In order to encourage the research and development of new drugs, in the Chinese Patent Law, implemented from June 1, 2021, a patent term compensation mechanism for drug related patents and an early resolution mechanism of disputes for drug related patents are put forward. The patent term compensation mechanism can not only promote the innovation of drugs in China, but also encourage foreign new drugs to enter the Chinese market as early as possible. The early resolution mechanism of disputes for drug patents can resolve patent disputes in a timely manner, guarantee the legitimate rights and interests of patentees, and try to avoid the risk of delisting generic drugs after they are marketed. We briefly introduce these two mechanisms as follows.
1. Patent Term Compensation Mechanism In accordance with Article 42 (3) of the Chinese Patent Law, in order to compensate for the time spent in the review and approval of a new drug for marketing, the CNIPA shall provide a patent term compensation for an invention patent related to a new drug that has been approved for marketing in China, at the request of the patentee. The compensation period shall not exceed 5 years, and the total valid patent term after the new drug is approved for marketing shall not exceed 14 years.
In accordance with the provisions of the “Draft for Amendments to the Implementation Rules of the Chinese Patent Law”, the remaining protection period of patents for which compensation for patent term is requested shall not be less than 6 months. In addition, if the patentee requests compensation for the patent term, it shall submit a request for compensation for the patent term to the CNIPA within 3 months from the date of approval of the drug marketing license application.
In addition, according to the “Draft for Amendments to the Implementation Rules of the Chinese Patent Law”, the calculation method of the compensation period for drug related patents is the resultant time of the date of approval of the drug marketing authorization application minus the filing date of the Chinese patent and the time of 5 years. Considering the provisions of the Chinese Patent Law above, the compensation period calculated based on this calculation method does not exceed 5 years, and the total valid patent term after the approval of the drug marketing authorization application does not exceed 14 years.
2. Early Resolution Mechanism of the Disputes for Drug Related Patents According to Article 76 of the Chinese Patent Law, in the process of review and approval of a drug, if there is a dispute over the patent right related to the drug between a drug marketing authorization applicant, a relevant patentee or interested party, the relevant party may file a lawsuit with the court, requesting a judgment on whether the drug related technical solution applied for registration falls within the protection scopes of the patent rights of others’ patents. The drug regulatory department under the State Council may, within the prescribed time limit, makes decision on whether to suspend the approval of the marketing of relevant drugs in accordance with the effective judgment of the court.
Applicants for drug marketing authorization and relevant patentees or interested parties may also request administrative adjudication from the CNIPA regarding patent disputes related to the drugs for which registration is applied for.
The drug regulatory department under the State Council, in conjunction with the CNIPA, shall formulate specific measures to resolve patent disputes at the stage of drug review and approval and drug marketing approval application. The measures shall be implemented after the approval of the State Council.
In accordance with the amendment of the Chinese Patent Law, subsequently, on July 4, 2021, the State Food and Drug Administration and the CNIPA issued the “Measures for the Implementation of Early Resolution Mechanisms for Drug Patent Disputes (Tentative)”. The Measures clearly mention that in order to protect the legitimate rights and interests of drug patent holders, encourage new drug research and promote the development of high-level generic drugs, establish an early resolution mechanism for drug patent disputes, and formulate these Measures.
According to the measures, the State Food and Drug Administration established a patent information registration platform for marketed drugs in China, for drug marketing license holders to register drug related patent information registered in China, and the marketing authorization holder of the drug shall, within 30 days after obtaining the drug registration certificate, register patent information on the platform. These Measures do not apply to those who have not registered relevant patent information on the patent information registration platform for marketed drugs in China.
When an applicant for a generic drug submits an application for a drug marketing authorization, he shall make a statement regarding each related drug patent of the innovator drug in accordance with the patent information that has been published on the patent information registration platform for marketed drugs in China. If the patentee or an interested party has objections to the patent statement of the generic drug applicant, a lawsuit shall be filed, or an administrative adjudication from the CNIPA can be requested.
When a generic drug applicant submits a marketing application, it shall make a statement for each related drug patent of the innovator drug. There are four types of statements:
Statement of Type I: There is no patent information related to the innovator drug in the patent information registration platform for marketed drugs in China;
Statement of Type II: The relevant patent right of the innovator drug included in the patent information registration platform for marketed drugs in China has been terminated or declared invalid, or the applicant of the generic drug has obtained relevant patent implementation license from the patentee;
Statement of Type III: The patent information registration platform for marketed drugs in China includes patents related to the innovator drug, and the applicant of generic drug promises that the generic drug applied for will not be marketed before the expiration of the corresponding patent right; and Statement of Type IV: The patents related to the innovator drug included in the patent information registration platform for marketed drugs in China shall be declared invalid, or the generic drug does not fall within the protection scope of the related patents.
For statements of Type I and Type II, because there is no relevant patent right, or the generic drug applicant has obtained the relevant patent implementation license of the patentee, the review and approval of the generic drug registration application will not be affected by the patent.
For the statement of Type III, although there are patents related to generic drugs, the generic drug applicant promises not to market the product before the expiry of the patent, and there is no dispute with the patentee.
For the statements of Type IV, the applicant for generic drugs claims that the patent right should be invalidated or that the generic drug does not fall within the protection scope of the patent, and it requires the production and sale of generic drugs before the expiration of the patent. Thus, the statements of Type IV constitutes a challenge to the patent and there are patent disputes between the parties. Therefore, it can be considered that this measure mainly solves the objections to the statements of Type IV.
Although the Measures might not resolve all drug related patent disputes at this stage, it is believed that with the continuous development of the “platform”, it will play an increasingly important role in resolving patent disputes in the development of generic drugs in China.
