In a ruling issued this week concerning the patent rights of research universities, the US Supreme Court ruled in favor of Roche in a long-standing patent dispute the company had with Stanford University regarding patent rights to technology to detect HIV blood levels using polymerase chain reaction (PCR) technology. The ruling is significant in that it provides clarity in this particular case to technology transfer and related rights between universities using federal funding and private companies.
The issues surrounding the patent-dispute case date back to 1988, when a California-based research company, Cetus, began to collaborate with scientists at Stanford University’s Department of Infectious Diseases to test the efficacy of new AIDS drugs. Mark Holodniy, a research fellow at Stanford at the time, was assigned to Cetus to conduct research and developed a PCR-based procedure for measuring the amount of HIV in a patient’s blood. Upon returning to Stanford, he and other Stanford employees tested the procedure, and Stanford secured three patents relating to the measurement process. Roche later acquired Cetus’s PCR-related assets, and after conducting clinical trials on the HIV quantification method developed at Cetus, commercialized the procedure. In his capacity at Stanford, Holodniy had signed an agreement assigning his interests to the university for inventions that resulted from his employment there and also had signed an agreement with Cetus, as part of gaining access for his research at Cetus, that assigned his interests to Cetus.
The crux of the case centered on whether Holodniy had the right to assign his interest to Cetus or whether the rights belonged to Stanford under the University and Small Business Patent Procedures Act of 1980 (i.e., Bayh-Dole Act), which established a framework for determining ownership interest in federally funded research. Stanford first sued Roche in 2005, and in 2009, a federal appeals court ruled that Stanford did not have grounds for patent infringement. The US Supreme Court ruling this week affirmed the lower court’s decision. Chief Justice John Roberts, who delivered the opinion of the court stated: “The Bayh-Dole Act does not automatically vest title to federally funded inventions in federal contractors or authorize contractors to unilaterally take title to such inventions.”
Although the opinion of the Court involved the specific contractual details of the case, including the timing of the agreements and whether research performed at the time in question was under federal funding, the ruling raises important issues in intellectual property rights, technology transfer, and the role of public and private funding in research, particularly in light of pending US patent reform. In today’s quest for innovation, pharmaceutical-based and other industrial-based research is increasingly reliant on partnerships between academia, the private sector (both large and small companies), and government. The financial interests of the private sector and universities in intellectual-property ownership are clear, but what is more murky is how to best marry those interests in a robust and equitable system of mutual benefit. Although cliched, the term “win–win” should be more than lip service, but something that is put into practice in the design and implementation of research, technology transfer, and the rewards of eventual commercialization. Current patent law or any pending reforms can create a framework, but ultimately, it is the specific parties involved in these academic–industy–government partnerships, which need to recognize and legitimize the symbiotic nature of their common efforts.