Last week, I attended a discussion organized by the Harvard chapter of the student-oriented Universities Allied for Essential Medicines (UAEM) on “Global Access Licensing of Biomedically Relevant Technologies” (Harvard UAEM). The panelists were representatives of local university and medical center technology transfer offices (TTOs) who spoke for about an hour on their efforts to promote access to essential medicines and improve global health in the rest of the world (ROW) specifically through application of a “Statement of Principles and Strategies for the Equitable Dissemination of Medical Technologies” (AUTM Statement), a document written by tech transfer officers and backed by the UAEM in 2009. The Statement provides guidance on patenting and licensing (and calls for biannual self-assessment), but, in my opinion as expressed my post, “An Academic Approach to Global Health”, was unlikely to have much effect. The organizers did a great job in selecting the speakers and attracting a small but informed audience of mostly academics (students and faculty), who participated during the hour and a half question and answer period. My regret was that the time was too short to allow a full discussion of the issues and to ask the TTO reps what progress, if any, they have actually made.
First, a bit of background on university technology transfer. US government funding of health-related research has been and continues to be in the tens of billions of dollars per year. For example, our local complex of academic institutions and medical centers received $1.8 billion in 2012 (Boston Globe 4/25/13 article), and the funding results in a tsunami of information, the vast majority of which is made public and used mostly by other scientists to generate more information, but a small amount is diverted mixed with existing information, becomes knowledge, and is used to make products, mostly by companies looking to make a buck. TTOs facilitate the process by creating a financial incentive to companies to use the information by turning it into a patent-protected “invention,” even though the relation of the invention to a useful product is hypothetical and the universities lack the wherewithal and inclination to find out. The idea is that a company would be more likely to develop a product if it, or some aspect of it, is patented and therefore exclusively owned by the company and not available for copying by a competitor, at least until the patent expires (now 20 years). So TTOs spend time and money on patents with the hope that a company will negotiate an exclusive, income-generating license. This rarely happens because the university invention is typical many steps away from being a product and the majority of TTOs lose money, but it happens often enough that just about every research university has a TTO with an average of six employees. To hedge their patent strategy, TTOs patent methods of finding or making products which are even more removed from products but are attractive to start-up companies and venture capital because they could generate multiple products and revenue (for more on VC funding strategies and view of academic inventions, see Bruce Booth’s recent post at Life Sci VC).
So has the UAEM been effective in getting TTOs to facilitate the diversion of the academic tsunami into yielding products for global health? As far as I can tell, no. In his introductory presentation, Anthony So, UAEM advisor and Duke University faculty member (So Bio), stated that the potential is there since academic patents underlie 153 pharma products sold over the past 40 years, citing a study of Stevens et al. 2010, but which I found in my review of the publication was closer to 40 (see my post, “Slicing the Baloney”). He also cited an example of a method of making a standard malaria drug that originated at UCSF, was licensed to Amyris, a startup, in 2003 and as of last month will used in making drugs by a major pharma, Sanofi (Amyris press release). Use of the process will lower the cost of the drug, which is good, but the invention is not resulting in new, essential, medicines. As was pointed out by the TTO discussants, their technology (and patents) is very early on the path to products and their ability to induce their licensees (should they even have one) to develop ROW products diligently or at all is minimal.
Well, what can the UAEM do to hold the universities’ and the TTOs’ feet to the fire for getting research that is generously funded by the US public to yield products to improve ROW health? The UAEM can first, redefine their mission as improving ROW health rather than improving access to medicines which is only part of the larger problem. It can then encourage university administrations to:
- recognize the reality of tech transfer and, rather than regarding the TTOs as profit centers, view them a facilitators of early-stage product development regardless of whether they think those products will be “profitable” or not; and
- lower the barrier for using university inventions in ROW product development by promoting the use of internal technology development funds on projects that may lead to ROW/affordable products (Harvard received a $50 million gift to fund their accelerator program this week [Harvard Gazette article]).
For the TTOs, the UAEM can push them to:
- not patent methods of discovery or manufacture (patent products only);
- avoid worldwide exclusive licensing (which constrains opportunity to license for the ROW) and actively seek licensees that are developing ROW/affordable products;
- apply the “Statement of Principles” to all future licenses for health-related technologies not only those relevant to the neglected diseases (i.e., include the non-communicable diseases like cancer and diabetes) and for all middle- and low-income countries not only those defined by the World Bank as “undeveloped;”
- apply the above to existing licenses and try to renegotiate them; and
- promote the start-up of global health-relevant or affordable healthcare-relevant companies by helping aspiring entrepreneurs, whether enthusiastic students or someone in off the street, in business planning, advising, fund-raising, and no/low cost licensing.
And if the UAEM or the TTOs choose to take up my suggestions, I’m available to help.