The mouse that trolled: The long and tortuous history of a gene mutation patent that became an expensive impediment to Alzheimer's research

Authors

Tania M. Bubela, University of Alberta, CanadaFollow
Saurabh Vishnubhakat, Duke University, United States
Robert Cook-Deegan, Duke University, United States

Document Type

Article

Department

Office of the Provost

Abstract

This case study presents the tale of the academic discovery of a rare mutation for early-onset Alzheimer's disease that was patented by a sole inventor and licensed to a non-practicing entity (NPE), the Alzheimer's Institute of America (AIA). Our aims are (1) to relate this story about patents, research tools, and impediments to medical progress, and (2) to inform ongoing debates about how patents affect research, disposition of university inventions, and the distribution of benefits from publicly funded research. We present an account of the hunt for Alzheimer's genes, their patenting, assignment, and enforcement based on literature, litigation records and judicial decisions. While AIA's litigation eventually failed, its suits against 18 defendants, including one university, one foundation, and three non-profit organizations were costly in court years, legal fees, and expert time. Reasons for the failure included non-disclosure of co-inventors, State laws on ownership and assignment of university inventions, and enablement. We discuss the policy implications of the litigation, questioning the value of patents in the research ecosystem and the role of NPEs (“patent trolls”) in biotechnological innovation. The case illustrates tactics that may be deployed against NPEs, including, avenues to invalidate patent claims, Authorization and Consent, legislative reforms specifically targeting NPEs, reforms in the America Invents Act, and judicial action and rules for judicial proceedings. In the highly competitive research environment of Alzheimer's genetics in the 1990s, patents played a minor, subordinate role in spurring innovation. The case produces a mixed message about the patent system. It illustrates many mistakes in how patents were obtained, administered, and enforced, but, eventually, the legal system rectified these mistakes, albeit slowly, laboriously, and at great cost.

Comments

This work was published before Tania joined Aga Khan University.

Publication (Name of Journal)

Journal of Law and the Biosciences

DOI

10.1093/jlb/lsv011

Recommended Citation

Bubela, T. M., Vishnubhakat, S., Cook-Deegan, R. (2015). The mouse that trolled: The long and tortuous history of a gene mutation patent that became an expensive impediment to Alzheimer's research. Journal of Law and the Biosciences, 2(2), 213-262.
Available at: https://ecommons.aku.edu/provost_office/759

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.