By pharmaceutical patent link is meant a link of pharmaceutical approval with patents for the purpose of resolving patent disputes and addressing infringement risks before pharmaceuticals are launched in the marketplace. On July 4, 2021, China National Medical Products Administration and National Intellectual Property Administration jointly issued the Measures for the Implementation of the Mechanism for Early Settlement of Drug Patent Disputes (interim) (hereinafter referred to as "the Measures"), and the Patent Information Registration Platform for Marketed Drugs was formally put into operation on the same day. On July 5, the CNIPA released the Measures for Administrative Adjudication of Early Settlement Mechanism on Drug Patent Disputes, and on the same day the Supreme Court released the Provisions on Several Issues Concerning the Application of Law to the Trial of Civil Cases of Patent Disputes Related to Drugs for Registration. The implementation of series of measures and rules shows that the pharmaceutical patent link system has been officially launched in China.

 

The main contents of the Measures include, among other things, the platform construction and information disclosure system, patent right registration system, generic pharmaceutical patent declaration system, judicial link and administrative link system, approval waiting period system, pharmaceutical review and approval categorizing system, and first generic pharmaceutical market exclusivity system.

 

Following is an overview of the main parts of the pharmaceutical patent link system.

 

I. Pharmaceutical Marketing Authorization Holders to Register Patents

The pharmaceutical marketing authorization holders, usually original pharmaceutical development businesses or companies, shall register their registered patent-related pharmaceuticals or drugs with the CNMPA’s Patent Information Registration Platform for Marketed Drugs within 30 days upon obtaining their pharmaceutical registration certificates, and update information within 30 days after any change in the patent information takes effect. In particular, the patent link system does not apply to registered pharmaceuticals with their patent information not registered on the patent information registration platform. Therefore, the original pharmaceutical development businesses with approved registration are advised to register all patent information of their registered pharmaceuticals or drugs at the earliest possible date.

 

The specific pharmaceutical patents registrable on the marketed pharmaceutical patent information registration platform include pharmaceutical active ingredient compound patents of chemical pharmaceuticals (excluding APIs), pharmaceutical composition patents containing active ingredients, and pharmaceutical use patents; traditional Chinese medicine compositions of traditional Chinese medicine patents, Chinese medicine extract patents, and drug use patents; serial structure patents, and medical use patents of active ingredients of biological products. The relevant patents do not include patents relating to intermediates, metabolites, crystal forms, preparation methods, and detection methods.

 

II.  Generic Pharmaceutical Applicants’ Declarations

On the basis of the completed relevant patent registration of registered pharmaceuticals, a generic pharmaceutical applicant, when filing an application for a generic pharmaceutical marketing authorization, is required to make a declaration on the patent of the original pharmaceutical (that is, the originally developed pharmaceutical) registered on the NMPA’s patent information registration platform. The declarations are of the following four types:

Type One Declaration: There is no patent information relating to the generic pharmaceutical on the patent information registration platform.

 

Type Two Declaration: The patent relating to the generic pharmaceutical included in the patent information registration platform has been terminated or declared invalid, or the generic pharmaceutical applicant has been licensed by the patentee to exploit the relevant patent.

Type Three Declaration: The patent information registration platform enlists a patent relating to generic pharmaceutical, and the generic pharmaceutical applicant is committed not to launching the generic pharmaceutical in the marketplace before the expiry of the corresponding patent.

Type Four Declaration: The patent relating to the generic pharmaceutical enlisted or included in the patent information registration platform shall be declared invalid, or the generic pharmaceutical does not fall within the scope of protection of the relevant patent.

 

Regarding a generic pharmaceutical applicant’s declaration, the NMPA will disclose the application information and corresponding declaration to the public on the information platform within 10 working days after the application is accepted, and the generic pharmaceutical applicant will notify the generic pharmaceutical marketing authorization holder. If the marketing authorization holder is not the patentee, the marketing authorization holder shall notify the patentee.

 

III. Dispute Resolution: Civil Litigation or Administrative Adjudication

If any patentee or interested party has objection to the four patent declarations, he or it may, within 45 days from the date when the NMPA publishes the application for pharmaceutical marketing authorization. They may file a lawsuit with the court or request the CNIPA for administrative adjudication on whether the relevant technical solution of the pharmaceutical applied for marketing falls within the scope of protection of the relevant patent. An interested party, if dissatisfied with the CNIPA’s administrative decision, may file a lawsuit in the court under the law after receiving the administrative decision. If the lawsuit involving the same patent dispute is docketed with the court, the CNIPA will not accept the request filed by the interested party for the administrative adjudication. Where a party files a request for invalidation of the patent involved during the court proceedings of the case, the CNIPA may not suspend the handling of the case. Administrative adjudication does not deal with issues of patent validity.

 

IV. Waiting Period for Initiation

For a generic pharmaceutical application, the NMPA will set a 9-month waiting period (calculated from the date of docketing or acceptance) for the registration application upon receiving a copy of notification on docketing by the court or acceptance in connection with the administrative adjudication. The waiting period is set only once, within which technical review is not suspended. In respect of the four types of declarations regarding traditional Chinese medicines and biological products, patentees and interested parties can also resolve disputes through civil litigation or administrative adjudication, but there is no waiting period set for approval.

 

V. Categorized Approvals

Applications for registration of pharmaceuticals that have passed the technical review shall be dealt with by the NMPA in connection with the effective court or administrative decision:

 (1) Falling into the scope of protection of relevant patents: Applications for registration of the relevant generic pharmaceuticals are transferred to the administrative examination and approval cycle before expiry of the term of the patent.

 (2) Not falling into the scope of protection of the relevant patents or in case of settlement reached between the two parties: They are transferred to the administrative examination and approval cycle.

 (3) The patent is invalidated: They are transferred to the administrative examination and approval cycle.

(4) With the waiting period exceeded and the effective court decision or mediation letter, or the CNIPA’s administrative decision not received: They are transferred to the administrative examination and approval cycle.

 (5) Where the effective court or the CNIPA’s administrative decision is received, determining that it falls within the scope of protection of the relevant patent: Applications for registration of the relevant generic pharmaceuticals are transferred to the administrative examination and approval cycle before expiry of the term of the patent.

 

VI. Market Exclusivity Period

Regarding the first generic pharmaceutical having succeeded in challenging the patent (that is, the Type Four Declaration is submitted and the relevant patent is declared invalid at request) and approved for marketing, the NMPA shall, within 12 months from the date of approval of the generic pharmaceutical, not approve any same generic pharmaceutical for marketing. But, the 12-month market exclusivity period system does not exist for traditional Chinese medicines and biological products.

 

The above is an overview of the pharmaceutical patent link system in China, which will tremendously change the market for the pharmaceutical businesses. All original pharmaceutical development and generic pharmaceutical businesses should fully study the new system, and utilize it to seek a favorable market position.