As we enter week four since President Trump recognized the COVID-19 outbreak as a global pandemic and a national emergency,[1] many wonder when this will all end. While our hospitals continue to fill with infected patients, we look hopefully to the labs active with scientists racing to improve testing, find treatments, and develop a vaccine, and to the manufacturers scrambling to put together means to produce vital medical supplies.
A balance between the rights of innovators and the public underlies all intellectual property systems.[2] However, given the present global pandemic, exclusive rights in certain intellectual properties may increase in value, tipping the scale excessively in favor of rightsholders. Conscious that this imbalance may end up restricting innovation by discouraging researchers from working on private technologies, on March 30, 2020, a team of scientists and lawyers publicly rolled out a project called the “Open COVID Pledge.” This project aims to strengthen the efforts made by our scientists and engineers to end the pandemic by boosting cooperation, pooling resources, and making intellectual property widely available.[3]
The Pledge can be made by rightsholders by posting a public letter pledging to make their IP “available free of charge for use in ending the COVID-19 pandemic and minimizing the impact of the disease.”[4] Rightsholders that make the Pledge will be entered into and promoted in a searchable database.[5] Implementation of the pledge through an open license will be at the discretion of the rightsholder, but the model Open COVID License created by the initiative’s team envisions an effective period from December 1, 2019 through one year after WHO declares the pandemic to have ended.[6] The term “intellectual property” is construed broadly under this model license, which makes available for exploitation all “patent, copyright and other intellectual and industrial property rights (other than trademarks and trade secrets) in products, services, compositions of matter, machines, articles of manufacture, processes, and works of authorship” that the rightsholder can license.[7]
Such an open pledge may be a necessary catalyst to ensure technological collaboration at this time. As Stanford Law Professor Mark Lemley, a founding member of the Open COVID Pledge initiative and IP law expert stated, “Companies might be reluctant to do this if they thought they were the only ones, so the commitment provides a way for universities and companies to feel comfortable that they are not alone.”[8] Unified Patents, a San Jose-based organization whose goal is to reduce the number of assertions made by non-practicing entities, or patent trolls, in technological areas, has made the Open COVID Pledge. [9]
Companies with large IP portfolios have so far responded to COVID-19 in a multitude of ways. Drug manufacturer AbbVie has taken a stance in accordance with the Open COVID Pledge by suspending enforcement of its patent rights on all formulations of Kaletra, a medication originally for HIV, while it is being evaluated as a candidate to treat COVID-19.[10]
Initially taking a more protectionist stance, another drug manufacturer, Gilead Sciences, who managed to obtain orphan drug status for Remdesivir, a drug that has previously been used to treat EBOLA, MERS, and SARS, and is currently being evaluated for its effectiveness in treating COVID-19.[11] An orphan disease is a rare disease that affects fewer than 200,000 people in the U.S., and orphan drug designation gives benefits to drug companies developing drugs for orphan diseases[12], including a seven-year monopoly.[13] While confirmed COVID-19 cases has surged past the 200,000-person threshold[14], Gilead Sciences’ orphan drug application was granted because the application was filed before the threshold was crossed.[15] However, due to overwhelming demand, Gilead Science has retracted from a strict protectionist standpoint, and have transitioned to expanded access programs.[16] Information and access to the Remdesivir expanded access treatment protocol is available on the U.S. National Library of Medicine Clinical Trials website (https://clinicaltrials.gov/ct2/show/NCT04323761).
Consumer backlash of socially unconscionable IP enforcement seems to be a driving force for the Open COVID Pledge movement. For example, Labrador Diagnostics experienced a very negative public response after their attempted lawsuit against BioFire. Labrador Diagnostics sought injunctions against BioFire that would potentially shut down BioFire’s COVID-19 testing. However, after consumer backlash, Labrador Diagnostics made a public statement that the lawsuit was not directed at the COVID-19 testing and issued a royalty-free license relating to the pandemic.[17]
The charitableness of organizations and rightsholders may not be the only means by which IP may be made available during this pandemic. The U.S. government may resort to 28 U.S.C. § 1498, which can undercut the enforcement of patent rights against use made by or for the United States if the United States was substantially justified or that special circumstances make an award unjust, or 35 U.S.C. § 203, which grants march-in rights to the U.S to grant patent licenses if the research and development of the patented invention was federally funded.[18] There is no clear sign yet that the U.S. government will resort to these provisions for the COVID-19 crisis.
Footnotes
[1] https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/
[2] https://www.wipo.int/about-ip/en/
[3]https://www.bloomberglaw.com/exp/eyJjdHh0IjoiSVBOVyIsImlkIjoiMDAwMDAxNzEtMWRiNC1kZDYyLWFmN2ItM2RmNjI3YTgwMDAxIiwic2lnIjoiS3ljbmNxbElXL2RWT1kwT2VoM0ZXUTBMUm1RPSIsInRpbWUiOiIxNTg1NTY2NjU4IiwidXVpZCI6Ik51MFdGT0toSUlkT09FM0xDODloUVE9PVlFeE9NWnlocDBvMnlKd2hJVGwyaUE9PSIsInYiOiIxIn0=?usertype=External&bwid=00000171-1db4-dd62-af7b-3df627a80001&qid=6883523&cti=LSCH&uc=1320017973&et=CURATED_HIGHLIGHTS&emc=bipnw_hlt%3A8&context=email&email=00000171-1e81-d7dd-a1f1-5e85be770000
[4] https://opencovidpledge.org/; https://opencovidpledge.org/sign/
[5] https://opencovidpledge.org/sign/
[6][6] https://opencovidpledge.org/license/v1-0/
[7] Id.
[8] https://law.stanford.edu/2020/04/01/stanfords-mark-lemley-on-call-to-make-ip-available-to-end-covid-19-pandemic/
[9] https://www.unifiedpatents.com/open-covid-pledge
[10] https://www.natlawreview.com/article/covid-19-update-patent-rights-covid-19-pandemic-how-will-industries-and-governments
[11] Id.
[12] https://www.cancer.gov/publications/dictionaries/cancer-terms/def/orphan-drug-designation
[13] https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/orphan-drug-act-relevant-excerpts
[14] https://coronavirus.1point3acres.com/en
[15] https://www.ibtimes.com/coronavirus-treatment-gileads-potential-covid-19-treatment-labeled-orphan-drug-could-2945353; https://www.democracynow.org/2020/4/2/robert_weissman_public_citizen_economy_coronavirus
[16] https://www.gilead.com/purpose/advancing-global-health/covid-19/emergency-access-to-remdesivir-outside-of-clinical-trials
[17] https://www.natlawreview.com/article/covid-19-update-patent-rights-covid-19-pandemic-how-will-industries-and-governments; https://www.theverge.com/2020/3/18/21185006/softbank-theranos-coronavirus-covid-lawsuit-patent-testing
[18] https://www.natlawreview.com/article/covid-19-update-patent-rights-covid-19-pandemic-how-will-industries-and-governments