In response to the stipulations in Article 76 of the most recent version of the Chinese Patent Law, National Medical Products Administration (NMPA) and National Intellectual Property Office (CNIPA) issued Measures for the Implementation of Early Resolution Mechanisms for Drug Patent Disputes (Trial) on July 4, 2021, and the “Measures” comes into force on the same day.
The “Measures” is to provide a mechanism for resolving patent disputes during review and marketing approval of relevant drugs, protect the legitimate rights and interests of drug patentees, and reduce the risk of patent infringement of generic drugs after marketing approval.
The “Measures” provides the following stipulations:
A patent information registration platform for drugs marketed in China is to be established by the NMPA, which is for drug marketing license holders to register the patent information of drugs which obtain approval for marketing in China and is intended to disclose such information to the public. Thus, the “Measures” is not applicable to those drugs which have been on the market in China, but the patent information of which is not registered in the platform.
The drug patents that may be registered in this platform include: chemical-drug patents comprising patents for compounds as pharmaceutical active ingredients, patents for pharmaceutical compositions comprising active ingredients, and patents for medical use; traditional Chinese medicine (TCM) patents comprising patents for medicinal herb compositions, patents for medicinal herb extracts and patents for medical use; and biologics patents comprising patents for sequence structure of active ingredients, and patents for medical use. Kindly note that, according to the policy interpretation on the “Measures”, patents for intermediates, metabolites, crystal forms, preparation methods or detection methods are explicitly excluded from the drug patents that may be registered in the platform.
The generics applicant, when filing a request for drug marketing approval, shall make a declaration on each relevant drug patent. The declaration is classified into four types:
Type I declaration stating that there is no any information of relevant patents regarding drugs to be imitated in the platform;
Type II declaration stating that the relevant patents for drugs to be imitated registered in the platform have expired or have been invalidated, or alternatively the generics applicant has already obtained a license by the patentee to implement the relevant patents;
Type III declaration stating that the drugs to be imitated have already been registered in the platform and the generics applicant promises that the generics applying for marketing approval will not be on the market until the expiry of the relevant patents; and
Type IV declaration stating that the drugs to be imitated that have already been registered in the platform shall be invalidated, or alternatively the generics do not fall into the scope of the relevant patents.
If the patentee or interested parties have objections to the four types of declarations, they may, within 45 days from the date of disclosure of the generics application by the NMPA, file a lawsuit before the court (namely the judicial channel) or request the CNIPA to make an administrative ruling (namely the administrative channel) as to whether the relevant technical solutions of the drugs applying for marketing approval fall within the protection scope of the relevant patents.
For and only for chemical generics applications, the NMPA will set a 9-month waiting period after receiving the copy of the notification of acceptance of case from the court or the CNIPA. The 9-month waiting period is calculated from the date of acceptance of case by the court or the CNIPA, and is set for only once. During the waiting period, the NMPA will not suspend the technical review.
Regarding the chemical generics applications which incur the 9-month waiting period, the patentee or the interested parties shall, within 10 work days from the receipt of the judgment or decision, submit the relevant documents to the NMPA, and where the chemical generics applications have already gone through the technical review, the NMPA will pursue corresponding procedures in conjunction with the effective judgment or the administrative ruling. In particular, if the chemical generics fall into the protection scope of the relevant patents, the NMPA may pursue the marketing approval procedures only when the patent is close to expire; and if the chemical generics do not fall into the protection scope of the relevant patents or the two parties reach an agreement, the relevant patents have been invalidated, or the NMPA does not receive the judgment or the mediation paper by the court or the administrative decision by the CNIPA after the waiting period, the NMPA will pursue the marketing approval procedures.
For type I and II declarations, the NMPA shall make a decision as to whether marketing approval is granted, based on the conclusion from the technical review; and for type III declaration, the NMPA shall make a marketing approval decision after the generics application goes through the technical review, and the generics may be on the market only after expiry of the corresponding patent.
For the chemical generics which successfully challenge the patent for the first time, a 12-month marketing exclusion period is offered to the challenger, and the market exclusion period shall not exceed beyond the original patent term. That is to say, if the remaining patent term is only 5 months, then the market exclusion period would be only 5 months, too.
In addition, according to the “Measures”, the term “successfully challenge the patent” refers to the fact that the chemical generics applicant has filed type IV declaration and the relevant patents have been invalidated in accordance with the request for invalidation by the chemical generics applicant, so that the generics may be approved to be on the market.
For TCM generics and biosimilars applications, the whole procedures are quite similar to those for the chemical generics applications, except that the former shall not incur the 9-month waiting period. The NMPA shall directly make a decision as to whether the marketing approval is granted, based on the conclusion from the technical review; and if the court or the CNIPA judges that the relevant technical solutions fall into the protection scope of the patent, the relevant drugs may not be on the market until the expiry of the patent right.
As can be seen from the above, the “Measures” proposes the establishment of the platform for registering and disclosing the information of the relevant patents, the declaration system for generics, the judicial and administrative linkage system, the waiting-period system for approval, the market exclusion system for the first generics, and the like. With the “Measures”, there will be good balance of the benefit between the generics companies, the innovative companies, and the public.