Here’s my take on the patent issue: Open science needs open research sharing.
Here’s my take on the patent issue: Open science needs open research sharing.
I have had a front row seat to this unfortunate state of affairs. I worked in one of the 5% of labs (synthetic biology) where the research was being commercialized/patented (the professor I worked for simultaneously was the chairman of a biotech company based on the academic research being conducted in the lab).
Earlier this year I had a few discussions with others at my university about how ridiculous the whole thing seemed. Staff, and graduate students are made to sign a piece of paper outlining potential conflicts of interest…and then…well that’s it. No oversight, no actual inquiry into whether or not the PI is behaving in a way that demonstrates a conflict of interest. But that is actually besides the point–bioengineering professors are expected to commercialize their research, and so the idea that oversight at the institutional level would be effective is, in my opinion, laughable.
What really bothered me was that universities are allowed to hold patents on research outcomes that have been made with public funds. Your discussion of Bayh-Dole was illuminating. I did not know the history surrounding the legalities of the universities’ ability to patent research. The way I explained it earlier this year was by using a comparison to a tech or pharma company: If a pharma company pays for basic research, does it give away its patent rights to the entity contractually performing the research? Why should the public give away its patent rights to universities? As many have noted, they now behave mostly as any other for profit enterprise, regardless of their official 501c3 status. What we have now is largely a public IP gifting system benefiting knowledge gatekeepers.
I like the idea of policy/legal solutions, we do need to get very serious about this. I would be for a system where the government held the patent rights and non-exclusively licensed them for a percentage of future economic value. I also like the idea of institutions voluntarily opting in to a free patent licensing system of some kind (where economic gains of patents are expressly fed back in portion to the public). I could see this as a way smaller, independent labs could offer much more value to the public than what is currently being offered by universities.
The research enterprise blog is really well done. I agree with you, universities can do policies to not patent their work… it just (just… ) takes cultural work to get to this.
After having looked into the research patenting issue from a few directions I think that this piece is the most convincing call to avoid University patents that I’ve seen (although I guess I was somewhat primed to receive the message). This seems to be key:
You might work in one of very few select sub-disciplines (usually within bio-medical or IT research) at one of the few universities where university patents have had some historical financial returns. But for the other ninety-five percent of science, and for the academy as a whole, the value of sharing research far exceeds whatever near-term monetized return might be available.
Most of the academic and trade literature I’ve read seems to promote patenting for all of science but I suspect it comes from people who are working in, or want to be working in, the minority of sub-disciplines that might benefit from patents. I’d be really interested in seeing a comparative survey of patenting opinions and practices across all academic disciplines.
folks, i think mariana mazzucato has a movement on this. or the entire ‘stakeholder capitalism’ movement. let me find it.
you could check these out related to mm:
related to sc:
also check out the recent nyt reevaluation of milton friedman’s legacy:
I’ve often wondered about cases studies on how much value is lost or gained by patenting different technologies. These working notes from Ben Reinhardt start to get at that. Despite having a recent background in start-up acceleration, he seems very sympathetic to the idea that IP protection isn’t always the right way.
Aside, I really like the format used for these working notes, kind of a personal mini-Wikipedia. Does anybody know what tool is used to create that?
Thanks for the link!
Gerald Barnett has been on a tearful month about how universities can do much better tech transfer than exclusive patent licenses: https://researchenterprise.org/
And… it is a nice format… wonder how he does it.
I stumbled across this paper describing an open science business model for pharmaceutical development that uses regulatory protection rather than intellectual property. I like the companies perspective and hope that this business model works out for them. The experiment came from the Affordable Medicines Initiative of the Agora Open Science Trust, which also seems like an interesting OS organisation.
Open science and the discovery of drug targets
As exemplified by the Structural Genomics Consortium16, open science – the rapid multilateral sharing of knowledge, results, data, and materials without patent restrictions17 – has proven to be tremendously successful in pre-competitive research areas related to early-stage drug discovery18. Open science can: (i) lower transactional barriers to collaboration, (ii) encourage cross-disciplinary contributions of expertise, (iii) distribute project risk, (iii) reduce redundancy, (iv) enable more rapid generation of new hypotheses, (v) enable transparent peer review, and (vi) increase reproducibility3,17–19.
