April 29, 2020
By Noel Courage, Carmela De Luca and Aaraf Dewan
The COVID-19 pandemic and its unprecedented reach has focused public health authorities and researchers on pursuit of diagnostic, treatment and vaccine innovations. One response has been a global initiative to create a World Health Organization (WHO) -led voluntary patent pool of rights related to patented COVID-19 technologies.1 The Medicines Patent Pool (MPP), a United Nations backed, public health organization founded in 2010, has thrown its support behind the initiative and recently announced an extension of their mandate to include any health technology that could contribute to the global response to COVID-19.2
What are patent pools?
Patent pools are voluntary agreements between two or more entities possessing patents to a particular technology. Healthcare patent pools involve setting up an administrative system to facilitate sharing of IP and data of multiple IP owners. The pool may deal with proprietary rights in regulatory test data, know-how, cell lines and copyrights for diagnostic tests, devices, drugs, or vaccines. The administrator of the pool is granted power to facilitate licenses to third parties in accordance with the permitted licensing terms. The pools are, in effect, a one-stop-shop for licenses to the patented technology. There is a significant efficiency gain from a pool allowing third parties to obtain a single license to the group of patents through the pool, as opposed to having to negotiate multiple licenses between different parties. Fewer licenses typically also lead to reduced costs for vendors when manufacturing and selling products, which further allows for cost savings to be passed onto the end consumer. Patent pools have been commonly used in various industries, but primarily in high tech. In the tech industry, patent pools have been utilized to facilitate the adoption of certain technological standards. MPEG Licensing Administrator LLC (MPEG LA®) is a company which has established and maintains patent pools for several technologies such as MPEG-4, DisplayPort, and Qi Wireless Power.
How have they been used for patented medicines?
Patent pools have also been used in the public health sector to reduce the cost of manufacturing drugs, particularly for the treatment of low-income and middle-income countries. An example of this is the MPP whose mandate includes increasing accessibility to drugs for the treatment of HIV, hepatitis C, tuberculosis, and other essential medicines.3 The MPP has established licensing agreements for 18 patented medicines that allow sublicensees to develop, produce, and sell generic versions of the medication in the countries which are agreed upon. Currently, the MPP has sublicense contracts with 24 generic manufacturers and product developers.4 These sublicenses have led to the development of a number of generic drugs, such as generic versions of tenofovir disoproxil/lamivudine/dolutegravir (TLD), a once-daily, single-tablet regimen recommended by the WHO as the preferred first-line treatment for adults and adolescents living with HIV.5
In some cases, patent pools may also lead to further innovation. An example of this is the MPP’s licensing agreement with AbbVie in 2014 which allowed for the development of paediatric formulations of Lopinavir/Ritonavir.6 At the time, Lopinavir/Ritonavir was not available in a suitable form for infants and toddlers living with HIV. The MPP licensing agreement has allowed for the development of child-friendly Lopinavir/Ritonavir formulations such as heat-stable fixed dose combination granules with taste masking.7 The sublicensee, Cipla, received United States Food and Drug Administration (USFDA) approval for their oral pellet formulation of Lopinavir/Ritonavir in 2015.8
Also notable was a proposal by Simon et al., for the development of a severe acute respiratory syndrome (SARS) patent pool in 2005. In the proposal, patent rights from the Genome Sciences Centre of the British Columbia Cancer Agency, Center for Disease Control, Hong Kong University, and Erasmus Medical College would have been pooled to allow wide access to the SARS genome following the outbreak.9 The SARS patent pool faced unique challenges because at the time of proposal, the patents which were proposed to be pooled had not issued yet issued and the need for a pool diminished as the outbreak was contained. Nevertheless, the proposed SARS patent pool remains a lesson in the challenges faced when implementing a patent pool to combat a global outbreak.
The MPP’s announcement to support the WHO-led patent pool by temporarily expanding its mandate to include health technologies that could contribute to the global response to COVID-19 raises questions about how such a patent pool could be structured. No details have yet been provided. The WHO is currently working with Costa Rica to finalize details on the patent pool and has thanked the MPP for expanding to include medicines and diagnostics for COVID-19 in their licensing pool.10
The MPP has also updated their Medicines Patents and Licenses database (MedsPal) to include the status of patented candidate products for COVID-19. As of the writing of this article, the only candidate product on the MedsPal database that is described in the database as being for the treatment of coronaviridae viral infections is Remdesivir (remdesivir is an experimental drug, not currently approved for treating COVID-19). However, the patent and license information for Tocilizumab, Lopinavir/Ritonavir, and Sarilumab is also present on MedsPal, which are all drugs currently undergoing clinical trials for treating COVID-19 infections in Canada.11 Notably, the MPP already has a licensing agreement in place with Abbvie for Lopinavir/Ritonavir, however the agreement only encompasses sublicenses for the treatment or prevention of HIV in Africa and does not include the treatment or prevention of other viruses.12
How could a patent pool be useful in the battle against COVID-19?
