On February 4, 2020, the Wuhan Institute of Virology, Chinese Academy of Sciences, released a message on its official website: The Wuhan Institute of Virology and the National Emergency Prevention and Control Drug Engineering Technology Research Center of the Academy of Military Medical Sciences jointly discovered that a drug called Remdesivir can effectively inhibit the replication and infection of the novel coronavirus at the cellular level. The two parties jointly applied for a Chinese invention patent (use for anti-2019 novel coronavirus) on January 21, 2020, and will enter major countries around the world through the PCT route.

At the critical moment when the epidemic is spreading, the release of this news immediately became a major focus of public opinion, triggering heated discussions on the Internet. For a time, accusations such as "registering patents of American companies" and "Why not use it for clinical treatment first, but publish papers and apply for patents first?" The parties concerned were pushed to the forefront of public opinion. This article interprets and analyzes the incident from a legal perspective, attempting to find out the truth.

To accurately interpret this event from a legal perspective, it is necessary to understand the relevant background knowledge of Remdesivir, as well as relevant legal knowledge points such as utility patents, the Patent Cooperation Treaty, patent cross-licensing, and patent compulsory licensing.

Remdesivir, is a novel experimental broad-spectrum antiviral drug developed by an American company called Gilead Sciences. The original intention of developing this drug was to treat the terrible Ebola virus that was popular in Africa and other places a few years ago. Researchers found that it can also effectively inhibit the replication of SARS virus and MERS virus in respiratory epithelial cells. The drug is currently in phase III clinical trials for the Ebola virus. Recently, the New England Journal of Medicine published an article introducing the diagnosis and treatment process and clinical manifestations of the first confirmed case in the United States. Remdesivir showed good efficacy in fighting the novel coronavirus. Because Remdesivir's homonym is similar to "People's Hope" and is expected to treat the novel coronavirus, it is also called "People's Hope" drug by netizens.

Patent search shows that on September 16, 2016, American Gilead Sciences has applied for an invention patent for the new drug Remdesivir, and applied to China for an invention patent named "Method for treating sand grain virus family and coronavirus family virus infection" through the Patent Cooperation Treaty (patent application number is 201680066796.8). The patent document discloses the chemical formula of Remdesivir. The examination procedure for invention patent applications includes five stages: acceptance, preliminary examination, publication, substantive examination, and authorization. Currently, the patent is still in the substantive examination stage.

Recently, the Wuhan Institute of Virology and the National Emergency Prevention and Control Drug Engineering Technology Research Center of the Academy of Military Medical Sciences jointly discovered that Remdesivir can effectively inhibit the infection of 2019-nCoV at the cellular level, and applied for a Chinese invention patent (use for anti-2019 novel coronavirus) on January 21, 2020. The incident was triggered by this.

American companies have already applied for invention patents for Remdesivir, why can the Wuhan Institute of Virology still apply for patents?

According to Article 2 of the Patent Law, there are three types of patents in my country: invention, utility model and design. Among them, invention patent refers to "a new technical solution proposed for a product, method or its improvement." From a broad classification, invention patents include product patents and method patents.

Drug invention patents can be divided into: product patents, method patents and utility patents. A drug utility patent is essentially a special type of method patent. In the field of medical drugs, product patents usually have the highest value. Applying for a drug product patent requires disclosing a known preparation method and a known use to prove the practicality of the invention. If the drug itself is known, but the inventor discovers a new preparation method, a production method patent can be applied for based on this. If a new non-obvious use of the drug is discovered, a patent can be applied for for the new use. New uses include new uses for new drugs and new uses for old drugs. This time it should be the discovery of a new use for an old drug.

If the patent application request of Gilead Sciences of the United States for Remdesivir does not cover the use for treating the 2019 novel coronavirus, the Wuhan Institute of Virology can apply for a utility patent for Remdesivir against the 2019 novel coronavirus. After obtaining the utility patent, without the authorization of the utility patentee, other people, including the drug product patent holder, shall not implement the utility patent of the drug. As for whether the utility patent applied for by the Wuhan Institute of Virology can obtain patent rights, it needs to pass the novelty preliminary examination, and then pass the substantive examination of the novelty, practicality and creativity of the patent.

PCT is the English abbreviation of Patent Cooperation Treaty, which is an international treaty for cooperation in the field of patents and a supplement to the Paris Convention for the Protection of Industrial Property. The PCT stipulates that patent applicants can submit international patent applications through the PCT route to apply for patents in multiple countries. The purpose of the PCT is to solve the problem of reducing the duplication of labor for applicants and various patent offices when applying for patents in multiple countries for the same invention and creation. The Patent Cooperation Treaty was signed in Washington, USA in June 1970 and came into effect in January 1978. It now has 153 contracting states. China officially became a member of the PCT on January 1, 1994. Since then, China can directly apply for foreign patents through the PCT route. The China National Intellectual Property Administration, as the receiving office, international search unit, and international preliminary examination unit, accepts PCT international applications filed by Chinese citizens, residents, and units.

