The world is bracing for a pandemic as the novel coronavirus, now officially known as COVID-19, threatens to spread around the globe. In the past few months, COVID-19 has sickened more than 90,000 and killed over3,000 people. The virus has triggered a humanitarian crisis and has sparked a patent controversy surrounding the race for IP rights to potential COVID-19 treatments.
Remdesivir: A Promising Treatment
The World Health Organization has identified more than 70 candidate therapeutics that are potentially worth trying as treatments for COVID-19 infections.
A promising drug is remdesivir, a virus blocker made by Gilead Sciences, Inc. Remdesivir was first developed for treating the Ebola virus but clinical studies showed that it was not particularly effective. Gilead Sciences has secured or applied for composition of matter patents covering remdesivir and related compounds in a large number of countries, including China (e.g. Chinese application Nos. 107074902 and 110636884).
Gilead Sciences later discovered that remdesivir can inhibit a coronaviridae RNA-dependent RNA polymerase, thus preventing coronaviruses, such as SARS or MERS, from multiplying. In 2015, Gilead Sciences filed a US patent application directed to a method of treating a coronavirus infection by administering a therapeutically effective amount of remdesivir. This application No. 16/265,016 was recently allowed. The patent application does not discuss COVID-19 as it was not known to exist at that time. The corresponding Canadian Patent Application No. 2,998,189 is still pending.
Remdesivir’s efficacy against coronaviruses has been shown in both in vitro studies and animal studies (e.g. in mice and monkeys). In January, remdesivir was given to a Washington man infected with COVID-19 and the patient subsequently recovered. However, remdesivir has not yet received regulatory approval. Gilead Sciences also acknowledges that there is no data demonstrating the efficacy or safety of remdesivir in treating COVID-19 infections.
Use of Remdesivir to Treat COVID-19 Infections: Patentability Hurdles
Researchers at the Wuhan Institute of Virology found that a combination of remdesivir and chloroquine is effective in inhibiting COVID-19 in vitro. In announcing their findings, the Chinese institute also revealed that it had filed a Chinese invention patent application and a Patent Cooperation Treaty application to claim the use of remdesivir to treat COVID-19 infections.
Gilead Sciences’ prior patent application and its subsequent studies will undoubtedly pose a patentability hurdle to the Institute’s applications. Gilead Sciences’ prior patent application teaches a method for treating a coronavirus infection with remdesivir. The application includes data showing that remdesivir was effective against SARS and MERS. In addition, a subsequent study showed that remdesivir inhibits SARS’ and MERS’ RNA-dependent RNA polymerase, thus preventing the viruses from multiplying.
A comparison of nucleotide information using BLAST, shows that the RNA-dependent RNA polymerase of COVID-19 (NCBI Accession No. MN975263.1) is about 94% identical to that of SARS (NCBI Accession No. MK062183.1). This similarity in the nucleotide sequences may suggest that what works in treating SARS may also work in treating COVID-19, thereby posing a patentability hurdle to the Wuhan Institute of Virology’s applications.
To obtain patent protection, the Wuhan Institute of Virology will need to prove that the use of remdesivir to treat COVID-19 is new and non-obvious over the prior art. Given that Gilead Sciences has already demonstrated that remdesivir is effective in treating coronaviruses that are highly similar to COVID-19, it may be difficult for the Institute to achieve this. However, one way this could be achieved is if the Institute can demonstrate unexpected results showing that remdesivir works uniquely or surprisingly well in treating COVID-19 as compared with other coronaviruses already disclosed in Gilead Sciences’ earlier application.
Cross Licensing Potential
Even if the Institute secures its own patent, obtaining a patent on a new use of a patented drug does not give a positive right to use the patented drug. Instead, a patent on the new use would provide a negative right to exclude others from practising the new use of the patented drug.
This means that if the Wuhan Institute of Virology’s Chinese patent application is granted, the Chinese institute will still need a license from Gilead Sciences to make and use remdesivir, including for treatment of coronaviruses, given Gilead Science’s earlier composition of matter and method of use patents and applications. However, having its own Chinese patent could give the Institute more leverage in negotiating licensing fees for remdesivir with Gilead. This is because if Gilead Sciences wishes to use remdesivir to treat COVID-19 in China (and any other countries in which the Institute may secure patent protection), Gilead Sciences will need a license from the Institute.
In this case, the decision of the Institute to seek a patent is not necessarily intended to hinder access to medicine, but could be seen as a strategic use of patent rights to gain negotiation leverage. The Institute states that the decision to seek patent protection is to protect national interests and it will not enforce any patent rights that it may have if foreign companies contribute to the prevention and control of the COVID-19 epidemic.
Global Collaborative Effort
Despite the ongoing controversy over the Wuhan Institute of Virology’s attempt to patent the use of remdesivir to treat COVID-19 infections, the Institute’s decision to seek patent protection does not appear to hinder access to medicine at this time as no patent has yet been secured and there have not yet been reports of the Institute trying to assert exclusivity over the treatment of the virus. It is good to see that there has been considerable global collaboration with experts racing against the clock to find a treatment. Gilead Sciences is working with health authorities in China to establish a randomized, controlled trial to determine the efficacy and safety of remdesivir to treat COVID-19.
This scenario illustrates how in today’s innovation-driven economy, IP strategy should be considered as an integral part of an organization’s business strategy, and that humanitarian considerations are not necessarily incompatible with seeking patent protection.
*This article was originally published by The Lawyer’s Daily (www.thelawyersdaily.ca), part of LexisNexis Canada Inc.