The Biden administration recently announced support for a push by the World Trade Organization to strip intellectual property protections from COVID-19 vaccines.
That endorsement, though well-intentioned, should send shivers down the spines of university and corporate R&D lab workers across America. Especially since it follows on the heels of some policymakers’ attempts to seize American firms’ intellectual property, using a strained interpretation of a four-decade-old law.
Gutting IP protections would eliminate the incentives for private sector investors to take initial discoveries — often made in university labs — and turn them into tangible medicines and medical devices that actually benefit patients. It’d be a disaster not just for health care workers striving to save people’s lives. It’d also prevent the commercialization of ground-breaking discoveries arising in universities — including those that could spawn entirely new industries.
Advocates for stripping IP protections often point to successful drugs that initially benefitted from research at a university that was federally funded and thus should be “controlled” by the government. These IP rights, however, are currently protected by the University and Small Business Patent Procedures Act. This bipartisan legislation, enacted in 1980 and better known as the Bayh-Dole Act, allows universities to own and to license inventions that arose from federally-funded research.
Universities license IP rights to private sector companies that commercialize research discoveries and make products available to the public. Before this law, the federal government (not universities) held the rights to such patents. Some 30,000 of those patents languished, gathered dust in federal filing cabinets, with fewer than 1 in 20 ever reaching the clinic or the open market.
For Sens. Birch Bayh, D-Ind., and Bob Dole R-Kan., the purpose of the act was to “spur the interaction between public and private research so that patients would receive the benefits of innovative science sooner.” In the ensuing 40 years, their legislation has enabled universities and industry licensees to develop and bring to market more than 200 life-saving new medicines. Many such advances have arisen from research at the University of California, including UC Berkeley.
I had a front-row seat to the ground-breaking T-cell research performed at UC Berkeley by James Allison that led — thanks in large part to the Bayh-Dole Act — to the monoclonal antibody ipilimumab and the birth of immunotherapy to attack a patient’s cancer cells. Today, Allison’s approach is used to treat 15 types of cancers, including Hodgkin lymphoma, colon cancer and breast cancer.
All have witnessed the most recent fruit of the Bayh-Dole Act — mRNA technology from the University of Pennsylvania was licensed to Pfizer and Moderna, who used it to develop COVID-19 vaccines.
Similarly, and thanks to the public-private sector bridge built by Bayh-Dole, research from UC Berkeley’s Robotics and Human Engineering Laboratory, licensed by SuitX, has created robotic exoskeletons that allow people living with paralysis or neurological disorders to walk.
I fear that Biden’s IP waiver on Covid-19 vaccines, coupled with ongoing attempts to twist the Bayh-Dole Act to allow government officials to modify the terms of IP licenses that companies receive from universities, will disincentivize the private sector from investing in early-stage university inventions that are years away from becoming viable commercial products.
An existing clause in the Bayh-Dole Act allows the government to “march in” and take away patents from licensees — but only in rare cases, such as when licensees are not commercializing an invention deemed potentially valuable. Many lawmakers want the government to use march-in rights to seize brand-name drug patents and relicense them to generic manufacturers.
They have good intentions. Everyone wants to make prescriptions more affordable for patients.
But if companies fear that the government will intervene after years of expensive R&D, they will not invest in the first place.
Industry spends, on average, nearly $3 billion to bring a single drug to market; by contrast, the average federal grant to a university researcher whose work may lead to patentable material is in the range of $3 million — one-tenth of 1% of the upfront costs invested by the private sector. Hence, the level of investment by the federal government is exceptionally effective “seed money” for fostering innovation. Upsetting this relationship and partnership would be exceedingly deleterious.
IP protections exist for a reason — because they work. We must not allow the admirable quest for health equity to kill the research goose that lays innovation’s golden egg.
Carol Mimura is the former executive director of the Office of Technology Licensing at the University of California, Berkeley, and current UC Berkeley Assistant Vice Chancellor for Intellectual Property & Industry Research Alliances.
