Another IP Professor Attack On Patenting

By Joseph Allen
November 29, 2017

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.

The Author

Joseph Allen

Joseph Allen is a Featured Contributor on IPWatchdog.com, and a 30-year veteran of national efforts to foster public/private sector commercialization partnerships, and author of numerous articles on technology management for national publications.

Joe served as a Professional Staff Member on the U.S. Senate Judiciary Committee with former Senator Birch Bayh (D-IN), and was instrumental in working behind the scenes to ensure passage of the historic Bayh-Dole Act. He is our resident Bayh-Dole expert, and will write frequently about Bayh-Dole and issues surrounding the commercialization of university research.

In 2008, Joe founded Allen & Associates, through which he offers consulting services assisting clients in technology transfer issues, including developing effective communication strategies with national policy makers.

Warning & Disclaimer: The pages, articles and comments on IPWatchdog.com do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author and should not be attributed to the author’s employer, clients or the sponsors of IPWatchdog.com. Read more.

Discuss this

There are currently 20 Comments comments. Join the discussion.

  1. f32fff32f November 29, 2017 9:40 am

    “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.”

    I mean, the (initially government funded and non-patented) internet was the biggest spur of economic development since the industrial revolution…

  2. American Cowboy November 29, 2017 10:12 am

    As I recall, Bayh-Dole was enacted because government funded inventions were not being commercialized or practiced because nobody saw any profit in doing so, since taking a basic scientific advance made in academia still needed to make a big investment to have a commercial product. The big investment would be at risk because copiers could jump into the market and deny a possibility of recoupment of the investment.

    see https://en.wikipedia.org/wiki/Bayh%E2%80%93Dole_Act

  3. EG November 29, 2017 10:48 am

    Hey Joe,

    Excellent expose of the thoroughly flawed factual basis for the Rai/Cook-Deegan article. These so-called IP law academics should be embarrassed for spouting such nonsense having no basis in fact. Indeed, the portions you bolded in your post show that these so-called IP law academics are apparently uninterested in what the facts are, but strictly in pushing an agenda that only the unformed would ever buy into.

  4. angry dude November 29, 2017 12:05 pm

    yeah

    anti-patent patent professors

    or anti-patent patent lawyers

    do those idiots really think that they can kill the cow and still milk it forever ???

  5. Curious November 29, 2017 2:20 pm

    do those idiots really think that they can kill the cow and still milk it forever ???
    I don’t think any of them think the cow will be entirely killed (effectively killed is another matter). That being said, an IP system will always continue to exist, so they’ll keep their tenured positions and enjoy the benefits from Google et al. that flow their way.

  6. EG November 29, 2017 2:59 pm

    “[S]o they’ll keep their tenured positions and enjoy the benefits from Google et al. that flow their way.”

    Hey Curious,

    LOL! How true.

  7. Night Writer November 29, 2017 7:21 pm

    Arti Rai has long been virulently anti-patent. The academics think that patents are bad because they aren’t liberal enough.

  8. Night Writer November 29, 2017 7:22 pm

    The key to all the Arti Rai, Lemley, (and that one at San Jose) is that none of them ever use real world examples nor deal in the real world. They all fabricate abstractions.

  9. Night Writer November 29, 2017 8:24 pm

    If you ever engage one of them in conversation, you find they act as if they are on a mission to destroy the patent system to free ideas. That is their belief. See academics like this group makes me think that maybe the Republicans are right. The universities need some major house cleaning and the wiping out of tenure.

  10. Corinne Le Buhan (IPStudies) November 30, 2017 4:36 am

    Thanks for pointing out the NIH statement. There are plenty of other facts in the worldwide CRISPR patent & licensing landscape that show evidence of stimulated innovation regardless of this legal battle:
    – more than 50 publicly announced licensing deals, many non-exclusive, and a patent pool initiative has been developed in the past few months (MPEG-LA)
    – more than 2000 thousands of CRISPR-derived published inventions – and in average, adding 3 new inventions every day to this set!
    – these inventions are from more than 600 hundred different companies and institutions all over the world… why would they invest in patenting themselves in this area if they had been blocked by the pioneering patent battle in the first place?
    – the notion of broad claims is abusive language, good wording for the media, but not in line with the reality of the legal and technical analyses. In the second wave of CRISPR patent application claims filed after the first wave pioneering patents have been published in 2014, we’ve seen different tactics to escape the “broad” claims – just by looking into the patent coverage to try and guess the patent strategy behind a company or even some of the research institutes highly involved in that field, we often observed that the scientists find out what to “design-around” and the lawyers proposed what to “word-around”… and trust them, they have been very inventive!

