PATENT PLEDGING PROBLEMS: THE OPEN COVID PLEDGE AND LONG-TERM SOLUTIONS TO LICENSING INTELLECTUAL PROPERTY IN GLOBAL EMERGENCIES
By: Marra Clay, Volume 105 Staff Member
The American intellectual property system has a single primary goal: to encourage creators to make new things that benefit society in exchange for an exclusive right to use and license the creation for a limited time.[1] The United States government currently lacks authority to mandate most intellectual property licensing.[2] But what happens when a pandemic or other emergency strikes and those inventions are suddenly necessary tools for solving a global crisis? The Open COVID Pledge comes into play. The Open COVID Pledge is a private pledge that intellectual property owners have signed, donating their intellectual property to fight the COVID-19 pandemic.[3]
From vaccine technology to contact tracing, companies from many different medical and technology sectors voluntarily relinquished their exclusive rights to their intellectual property in the hopes that it can be used to combat COVID-19 and minimize the virus’ effects. Companies such as Amazon, Facebook, IBM, Intel, Amazon, and Microsoft have pledged their intellectual property in the Open COVID Pledge.[4] Though a vaccine has now been developed for the virus,[5] contact tracing and COVID treatment plans are still necessary tools for combating the pandemic,[6] and the pledged technology is still incredibly useful. The Open COVID Pledge is unquestionably honorable, but it is not a long-term solution to accessing intellectual property during global emergencies due to its voluntary nature. This De Novo post will provide an overview of the Open COVID Pledge, its limitations, and propose two solutions for future emergencies: statutory compulsory licensing and a national emergency defense against infringement.
I. THE OPEN COVID PLEDGE
In 2020, a group of scientists, lawyers, entrepreneurs and individuals created the Open COVID Pledge (the “Pledge”) to help fight the COVID-19 pandemic.[7] It is now lead by Creative Commons.[8] The Pledge calls on businesses to make their intellectual property freely available to those who want to use it to combat the pandemic.[9] This section will discuss the different licenses available, as well as scholarly and legal commentary on the Pledge.
A. Pledging Specifics
To make the Pledge, a company must sign a license.[10] The Pledge provides two versions of these contracts: a standard license that can be adopted by any organization or individual taking the Pledge, and a compatible license that provides a set of minimum use permissions.[11] The Pledge also allows companies to write an alternative license. For example, an alternative license may limit the use to a particular country or field.[12] However, companies are not allowed to write alternative licenses that limit duration, restrictions to non-commercial purposes, or require that the licensee make licensed products available at no charge, among other things.[13] Intellectual property owners must sign one of these licenses to make their IP available so that individuals who use it will not be liable for infringement.
The Open COVID Pledge licenses grant a “non-exclusive, royalty-free, worldwide, fully paid-up license” to the Pledgor’s patents and copyrights, and provides for the right to “make, use, sell and import any patented invention, and reproduce, adapt, translate, distribute, perform, display, modify, create derivative works of and otherwise exploit any copyrights.”[14] The license is limited to use “solely for the purpose of diagnosing, preventing, containing, and treating COVID-19.”[15] The license is effective as of December 1, 2019, and lasts until one year after the World Health Organization declares that the COVID-19 pandemic has ended, but will not extend beyond January 1, 2023 without the Pledgor’s permission. [16]
Pledgors range from technology companies like Facebook and Uber to scientific organizations like the NASA Jet Propulsion Laboratory and Sandia National Laboratories.[17] If an individual is interested in using the pledged intellectual property, they can search the Open COVID Pledge database.[18] Pledged intellectual property include “3D-printed respirators, touch screens that use ultraviolet light to prevent the spread of infection, a WiFi enabled floating hospital, methods for designing grocery stores to ensure social distancing, . . . software for accelerating disease diagnosis, algorithms for routing emergency vehicles through traffic, a drive-up booth for Covid-19 testing,” and many other types of technology.[19] Anyone may use this pledged technology as long as they are combating the COVID-19 pandemic.[20]
B. Professional and Scholarly Commentary on the Open COVID Pledge
Though Pledgors should certainly be applauded (or, at the very least, acknowledged) for their contribution to fighting the pandemic, a handful of law firms instructed their clients to consider several factors before signing the Pledge. These factors include companies’ ability to track the license,[21] balancing data sharing and open access with the company’s need for financial stability,[22] and the license’s scope.[23] Generally, most of these firms encouraged companies to sign alternative pledges that are uniquely tailored to their specific patent portfolio.[24]
Many economic and scientific scholars also discussed the effects of the Pledge on future technology development. Practicing scientists and professors hope that this will yield increased collaboration and information sharing in the future.[25] As one economist noted, “Patents can block the search for a solution, but they can also accelerate it.”[26] Intellectual property restrictions are often a hurdle that makes designing new treatment plans impossible. In the past, pharmaceutical giant Gilead Sciences suggested it would enforce their patent rights over remdesivir, an experimental antiviral drug that can be used to help treat COVID-19 in patients.[27] Open access licenses on Gilead’s patent would allow the sale of generic version of these life-saving drugs.[28] But, the government cannot mandate Gilead to license its remdesivir patent, and Gilead is not obligated to sign the Pledge due to its voluntary nature. Thus, Gilead still has an abusable monopoly on the drug. Though the Pledge is a helpful tool in minimizing the effects of this pandemic, it is not a viable solution to future global emergencies due to its voluntary nature.
