Jorge Contreras

Broad public concern over the availability of equipment, diagnostics and therapies needed to address COVID-19 has led numerous companies and institutions to pledge their intellectual property (IP) to this cause on a compensation-free basis (some background on IP pledging can be found here and here). The following table and discussion, adapted from a longer paper forthcoming in the Utah Law Review, summarizes the more prominent of these in roughly chronological order.

PledgeDateFormDurationIPRestrictions and limitations
Wellcome Trust Publishers’ Group1/31/20PledgeDuration of outbreakPublications relating to COVID-19n/a
Fortress/Labrador3/17/20Pledge?Diagnostic patents relating to COVID-19n/a
AbbVie3/19/20Pledge?Kaletra/Aluvia patentsn/a
Smiths3/21/20Pledge?Ventilator designs, software, patentsOnly offered to members of UK Ventilator Challenge Consortium
UC Berkeley Innovative Genomics Inst.3/23/20Pledge + Bilateral LicenseTerm of patentsSpecified patentsOnly covers technology invented after 3/13/20
Medtronic3/30/20Public LicensePHEIC* or 12/1/24Designs, software, patentsSharealike for modifications; User registration/identification
Open COVID Pledge4/7/20Pledge + Public LicensePandemic** + 1 year or 1/1/23Patents, copyrightsDefensive suspension
Harvard-MIT-Stanford4/7/20Pledge + Bilateral LicensesPandemic** + short periodUnspecifiedLicensed products must be distributed at low cost
Oxford – AstraZeneca4/8/20Pledge + Bilateral LicensesPandemic**UnspecifiedLicensed products must be distributed free of charge, at-cost or cost + limited margin
Open COVID-19 Declaration (Japan)5/7/20PledgePHEIC*Patents, utility models, designs, copyrightsApplies to activities whose “sole purpose” is addressing COVID-19. Add’l restrictions may be added by pledgors
Gilead Sciences5/12/20LicensesPHEIC* or approval of alternate drugRemdesivir patents, know-howLicensed to 5 generic drug makers for sale in low-income countries
Moderna10/8/20Pledgen/amRNA vaccine patentsn/a

*      Duration of WHO-declared Public Health Emergency of International Concern

**    Duration of WHO-declared COVID-19 pandemic

(a)  Wellcome Trust Publishers Pledge

The first pandemic-related IP pledge addressed copyrights. On January 31, 2020, the Wellcome Trust, a large UK-based medical charity, led a group of approximately thirty scientific and medical publishers in committing to make all peer-reviewed research publications relating to COVID-19 available without charge on an open access basis. The signatories included Elsevier, Cell Press, Karger, the JAMA Network, the New England Journal of Medicine, Oxford University Press, Springer Nature, Taylor & Francis, Wiley, and Wolters Kluwer. The initiative echoed earlier Wellcome-led pledges of similar scope made with respect to research concerning the Zika and Ebola outbreaks.

(b)  Fortress/Labrador

In March, patent assertion entity (PAE) Labrador Diagnostics sued French firm bioMérieux and its Utah-based subsidiary BioFire Diagnostics for patent infringement. Labrador alleged that diagnostic kits being developed for COVID-19 infringed patents it had acquired from defunct blood testing company Theranos. News of the lawsuit sparked a wave of negative publicity that quickly persuaded Labrador’s parent company, Fortress Investments, to end the lawsuit and offer royalty-free licenses to anyone conducting COVID-19 testing.

(c) Ventilator Manufacturers

Some of the first pandemic-related patent pledges were made by hospital ventilator manufacturers Smiths Group (March 21, 2020) and Medtronic, Inc. (March 30, 2020). In connection with its pledge, each company released the electronic design files associated with a particular ventilator model and authorized others to use those files and accompanying software to manufacture and sell ventilator products on a royalty-free basis. Medtronic requires any user that wishes to download its design files to register on its website. It then grants users a non-exclusive license that extends until the later of the end of the WHO-declared Public Health Emergency of International Concern or October 1, 2024. The license requires users that modify the Medtronic files or software to make those modifications available on terms identical to those extended under Medtronic’s license (i.e., a share-alike or copyleft-style requirement). The Smiths pledge is not publicly available and appears to be extended only to other members of the UK government’s Ventilator Challenge Consortium.

(d)  UC Berkeley Innovative Genomics Institute

The Innovative Genomics Institute (IGI) at University of California Berkeley is a Howard Hughes-funded, semi-autonomous research group that has achieved global recognition for its groundbreaking work on CRISPR-Cas9 gene editing (an accomplishment for which its President, Jennifer Doudna, received the Nobel Prize in Chemistry for 2020). On March 23, IGI released an “Emergency COVID-19 Technology Pledge” in which it committed to make technology that its researchers developed after March 13, 2020, available on a royalty-free basis to any entity conducting research on the diagnosis or treatment of COVID-19. To effectuate these rights, a user is required to enter into a license agreement with the University of California enumerating the specific patents that are licensed.

(e)  Open COVID Pledge (OCP)

In April, a group of ten lawyers, engineers and researchers from academia and the private sector launched a lightweight framework for pledging patents and copyrights to the COVID-19 response.  This Open COVID Pledge (OCP) is open to any IP holder that wishes to participate, and utilizes a licensing structure modeled on Creative Commons and open source software precedents.  Licenses are granted on a royalty-free basis for the duration of the COVID-19 pandemic plus a one-year ramp-down period.  There are no requirements on licensees, other than any patent assertion by a licensee against a pledgor results in the suspension of the OCP license. Pledgors may utilize a template licensing agreement created by OCP, or customize a license of their own.  It is estimated that approximately 500,000 patents and an unspecified number of copyrights have been pledged through the OCP, focused largely on the information technology and medical equipment sectors.  Universities Allied for Essential Medicines (UAEM) has adopted the OCP as its recommended framework for increasing the availability of COVID-19 vaccines (the “free the vaccine” campaign), and the OCP is included as an integral “operational part” of the World Health Organization (WHO) COVID-19 Technology Access Program (C-TAP).