The innovative hearts and minds of scientists and industry leaders have led to the development of several COVID-19 health technologies such as diagnostic testing devices and drug treatments undergoing clinical trials.13 Similar to the HIV and proposed SARS patent pools, a COVID-19 patent pool could serve to improve accessibility to essential medicines or future vaccine and improve standardization of diagnostic testing. As the COVID-19 patent pool is developed, the WHO will need to determine which patents are essential and recruit them for the pool in order to initiate meaningful license negotiations that can increase access to IP. Due to the emergence of COVID-19 being a relatively recent event, patents specific to the current strain have not yet been issued and the applications have generally not even been published yet (early patent publication and expedited examination is often available upon request). However, patents directed to coronaviridae viral infections, such as Gilead’s patent for Remdesivir,14 have previously been issued and these patents could form the foundation for a patent pool in its early stages, if these therapeutics are proven effective against COVID-19 (many clinical trials are underway, including some off-patent compounds). Further, a major notable difference between the proposed COVID-19 patent pool and the proposed SARS patent pool is the existence of issued patents for drugs currently undergoing clinical trials. The proposal also comes during the height of the pandemic and prior to the emergence of subsequent viral waves. Therefore, specific challenges for the SARS patent pool, such as a potentially for diminished need for the pool if COVID-19 dissipates, and uncertainty as to what essential patents would be included in the pool may not be faced by the COVID-19 patent pool. Licensing negotiations will require experienced legal counsel to determine the terms necessary to address public health concerns and to also allow for reasonable compensation for patent holders. If implemented properly, a COVID-19 patent pool could encourage innovation and improve accessibility to life-saving medications, encourage further innovation, as well as streamline and accelerate the adoption of diagnostic standards.
1 Marie-Paule Kieny and Charles Gore, “The World Needs a Master Plan for Covid-19 Patents. We’re Creating One.” (April 10, 2020), Barrons, online:<https://www.barrons.com/articles/the-world-needs-a-master-plan-for-covid-19-patents-were-building-one-51586524940>
2 Medicines Patent Pool April 3, 2020 media announcement, online:<https://medicinespatentpool.org/mpp-media-post/the-medicines-patent-pool-and-unitaid-respond-to-access-efforts-for-covid-19-treatments-and-technologies/>
3 Medicines Patent Pool, “2018 Annual Report: Vision and Mission” (2019) at page 12, online:<https://annual-report-2018.medicinespatentpool.org/downloads/MPP_2018_Annual_Report_Vision-and-Mission.pdf>
4 Ibid at page 15
5 Medicines Patent Pool, “2018 Annual Report: HIV” (2019) at page 24, online:<https://annual-report-2018.medicinespatentpool.org/downloads/MPP_2018_Annual_Report_HIV.pdf>
6 Medicines Patent Pool December 1, 2014 media announcement, “The Medicines Patent Pool (MPP) Signs Licensing Agreement with AbbVie for HIV Paediatric Formulations of Lopinavir and Ritonavir”, online:< https://medicinespatentpool.org/mpp-media-post/the-medicines-patent-pool-mpp-signs-licensing-agreement-with-abbvie-for-hiv-paediatric-formulations-of-lopinavir-and-ritonavir/>
7 Supra at note 5 at page 28
8 Drugs for Neglected Diseases Institute, “Child-friendly formulation of WHO-recommended treatment now approved by the US FDA for children living with HIV” (June 3, 2015), online:< https://www.dndi.org/2015/media-centre/press-releases/pr-phti-fda-approval-pellets/>
9 James Simon et al, “Managing severe acute respiratory syndrome (SARS) intellectual property rights: the possible role of patent pooling” (2005), Bulletin of the World Health Organization, Volume 83, p. 707-710
10 World Health Organization, “WHO Director-General's opening remarks at the media briefing on COVID-19” (April 6, 2020), online:<https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---6-april-2020?_sm_au_=iVVJ6rFR4Zr4ZrDsvMFckK0232C0F>
11 Health Canada, “Vaccines and treatments for COVID-19: List of all COVID 19 Clinical Trials Authorized by Health Canada” (last modified April 20, 2020), online:<https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-clinical-trials/list-authorized-trials.html>
12 Abbvie-MPP License Agreement for Lopinavir/Ritonavir, see “Field” at page 2 and see “Exhibit A”, online:<https://medicinespatentpool.org/uploads/2017/07/MPP-AbbVie-License-Agreement-for-Africa-execution-copy.pdf>
13 Drugs undergoing clinical trials - see footnote 11; Diagnostic testing - Health Canada, “Diagnostic devices for use against coronavirus (COVID-19): List of authorized devices” (last modified April 17, 2020), online:<https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/covid-19/diagnostic-devices-authorized.html>
14 United States Patent No. 10,251,904 B2
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