Supreme Court: Bayh-Dole Act
Carlton Hoyt
Last week, the Supreme Court ruled in the case of Stanford vs. Roche Molecular Systems, which has implications for academic inventors who receive federal funding for their research. Stanford was suing Roche Molecular Systems, claiming saying RMS did not have the rights to a patent which described a test to quantify the HIV load in a patient’s blood, which is now commonly used. RMS had bought the rights from Cetus Corporation, a private company at which a Stanford fellow, Dr. Mark Holodniy, had been assigned by Stanford to conduct research and at which Dr. Holodniy had invented the HIV load test in question.
In their prosecution, Stanford used the Bayh-Dole Act to argue that the intellectual property was rightfully theirs. For those who may be unfamiliar with the act, the Bayh-Dole Act (also known as the Patent and Trademark Law Amendments Act) granted universities, non-profit institutions, and small businesses within the United States the rights to intellectual property resulting from U.S. government-funded research. In defense, Roche Molecular Systems argued a simple point of wording. Dr. Holodniy’s contract with Stanford stated that “I agree to assign” intellectual property resulting from his fellowship at Stanford to the university, while his contract from Cetus stated that “I will assign and do hereby assign” such IP.
Despite that the Bayh-Dole Act states (albeit extremely verbosely) that rights to government-funded inventions lie first with the funded firm, then with the United States government, and lastly with the individual inventor, the Supreme Court ruled 7-2 that Cetus indeed rightfully owned the IP that they sold to Roche Molecular Systems. Chief Justice John Roberts wrote for the majority that the Bayh-Dole act does not automatically strip employees of the rights to intellectual property and because of the weak wording of Stanford’s contract (saying “will assign” instead of “do assign”) that Stanford never actually held the rights to Dr. Holodniy’s invention in the first place. You can read the full case syllabus and opinions in this pdf on supremecourt.gov.
What is of significance here is that Justice Roberts affirmed in the court opinion “the general rule that rights in an invention belong to the inventor”. This would indicate that companies, universities, and other institutions may need to have a very clear and explicit agreement that the individuals turn over their intellectual property to their institutions or else the individual may actually retain the rights, especially when the work is federally funded.
Disclaimer
BioBM Consulting is not a law firm and does not provide legal advice. If you have any questions regarding the law, please refer them to an appropriate licensed legal professional. For questions related to patent law, especially as it pertains to life science or biomedical patents, we highly recommend Gordin IP.
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