II. THE PLEDGE IS NOT A LONG-TERM SOLUTION FOR EMERGENCY USE OF INTELLECTUAL PROPERTY
Though the World Health Organization recognized the Pledge as a “means to advance research and science in the fight against COVID-19,”[29] its voluntary nature proves it is not a viable solution for future emergencies. There is nothing forcing companies to contribute their intellectual property for the greater good. Thus, there should be changes in intellectual property law to allow for the open sharing of information to combat future emergencies similar to the COVID-19 pandemic, especially when intellectual property is an important part of the solution. Possible options include compulsory licensing and a national emergency common law defense against infringement.
A. Congress Should Enact a Compulsory Licensing Statute
The Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS Agreement”) provides minimum intellectual property law standards for World Trade Organization nations, including the United States.[30] The TRIPS Agreement includes an option for compulsory licensing. Compulsory licensing is when the government allows a third party to produce a patented product or process without the patent owner’s consent.[31] Under the TRIPS Agreement, compulsory licensing may be authorized “in the case of a national emergency or other circumstances of extreme urgency or in cases of nonpublic commercial use.”[32]
Most European countries, as well as India and Canada, have statutory compulsory licensing.[33] But, the United States lacks a general compulsory licensing statute.[34] The closest thing that the United States has to compulsory licensing are “march-in rights” which allow the U.S. government to grant licenses on patents when the development of that patent was funded by the federal government.[35] In practice, march-in rights have never been invoked.[36] Thus, one long-term solution to open access intellectual property is the establishment of compulsory licensing. Some health scholars have argued for years that compulsory licensing should be available, at least for pharmaceutical patents to ensure patients have access to life-saving medicine and to prevent pharmaceutical companies from charging exorbitant prices.[37] If Congress passes a compulsory licensing statute, it would give the government the ability to force licensing and distribution of important technologies, such as vaccines, in times of national emergency.
B. A National Emergency Common Law Defense is a Short-Term Solution
A second possible solution to intellectual property access during national emergencies is the creation of a common law national emergency defense against infringement. Some legal scholarship has urged courts to adopt this defense.[38] Under this proposed national emergency defense, inventors would be able to use patented and copyrighted technology in efforts to combat a national emergency.[39] This defense would allow critical technology and information to be shared freely with those who are developing solutions to situations like pandemics. This might also serve as a short-term solution until Congress establishes a statutory compulsory licensing scheme.
CONCLUSION
The Open COVID Pledge has honorably sought to do what the United States government lacks authority to do: encourage the open access of important intellectual property that serves as a tool for combating the COVID-19 pandemic. However, it is not a long-term solution to future national emergencies due to its voluntary nature. Thus, Congress should consider adopting compulsory licensing and the courts should implement a common law national emergency defense to patent infringement. These two solutions would allow for the open sharing of important intellectual property during times of need.
[1] Jay Jr. Dratler, Incentives for People: The Forgotten Purpose of the Patent System, 16 Harv. J. on Legis. 129, 133 (1979).