Our hypothesis is that such an open organizational framework can be successfully applied not only to accelerate basic science but also to advance an innovative new drug candidate through discovery, preclinical and clinical development, regulatory approval, and health system uptake. Expanding the scope of open science to include more aspects of drug discovery would amplify its impact by: (i) permitting secondary and meta-analyses to improve decision-making by researchers, funders, health regulators, payers, prescribers, and patients; (ii) providing a mechanism to share failed projects and trials; and (iii) better respecting clinical trial participants by maximizing the scientific benefits of their generous contributions while minimizing their exposure to risk in duplicative studies4,19.
Application of open science to drug discovery and development
Although open science has the potential to create a far more efficient drug discovery ecosystem, it has proven difficult to apply to individual drug discovery and development programs. The greatest concern is that practicing open science makes it more challenging to manage and protect intellectual property: open science creates prior art in the public domain and also distributes inventorship among scientists in many institutions, potentially without legal agreements in place. The problem is that these properties of open science are inconsistent with creating a patent position, which is the most common intellectual property tool to shield a new drug from generic competition. In fact, it is widely believed that patenting is not only important, but is actually essential to incentivize drug development20,21. This is not the case. As detailed in the next section, sponsors of newly approved medicines in most commercially important jurisdictions are also granted other powerful intellectual property protections in the form of regulatory data and market exclusivities22. These protections are granted whether the drug product is patented or not, as well as provide better, and sometimes longer, barriers to entry from generic competition. In essence, these protections offer a strong alternative to patents for incentivizing drug development and commercialization23–25 and allow for an open science approach to drug discovery and development.
Some great ideas here. A book that came out a while ago (2008) Biobazaar that didn’t get as much attention as it should have, covers some of the same ground, and goes through some of the standard objections to an open-source model in biotech point by point. I read it some years ago, so the details are a bit hazy, but I remember it doing a good job in dealing with the arguments against open-source approach on their own terms (i.e. the stories that biotech likes to tell about itself as being an engine of “innovation” that is driven by IP, as opposed to a simplistic “Big Pharma” = “big profits” = evil) https://www.jstor.org/stable/j.ctt13x0j7x
The idea that you can trade money for time in the innovation of new medicine has been weaponized by pharma to claim that they need the retail returns for new drugs to drive their research. They use exclusive IP to prevent the spread of innovation away from their own work… If all medicines were sold at a cost-of-manufacture rate, and all research shared by public research institutes (including universities) through state funding, and without IP fences creating anti-commons, the “money-for-time” outcome would be a lot greater, and the overall cost to the society a fraction of what it is today. California is already building public generic pharmaceutical production plants. What we need is vision of a public-goods based health economy…
Glad to see the interaction of OS and IP is getting more discussion:
This online meeting brought together over 500 participants who engaged in a lively debate with the invited experts: Mr Marco Aleman, Assistant Director-General, IP and Innovation Ecosystems Sector in WIPO; Ms Brigitte Vezina, Director of Policy in Creative Commons; Ms Alessandra Baccigotti, Knowledge Transfer Manager and Head of Intellectual Property Protection at the University of Bologna’s Knowledge Transfer Office; Ms Ruth L. Okediji, Professor of Law at Harvard Law School and Co-Director of the Berkman Klein Centre; Ms Margo A. Bagley, Professor of Law at Emory University School of Law; Ms Carolina Botero Cabrera, Director of the Karisma Foundation.
The discussions focused mainly on the complexity of the different Open Science elements under IP rights and insights of existing tools and mechanisms; different existing instruments and mechanisms and examples of innovative ways of reconciling ownership and sharing/openness in institutional approaches but also in scientific communities; and the current international negotiations and agreements on the topic and how they are currently formulated considering the experience built during the COVID-19 crisis.
The experts concurred that IPRs are not an obstacle to Open Science. On the contrary, the correct definition of the IP framework can be an essential tool for Open Science to stimulate collaboration and ensure, among others, that all contributors that share their scientific data, information and knowledge are adequately acknowledged and recognized.
They also argued that different types of IPRs have different impacts on the Open Science ecosystem since they facilitate different levels of openness, regulatory exclusivities and protection against misuse of data and knowledge.
Finally, they agreed that balanced policies and strategies are needed to reconcile possible tensions between Open Science and IPRs and provided examples of good practices going forward.