Patents and Their Role in a COVID-19 Cure
April 22, 2020
By Melanie Szweras and Carmela De Luca
In the current COVID-19 climate, many researchers and pharmaceutical companies are rushing to find both treatment and vaccines. COVID-19 (SARS-CoV-2) is a new type of coronavirus related to the Severe Acute Respiratory Syndrome (SARS) coronavirus (SARS-CoV) and the Middle East Respiratory Syndrome (MERS) coronavirus (MERS-CoV). According to the BIO SmartBrief article of April 13, 2020, there are over 160 drug and vaccine candidates that are currently being pursued at various stages of development.1 There is a great emphasis on the sharing of innovative technology and know-how as everyone comes together to fight this common enemy. This is evident in the collaborations between various players in the industry and the access being afforded to proprietary resources. Excelra has made their COVID-19 Drug Repurposing Database open access,2 CAS has produced an overview of published scientific information with an emphasis on patents in the CAS content collection with a focus on agents known to be effective against other RNA viruses including SARS-CoV and MERS-CoV and another initiative has scientists and tech companies providing access to their patents until 1 year after the pandemic ends, with Intel alone opening more than 72,000 patents to the world.3 Canadians are also ramping up their COVID-19 Collaborations. As reported earlier, companies are not only sharing IP, they are enabling others to copy their products. The extent of access and sharing is unprecedented.
Instead of blocking competitors, companies and researchers are looking for partners to help drive the innovation at an accelerated pace. This collaboration among players of various stages of the development of an innovation can be accomplished by transactional licensing, or other forms of open source collaborations. Terms can be negotiated to encourage disclosure, to bring together parties that have different expertise required to get a medicine or vaccine through clinical trials and out to patients as quickly as possible, while still providing incentives and reasonable compensation for the initial innovator. For example, a manufacturing company that has the ability to scale up under GMP conditions, especially ones that have vaccine expertise, might be an important partner for a research company that has a possible vaccine candidate. Indeed, Pfizer and BioNTech have come together to jointly develop a COVID-19 vaccine, with the aim to scale up manufacturing capacity to support global supply and supply millions of vaccine doses by the end of 2020. BioNTech will contribute multiple mRNA vaccine candidates and Pfizer will contribute its leading global vaccine clinical research and development, regulatory, manufacturing and distribution infrastructure.4 Sharing of patented technology can provide the impetus for accelerating the development process.
Many have suggested that the COVID-19 virus may become seasonal, like the flu. Research on flu vaccines, strategies and treatments has long been an active area and has resulted in various vaccines and antivirals like Tamiflu®. In a 2012 review,5 approximately 3800 patent families were identified as being directed toward vaccines against influenza A virus, including vaccine compositions and disclosures relating to supporting vaccine development. According to the review, as expected, publications (and thus patent filings) increased dramatically after outbreaks of H5N1 and H1N1. The top-filers included major pharmaceutical companies such as Novartis, GlaxoSmithKline, Pfizer, Merck, Sanofi and AstraZeneca. However, a large number of governmental and nonprofit institutes were also heavy contributors.
Also, in the flu space, the World Health Organization has a framework that balances intellectual property ownership of viral resources with the sharing of benefits. This system called “Pandemic Influenza Preparedness” or “PIP” framework has set out the following key goals “to improve and strengthen the sharing of influenza viruses with human pandemic potential; and to increase the access of developing countries to vaccines and other pandemic related supplies”.6 The purpose of the PIP is to allow for greater access to genetic sequence data and analyses to be shared in a rapid manner to institutions, organizations and entities, subject to certain contractual obligations. A number of manufacturers of vaccines and antiviral treatments have signed agreements with the WHO7 as well as a couple of manufacturers of other pandemic related products.8 Some of these treatments may also be useful for treating other viral infections.
COVID-19 although unprecedented in scope is not the first Coronavirus to incite massive public health measures. The first case of SARS, a serious form of viral pneumonia caused by the SARS coronavirus, occurred in late 2002 in the Guangdong Province of the People’s Republic of China. The epidemic spread quickly around the globe. Final statistics from the World Health Organization showed that 8096 reported illnesses and 774 deaths occurred in 30 countries.9 Despite a concerted global effort, no effective treatment was found for SARS. Although the scale of the outbreak does not compare to COVID-19, the death rate was reported to be higher at about 10%. The last known transmission of SARS was in 2004. However, future outbreaks of SARS are still possible as the virus lives in wild bats and civets as well laboratory cultures.
Initial SARS research efforts and patenting were robust. Searching the World Intellectual Property Database for patent families referring to SARS in the 1) title or abstract and 2) claims, identified 773 distinct patent families (and about 1112 patent documents). Based on their publication dates (which typically occurs 18 months after filing a patent application), we see that in the first few years after SARS hit, there was a lot of patent filing activity, that dwindled quickly within a few years after the epidemic. For example, in 2004 there were 155 patent filings published generally reflecting cases filed in 2002 and 2003 during the heart of the epidemic. In 2005 there were 216, before dropping to 85 in 2006 and down to 33 in 2008.
MERS, first detected in a resident of Saudi Arabia, has infected more than 2442 people in several countries, with 80% of cases occurring in Saudi Arabia. It has been reported to be fatal in approximately 35% of patients infected although this may be an overestimate due to the exclusion of mild cases.10
Patenting for MERS related inventions is significantly less with reports showing over a 10 times greater number of patents for SARS.11 Although SARS was earlier which could explain a portion of the discrepancy, the fact MERS was mostly limited to Saudi Arabia and was not widespread, may also have contributed to the limited patenting for MERS.
Drug-repurposing efforts like those of Excelra and CAS, are ongoing. The CAS patent analysis of coronavirus-related biologics shows that it includes therapeutic antibodies, cytokines, and nucleic acid-based therapies targeting virus gene expression as well as various types of vaccines, which may be applicable to COVID-19.12
Patenting is associated with innovation particularly in research intensive industries such as pharmaceuticals and biologics and can be used to encourage collaboration and spur innovation. As future outbreaks of coronavirus diseases are likely, patents can be a valuable tool and source of patent knowledge. Given the global impact of COVID-19 and the possibility of seasonal recurrence, research and patent filings will likely increase and begin to mirror the influenza space. This virus will likely garner another sort of PIP-type or other long term open source program that will encourage contractual licensing of innovative IP in exchange for access to specialized expertise or important biological data.
1 “Vanquishing the Virus: 160+ COVID-19 Drug and Vaccine Candidates in Development”, Alex Philippidis, April 13, 2020, https://www.genengnews.com/a-lists/vanquishing-the-virus-160-covid-19-drug-and-vaccine-candidates-in-development
5 “Patent Landscape of Influenza A Virus Prophylactic Vaccines and Related Technologies”, Jon R. Cavicchi et al., University of New Hampshire Scholars’ Repository, 1-1-2012
11 ACS Cent. Sci. 2020, 6, 3, 315-331 Publication Date:March 12, 2020, https://doi.org/10.1021/acscentsci.0c00272
12 Ibid 11.
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