The curious case of Wuhan’s Institute of Virology and remdesivir

The Patent Law of the People’s Republic of China first went into effect on April 1, 1985. It has been amended three times with a fourth amendment scheduled to take effect on June 1, 2021.

The Chinese patent system includes an invention patent, similar to the utility patent of the US. The invention patent application is substantively examined by patent examiners to determine if the invention is novel, inventive, and has “practical applicability”.

The author found that personal interviews with Chinese patent examiners can be effective in advancing prosecution because many examination problems are the result of translation confusion.

Another type of patent in China, the utility model patent, has the same requirements although it is not ordinarily subjected to substantive examination prior to grant. The US has no parallel type of patent.

The last three and a half decades witnessed the development of China’s patent system from one providing only the most basic protection to a modern and generally comprehensive approach to protecting a range of inventions, utility models, and designs.  The fourth amendment provides further improvement to this system by introducing several new and expanded aspects to patent protection, some of which are directed to biotechnology. It is these improvements in particular which help to set the stage for better pharmaceutical protection in China. But many of the changes related to the protection of drugs may be tested given unexpected developments, such as the curious case involving Gilead, remdesivir, and Wuhan’s Institute of Virology.

Amendments to the patent law

The fourth amendment to the Patent Law leaves most features related to the patenting of biotechnology intact. For example, the prohibition on the patenting of methods for the diagnosis or the treatment of diseases (article 25) remains unchanged.

Also unchanged is the requirement that an applicant must disclose the “direct source and the origin” of genetic resources if the application is based on genetic material (article 26).

The amended Patent Law includes several important changes. Some of these are directed to increased statutory damages and increased damages for willful infringement while others are directed to patent term compensation, patent term extension, and the highly anticipated (and long overdue) system of patent linkage.

More changes

Several other important amendments appear in the amended Patent Law, such as provisions for patent term compensation. According to the amended article 42, when four years have passed from the invention patent application date and three years have passed from the date on which the request for substantive examination was filed when the patent is granted, the patent administrative organ under the State Council shall, upon the patentee’s request, provide compensation for the duration of the patent right for unreasonable delay in the process of granting, unless the unreasonable delay was caused by the applicant.

Another important amendment to the Patent Law relates to patent term extension for pharmaceutical patent applications. Again, according to amended article 42, in order to compensate for the time taken for the review and approval for the marketing of new drugs, the patent administrative organ under the State Council shall, upon the request of the patentee, provide compensation for the duration of the patent right for new drug-related invention approved for marketing in China. The compensation period shall not exceed five years, and the total effective duration of the patent right shall not exceed 14 years after the new drug is approved for marketing.

Patent linkage

In the US, pharmaceutical patenting requires two agencies to coordinate efforts—the patent granting authority (the US Patent and Trademark Office) and the drug approval and oversight authority (the US Food and Drug Administration).

Introduced in the US in the Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Act), patent linkage associates (or “links”) marketing approval of generic drugs to the term of the patented pharmaceutical.

China’s introduction of a patent linkage system attempts to fulfil its obligation under the 2020 US-China “Phase One” trade agreement.

Drug marketing

The amended Patent Law introduces new article 76, which provides that during the review and approval for drug marketing, where the applicant for a drug marketing licence and a related patentee or person of interest have disputes over the patent rights related to the drug applying for registration, the concerned parties may appeal to the People’s Court and request it to determine whether the technical solutions related to the drug applying for registration fall within the scope of protection of a patent for drug of others.

This article also provides that the applicant for drug marketing approval and the patentee or the person of interest may ask for administrative adjudication of the patent administrative organ under the State Council regarding the dispute over patent rights related to the drug applying for registration.

The drug regulatory administration under the State Council, in conjunction with the patent administrative organ under the State Council, shall formulate specific measures for resolution of disputes over patent rights during the handover period of reviewing and approval for a drug marketing licence and the drug marketing licence application stage, which shall be implemented after the approval of the State Council.