Open Science and Intellectual Property Rights: How can they better interact? State of the art and reflections

“Open science (OS) is considered the new paradigm for science and knowledge dissemination. OS fosters cooperative work and new ways of distributing knowledge by promoting effective data sharing (as early and broadly as possible) and a dynamic exchange of research outcomes, not only publications. On the other hand, intellectual property (IP) legislation seeks to balance the moral and economic rights of creators and inventors with the wider interests and needs of society. Managing knowledge outcomes in a new open research and innovation ecosystem is challenging and should become part of the EU’s IP strategy, underpinning EU policies with the new open science–open innovation paradigm. The usual justification for copyright and patents is the incentive and reward for inventors, resulting in benefits for society, fostering innovation and societal impact. Various organisations recognise the need to maintain a balance between the rights of authors and the larger public interest, particularly in education, research and access to information, and to consider the scope, extent and application of intellectual property rights (IPR) in relation to the equitable production, distribution and use of knowledge. However, there are cases of tacit tension in the relationship between IPR and open knowledge distribution noticed on a global scale in different contexts, initiatives and attitudes of the scientific community. This tension has been confirmed during the COVID-19 pandemic, where there is a concern that IPR may prevent public access to medicines, particularly vaccines. Governments, scientists, media and society at large are discussing new licensing provisions to circumvent barriers to human rights such as the right to health or the right to science, without preventing innovation. There is a clear need for reflections such as the one we present here, to address the necessary compatibility of some IPR with OS and open innovation. This report provides a critical analysis of the literature on the relation between OS and IPR protection and how they might live harmoniously, by scoping the statement ‘as open as possible, as closed as necessary’. The starting point for the analysis about IPR and OS in Europe is the following hypothesis. • There are no incompatibilities between IPR and OS. ‘On the contrary the IPR framework, if correctly defined from the onset, becomes an essential tool to regulate open science’ (Barbarossa et al., 2017, p. 2). • The European Commission has a role in promoting OS and its balance with IPR. This was especially important when copyright was redefined in Europe and the European Open Science Cloud was being established. • Existing best practices have to be a source of inspiration, for example understanding how public research-performing organisations and industrial partnerships are striking a balance between IPR and open knowledge….”

Open Science and Intellectual Property Rights | European Commission

“This report presents the result of a study that explores the inter-actions and the balance between Open Science and Intellectual Property Rights. The report presents the state of the art and re-flections to scope the statement ‘as open as possible, as closed as necessary’ in the context of an evolving and open Research and Innovation ecosystem. Furthermore, the report identifies concrete recommendations for policy makers and for IPR practitioners on the promotion of Open Science and its balance with IPR for better knowledge dissemination to the benefit of all.”

FFII | Foundation for a Free Information Infrastructure information on software patents, enforcement of IP, trade agreements

“The Foundation for a Free Information Infrastructure (FFII) is a European alliance defending your right to free and competitive software creation since 1999. We are working towards the mitigation of legal risks in software development. We do so by keeping software free from patents and promoting a digital infrastructure based on genuine open standards and free and open hardware and software.

The FFII famously made a difference to prevent a EU software patent directive and continues to shed light on the schemes of the patent system to enter the software sphere and detach itself from democratic and fiscal oversight. One recent example is the Unified Patent Court (UPC). A specialised court which fences patent reforms off. We rely on networking with the European Parliament members and partners from industry and civil society. Its work won the FFII the Outstanding contribution to software development prize by CNET….”

U.S., EU, India, S.Africa reach compromise on COVID vaccine IP waiver text | Reuters

“The United States, European Union, India and South Africa have reached a consensus on key elements of a long-sought intellectual property waiver for COVID-19 vaccines, according to a proposed text reviewed by Reuters.

Sources familiar with the talks described the text as a tentative agreement among the four World Trade Organization members that still needs formal approvals from the parties before it can be considered official. Any agreement must be accepted by the WTO’s 164 member countries in order to be adopted….

The document authorizes use of “patented subject matter required for the production and supply of COVID-19 vaccines without the consent of the right holder to the extent necessary to address the COVID-19 pandemic”.

It said IP rights would also be waived for ingredients and processes necessary for COVID-19 vaccine manufacture, a move aimed at granting critical know-how to many countries lacking expertise, especially for advanced mRNA-type vaccines….”

Will ‘open-source’ vaccines narrow the inequality gap exposed by Covid? | Financial Times

“The Cape Town initiative is part of a new push by global health authorities, academics and philanthropists to address that and promote alternatives to “Big Pharma’s” business model, which relies on legally enforceable patent protections to raise investment to fund new drugs. The chronic lack of access to vaccines in the developing world has emboldened some researchers to embrace the concept of “open-source pharma” — an idea modelled on the free software movement, which encourages collaboration and sharing to improve code….

