Gilead’s vaccine against the Ebola virus, Remdesivir, is proving effective in combating COVID-19, according to news reports and clinical trials. Many of the COVID patients treated with the vaccine are recovering from the virus. Although remdesivir has not yet completed trials here in the U.S., there is promise that it will help keep patients alive. Gilead’s severe COVID-19 study currently includes 2,400 participants from 152 different clinical trial sites all over the world. Its moderate COVID-19 study consists of 1,600 patients in 169 centers, also across the globe, according to STAT News. However, there is not a control group, which will make interpretation of the results more challenging.
The Patent Problem
Since the drug had promising results in trials, Gilead gave China samples of Remdesivir in February to use in clinical trials. The Wuhan Institute filed a patent on the use of Remdesivir in combination with a well-known malaria fighting drug, hydroxychloroquine, on January 21, 2020. According to the Institute, the combination of those two drugs is a potential cure for COVID-19. The Wuhan Institute is a Biosafety level 4 (BSL-4) lab, which is the most secure, dangerous, high-level type virus facility in all of China. It is also the target of many unsupported accusations that it leaked COVID-19 out of its secure laboratory.
The Wuhan Institute filed the Remdesivir patent in conjunction with the Military Medicine Institute of the People’s Liberation Army Academy of Military Science through the Patent Cooperation Treaty (PCT). The PCT is designed to assist applicants in seeking patent protection internationally for their IP, as well as help patent offices with their patent granting decisions, and facilitate public access to a wealth of technical information relating to those inventions. By filing under the PCT, the applicant is able to quickly and inexpensively get a toehold in many countries.
It is a provocative move. The concern amongst the legal community is that the basis of the Wuhan Institute’s patent is on a product they were given freely to help the global community during this pandemic, and one that is extensively covered by Gilead’s own patent arsenal. Is it IP theft? Is there a legitimate reason behind the patent? It is hard to know, especially since we cannot access the PCT filing yet.
The only way this patent application could be valid is if Remdesivir, along with the addition of chloroquine, is more effective in treating COVID-19. For example, if Remdesivir is 80% effective without chloroquine, and 90% effective with the chloroquine additive. That could be a patentable idea. They would not be blocking anyone from using Remdesivir. In that case, the Wuhan Institute would only be able to prevent somebody from using the combination of those two drugs.
However, the more cynical part of me thinks that if the USA gave the Institute 500 free doses, how easy is it to reverse engineer and for China to start producing a copy on their own, just adding a tiny percentage of chloroquine and calling it a new and protected cure? It is similar to a race to the moon. This could be like the USA versus the Russians, and China wants to appear to be the first one to get to the vaccine.
Related: A New Plaintiff on the Patent Front: The U.S. Government vs. Gilead
Why Did They File a Patent?
The Wuhan Institute, along with the Chinese Military Academy have publicly stated that enforcement of this patent will not occur against those who ‘willingly’ assist China in fighting the virus. This could be a veiled threat to enforce against anyone who does not hand over technology at below-market prices. On the other hand, it could merely be a defensive strategy looking to force a cross-licensing regime with Gilead and to avoid having to pay excessive prices for access to a successful COVID-19 vaccine.
China has a rough track record of violating IP, though they have made strides in recent years; anyone who has shopped on wish.com can see millions of examples. This move may be an attempt by China to improve on its history of global IP theft and show the world that they can develop their own ideas and IP. They have laws that would authorize a taking of the drug in return for a compulsory license, but pursuing patent protection instead could make for a better international image.
Related: Update on China’s Amended Trademark Laws
What About Gilead?
Gilead has a plethora of patents on this drug, so their ability to stop China from selling or using Remdesivir in other countries would be substantial. Even if China could patent a combination of Remdesivir and an additional ingredient, Gilead would still own the rights to the primary compound and thus China would still infringe.
Yet, this pandemic has led many countries to turn to rarely-used laws that subvert intellectual property rights or call for compulsory licenses to the governments, which could make it very difficult for Gilead to pursue its rights against China during the pandemic. Even if China does copy the drug for unlicensed use, there may not be any countries willing to hear the case during this emergency, thus giving China free reign to make and use the drug under the guise of its own patent filing (which may not even be examined for many months or years).
The questions being faced now are; will the Wuhan Institute’s combination of hydroxychloroquine and Redesivir be a successful COVID19 treatment? Will we see countries around the world pumping vast amounts of money into China’s drug combination, and not Gilead’s?
If Gilead cannot enforce its rights on Remdesivir, and scrape back some of the millions it spent on R&D, it makes for a very poor incentive to continue drug development.
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