Bayh-Dole Has its Consquences
The sequester will have a negative effect on federal R&D of $9.6 billion, that is about a 7 percent cut with respect to the 2012 budget. These cuts will renew the urgency of figuring out how to maximize the social return on public R&D investments. That is a complex question because social returns are not only a function of the pace of innovation but also depend on how the benefits of innovation are distributed across society. Federal agencies that fund research as well as universities and national laboratories have an important role to play here. Not only can they rebalance their research portfolios but also they can improve technology transfer—the dynamic exchange of knowledge between research organizations and the private sector.
One important channel for technology transfer is patenting and the licensing of those patents to industry. These activities are primarily regulated by the Bayh-Dole Act of 1980. Think privatization of public assets where the assets are public patents—patents derived from federally funded research. The act introduced in this way the profit incentive to develop commercial products from public research. Under this act, the research contractor (generally a university or national laboratory) can take title to patents and to subsequently license those patents to private companies or other agents with the only proviso that the licensee takes reasonable efforts to practice the patent, that is, to develop it into a practical application.
The ostensible goal of Bayh-Dole was precisely to maximize the social benefit of federal R&D investments. We must then ask if this policy has delivered and if taxpayers are receiving a social return commensurate to their investment in research. The answer is inconclusive. There is some evidence that the translation of federally funded research into market products has increased but Bayh-Dole has also had unanticipated consequences—patenting has moved upstream to research tools creating what legal scholars Michael Heller and Rebecca Eisenberg have characterized as the tragedy of anticommons. In addition, it is not at all clear how widely the benefits of public patents have been distributed. Therefore, a fair assessment of Bayh-Dole must address at least two questions: Are the unanticipated consequences undercutting efficiency gains? And, are social returns from innovation concentrated or broadly distributed?
Regarding efficiency, a concern of the first order is that universities are patenting research tools. Scientific research is a collective effort that requires an active intellectual exchange at the outer boundaries of knowledge. Among the goods traded there are research tools, materials, and data. The patenting of reagents, cell lines, chemical compounds, raw datasets and other materials and the strict enforcement of those patents poses the risk of slowing down innovation at the headspring. A sensible answer to this problem would be to modify the statute to allow an exemption for non-profit research institutions. The exemption must at least apply to public patents. Universities and laboratories wanting to negotiate exclusive licenses on research tools would then be required to demonstrate that such an arrangement is in the interest of science and the public good. Complementing this solution, federal research contractors could benefit greatly from organizing a system-wide consortium for sharing research tools. This patent pool, chartered as a not-for-profit organization, would guarantee access to its patents (or at least patents on research tools) to all its members at fair licenses fees.
Beyond efficiency, there is an equity concern. That a public patent is developed into a product doesn’t directly imply maximum social benefit. If a new product is priced so high that only very few people can afford it, the social return will be minimal. Consider the effect of innovation in the pricing of drugs. If pharmaceutical companies are allowed to charge as high prices as they wish, only patients with prescription drug coverage in their health insurance will afford new medicine. If health insurance is universal, the effect will be deleterious for society because insurance prices will have to keep pace with drugs prices. A good indicator of the social return on public investment in biomedical research is therefore affordability. Amidst budget cuts and inflationary pressure on prescription drugs, policymakers are taking this issue seriously; for instance, Senator Ron Wyden (D-OR) has recently asked the NIH to “revisit the idea of striking a better balance between encouraging profit, innovation, accessibility and affordability.”
If public patents are a steady source of innovation in the biomedical sector, pricing excesses should be disallowed or at least regulated. Let’s be clear that companies that take a public patent and commit significant resources to its development are justly entitled to recoup their investments and even to retain a profit margin. But they did not incur in the full back-to-back investment—they did not invest in the expensive portfolio of blue-sky research out of which one program resulted in the patent they have come to license—it was the taxpayer that incurred in that high-risk investment. Put shortly, companies cannot assume a right to maximum profit when selling products based on public patents.
Federal agencies should be empowered, under Bayh-Dole, to promote competitive markets in high-tech sectors. One area where this can be done is defining better the conditions for exclusive licenses. While exclusive licenses are well justified in the case of start-up companies—they use these intangible assets to raise investment capital—the same rationale does not hold for large companies with high liquidity or easy access to credit. This kind of safeguard was part of the original intent of the act; Bayh-Dole originally limited to five years exclusive licenses for large companies. Another safeguard is the march-in rights provision. Federal agencies retain a royalty free license to all public patents and they can practice their licenses if the private sector shows no active effort to develop the patents or to satisfy public health and safety needs. Executive action should allow federal agencies to apply this provision to curb pricing excesses, for instance by linking need to affordability. The sole threat of intervention would curb pricing while still allowing companies to make some profit.
Congress and the federal government can help universities and national laboratories maximize the social returns of research by encouraging licensing practices that ease scientific collaboration and by curbing pricing excesses.
Walter D. Valdivia is a Fellow in Governance Studies and the Center for Technology Innovation at the Brookings Institution.