Licensing of IP to maximize public benefit
The astonishing pace of modern health innovation in the US is due not only to brilliant, collaborative scientists, but also to far-sighted Federal policies. One important but lesser-known aspect concerns the licensing of intellectual property (IP).
With the Bayh-Dole Act of 1980, Congress changed the way IP generated under federal research grants is licensed: the law shifted control from the US government to the institutions that had received the grant.
Congress’s purpose was clear: It felt the American public would be better served by such a system, because grantee institutions would be more knowledgeable and more vigorous in ensuring that the IP was licensed to industry to benefit consumers—including patients.
This prompts an important question: How should academic and other non-profit institutions make IP licensing decisions to best fulfill their responsibilities to the public?
The purpose of this piece is to talk about some principles that we think should guide IP licensing decisions. These are the principles we seek to apply to such decisions at the Broad Institute of MIT and Harvard:
- IP should be made freely available for use by other academic and non-profit institutions, because unfettered access to such tools and knowledge will maximize the generation of public knowledge.
- When licensing IP to industry, non-profit institutions should, in general, favor non-exclusive licenses over exclusive licenses. In general, non-exclusive licenses maximize innovation by enabling creativity and competition among many parties.
- In some specific situations, however, an exclusive (or semi-exclusive) license may be appropriate because there is a clear case that it will better serve the public good. These are situations (i) in which a company would need to make a large investment to turn the IP into a commercial product and (ii) where it could not recoup this investment without exclusive rights. The most common situation pertains to human therapeutics, with the classic example being the licensing of a drug candidate. No sensible company would invest hundreds of millions of dollars in a clinical trial to determine whether the drug is safe and effective, if a competitor could come along and seek approval for the (now de-risked) drug.
We’ve applied these principles to the licensing of CRISPR genome editing tools: we make CRISPR IP freely available to the academic community and license it non-exclusively for commercial research and non-therapeutic applications, but we granted an exclusive license for human therapeutics -- subject to our inclusive innovation model, described here. This model allows other companies to apply to license certain CRISPR IP for use against genes of interest not being pursued by the primary licensee after a defined period of time.
Finally, it’s worth mentioning a related topic: the sharing of large-biological datasets. From the Human Genome Project onward, many projects have demonstrated the tremendous value of such information for propelling progress in biomedicine. We believe in making such data broadly available to the world.
We’re interested to hear about the principles that guide IP licensing decisions at other institutions in order to achieve the outcomes envisioned in 1980 with the Bayh-Dole Act. It’s an important and sometimes tricky topic that is worthy of ongoing public discussion.