[2] Nafsika Karavida, Dara Onofrio, & Deena Merlen, Patent Rights and Wrongs in the COVID-19 Pandemic: EU and U.S. Approaches to Compulsory Licensing, IP Watch Dog (May 19, 2020), https://www.ipwatchdog.com/2020/05/19/patent-rights-wrongs-covid-19-pandemic-eu-u-s-approaches-compulsory-licensing/id=121709/ [https://perma.cc/EM52-NVSU].
[3] About, Open COVID Pledge, https://opencovidpledge.org/about/ [https://perma.cc/75BK-L798] (last visited Dec. 28, 2020).
[4] Partners, Open COVID Pledge, https://opencovidpledge.org/partners/ [https://perma.cc/39K6-RFHA] (last visited Dec. 22, 2020).
[5] Coronavirus Disease (COVID-19): Vaccines, World Health Org. (Dec. 12, 2020), https://www.who.int/news-room/q-a-detail/coronavirus-disease-(covid-19)-vaccines?adgroupsurvey={adgroupsurvey}&gclid=Cj0KCQiAoab_BRCxARIsANMx4S6eMxNAGrGMeGBN03NLoaeZmworKNsmmICH7l6x0UITWU-L8GsZ3hgaAnJIEALw_wcB [https://perma.cc/8XGP-8WAR].
[6] Contact Tracing, Ctr. for Disease Control and Prevention (Dec. 3, 2020), https://www.cdc.gov/coronavirus/2019-ncov/daily-life-coping/contact-tracing.html#:~:text=Contact%20tracing%20slows%20the%20spread,to%20COVID%2D19%20get%20tested [https://perma.cc/P6MZ-NY9J] (discussing the importance of contact tracing); Information for Clinicians on Investigational Therapeutics for Patients with COVID-19, Ctr. for Disease Control and Prevention (Dec. 4, 2020), https://www.cdc.gov/coronavirus/2019-ncov/hcp/therapeutic-options.html [https://perma.cc/AL4M-PNTX].
[7] Supra note 3.
[8] Diane Peters & Eric Steuer, Creative Commons is now Leading the Open COVID Pledge – Here’s What that Means, Creative Commons (Aug. 27, 2020), https://creativecommons.org/2020/08/27/cc-ocp/ [https://perma.cc/3KFS-56PG].
[9] Id.
[10] Licenses, Open COVID Pledge, https://opencovidpledge.org/licenses/ [https://perma.cc/D5YP-992K] (last visited Dec. 28, 2020).
[11] Id.
[12] Id.
[13] Id.
[14] OCL-PC v1.1, Open COVID Pledge (Apr. 17, 2020), https://opencovidpledge.org/v1-1-ocl-pc/ [https://perma.cc/UJ55-TZ5R].
[15] Id.
[16] Id.
[17] Partners, supra note 2. It should be noted that, at the time of this writing, no pharmaceutical companies were listed as pledgors. Id.
[18] Search Open COVID Pledge IP, Open COVID Pledge, https://opencovidpledge.org/ip/ [https://perma.cc/3Z3F-CGZU] (last visited Dec. 28, 2020).
[19] Jorge Contreras, Putting Pledge IP to Work – Identifying IP Available under the Open COVID Pledge, Open COVID Pledge (June 12, 2020), https://opencovidpledge.org/2020/06/12/putting-pledged-ip-to-work-identifying-ip-available-under-the-open-covid-pledge/ [https://perma.cc/BU55-MG8R].
[20] Licenses, supra note 10.
[21] Michael S. Horikawa, The Open COVID Pledge – Don’t Say “I Do” Till You Think It Through, Pillsbury L. (June 24, 2020), https://www.pillsburylaw.com/en/news-and-insights/open-covid-pledge-ip-diligence.html [https://perma.cc/HU79-SXU6].
[22] Gunjan Argawal & Chipo Jolibois, IP Risks to Consider when Joining ‘Open COVID Pledge’, Fox Rothschild LLP (June 20, 2020), https://www.foxrothschild.com/publications/ip-risks-to-consider-when-joining-open-covid-pledge/ [https://perma.cc/3H84-UV98].
