I was just thinking how often someone teaching intellectual property law leads the attack on the patent system when “Racing for academic glory and patents: Lessons from CRISPR” appeared. It sounds a dire warning that “overly broad patents must be reined in” as the passage of the Bayh-Dole Act “invoking patents as a mechanism for promoting commercialization of federally funded research” set off an “often socially wasteful race…for glory in academic research and in the patent sphere.” It cites patenting by universities of a revolutionary gene editing technology as a prime example of the problem. An article touting the study asks: “What if a team of researchers is making progress on eliminating a genetic disease, for example, but is slowed because it cannot gain licensing to proceed?” The proposed solution: narrowing the scope of patents on “broadly useful technologies” combined with government supervision of university licensing.
What’s particularly striking is that neither the paper nor the articles hyping it provide any evidence the CRISPR patents are restricting research or blocking commercial development. Indeed, most signs point in the opposite direction.
The article’s co-author, Arti Rai, teaches at Duke Law Center which lists her as “an internationally recognized expert in intellectual property law” and former External Affairs Administrator at the PTO where she “led policy analysis of the patent reform legislation that ultimately became the American Invents Act…” Judge for yourself how well that worked out. Her collaborator, Robert Cook-Deegan, teaches at the School for the Future of Innovation in Society at Arizona State.
This duo previously wrote Is Bayh-Dole Good for Developing Countries? which warned against adopting our Bayh-Dole patent driven model in favor of placing government funded discoveries in the public domain. Good luck with that spurring economic development.
The essence of their current argument is that the PTO issued “overly broad” CRISPR patents to MIT’s Broad Institute and the University of California at Berkeley. The two are engaged in a widely publicized dispute over their competing rights which is now before the Court of Appeals for the Federal Circuit. Unless the claims are narrowed the authors say Bayh-Dole must be “updated” so agencies can mitigate the damage when such patents emerge from government supported research.
How would agencies determine which patents are “overly broad?” Presumably, by allowing anyone who doesn’t like a government supported invention to petition that its licensing be restricted. One organization currently objects to every public notice that NIH intends to issue an exclusive license to slow down the process. Imagine the havoc they could wreak claiming any federal, academic or contractor invention is “too broad,” triggering an agency review.
The author’s proposed “regulatory improvements” to the Bayh-Dole Act include “recognizing situations in which patenting is not the shortest or best path to widespread application.” That’s a particularly odd “improvement” to a law which begins by stating: “It is the policy and objective of the Congress to use the patent system to promote the utilization of inventions arising from federally supported research…”
Apparently agencies would dictate to academic institutions and contractors which technologies are appropriate to patent and which are not. The article hopes the “CRISPR controversy” will spur the Dept. of Commerce, which oversees Bayh-Dole, to impose this and other similarly inspired ideas.
Strangely, their paper fails to note that a seventeen page petition to the National Institutes of Health asked that it supervise how universities license their CRISPR patents because of alleged threats to the public interest. Here’s the essence of NIH’s reply of August 3, 2017:
CRISPR-CAS9 technology is a foundational and broadly applicable platform technology that enables researchers to engage in scientific inquiry and companies to develop products and services that could benefit a broad range of patients. While there are ongoing legal proceedings regarding these patents and patent applications, the Broad Institute is a primary owner and licensor of patents on CRISPR-CAS9. According to the Broad Institute’s public statements:
Broad, the Massachusetts Institute of Technology, and Harvard University (co-owners of the patents) have developed a licensing program to provide for broad access of the CRISPR-CAS9 technology to researchers and commercial developers. In summary, Broad’s and its partners’ licensing program for the CRISPR-CAS9 states: (1) tools, knowledge, methods and other intellectual property for genome-editing will be freely available to the academic and non-profit community; (2) non-exclusive licenses will be granted to companies to use CRISPR-CAS9 in their commercial research and to companies who will develop and sell research tools and reagents for genome editing; and, (3) for commercial development of human therapeutics that will require a significant level of investment, exclusive license requests for specific gene targets not otherwise under development will be considered. Broad reports that, since February 2013, more than 37,000 plasmids and reagents have been provided to more than 2,000 institutions across 59 countries. (emphasis added)
Broad further explains that the technology will be licensed under a model that apparently has as its objective the efficient distribution of defined exclusive fields of use to commercial partners. (emphasis added) Under this model, Broad, Harvard, and MIT have licensed their CRISPR technology to a primary licensee, Editas Medicine, Inc. (Editas) to exclusively use the technology on targets of its choosing for the development of genomic medicines. However, Broad retains some controls over sublicensing decisions by Editas to allow for the breadth of the technology to be exploited commercially. After an initial period, other companies may apply for commercial licenses to certain CRISPR patents for use against genes of interest not being actively pursued by Editas.
While we have not received any inquiries or complaints about lack of access to the CRISPR-CAS9 technology for research or commercial development from those who are in a position to use the technology, (emphasis added) we continue to monitor access and use of the CRISPR technology that was funded by NIH with respect to public access and compliance with NIH principles and policies. At this time, we do not believe that a new NIH policy to address the licensing of CRISPR patented technology is necessary. (emphasis added)
This came out more than three months before the Rai/Cook-Deegan article. Doesn’t a finding by NIH that there’s no evidence of any problems with how universities are licensing their CRISPR patents deserve to be mentioned? It seems like a pretty important point.
The University of California provides similar protections insuring that those licensing the CRISPR patents it made in conjunction with the University of Vienna are also licensed in the public interest. That includes a humanitarian use clause providing royalty free licenses to meet the needs of economically disadvantaged countries.
A few days after their paper appeared another hole was punched in its thesis. “Editing genes with a more precise alternative to CRISPR” discuses a promising development at Yale of “an alternative gene-editing technology that they say replaces CRISPR’s ‘hacksaw’ effect with a more precise ‘scalpel.'” It doesn’t seem the CRISPR patents are blocking potentially revolutionary advances in the field.
The allegation of a CRISPR crisis is part of the overall attack on the patent system claiming that it stifles science and that exclusive licensing threatens the public interest. The Bayh-Dole Act is a target because it encourages patenting and decentralized the management of federally funded discoveries from Washington to inventing organizations. The subsequent explosion in public/private sector partnerships helped reestablish the US as the undisputed leader in science and innovation. But that’s lost on the critics.
A recent hearing by the Senate Health, Education, Labor and Pensions Committee is a good introduction to the potential of CRISPR. It was a bipartisan effort, so rarely seen these days. Sen. Elizabeth Warren gave a glowing introduction to the President of Editas, the spinoff company from MIT’s Board Institute. It’s worth watching to get a sense of the hope CRISPR provides to those suffering from hundreds of diseases with no effective treatments. These will only come to fruition if government funded research moves out of the lab and into the marketplace. That requires tremendous risk and investment by the private sector over many years, which only happens through the incentives of patent ownership and licensing.
You’d think anyone teaching intellectual property law would know that. Sadly, you’d be wrong.