Since patent rights are territorial, and which country's application is protected by which country, the Wuhan Institute of Virology can declare the Remdesivir anti-2019 novel coronavirus utility patent to the treaty member states through the PCT, forming a patent protection layout in major countries around the world.

Regarding the official definition of "cross-licensing", Article 7 of the Anti-Monopoly Guidelines on Abuse of Intellectual Property Rights (Draft for Comment) issued by the Anti-Monopoly Committee of the State Council on March 23, 2017 stipulates: "Cross-licensing refers to the mutual licensing of intellectual property rights owned by operators." In layman's terms, patent cross-licensing is a negotiated agreement that conditionally allows each other to use the patent technology of the company when the other party needs to have patent technology in the product or product production process. Patent cross-licensing is an important way to solve the inefficiency of the patent licensing market, allowing product manufacturers to more easily obtain the right to use patents, thereby reducing the cost of product manufacturing and innovation.

If both Gilead Sciences, Inc. of the United States and the Wuhan Institute of Virology have their respective patent applications approved, and the two parties have not signed a patent cross-licensing agreement, then Gilead Sciences, Inc. and its authorized manufacturers cannot indicate on the produced Remdesivir drugs that they can be used to treat the 2019 novel coronavirus; and the Wuhan Institute of Virology and its authorized manufacturers shall not bypass the U.S. company's patent barriers to directly produce Remdesivir. Only if both parties cooperate in the production and manufacture of Remdesivir anti-2019 novel coronavirus drugs in China through cross-licensing is the best win-win outcome.

Since drug use patents do not prohibit hospitals and doctors from using drugs for patented uses, but only prohibit other manufacturers from labeling drugs for patented uses, the actual exclusive effect is quite effective and has limited restrictions on product patentees. Therefore, the use patent is one of the important negotiating chips to promote patent cooperation between the two parties.

In the event that the two parties fail to reach a patent cross-licensing agreement, if the statutory circumstances are met, the patent administration department of the State Council may also adopt the 'ultimate move' of 'compulsory licensing' to compulsorily implement the patent in particularly urgent circumstances. What is the implementation of compulsory patent licensing? The relevant legal provisions are mainly stipulated in Articles 49 and 51 of the 'Patent Law'.

Article 49 of the 'Patent Law' stipulates: 'In the event of a state of emergency or extraordinary circumstances in the country, or for the purpose of public interest, the patent administration department of the State Council may grant compulsory licenses for the implementation of invention patents or utility model patents.'

Article 51 stipulates: 'If an invention or utility model for which a patent right has been obtained represents a significant technical advance of considerable economic significance in relation to an invention or utility model for which a patent right has previously been obtained, and its implementation depends on the implementation of the earlier invention or utility model, the patent administration department of the State Council may, upon application by the later patentee, grant a compulsory license to exploit the earlier invention or utility model.'

Compulsory licensing, also known as non-voluntary licensing, means that under the above-mentioned statutory circumstances, the patent administration department of the State Council may directly allow the compulsory license applicant to implement the patentee's invention or utility model without the patentee's consent. The licensee may implement the patented technology without the patentee's consent, but shall still pay appropriate remuneration to the patentee. Compulsory licensing is an administrative act and a decision shall be made by administrative ruling in accordance with the procedures of the 'Measures for Compulsory Licensing of Patents'. An administrative lawsuit may be filed if the administrative ruling is not accepted.

For this epidemic, compulsory licensing may be implemented by citing the above-mentioned Article 49 or Article 51 of the 'Patent Law'. Compulsory licensing is a double-edged sword. Although it can break patent barriers, this administrative intervention will seriously interfere with the rights of patentees, is unfair to patentees, and has a negative impact on the country's international reputation in terms of intellectual property protection. China promulgated the 'Patent Law' in 1984, which stipulated the compulsory licensing system, but there has been no precedent to date. When the H5N1 avian influenza outbreak occurred in 2005, there was a strong social appeal for its use, but the government ultimately did not approve Guangzhou Baiyunshan's request for compulsory licensing of the 'special drug' Tamiflu, but instead negotiated to allow Roche to authorize the production rights of the drug to two production companies. It will generally not be used lightly in this epidemic unless the situation is particularly critical and as a last resort. However, the compulsory licensing system can also be used as a negotiating chip for patent cooperation.

VI. Conclusion and Expectations