Potential Coronavirus Drug: Patent Rights Amid Global Pandemic
Currently, all the countries in the world are racing to contain the coronavirus spread. The rush to find an effective coronavirus cure raises many intellectual property issues. Particularly, the patent rights of coronavirus treatment may be at dispute in terms of ownership and patentability.
One of the most promising coronavirus drugs, remdesivir, has already raised such controversies. Remdesivir is an experimental drug that has been under development by Gilead Sciences, Inc. (“Gilead”) for several years. To date, the drug has not acquired the FDA’s market approval. When China was experiencing the world’s first wave of coronavirus crisis, China’s Wuhan Institute of Virology (“WIV”) filed a Chinese national patent on January 21, 2020 to use remdesivir to treat the novel coronavirus.[1]
Gilead has an inspiring second try story with remdesivir. Initially, it developed remdesivir to treat the Ebola virus but the unsatisfactory clinical results placed the project on hold.[2] Later, Gilead repurposed remdesivir to successfully treat some other viral infections, such as the MERS and SARS viruses (two subtypes of coronaviruses). Gilead owns the product patent claiming the new chemical substance of remdesivir. The product patent and the use patent are two kinds of patents commonly pursued by the pharmaceutical industry; while the product patent protects the new chemical entity of the drug, the use patent protects the use of the drug to treat a disease. From 2015 to 2016, Gilead started to apply for a patent family of use patents covering the use of remdesivir for treating adenovirus and coronavirus. These use patent and patent applications titled “[m]ethods for treating arenaviridae and coronaviridae virus infections” include, e.g., PCT/US/2016/052092[3] (filed internationally in September 2016, entering into national phases of at least nine countries/regions such as European Union, China, Japan, and Australia), U.S. Patent No. 10,251,904[4] (filed in September 2016 and granted in March 2019), and its continuation Allowed U.S. Patent Application No. 16/265,016[5] (filed in February 2019 and allowed in February 2020).
Comparing Gilead’s patent profile to the WIV’s patent application, Gilead has claimed the chemical substance of remdesivir and the use of remdesivir to treat coronavirus, while the WIV, based on their press release,[6] appears to claim the use of remdesivir to treat COVID-19, the newly identified subtype of coronavirus currently spreading globally.
So here comes the question: does the WIV’s patent application have patentability in view of Gilead’s remdesivir patents?
Under the U.S. patent law, the subject matter of the patent application must be novel and nonobvious. Pursuant to the novelty requirement under 35 U.S.C. 102, the prior art cannot anticipate the new invention and the prior art cannot teach each and every element of the subject matter in the new invention.[7] Specifically, the USPTO’s Manual of Patent Examining Procedures (MPEP) provides that “a generic disclosure will anticipate a claimed species covered by that disclosure when the species can be ‘at once envisaged’ from the disclosure”.[8] The disclosures of Gilead’s patents and patent applications do not mention COVID-19 because this new type of coronavirus had not been identified back then. Indeed, the Chinese researcher at the WIV and the Academy of Military Medical Sciences (“AMMS”) pioneered in characterizing COVID-19 and published their discovery in January 2020.[9] The difficulty to previously envision COVID-19 may ameliorate the anticipation concerns of the WIV’s patent application.
Under 35 U.S.C. 103, the subject matter of the patent application must be nonobvious in view of the prior art. In the genus-species situations, we look to “whether the claimed species or subgenus would have been obvious to one of ordinary skilled in the art at the time of the invention was made.”[10] To constitute obviousness, a person skilled in the art has to have a motivation to modify the prior art in order to reach the new invention. Patent practitioners suggest that Gilead’s findings show the use of remdesivir to treat the SARS and MERS viruses with structures similar to COVID-19 and likewise infecting human airway epithelial cells, so Gilead’s disclosure may likely provide an impetus for applying remdesivir to other coronavirus applications.[11]
Even with motivation to modify, the subject matter may still fulfill the nonobviousness requirement if a person skilled in the art may not have a reasonable expectation of success to modify the prior art.[12] When a person skilled in the art faces an infinite number of unpredictable solutions, the person may be discouraged from modifying the prior art. Here, it is uncertain how many types of viruses or coronaviruses the drug is effective against. Considering the failure to treat Ebola, one may not expect the drug to be easily effective to another virus. In contrast, the treatment of coronavirus subtypes in SARS and MERS seems to suggest wider applications of the drugs to other coronaviruses. In addition, the new use on COVID-19 may need to present unexpected results to rebut a prime facie case of obviousness. The unexpected results must be based on evidence of improved properties, such as increase in efficacy and decrease in toxicity in comparison with the prior art. The Chinese patent application by the WIV has not published so now it is difficult to conclude whether it has unexpected results.
To date, China’s National Intellectual Property Administration has not granted the WIV’s patent application and the WIV states that it plans to file a PCT international application to seek global patent protection over the use of remdesivir to treat COVID-19.[13] A China-based IP counsel points out that even if the WIV acquires the new use patent, the treatment may be limited because Gilead still owns the fundamental product patent protecting the chemical substance of remdesivir.[14]
Right now, many patentability issues are still pending for further analysis upon the publication of the WIV’s patent application. But one thing is sure: the pharmaceutical researchers need incentives of patent rights to fuel their motivation to invent. The patent rights of true inventors should be protected to serve the public. We may not see an immediate fight for the patent rights here. Instead, both Gilead and the WIV are currently focusing on fighting the virus. A Gilead representative makes clear that its focus now is to determine the potential for remdesivir to treat COVID-19 and to accelerate manufacturing in anticipation of potential future supply needs.[15] The WIV also notes that it would temporarily pause the enforcement of patent rights if foreign pharmaceutical companies are willing to contribute to the disease control of COVID-19 in China, which Gilead already did by helping the Chinese researchers with clinical trials.[16]
Footnotes
