institutions, such as the agreement with UCL, were signed before this copyright registration; for example, UCL’s license dates back to 2017.

In its complaint, MMAS seeks immediate injunctive relief to bar all named parties from continuing to use the Software. It also requests statutory damages of up to $150,000 for each alleged infringement. According to MMAS, defendants committed approximately 2,840 acts of infringement, potentially entitling MMAS to a staggering $426 million in statutory damages—an extraordinary sum.

The case is expected to proceed with defendants filing their answers, followed by discovery and depositions. Unless a settlement is reached early, this could become another long-running case that we follow. We will continue to report updates as significant events unfold.