Tech Transfer has the potential to create significant value from academic research, but also has the potential to create new temptations and abuse. It is important that TTOs have a strong moral compass to guide their dealings, while institutions need strong Conflict of Interest and Conflict of Commitment policies to govern faculty and students.
The document that provides the starting point for this “moral compass” is the “In the Public Interest: Nine Points to Consider in Licensing University Technology” document. It was developed by a committee of 12 leading university TTOs and the Association of American Medical Colleges. It is maintained by AUTM and has been signed by roughly 120 universities and companies from around the world. All universities should consider signing the document.
The ninth point is titled: “Consider including provisions that address unmet needs, such as those of neglected patient populations or geographic areas, giving particular attention to improved therapeutics, diagnostics and agricultural technologies for the developing world.” Some academic technologies have major humanitarian implications and potential and this point requires that the needs of the developing world be borne in mind in licensing such technologies.
This issue came to the fore in the early 2000’s when an antiretroviral medication used to prevent and treat HIV/AIDS was developed at Yale with NIH funding. The drug, stavudine or d4T, was exclusively licensed to Bristol Myers Squibb (BMS) which received Food and Drug Administration (FDA) approval for it and marketed it as Zerit. The license allowed BMS to select the countries in which to seek patents and BMS included South Africa as one of them. The World Health Organization (WHO) included stavudine in its list of essential medicines, and Médecins Sans Frontières solicited bids from Indian generic drug makers to supply generic stavudine to South Africa. BMS sued, and Yale and BMS were depicted in a very unflattering light on the front page of the business section of the New York Times. In response, BMS rapidly announced that they wouldn’t assert the South African patent.
This sensitized universities to how their technologies might impact developing nations, and the need to incorporate that impact when developing a licensing strategy. A set of licensing principles were developed and a number of universities now include humanitarian provisions in their license agreements. The obvious areas where there are both developed and emerging market potentials for university inventions are healthcare – drugs, vaccines, devices, diagnostics, etc., – and agriculture. Other inventions may only have relevance to the emerging world – clean water, waste disposal, off-grid electric generation, etc.
It is important to take the emerging world implications of technologies into account when developing licensing strategies. The primary motivation for Tech Transfer is to use our inventions to help people. Monetary profit is secondary to benefitting society.
Below is a presentation on humanitarian licensing and an article on the same subject:
Available here is a two-volume book on IP Management in Health and Agricultural Innovation which includes extensive details on all aspects of IP management with a humanitarian mindset.
Recently, some media reports raised concerns that IP issues could slow or block development of life saving tests, treatments and vaccines for the COVID-19 pandemic. This has not happened. The University of Oxford negotiated outstanding humanitarian provisions in its agreement with AstraZeneca for rights to Oxford’s COVID-19 vaccine. AstraZeneca and Oxford have confirmed that the partnership would deliver the vaccine on a not-for-profit basis until at least July 2021 worldwide, and in perpetuity to low- and middle-income countries. This is probably the most impactful and certainly the highest profile implementation of humanitarian and socially responsible licensing to date. Read more on how Oxford negotiated the partnership and details on the terms.
While the COVID-19 vaccine collaborations are success stories, the pandemic has illuminated the difficulties and slowness of changing the global IP system. In October 2020, nine months after the pandemic started, India and South Africa proposed that the U.N. suspend COVID-related IP rights under Trade-Related Aspects of Intellectual Property Rights treaty (TRIPS).
However, licensing behavior can be changed overnight—it’s a business decision taken by companies (including not-for-profit corporations like universities) not by governments. By April 7, 2020, less than a month after the pandemic started to spread in the United States, Harvard, MIT and Stanford published a “COVID-19 Technology Access Framework” in which they pledged to license any COVID-19 related technologies quickly, non-exclusively and royalty-free for the duration of the pandemic and for a short period thereafter. Twenty additional institutions have since signed on to this pledge. Ten days later, on April 17, AUTM released its “COVID-19 Licensing Guidelines” which were identical to the Harvard / MIT / Stanford protocol. Ninety-five institutions have signed the AUTM protocol. Paralleling academia’s thinking, ten very large companies created the “Open COVID Pledge,” with an additional 23 companies later joining the pledge.