On the 31 January 2020 local time the New England Journal of Medicine, a US medical journal published a study report of clinical features of the first confirmed novel coronavirus infection case in the US. In this case the patient felt better after taking the Gilead Scientific Company’s anti-virus drug Remdesivir [1]which was still in the R&D stage and used by doctors on “compassionate” grounds. Then Merdad Parsey, PhD, Gilead Scientific stated publicly that the company was collaborating closely with health organizations worldwide to use the unfinished drug Remdesivir in treatment trials to fight against the new coronvirus (2019-nCoV) epidemic. Meanwhile, the Chinese medical team confirmed that Gilead was cooperating with the Chinese health department in a randomized double blind controlled trial in order to determine the safety and efficacy of Remdesivir in 2019-nCoV infected people[2]. On 2 February Beijing time the China-Japan Friendship Hospital stated that it would initiate a clinical study of Remdesivir treatment of the new coronvirus infections in the afflicted area of Wuhan, giving hope to fight against the epidemic[3].

According to recent postings on social media, the US agreed to grant patent immunity for the new drug, allowing China to copy it. It attracted my interest. What is patent immunity? Is the eagerly anticipated drug Remdesivir tested in the clinical trial in China a case of patent immunity?

1. Does China have “patent immunity” rules?

Patent immunity is not a term used in existing Chinese laws, but we may associate it with the compulsory license for enforcing Chinese patents set forth in Part VI of the Patent Law of China. Article 50 thereof states that for the purpose of public health the patent administration department of the State Council can grant compulsory licenses to manufacture and import patented drugs to countries or regions defined in relevant international convention to which the People’s Republic of China is a party. The licensee under a compulsory license for enforcing a patent should pay the patent owner reasonable royalties under Article 57 of the Patent Law. Organizations or individuals having obtained a compulsory license should pay reasonable royalties to the patent owner or deal with royalty related issues according to relevant international convention to which the People’s Republic of China is a party. The amount of the royalties is agreed by the parties involved through discussions. If the parties involved cannot reach an agreement, the royalties will be awarded by the patent administration department of the State Council.

2. “Patent immunity” in the context of international law

“Patent immunity” in the context of international law is described in the Declaration on the TRIPS Agreement and Public Health (“Doha Declaration”), which is mainly about starting to find solutions to public health crises in developing countries through negotiations. Article 6 thereof states that it is anticipated to reach an agreement to implement the patent drug compulsory licensing rules to save developing countries as WTO members from public health crises. It reads as follows: “We recognize that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002.” Developing countries supported by the Doha Declaration can take full advantage of the flexibility of the TRIPS Agreement, including the commitment of developed-country members to provide incentives to their enterprises and institutions to promote and encourage technology transfer to least-developed country members. The terms of drug patents of the least-developed country members may be extended until 1 January 2016, without prejudice to their right to seek other extensions of the transition periods as provided for in Article 66.1 of the TRIPS Agreement. (Article 7 of the Doha Declaration) The emergence of the Doha Declaration is an important event in the international intellectual property area.

In the Doha Declaration the terms of drug patents of the least-developed country members may be extended. Such extension is a kind of “patent immunity” and the extended terms are “patent immunity periods”. As stated in the Doha Declaration, “patent immunity periods” may be extended. In 2015 WTO agreed to extend immunity periods of drug patents of the least-developed country members, granting them immunity from implementing intellectual property rights in drugs before 2033[4].

3. Do the clinical trials and studies of Remdesivir in China relate to “patent immunity”?

Neither the statement of Gilead Scientific Company nor the press has mentioned Remdesivir drug patent related issues. Clinical trials and studies of Remdesivir are obviously not under a compulsory license in Chinese patent law. Is it related to “patent immunity” in international law? No, it isn’t. People’s Daily published a statement clarifying false information on the internet[5].

The molecular structure of Remdesivir is not mentioned in the statement of Gilead Scientific Company but can be found by the website of MCE (MedChemExpress), a reagent supplier. Remdesivir is a nucleoside analogue with effective antiviral activity and, to some extent, can inhibit the activity of SARS and MERS viruses. Remdesivir was used in clinical trials to kill the ebola virus.

(Source: MedChemExpress)

Remdesivir is a new drug which is still in the R&D stage and has not passed the safety and efficacy assessments long after Gilead Scientific made a patent portfolio for the drug. The Chinese patent on the“method and compound for treatment of paramyxovirus related infections” which Gilead Scientific applied for on 22 July 2011 was granted (ZL201180035776.1). This patent has the same molecular structure as the above one. After that Gilead published other patents on the Remdesivir compound used to treat infections related to filoviruses (ebola, marburg, etc.), arenaviruses (lassa, junin, etc.), coronaviruses (sars, mers, feline coronavirus, etc.) and flaviviruses (zika, etc.). Gilead’s patent portfolio shows good prospects of Remdesivir as a broad spectrum anti-virus drug.

Remdesivir was introduced into China directly for the Phase III clinical trial and is expected to promptly cure the pneumonia patients and relieve the severe epidemic.

[1]L.S.2.M.K.Z.No.14 Tenancy Contract Case of Second Trial between Dalian Pengcheng Holiday Damu Co., Ltd. and Dalian Zhengdian Watches Co., Ltd.

[2](2004) H.2.Z.M.2.(M) Z.Z.No.354 House Lease Contract Case between Shanghai Pipe Entertainment Co., Ltd. and Shanghai New Huangpu (Group) Co., Ltd.

[3]cf. Government’s Abstract Administrative Act Resulting in Non-Performance of a Contract Can Be Considered as a Force Majeure Event, by Li Hu, People’s Judicature, 20th issue 2009, pp.83-86; and the written judgement for the (2016) SPC.M.Z.No.220 contract case of second trial between Bai Junying and the Government of Tumd Zuoqi

[4]http://www.sipo.gov.cn/zfwq/wqyzgndt/1074503.htm

[5]tps://mp.weixin.qq.com/s/TR6g33Ic6SV8SZDD4feMDQ