The original motivation for the Bayh-Dole Act was to encourage the commercialization of academic innovation so that new technologies could be available for the benefit of all. Yet today, I feel compelled to call attention to a compliance landscape that is significantly different than that of the past four decades—one that could have dire consequences for institutions if they choose to be complacent.
Not only do sponsoring agencies have an interest in how tech transfer complies with Bayh-Dole regulations, other entities have entered the competitive landscape looking for opportunities to turn lack of compliance to their advantage. In just the past two years we’ve seen a spike in requests for the government to exercise march-in rights by a variety of non-governmental advocacy groups (NGOs). These NGOs are staffed by PhDs who are well-versed in the academic tech transfer ecosystem and they actively seek out pockets of non-compliance. An attempt is then made to extricate key technologies using non-compliance as a lever and the NGOs become the primary influence on how innovation is put into the marketplace. I would ask the question, “Who will pick up on these inventions?” If you follow this chain of events we may find ourselves in a situation where innovation is not freely available to all (the original intent of Bayh-Dole) but an endpoint where NGOs and their backers control how technologies get into the marketplace.
Today, tech transfer professionals are under siege. With the advent of new Bayh-Dole regulations amended last May, there is now no time limit in which the government can obtain title of a federally funded invention based on non-compliance with the required deadlines. The consequences of non-compliance are a possible loss of title at any time during the life of patent. We know that, even before the 2018 rule changes, many universities and medical research centers had a backlog of iEdison notifications, rooted in messy disclosure data, in some cases going back decades. Many tech transfer offices are under-resourced, particularly around compliance. The difference today is that Bayh-Dole is under scrutiny as never before.
Bayh-Dole and March-In Rights
Beyond the federal agencies, there is evidence to suggest that special interest groups with varying agendas are on the prowl for non-compliance. In an effort to influence policy, NGOs are monitoring whether academic tech transfer is compliant with disclosures of intellectual property. One prominent example of such scrutiny is by the public watchdog group, Knowledge Ecology International (KEI), which has filed multiple requests and even initiated legal action to push the National Institutes of Health (NIH) to exercise march-in rights for the first time. This group, founded in 1995 by Ralph Nader, was called the Consumer Project on Technology. Now, as KEI, its stated charter is to deal with issues related to the effects of intellectual property on public health, cyber law, e-commerce, and competition policy.
Two recent cases where the lack of Bayh-Dole compliance provided the basis for NGO action stand out...
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