Universities, Bayh-Dole: Rules and Regulations – Don’t Throw the Baby Out with the Bathwater

A recent editorial “Don’t Throw the Baby Out with the Bath Water” from Mark C. Rogers, M.D., M.B.A., former anesthesiologist-in-chief at Johns Hopkins and Editor-in-chief of the journal, Medical Innovation & Business notes that the whole purpose of the Bayh-Dole Act has been forgotten. The act, which gave the ownership of intellectual property discovered under government-sponsored research grants back to the university and the scientists who had gotten the grants, was to specifically encourage commercialization in the interests of expanding our national economy. 

Although he thinks that commercialization of biotechnology is misplaced at a university, he notes there is an important balance to maintain because of the “underlying clinical and economic importance of biologic discoveries that occur in universities,” a product of the Bayh-Dole Act. As a result, he proposes that to maintain this balance, universities need adequate standards and supervision of commercialization. Without such guidance, Dr. Rogers does not want to “risk stifling the process and even driving inventive faculty to other universities with more appropriate standards for commercialization.”

His experience however, tells us that university officials are not always prepared to take on such endeavors. Consequently, he asserts that universities should carefully consider the “role that entrepreneurial driven commercialization can play in a university if properly managed instead of shut down.” He emphasizes this role due to the diminishing medical reimbursements that universities are seeing, smaller university endowments, and reduced funding at the NIH.

Ultimately, Dr. Rogers does not want universities to become obsessed with creating complex rules and regulation that “effectively stifle entrepreneurial mentality and neuters the potential for commercial success with university-sponsored research.” In agreement with his contention, universities, Congress, and health related agencies should re-evaluate the importance of the Bayh-Dole Act and go back to its original intent of bringing medical advances to the public in a timely manner through the collaboration and mutual benefit of industry, government and academia.