For months, the battle for access was centred on intellectual property rights. But the so-called Trips waiver — proposed by India and South Africa in 2020 — which would allow for flexibility in patents for the manufacture of vaccines, is still being discussed at the World Trade Organization. The hub, in contrast, aims to make the technology accessible to poorer nations and also train qualified staff to produce vaccines locally without breaking any intellectual property rules….

Even if it passes all of its regulatory hurdles, Afrigen’s will not be the first open-source vaccine to go into people’s arms, although it would be the first mRNA one to do so….

 

But the promise of the open-source model is, according to its backers, unprecedented. “A year ago we thought that if only we could get Moderna to give us the tech, the recipe, we would fast-track [vaccine production],” says Afrigen’s Terblanche. “Today, I am in a way grateful that they didn’t, because a turnkey tech transfer from a company like Moderna or Pfizer, you get a box, you sit in the box, and your freedom sits only in that box. The scientists would have learned to bake,” she says. “Now they have learned to make.” ”

Texas scientists’ new Covid-19 vaccine is cheaper, easier to make and patent-free | Texas | The Guardian

“A new Covid-19 vaccine is being developed by Texas scientists using a decades-old conventional method that will make the production and distribution cheaper and more accessible for countries most affected by the pandemic and where new variants are likely to originate due to low inoculation rates….

Patent wars over mRNA vaccines have recently heated up. Moderna and the National Institutes of Health are in a dispute over who should get credit for specific discoveries that led to a Covid-19 vaccine which has been delivered to more than 73 million Americans. If Moderna is found to have infringed on the federal government’s patent, it could be forced to pay more than $1bn.

At the same time, activists have called for Pfizer and Moderna to share the technology and knowhow for producing their vaccines, including taking the fight to the World Trade Organization. Low-income countries, which have few vaccine research and production facilities, have vaccinated just one in nine people, according to the World Health Organization. The US has fully vaccinated 67% of the population and provided a third vaccine dose to more than one-third.

Corbevax’s clinical trial data has yet to be released due to resource constraints, but Texas Children’s hospital said the vaccine was over 90% effective against the original Covid-19 strain and over 80% effective against the Delta variant. The vaccine’s efficacy against the Omicron variant is currently being tested….

After being overlooked by government organizations for funding, Bottazzi said, the developers behind Corbevax relied on philanthropic donations to get them over the finish line….

Bottazzi said the reason she and her team did not patent the vaccine was because of her team’s shared philosophy of humanitarianism and to engage in collaboration with the wider scientific community….”

Unpatented Shot Dubbed ‘The World’s Covid-19 Vaccine’ Wins Emergency Approval in India

“An unpatented Covid-19 vaccine developed by the Texas Children’s Hospital, Baylor College of Medicine, and the pharmaceutical firm Biological E. Limited received emergency-use authorization from Indian regulators on Tuesday—news that the jab’s creators hailed as a potential turning point in the push to broaden global vaccine access.”

Preprint servers and patent prior art

“Preprint publications are often “prior art” that render later-filed patent applications either lacking in novelty or an inventive step both of which are primary requirements under the patent laws. Prior to their dispersion on the Internet, preprints were only considered primary art if they were “available to the public”, which was not always the case for preprints distributed in closely held conferences. Internet preprint servers, however, change that calculus, making any research results available to everyone, everywhere. This tension between Internet preprints and patents may have nega tive effects on the research enterprise, including encouraging researchers to manufacture a delay in putting their preprints online-a perverse effect of preprint servers’ openness and accessi bility. Researchers should therefore be deliber ate in their choices about placing preliminary research results on preprint servers and, in particular, should investigate whether patents are necessary to achieve their research’s commercial ends, if any.”

Is Protecting Copyright More Important Than Saving Lives During The COVID-19 Pandemic?

“Although the COVID-19 pandemic has wreaked terrible suffering across the world, we are fortunate that we already have several vaccines that have been shown to be highly effective in reducing the number of deaths and hospitalization rates. Discovering vaccines proved easier than expected, but ensuring that everyone – including people in developing countries – has access to them has proved much harder. The main reason for that is an intellectual monopoly: patents. Even though at least two of the main vaccines were developed almost entirely using public funds, which ought by rights to mean that the results are in the public domain, companies have obtained exclusionary patents on them. This has led to calls for a patent waiver of some kind to allow countries to produce their own supplies of medicines, without needing to pay licensing fees.

The proposal from India and South Africa to the World Trade Organization (WTO) does not mention patents at all, but lists instead what the waiver seeks to achieve: “the prevention, containment and treatment of COVID-19″. A paper from Sean Flynn, Erica Nkrumah and Luca Schirru points out that works covered by copyright also need a waiver if we are to combat COVID-19 effectively….”

The Lens Collective Action Project levels the playing field with universal open access to patent and research knowledge.

“Today The Lens, an Australian-based non-profit and world leader in providing free and open innovation knowledge, announced the Collective Action Project (CAP), a multi-year initiative to equip individuals and institutions with the tools to contribute to shared solutions to these crises. Now, all scientists, investors, publishers, governments, businesses, and civil society can navigate open global research and patent information from over 134 million patent records linked with data from over 236 million research publications and 393 million biological sequences from patents….

