The revised Rules on the Implementation of the Patent Law of the People’s Republic of China (hereafter referred to as the Rules) is set to come into effect on January 20, 2024. The revised Rules includes provisions specifically related to drug patents which are significant for new drug applicants.
Definition of New Drug-Related Invention Patent
According to the Rules, the new drug-related invention patent refers to a patent granted for new drug products, their preparation methods, and their medical uses in compliance with regulations.
Drug Patent Term Compensation
Under Article 42, Clause 3 of the Patent Law, to compensate the time spent in the review and approval process prior to the marketing of a new drug product, the patentee can request an extension of the term for the new drug-related invention patent.
The revised Rules specifies that the patentee must file the request within three months from the date of the marketing authorization of the new drug product. Additionally, the request can only be submitted when the patentee fulfills the following conditions.
If the new drug product is covered by multiple patents, the patentee can request patent term compensation for one of the patents.
If a patent covers multiple new drug products, the patentee can request patent term compensation for one of the new drug products.
The patent is valid and has not received new drug-related invention patent compensation.
Regarding the duration of the compensation term, the Patent Law stipulates that it should not exceed five years, and the total effective term of the patent right shall be no more than 14 years from the date of marketing authorization. The revised Rules specifies that the compensation term should be calculated also based on the time period between the patent application date and marketing authorization date in China, minus five years.
Patent Protection Scope During Compensation Term
According to the revised Rules, during the patent compensation term, the scope of patent protection is limited to the technical solutions related to the new drug and its approved indication. Within the scope of protection, the patent holder retains the same rights and responsibilities as before the patent term compensation.
If you would like to know more about drug patent regulation in China, please refer to the article “How Does China's Drug Patent Linkage System Work?”.