On 4th July 2021, the Measures for Implementation of an Early Resolution Mechanism for Pharmaceutical Patent Disputes (Trial Implementation) (“Measures”) were officially published on the website of National Medical Products Administration (“NMPA”), and immediately came into effect. The Measures, jointly issued by the NMPA and China National Intellectual Property Administration (“CNIPA”), are a further step to establish a patent linkage system in China, after the major amendments in the new Patent Law.
In the newly published, immediately effective Measures, the concept of following the main conditions of the new system are stipulated and cover the following: the Drug Patent Information Record Platform (“the Platform”) for registration and information disclosure; the Types of Patents that can be registered; the Categories of Declarations for relevance to patents for generic drugs; the judicial path and administration path for enforcement; the waiting period; the different types of Decisions for Chemical Drug evaluation and approval; the market exclusivity period; and the different handling of TCMs with the same name and the same prescription as well as Biosimilar drugs. We introduce these aspects in more detail below.
The Drug Patent Information Record Platform for registration and information disclosure (Articles 2 to 4)
Marketing authorisation holders (“MAH”) are required to register the related information on the platform as specifically listed within 30 days after obtaining the drug registration certificate and must update the information within 30 days if any related information has changed.
The information registered on the Platform should be consistent with the related information for the patent and that in the drug registration certificate. For a medical use related patent right, the use shall be consistent with the indication on the Drug Instruction of the approved marketed drug and the protection scope thereof should cover the corresponding technical solutions of the approved marketing drug. For any received objection, it should be verified and recorded in a timely manner.
The types of patents that can be listed on the Platform (Articles 5 and 12)
Patents that can be listed on the Platform include the following:
- For chemical drugs: Active pharmaceutical ingredient (“API”) compound patents, API-containing pharmaceutical composition patents and medical use patents;
- For traditional Chinese medicines (TCM): TCM composition patents, TCM extract patents and medical use patents; and
- For biologics: API sequence structure patents and medical use patents.
It should be noted that patents which can be listed on the Platform do not include patents for intermediates, metabolites, crystal forms, preparation methods or detection methods.
MAHs for TCM and biologics can register the related patent information on the Platform in a similar manner as for chemical drugs (Articles 2, 3, 4 and 7).
The categories of declarations for relevance to patents for generic chemical drugs (Article 6)
Applicants for generic chemical drugs shall make a declaration for each related patent disclosed on the Platform, and the declaration would be classified into the following four categories:
- Category I: There is no patent information on the Platform related to the innovator drug.
- Category II: The patent information for the innovator drugs is included in the Platform, while the patent right has expired or been declared invalid, or the applicant of the generic drug has obtained a patent license from the patentee.
- Category III: The Platform lists the patents related to the innovator drugs, and the generic drug applicant certifies that the generic drugs will not go on the market before the expiration of the corresponding patent rights.
- Category IV: Patent rights related to the innovator drugs listed in the Platform shall be declared invalid; or the generic drugs do not fall into the protection scope of patent rights related to the innovator drugs.
The Center for Drug Evaluation (“CDE”) shall disclose the information of the applications and the corresponding declarations within ten working days; and the applicant for generic drugs should notify the MAH through the email address registered on the Platform. In case the generic is declared to not fall into the scope of the patent, a claim analysis should be provided.
The judicial path and administration path for enforcement in the bifurcated system and the waiting period (for chemical drugs only) (Articles 7 to 9)
Patentees, or interested parties holding an objection to the declaration of Category IV, should file a lawsuit to the responsible court or request an administrative ruling by CNIPA within 45 days from the date on which the application for marketing authorisation is disclosed; and should submit a copy of notification of acceptance of the case to CDE within 15 working days after the case is accepted, and notify the applicant for generic drugs.
In case of a chemical drug (and only for those) and once receiving the copy, NMPA will set a nine month waiting period starting from the date of acceptance of the case by the court or CNIPA. The waiting period is only set once. During the waiting period, CDE will not stop the technical evaluation.
