Wuhan Institute of Virology Applies for a Patent on Gilead’s Remdesivir

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The Wuhan Institute of Virology announced on February 4, 2020 that they applied  for a Chinese patent on Gilead’s Remdesivir for treating the novel coronavirus (2019-nCoV) that originated in Wuhan in late 2019.  The Chinese patent application was filed on January 21, 2020 and the Institute plans to file internationally via the Patent Cooperation Treaty

The patent application corresponds with a letter in Nature that was published simultaneously with the announcement. The letter discussed the Institute’s evaluation of ribavirin, penciclovir, nitazoxanide, nafamostat, chloroquine and two well-known broad-spectrum antiviral drugs remdesivir (GS-5734) and favipiravir (T-705) against a clinical isolate of 2019-nCoV in vitro.  Notably, remdesivir  and chloroquine (an 80-year-old malaria drug) potently blocked virus infection at low-micromolar concentration.  

Fig. 1: The antiviral activities of the test drugs against 2019-nCoV in vitro. From: Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro

As there is significant prior art (e.g., Gilead’s own patent applications including CN108348526A entitled “Methods for treating arenaviridae and coronaviridae virus infections”) it is unclear if the China National Intellectual Property Administration will grant a patent. Interestingly, the Institute did not apply for a patent on chloroquine, which China can produce without a license.

Note the Institute stated, 

“If relevant foreign companies intend to contribute to the prevention and control of China’s epidemic, we both agree that if the state needs it, we will not require the implementation of the rights claimed in the patent for the time being, and we hope to work with foreign pharmaceutical companies to minimize the epidemic.

Accordingly, as Remdesivir is unavailable in China and chloroquine is, it seems the Institute’s goal is to enable a cross-license with Gilead and so avoid having the Chinese government invoke compulsory licensing under Articles 48- 50  of the Patent Law, which might cause political repercussions with the U.S. in light on the Phase I trade deal.

Article 48 Under any of the following circumstances, the patent administration department under the State Council may, upon application made by any unit or individual that possesses the conditions for exploitation, grant a compulsory license for exploitation of an invention patent or utility model patent:
(1) When it has been three years since the date the patent right is granted and four years since the date the patent application is submitted, the patentee, without legitimate reasons, fails to have the patent exploited or fully exploited; or
(2) The patentee’s exercise of the patent right is in accordance with law, confirmed as monopoly and its negative impact on competition needs to be eliminated or reduced.

Article 49 Where a national emergency or any extraordinary state of affairs occurs, or public interests so require, the patent administration department under the State Council may grant a compulsory license for exploitation of an invention patent or utility model patent.

Article 50 For the benefit of public health, the patent administration department under the State Council may grant a compulsory license for manufacture of the drug, for which a patent right has been obtained, and for its export to the countries or regions that conform to the provisions of the relevant international treaties to which the People’s Republic of China has acceded.

 

Author: Aaron Wininger

Aaron Wininger is a Principal and Director of the China Intellectual Property at Schwegman Lundberg & Woessner.

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Author: Aaron Wininger

Aaron Wininger is a Principal and Director of the China Intellectual Property at Schwegman Lundberg & Woessner.