(f)  Harvard-MIT-Stanford (HMS)

The same day that the OCP was launched, Harvard University, the Massachusetts Institute of Technology (MIT) and Stanford University (collectively referred to as HMS) announced a COVID-19 Technology Access Framework that “includes the use of rapidly executable non-exclusive royalty-free licenses to intellectual property rights that we have the right to license, for the purpose of making and distributing products to prevent, diagnose and treat COVID-19 infection during the pandemic and for a short period thereafter.” As of January, 2021, twenty additional U.S. research institutions and one non-U.S. university had also “signed” this commitment. While the HMS Framework does not utilize a self-executing “public” licensing agreement, the universities commit to using a “rapidly executable” agreement. The licenses to be granted are both non-exclusive and royalty-free, features designed to ensure broad access. The term of the licenses is the COVID-19 pandemic plus “a short period thereafter,” and their scope is limited to making and distributing products intended to prevent, diagnose and treat COVID-19 infection. One important feature of the HMS licenses is their express expectation that users will commit “to distribute the resulting products as widely as possible and at a low cost that allows broad accessibility during the term of the license.” This type of “downstream” pricing constraint is intended to ensure that technology licensed on a royalty-free basis is not priced so high by manufacturers that certain users cannot afford it. It is unclear at this time how many, and to whom, licenses have been granted under the HMS Framework, and with respect to what intellectual property, as this information does not appear to be publicly available.

(g)  Oxford and AstraZeneca

Approximately two weeks after the announcement of the HMS Framework, Oxford University unveiled a similar program that also included the express expectation of downstream pricing constraints. But in August, Oxford is reported to have granted pharmaceutical giant AstraZeneca an exclusive license to the university’s COVID-19 vaccine technology with no pricing constraints. Oxford’s apparent abandonment of its earlier pledge has attracted criticism, but has not yet been challenged on legal grounds. Interestingly, AstraZeneca itself pledged to distribute the vaccine “at no profit for the duration of the pandemic,” though some debate has emerged regarding the company’s apparent discretion to declare an end to the pandemic far earlier than public health authorities.

(h)  AbbVie-Kaletra

On March 18, 2020, Israel’s Minister of Health issued a permit for the importation of generic versions of AbbVie’s patented AIDS drug Kaletra for the purpose of treating COVID-19. Two days later, pharmaceutical manufacturer AbbVie announced that it would no longer enforce patents relating to Kaletra anywhere in the world. AbbVie’s pledge was widely viewed as a response to Israel’s action, and was possibly an attempt to avoid compulsory licensing orders by other governments.

(i)  Open COVID-19 Declaration (Japan)

In early May 2020, two Japanese business executives and a professor from Kyoto University organized a Japan-focused pledge community similar to the OCP. The pledge, administered by a venture-backed biotechnology firm called GenoConcierge, quickly attracted major Japanese industrial firms from the automotive, electronics and healthcare industries. To date, the Japanese program claims that over one hundred organizations have pledged nearly one million patents toward “any activities whose sole purpose is stopping the spread of COVID-19, including diagnosis, prevention, containment and treatment.” In addition to patents, the pledge covers utility models, designs and copyrights. Like the OCP, the Japanese pledge permits firms to modify the terms on which they are willing to make their IP available to users. As reported by one press account, eighteen pledgors had modified these terms by late May 2020. The modifications include requirements that users notify pledgors of their activities and the patents that they intend to use, and potential limitations to the term of the license extended. In addition, concerns have been raised regarding the language of the pledge, which extends only to activities whose “sole” purpose relates to COVID-19.

(j)  Gilead-Remdesivir

In May 2020, amidst calls for foreign governments to impose compulsory licenses on Gilead’s patented drug remdesivir, Gilead granted non-exclusive licenses to, and committed to share manufacturing technology with, five generic pharmaceutical manufacturers based in Egypt, India and Pakistan for distribution in 127 low-income countries. The licenses will remain royalty-free until the WHO declares the end of the COVID-19 Public Health Emergency of International Concern, or until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent COVID-19.

(k)  Moderna—mRNA Vaccine

On October 8, 2020, mRNA vaccine maker Moderna, Inc. publicly pledged not to enforce its COVID-19 related patents against “those making vaccines intended to combat the pandemic.” In its pledge, Moderna refers to its “special obligation under the current circumstances to use our resources to bring this pandemic to an end as quickly as possible.” Yet, as I have previously written, other benefits may accrue to Moderna from its commitment not to assert its patents. First, the U.S. National Institutes of Health (NIH), which funded at least some of Moderna’s vaccine R&D, is reported to have claimed an interest in some of Moderna’s patents. Moderna’s pledge could have helped to persuade NIH to drop its claims to the patents, given their reduced licensing value. In addition, one watchdog group has alleged that Moderna failed to make legally required disclosures of federal funding for the inventions underlying some of its patents, leading to an ongoing investigation by the Defense Advanced Research Projects Agency (DARPA). Unlike most of the other pledgors discussed above, Moderna was the subject of a significant public campaign led by Universities Allied for Essential Medicines (UAEM), a civil society organization dedicated to expanding access to medicines, to make its vaccine technology more broadly available.