[23] The Open COVID Pledge: What You Need to Know, Wolf Greenfield (May 1, 2020), https://www.wolfgreenfield.com/publications/articles/2020/the-open-covid-pledge [https://perma.cc/M99A-SANC].
[24] Argawal, supra note 18.
[25] Edwin G. Tse, Dana M. Klug & Matthew H. Todd, Open Science Approaches to COVID-19, F1000Research 5 (2020), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7590891.1/pdf/f1000research-9-28785.pdf [https://perma.cc/UU4V-4BA9]; Robert C. Miller, C. Jillian Tsai, Scholarly Publishing in the Wake of COVID-19, Int. J. of Radiation Oncology Biology Physics (2020), https://pubmed.ncbi.nlm.nih.gov/32890542/ [https://perma.cc/GE59-3UHQ].
[26] George Abi Younes, Charles Ayoubi, Omar Ballester, Gabriele Cristelli, Gaétan de Rassenfosse, Dominique Foray, Patrick Gaulé, Gabriele Pellegrino, Matthias van den Heuvel, Elizabeth Webster & Ling Zhou, COVID-19: Insights from Innovation Economists, Oxford J. of Science and Pub. Policy 7 (2020).
[27] Vidya Krishnan, How Secret Deals Could Keep a COVID-19 Drug out of Reach of Millions, L.A. Times (July 1, 2020), https://www.latimes.com/world-nation/story/2020-07-01/gilead-patent-limits-access-to-covid-19-drug-remdesivir [https://perma.cc/68YD-RE9M].
[28] Younes, supra note 22.
[29] Diane Peters, WHO Recognizes the Open COVID Pledge as a Means to Advance Research and Science in the Fight Against COVID-19, Open COVID Pledge (May 30, 2020), https://opencovidpledge.org/2020/05/30/who-recognizes-the-open-covid-pledge-as-a-means-to-advance-research-and-science-in-the-fight-against-covid-19/ [https://perma.cc/TD6B-395G].
[30] Overview: the TRIPS Agreement, World Trade Org., https://www.wto.org/english/tratop_e/trips_e/intel2_e.htm [https://perma.cc/UCU2-3VE6].
[31] Compulsory Licensing of Pharmaceuticals and TRIPS, World Trade Org., https://www.wto.org/english/tratop_e/trips_e/public_health_faq_e.htm#:~:text=What%20is%20compulsory%20licensing%3F,the%20patent%2Dprotected%20invention%20itself [https://perma.cc/VE9S-GWEM] (last visited Dec. 28, 2020).
[32] Agreement on Trade-Related Aspects of Intellectual Property Rights, WTO, art. 31 § b, Apr. 15, 1994, 1869 U.N.T.S. 299. The Doha Declaration in 2001 required compulsory licensing for access to live-saving medicines and vaccines. Declaration on the TRIPS Agreement and Public Health, WTO, Nov. 14, 2001.
[33] Karavida, supra note 2.
[34] Mark W. Lauroesche, General Compulsory Patent Licensing in the United States: Good in Theory, But Not Necessary in Practice, Santa Clara High Tech. L. J. 41 (1990).
[35] For a detailed scheme for march-in rights and its requirements, see 35 U.S.C. § 203(a).
[36] Declaration, supra note 29.
[37] See, e.g. Kyung-Bok Son, Importance of the Intellecual Property System in Attempting Compulsory Licensing of Pharmaceuticals: A Cross-Sectional Analysis, 15 Globalization and Health (2019), https://globalizationandhealth.biomedcentral.com/articles/10.1186/s12992-019-0485-7 [https://perma.cc/CBJ6-W4LP].
[38] Such scholarship has suggested that a national emergency defense may be derived from the experimental use defense. See, e.g. Rachel Halpern, National Emergency Exception: Patents in the Time of Coronavirus, Colum. Undergraduate L.V. (June 20, 2020), https://www.culawreview.org/journal/national-emergency-exemption-patents-in-the-time-of-coronavirus [https://perma.cc/V2TW-W5XS]. This defense was notably explained and exemplified in Madley v. Duke University, 307 F. 3d 1351 (Fed. Cir. 2002).
[39] Id.