    The Bayh-Dole act has had plenty of unfortunate side effects, but in my view, CRISPR is definitely not the example to use to criticize it, because it has worked! It has been driving significant investments and job creations around the pioneering universities who have properly dealt with its promise from the very beginning… would this be the case if there was no hope for licensing money-back to the investors? has this impact been measured, too?

  11. Benny November 30, 2017 5:24 am

    “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?”

    Silly question. Patents don’t slow academic research, they block markets. Both research and pharma production tend to be multinational, you shift your markets and production to the EU (where the health insurance plans covering the costs are generally far in advance of anything the US ever came up with), and ramp up the “medical tourism” industry (that really is a thing).

  12. Night Writer November 30, 2017 8:35 am

    I’ve said it before and I will say it again. We need to discredit the professors for their sloppy papers. These professors are being used by the judges as justification for burning down the patent system.

    Most of these professors are highly unethical people who hide behind the protection offered by their universities. The believe they are on a mission that justifies misrepresenting cites, not normalizing data, making ridiculous unsupported assertions as if they are fact, etc.

    The best way to protect the patent system would be to go after these people and discredit their work and their ethics.

  13. Night Writer November 30, 2017 9:02 am

    And, the other thing is get them to disclose the money they are getting from Google and others.

    I’d bet that John Duffy was paid a lot to push the false narrative that there are these “new references” that justify IPRs. I watched him talk about it. Looked like he knew he was fabricating nonsense but was getting so much money he didn’t care.

  14. Anon November 30, 2017 10:02 am

    I see your point Night Writer about putting the false narratives into the spotlight.

    But going forward, should we not also be considering putting in place some real (as in having real teeth) ethics requirements for academics (or at a minimum, academics engaged in attempts to shape the law)?

    I have noted previously the disparity that attorneys must abide by ethical constraints in our profession because of our proximity to shaping the law.

    How in the world are legal academics – who actively shape the minds of attorneys-to-be AND are active in shaping the law through their writings and Amici briefs – NOT EVEN MORE constrained?

  15. Chris Gallagher November 30, 2017 10:14 am

    Joe ….great post
    Investment uncertainty sure to result from inserting fuzzy definitions like “overly broad” into Bayh-Dole’s functioning is the holy grail of faculty lounge socialists like Arte Rai. Such vagueness would choke commercialization. She and her leftist friends are promoting “re-centralization” of BD’s decentralized commercialization that ultimately justifies federal funding of basic research. Similar intentions appear in this excerpt from your excellent post. “Bayh-Dole must be “updated” so agencies can MITIGATE the damage when such patents EMERGE from government supported research.”

  16. Joe Allen November 30, 2017 9:57 pm

    Corrine: regarding your question if the impact of Bayh-Dole has been measured, see this report on its substantial economic contribution in the US: https://www.bio.org/sites/default/files/BIO_Eco_Impact_of_Uni_Lic_PolicyBrief.pdf

  17. EG December 1, 2017 8:12 am

    ” Patents don’t slow academic research, they block markets.”

    Hey Benny,

    I see you’re still drinking the Kool-aid of the Goliath multi-nationals, as well as Bessen/Meurer. Where’s your factual proof for the the statement that patents “block markets”?

  18. Night Writer December 1, 2017 9:04 am

    @14 Anon: real ethics requirements? haha. The universities don’t care. They promote and hire the ones that can make the biggest noise and don’t care how unethical they are.

  19. Anon December 1, 2017 9:25 am

    Night Writer,

    I hear you.

    If universities won’t take that step, maybe courts (who are the ones asking for amicus briefs) should.

  20. Joachim Martillo December 2, 2017 10:36 pm

    My father used to say that some ideas or assertions are so stupid that only academics can believe them.

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