Supplemental Protection Period for pharmaceutical patents in China - Update

By Martoe Xu, Alison Wong

12-2020

On 27 November 2020, the China National Intellectual Property Administration (“CNIPA”) issued the draft Implementing Regulations of the PRC Patent Law (“Draft Amendments for Implementing Regulations”) for public consultation. The deadline for submitting opinions is 11 January 2021. The Amendments for Implementing Regulations, once finalised, will supplement the New Patent Law which will come into effect on 1 June 2021.

1. Supplemental Protection Period for pharmaceutical patents

The introduction of Supplemental Protection Period for pharmaceutical patents (the “SPP”) in the New Patent Law (Article 42(3)) is a significant boost for pharmaceutical patent holders (see our previous article - China passes Patent Law Amendments 2020 and introduces Drug Patent Linkage and Supplemental Protection Period systems). Article 42(3) provides that, to compensate the time taken to review and approve a new drug for marketing, the patentee can apply for a SPP. CNIPA will grant SPP for an invention patent for a new drug which has obtained marketing authorisation in China, provided that the SPP shall not exceed 5 years, and provided that the total patent valid term after the new drug is approved for marketing shall not exceed 14 years.

Articles 85 (4) to 85 (8) of the Draft Amendment for Implementing Regulations also set out the following in relation to SPP:-

(1) Scope of SPP

New chemical drugs, biologics and traditional Chinese medicines (“TCM”) approved for marketing in China are eligible for SPP.

Pharmaceutical invention patents include product patents, process patents and indication patents.

“Relevant patent of the new drug” is defined as the patent related to the API of the new drug, which is the first approved for marketing by the National Medical Products Administration (“NMPA”). The relevant patent of new TCM includes the patent related to innovative TCM and improved new TCM with additional indications.

(2) SPP term

The SPP term will be the time period from the date of the patent application to the date of the grant of the marketing approval for the new drug in China reduced by 5 years (but subject to the 5 years limitation of SPP and 14 years limitation for the total patent valid term after the new drug is approved).

(3) Effect of SPP

The protection scope of the patent during the SPP will be narrowed to the scope of the related new drug, i.e. the patentee may only enforce the patent for the same drug and indication.

The patent during the SPP will have the same rights and obligation as the originally granted patent (subject to above provisions).

(4) Conditions for obtaining SPP

A patentee must file a request for a SPP within 3 months of the grant of the marketing authorisation for the new drug (together with supporting documents) and the following requirements must be met:-

  • The patentee can only apply for SPP for one patent, even if the drug is protected by several patents;
  • The patentee can only apply for SPP for one drug, even if the same patent may protect several drugs;
  • No SPP has been granted in respect of the patent; and
  • The remaining term of the patent is not less than 6 months.

(5) Examination and Publication

CNIPA will review the patentee’s SPP application, and will reject the application if it does not meet the conditions. If the patentee meets the requirements, CNIPA will grant and publish the SPP.

(6) Invalidation

After publication of the grant of SPP, any entity or individual can file an invalidation with the CNIPA. The invalidation applicant or the patentee may file administrative proceedings against the CNIPA on its decision to maintain or invalidate the SPP within 3 months of receipt of the CNIPA decision.

(7) Fees

The patentee will have to pay fees for the SPP, but the fees have not been set out.

2. Other amendments- supplemental protection period for unreasonable delay

There are also other implementing proposals in the Draft Amendments for Implementing Regulations which may affect the pharmaceutical industry, such as the Articles 85 (2) and 85 (3) which specify the details for the supplemental protection period for unreasonable delay during the examination of an invention patent.

Article 42 (2) of the New Patent Law introduces the supplemental protection period for unreasonable delay, and the patentee will have the right to file a request if the invention patent is granted after four years from the application date and three years from the request for substantive examination (unless the delay has been caused by the patentee). The main proposals in the Draft Amendments for Implementing Regulations are as follows:-

  • The patentee must file a request for the supplemental protection period for unreasonable delay within 3 months of the grant of the patent;
  • The supplemental period will be the same as the period of delay;
  • The unreasonable delay caused by the patentee will include not responding to office actions within the required timeline, and deferred examination, etc;
  • A stay pursuant to Articles 86 and 87 of the Implementing Regulations does not constitute an unreasonable delay.

The publication, invalidation procedures and fees requirement for SPP will apply to supplemental protection period for unreasonable delay.

There are no references to patent linkage in the Draft Amendments for Implementing Regulations, as these will be specified in the measures formulated by NMPA and CNIPA separately.

As the consultation period for Draft Amendments for Implementing Regulations will last for more than one month, there may be potential changes for the implementing proposals for SPP. In addition, CNIPA may also amend the Patent Examination Guidelines on the application and invalidation procedures for SPP and supplemental protection period for unreasonable delay. Bird & Bird will keep monitoring the status and provide updates.