As the COVID-19 outbreak continues its spread across the globe—resulting in more than four million infections worldwide and thousands dying of the virus every day, a growing community of scientists, software developers, health organizations, public consortia, private companies, and federal agencies (e.g., NIH) have been collaborating and sharing their patented technologies and IP rights with the shared goal of understanding and responding to COVID-19.
We briefly look at some of the mechanisms, including open source software, patent pool, and open patent pledge, that are helping facilitate this open innovation paradigm.
Open Source Software
Open Source Software (OSS) is widely known for its platform of open innovation. OSS promotes collaboration and sharing among the developers, and is typically released under a copyright license that grant users the right to copy, modify and distribute the source code. The distribution terms of open-source software must comply with the license terms and conditions. Depending on the developers’ preferences, there are multiple licensing options used by open-source projects.
The two major types of open-source licenses are copyleft and permissive licenses.
Copyleft licenses require all derivative works to be subject to the original copyleft license. To put it another way, when the derivative works are released, the source code must also be released to comply with the licensing terms, thus requiring all modified and extended versions to be free as well. As such, developers cannot redistribute a modified derivative work under a proprietary license. The most popular copyleft license is the General Public License (GPL). The developers should be mindful not to use this type of copyleft license if they have their own proprietary codes that they do not want to share with the public.
The permissive licenses are free-software licenses with minimal requirements governing the software’s use, modification, and redistribution. The best known permissive licenses include MIT, Apache and BSD. The MIT license, for example, states that the software is provided “as is” and that copyright holders will not be held liable for any claims or liabilities. The holders of the MIT license can produce, without restrictions, any derivative works from the original software and even reap commercial benefits from the sale of the derivative works. An example of application released under the MIT License is the open-sourced COVID-19 Hospital Impact Model for Epidemics (CHIME) which assists hospitals with capacity planning around COVID-19. Medtronic also released its design specifications and 3D CAD files for the PB560 Ventilator under a modified permissive license for a limited time, to respond to the COVID-19 pandemic.
Generally, a patent pool is an agreement between two or more patent holders to the cross-license of their respective patents to one another or to third parties. The formation of patent pools often arises when multiple essential patented technologies are needed to promote a new innovation. Patent pooling can clear blocking patents, decrease infringement litigation, and substantially reduce licensing transaction costs because it removes the need for patent-by-patent licensing. However, it may trigger antitrust scrutiny if the arrangements result in price fixing, unfair competition, or hinder new companies from entering into the market. Further, the establishment of a patent pool is a long and complex process. It is challenging to determine the license fee split as patent valuation is a difficult and subjective task, especially in the pharmaceutical industries.
Pool for Open Innovation against Neglected Tropical Diseases (POINT), with a clear public health mandate, was established in 2009 by GSK and administered by BIO Ventures for Global Health (BVGH). Pool contributors grant royalty-free and nonexclusive licenses to qualified participants with the aim to accelerate drugs development, vaccines and diagnostics to meet global needs.
A year later, the Medicines Patent Pool (MPP) initiated by UNITAID was established with the aim to increase access to AIDS medicines by negotiating with patent holders to share their intellectual property with the Pool, and then licensing it to generic pharmaceutical companies to facilitate the production and distribution of affordable generic medicines in developing countries. Thus, despite the name “Patent Pool,” MPP’s pool model is not a traditional one.
On April 3, 2020, the MPP temporarily expanded its mandate to include any health technology that could contribute to the global response to COVID-19.
Open COVID Pledge
An open patent pledge gives broad permission to the public, allowing temporary free access to the intellectual property (IP) rights. The Open COVID Pledge has been launched to urge universities and companies to make some or all of their patented technologies and copyrights available free of charge for the development of treatments and cures for COVID-19.
The Open COVID Pledge provides three similar pre-crafted standard Open COVID Licenses (OCL). All three OCLs offer a nonexclusive, royalty-free, worldwide, fully paid license for the purpose of diagnosing, preventing, containing and treating COVID-19. The pledgor agrees not to seek injunctive or regulatory relief to prevent any entity or individual from using the licensed IP. The license is a one-way commitment from the pledgor to licensees, which means the licensees are not required to grant rights back to the pledgor. The pledgor may adopt any one of these OCLs dependent on whether the scope of the license is to cover only patents, or both patents and copyrights, and the duration of the licensing term. The license is effective until one year after World Health Organization (WHO) declares the end of the COVID-19 pandemic. The license is granted without any warranties, and is suspended if the licensee threatens or initiates any legal proceeding against the pledgor. The license does not allow the licensee to sublicense to preserve a direct relationship between the pledgor and the user of the IP rights for purposes of enforcement and defensive suspension.
Instead of adopting one of the standard OCLs, pledgors are allowed to use their own or customized a standard OCL so long as their licenses are compatible with the OCL. To be compatible with the OCL, the licenses must not be more restrictive than the OCL, which means that while the pledgors can grant more permissions than the OCLs contain, they cannot impose more limitations. Licenses that require sharing back through copyleft are not compatible, and licenses that do not allow creation of derivatives or prohibit commercial uses are also not compatible.
What If I Have an Idea Concerning a Device or Technology Related to COVID-19?
First, never assume that your COVID-19-related device or technology is free from infringing any IP rights simply because it is related to COVID-19. To minimize the risk of infringement, do the due diligence (e.g., freedom-to-operate searches) before investing time, money and effort in developing your COVID-19-related device or technology.
If you rely on any of the mechanisms mentioned above to practice a patented technology, pay detailed attention to the licensing agreements as they are not crafted equally. For example, some are more restrictive than others. Regarding the Open COVID Licenses, you should be mindful not to exceed the scope of the license, or the pledgors may pursue all available legal remedies. Keep in mind that there is no requirement that the pledgor must license all of their IP rights. Thus, if your COVID-19-related device or technology exceeds the scope of the patent, you may run into the risk of infringing a different patent that is not listed in the Open COVID Pledge (that either belongs to the pledgor or a third party).