The applicant for a generic drug can also file a lawsuit or request an administrative ruling to obtain confirmation that the generic drug applied for registration does not fall into the protection scope of relevant patent rights, if the patentee or interested party does not file a case in a timely manner. If any party is not satisfied with the Decision by CNIPA, an appeal can be filed to the court.
NMPA can directly make a decision for marketing approval if no opposition is filed to the court or CNIPA within the 45 days.
For the application for generic chemical drugs pending in a waiting period, the patentee, the interested party, or the applicant for generic drugs, should inform the CDE on the result of the ruling or Decision within ten working days.
The different types of Decisions for drug evaluation and approval for chemical drugs (Articles 9 and 10)
For applications with a Category I or II declaration, the generic chemical drug registration application can be approved immediately based on technical evaluation results. For applications with a Category III declaration, generic chemical drug applications that pass the technical evaluation can also be approved immediately but must contain a notation that the generic drug applicant can launch its product only after the patent expiration date or after the market exclusivity period.
For a registration application of generic chemical drugs qualified by technical evaluation with a Category IV declaration, CDE makes the corresponding decisions based on the results of the effective rulings by the court or the decisions by CNIPA:
- If (a) the generic chemical drug does not fall within the patent protection scope or the parties settle the case; or (b) the patent is invalidated; or (c) an effective ruling or mediation by the court or a decision by CNIPA is not available within the nine month waiting period; the registration application for generic chemical drug would be transferred to proceed in the administrative approval process.
- If the generic chemical drug is confirmed to fall within the protection scope according to the effective ruling results by the court or the decisions by CNIPA, such registration application will not proceed in the final administrative approval by NMPA till approaching the patent expiration date (resulting in a stay of the market authorisation).
If the NMPA makes a decision to stay the MA approval, the generic drug applicant can apply to the NMPA for MA approval if:
- the court overturns the decision by CNIPA;
- the two parties enter into a settlement;
- the relevant patent rights are declared invalid; or
- the patentee or the interested party withdraws the case.
The NMPA can then make a decision on whether to approve.
The market exclusivity period (for generic chemical drugs only) (Article 11)
The first generic chemical drug to successfully challenge an innovator drug patent can enjoy a 12-month market exclusivity period, during which the NMPA may review but will not approve other generic drug applications. This exclusivity period will not exceed the term of the innovator drug patent being challenged.
To successfully challenge an innovator drug patent means that the applicant of a generic chemical drug submits a Category IV declaration, and the patent is invalidated pursuant to its invalidation request, whereby the generic drug can be approved for marketing.
The different handling of TCMs (with the same name and the same prescription) as well as Biosimilar drugs (Articles 12 and 13)
Applicants for TCMs (with the same name and the same prescription) and Biosimilar drugs can make a declaration in accordance with that for generic chemical drugs (Article 6). For TCMs (with the same name and the same prescription) and Biosimilar drugs, NMPA can approve for marketing based on technical evaluation results directly. Those falling within the scope of the related patents according to the ruling results or decisions, can hold launching the product on market until the patent right expires. No waiting period applies.
It should be noted in this regard that generally after the generic chemical drugs, TCMs (with the same name and the same prescription) and Biosimilar drugs are approved for marketing, any further disputes can be further resolved according to the related provisions in the Patent Law and other related Laws. The marketing authorisation approval would not be revoked and its effectiveness would not be affected.
Brief Summary
As seen from the Measures and new Patent Law, the main structure of China’s patent linkage system has been established. Meanwhile, as a trial version, some details of the Measures may need to be verified for practicability and may then be further changed. For example, a nine month waiting period may put a high burden on either the court or CNIPA. We expect this system to mature over time.
As the Measures came into effect as of 4th July, 2021, both innovator and generic drug companies should pay special attention to the new system, which brings challenges and opportunities. If you have any further questions or if you would like further details, please do not hesitate to contact us.