On 11 September 2020, the National Medical Products Administration ("NMPA") and the China National Intellectual Property Administration ("CNIPA") issued the draft "Implementing Measures for Drug Patent Dispute Early Resolution Mechanism (Trial for Implementation) (Draft for Public Opinions)" (the "Draft Patent Linkage Measures") for public consultation. The public consultation period will end on 25 October 2020.
The Draft Patent Linkage Measures cover chemical drugs, biologics and traditional Chinese medicines ("TCM"). The key provisions are set out as follows:
1. Creation of the Chinese Marketed Drug Patent Information Record Platform
NMPA will create the Chinese Marketed Drug Patent Information Record Platform (the "Platform") for marketing authorization holders ("MAH") to record the patent information for their drugs marketed in China, which will be available to the public. The Draft Patent Linkage Measures will not apply to patents which are not recorded on the Platform.
2. Scope of the patent information
At the time of submitting a marketing authorisation ("MA") application, the applicant needs to voluntarily record the information on the Platform, including the drug name, related patent number, patent type, patent status, patentee, MAH, patent expiry date, correspondence address, contact person, contact information, etc. Note that if the patent is granted during the MA review, the applicant will need to supplement the relevant information within 30 days. For drugs which are already on the market in China, the MAH will also be able to record the patent information on the Platform. If any information on the Platform is changed, the applicant/MAH is required to change the records within 30 days.
The following types of patents can be recorded on the Platform:-
- Chemicals – API compound patent, preparation (containing API) patent and indication patent;
- Biologics - sequence structure patent;
- TCM – preparation patent, extract patent and indication patent.
The applicant/MAH shall be responsible for the authenticity, accuracy and completeness of the information submitted to the Platform.
3. Patent statement
A generic applicant, filing an abbreviated new drug application ("ANDA") application, whether it is for a generic chemical drug, biosimilar or generic TCM, will have to submit a patent statement for each of the patents of the originator drug recorded on the Platform and provide support for the statement. The patent statement is classified into four categories:
- Category 1 – No patent information of the originator drug on the Platform;
- Category 2 – The patent information of the originator drug on the Platform has expired or been invalidated;
- Category 3 – There is patent information of the originator drug on the Platform, but the generic drug applicant agrees that the generic drug seeking MA will not be marketed before the expiry of the patent;
- Category 4 - There is patent information of the originator drug on the Platform, but the generic drug applicant considers the patent should be invalidated or the generic drug does not fall in the patent protection scope.
The generic drug application and the patent statement will be published on the NMPA website.
4. Opposition against the patent statement
If the patentee or an interested party opposes the patent statement and/or the reasons supporting the statement, it may, within 45 days upon the publication of the ANDA application, sue or file a complaint before the court or CNIPA respectively for a determination on whether the generic drug falls within the patent protection scope and submit a copy of the Case Acceptance Notice to NMPA within 10 days upon the case filing/acceptance date.
If the patentee or interested party does not instigate an action within the above prescribed time limit, the NMPA can determine whether or not to grant the MA depending on the technical review and the patent statement.
Interestingly, the time limit for filing court proceedings or making a CNIPA complaint under the Draft Patent Linkage Measures i.e. 45 days, is different from the time limit set out in the draft Patent Law, i.e. 30 days.
5. Moratorium for generic chemical drugs
If court proceedings or a CNIPA complaint is filed within the prescribed time limit in relation to a generic chemical drug, the NMPA will set a 9-month moratorium, during which the technical review can still proceed.
6. MA approval for generic chemical drugs
For generic chemical drugs, the NMPA will determine the approval according to the category of the patent statement:
For categories 1 and 2 – NMPA may or may not grant the MA depending on the technical review;
For category 3 – NMPA will grant the MA if the generic chemical drug passes the technical review, but NMPA will also indicate the drug may only be sold after the expiry of the patent;
For category 4 – If the patentee or interested party sues/files a complaint, they shall submit the judgment/decision received from the court/CNIPA to the NMPA within 10 days upon the receipt. If the generic chemical drug passes the technical review, the NMPA will then make a determination based on the outcome of the case:
- If the court/CNIPA determines that the generic chemical drug falls within the patent protection scope –
- where the court/CNIPA determination is made during the moratorium: the MA application may only enter the final approval 20 working days before the patent expiry date;
- where NMPA receives such judgment/decision during the final approval period: the final approval will restart on the 20 working days before the patent expiry date;
- The MA application may enter the final approval in due course under the following circumstances:
- the court/CNIPA determines the generic chemical drug does not fall in the patent protection scope,
- the parties settle the case,
- the patent is invalidated, or
- the court/CNIPA does not issue the effective judgment/decision/mediation within the moratorium.
- If NMPA stays the approval according to a judgment/decision from the court/CNIPA, but the judgment/decision is overturned by the final court judgement, the generic chemical drug applicant may request NMPA for MA approval, and NMPA may or may not grant the MA, based on the technical review and the final judgment.
7. MA approvals for biosimilar and generic TCM
For biosimilar or generic TCM MA application, NMPA may or may not directly grant the MA, based on the technical review. If the court/CNIPA determines that the biosimilar or generic TCM falls within the patent protection scope before the MA is approved, and the drug passes the technical review, NMPA may grant the MA but indicate that the drug shall only be sold after the expiry of the patent.
8. Market exclusivity for the first generic chemical drug applicant, successful in patent challenge
The first generic applicant to obtain approval for a chemical drug who is also the first one successful in challenging the originator’s patent will obtain 12 months' market exclusivity period but not exceeding the duration of the patent being challenged. During the market exclusivity period, NMPA will not grant the MA for other generic chemical drug of the same variety, but the technical review will not be suspended.
9. Remedies and liabilities
After an MA approval is granted for the generic drug, but the patentee considers that there is an infringement of its patent, this can be dealt with according to the Patent Law and other applicable laws and regulations. However, the already approved MA will not be cancelled.
An applicant and its agent who purposely make false patent statement(s) or purposely record irrelevant patent information on the Platform, will be liable for joint punishment for dishonesty, and the applicant will not be allowed to apply for the MA of the same variety for one year.
There is currently no guidance as to what irrelevant patent information means.
Given that the public consultation on the Draft Patent Linkage Measures does not close until October 2020, there could be further iterations of the patent linkage provisions before they are implemented. We will keep monitoring the situation and issue further newsletter updates as and when further revisions are released.