What are the key barriers to progress? Jurassic business models.

The ability to discover, measure, map and analyze research and patent knowledge worldwide is big business, estimated at well over US$1.5 billion a year, much of it paid by universities and public institutions. But the real costs are vastly greater: much of the world is excluded from contributing and countless opportunities are lost.

 

“The big corporations that sell this knowledge use closed and siloed data that can’t be shared, making it difficult to build on each other’s work or make informed decisions – the very foundation of how we’ve come so far as a species,” said Mark Garlinghouse, Director of Business Development at The Lens….

The Collective Action Project is guided by the Lens Equitable Access Program (LEAP). The Program charts a pathway towards community-supported autonomous financing of The Lens, to keep it inclusive, growing, open and comprehensive.

Under LEAP, every person in the world can use the platform anonymously for free with powerful analytic tools, and access to all the data. Any registered user can benefit from personalized workspaces and customized features – at no cost for personal public-good users, or for a modest cost for commercial use. Furthermore any institution worldwide that needs or wants suites of powerful management and exploration tools in our Institutional Toolkit will have access based on low, fair, tiered pricing. All fees go towards keeping knowledge universally available as a community-supported public-good. “We announce here that we are offering at no cost these Institutional Toolkits to all public-good institutions across much of the Global South – almost 130 countries – including universities, libraries, government agencies, NGOs and civil society,” said Richard Jefferson….”

Non-Patent Intellectual Property Barriers to COVID-19 Vaccines, Treatment and Containment

Abstract: As the World Trade Organization considers a proposal to waive or otherwise address intellectual property barriers to the global response to the COVID-19 pandemic, most of the attention given by scholars and policy makers has been focused on patents. The original proposals by South Africa and India, as well as the groundbreaking support of the United States, however, explicitly applied to all forms of intellectual property. This paper documents many instances where non-patent forms of intellectual property create barriers to the global scale up of access to vaccines, treatments, and the ability to contain the virus through social distancing. Addressing the full scope of such barriers would assist the global efforts to combat COVID-19.

The Great American Science Heist

“Rickover railed against the proposed policy changes. “Government contractors should not be given title to inventions developed at government expense,” he said. “These inventions are paid for by the public and therefore should be available for any citizen to use or not as he sees fit.”

This seemed self-evident to Rickover. After all, he noted, “companies generally claim title to the inventions of their employees on the basis that the company pays their wages.” It befuddled and angered him that the U.S. government would consider giving up its own shop rights to industries that would never do the same. …

In the summer of 1979, the latest such bill was entering its sixth month of hearings on the merits of pulling the Kennedy policy inside-out. Sponsored by Sen. Bob Dole, R-Kan., and Sen. Birch Bayh, D-Ind., it would shift the burden onto government to prove that its ownership of a patent better served the public than a private monopoly, rather than the other way around. The bill was considered a long shot to get past the dens of liberal lions in the Senate and President Jimmy Carter, but it was gaining traction among Democrats.

As the bill’s chances of passage grew, Rickover stepped up his warnings to lawmakers not to fall for “the age-old arguments of the patent lobby” and pass legislation that “promotes greater concentration of economic power [and] impedes the development and dissemination of technology.” …”

WUR gives away CRISPR intellectual property licenses for free in fight against hunger – Reader Mode

“The ultimate aim of plant breeding has always been to make plants resistant to drought and diseases. That could help eliminate hunger around the world. This is no longer a distant thought, thanks to a technology called CRISPR-Cas. Today Wageningen University & Research (WUR) announces it will provide potential partners with free licenses to work on its patented CRISPR technology. The license must be applied to gene-editing of plants for non-profit applications….”

WUR gives away CRISPR intellectual property licenses for free in fight against hunger – Reader Mode

“The ultimate aim of plant breeding has always been to make plants resistant to drought and diseases. That could help eliminate hunger around the world. This is no longer a distant thought, thanks to a technology called CRISPR-Cas. Today Wageningen University & Research (WUR) announces it will provide potential partners with free licenses to work on its patented CRISPR technology. The license must be applied to gene-editing of plants for non-profit applications….”

Intellectual Property in Open Projects

“While open source software is open by definition, this term applies only to the code of the project. The intellectual property (IP) of an open source project also includes other work produced to support the project, including the project’s name, logo, domain name, and website, which may be trademarked or copyrighted separate from the open source code. Project leads need to consider IP ownership of the open source code and other assets to avoid the worst case scenarios of infringement and inappropriate reuse. In 2020 we worked with Rhizome and Conifer, which is built on the open source project Webrecorder and we worked with these teams on an IP audit to help set up all parties for successful IP management.  This work was supported by a grant to Rhizome from the Andrew W. Mellon Foundation. Here, informed by that work, we outline some simple steps that any open project can take to audit their IP to identify and remedy areas of unnecessary risk….”