Written By: Sophia Iams
In response to the novel coronavirus (COVID-19) outbreak, infecting over 193,000 individuals and contributing to over 7,800 deaths [1], the Chinese government is aggressively trying to stop the transmission of the disease and treat those infected. The Wuhan Institute of Virology and BrightGene, a Chinese drug manufacturer, raised concerns of potential circumvention or violation of the intellectual property rights of Gilead Sciences’ investigational drug, remdesivir. [2] Recent in-vitro studies demonstrate remdesivir is a potential treatment against COVID-19. [3]
China’s reputation for lax intellectual property protections in the pharmaceutical industry [4] has the current situation playing into those fears. From a patent application filed in 2016, Gilead is still waiting for a decision from the Chinese Patent Office for a patent protecting remdesivir. [5] On January 21, 2020, the Wuhan Institute of Virology applied for a “use patent” in China for remdesivir for its specific use in treating COVID-19. [6] On February 12, 2020, BrightGene issued a press release indicating the company started mass-producing the active ingredient in remdesivir and working on creating complete doses. [7]
These initial actions are concerning for a few reasons. First, if Wuhan Institute of Virology receives the patent, the Chinese government could use that to negotiate an unfair price for licensing rights from Gilead. [8] Wuhan Institute of Virology has also noted that it would attempt to use the Patent Cooperation Treaty (“PCT”) to export the manufactured drug to cooperating nations. [9] The PCT allows patent protection in many countries through a single “international” patent filing with the World Intellectual Property Organization. [10] Alternatively, the Chinese government could act within its rights under World Trade Organization rules to issue a compulsory license that would enable remdesivir’s use without Gilead’s consent. [11] A compulsory license is intended to allow the original patent holder and presumably the manufacturer to receive a licensing fee, raising the question of which organization will ultimately hold the patent in China. [12] In addition, now that the drug is manufactured by BrightGene, Gilead could be excluded completely. [13]
As of late-January, Gilead is working with various global health authorities, including Chinese health agencies, to perform experimental human clinical trials using remdesivir. [14] Two phase 3 trials have been initiated in Wuhan with the goals of enrolling 760 patients and obtaining preliminary results in April 2020. [15] The U.S. and international intellectual property community will closely monitor the Chinese government despite the previously improved cooperation between the U.S. and China. [16]
[1] World Health Organization (WHO), Novel Coronavirus (COVID-19) Situation, world health organization, https://experience.arcgis.com/experience/685d0ace521648f8a5beeeee1b9125cd [https://perma.cc/N5M7-AHGG] (last viewed Mar. 18, 2020).
[2] Angus Liu, Chinese firm copies Gilead’s remdesivir, the most promising drug against the new coronavirus, FiercePharma (Feb. 12, 2020, 10:28 AM), https://www.fiercepharma.com/pharma-asia/chinese-firm-copies-gilead-s-remdesivir-most-promising-drug-against-new-coronavirus [https://perma.cc/962V-7QMD].
[3] Manli Wang, Ruiyuan Cao, Leiki Zhang, Xinglou Yang, Jia Liu, Mingyue Xu, Zhengli Shi, Zhihong Hu, Wu Zhong & Gengfu Xizo, Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro, Nature (Feb. 4, 2020) https://www.nature.com/articles/s41422-020-0282-0 [https://perma.cc/5J8K-Z8UB].
[4] Max Nisen, China’s Drug Patent Grab Makes Coronavirus Scary for Pharma, Wash. Post (Feb. 6, 2020, 12:10 AM), https://www.washingtonpost.com/business/chinas-drug-patent-grab-makes-coronavirus-scary-for-pharma/2020/02/05/40dbfbf6-4844-11ea-91ab-ce439aa5c7c1_story.html [https://perma.cc/2QXJ-TCRW].
[5] Associated Press, China scientists want to patent Gilead drug to treat coronavirus patients, MarketWatch (Feb. 6, 2020, 1:44 AM), https://www.marketwatch.com/story/china-scientists-want-to-patent-gilead-drug-to-treat-coronavirus-patients-2020-02-06 [https://perma.cc/3DEJ-5RHQ].
[6] Nisen, supra note 4.
[7] Liu, supra note 2.
[8] Associated Press, supra note 5.
[9] Mary Erica D. Manuel, ‘Owning’ the Cure: Patent rights in the midst of an outbreak, BusinessWorld Online (Feb. 11, 2020, 10:53 PM), https://www.bworldonline.com/owning-the-cure-patent-rights-in-the-midst-of-an-outbreak/ [https://perma.cc/5LZ4-9AY3].
[10] World Intellectual Property Organization (WIPO), Protecting your Inventions Abroad: Frequently Asked Questions About the Patent Cooperation Treaty (PCT), World Intellectual Property Organization, https://www.wipo.int/pct/en/faqs/faqs.html [https://perma.cc/988E-QSZ8].
[11] World Trade Organization, Compulsory licensing of pharmaceuticals and TRIPS, World Trade Organization (Mar. 2018), https://www.wto.org/english/tratop_e/trips_e/public_health_faq_e.htm [https://perma.cc/D2EW-8ULH].
[12] Nisen, supra note 4.
[13] Id.
[14] Press Release, Gilead Sciences, Gilead Sciences Statement on the Company’s Ongoing Response to the 2019 Novel Coronavirus (2019-nCoV) (Jan. 31, 2020), https://www.gilead.com/news-and-press/company-statements/gilead-sciences-statement-on-the-company-ongoing-response-to-the-2019-new-coronavirus [https://perma.cc/V62K-N856].
[15] Liu, supra note 2.
[16] Id.
