China's IP administration proposes amendments to patent examination guidelines

China

On 3 August 2021, the China National Intellectual Property Administration (CNIPA) published draft amendments to the Guidelines for Patent Examination (Draft Revision). Among other important amendments, the Draft Revision provides detailed rules on patent term adjustment, patent term extension, and invalidation involving drug patent disputes arising under the newly established patent linkage system. Comments on the Draft Revision are to be submitted before 22 September 2021.

Key amendments in the Draft Revision that pharmaceutical companies should be aware of include the following:

  • Patent term adjustment

According to Article 42 second paragraph 2 of the Patent Law, for an invention patent that is granted after four years from the application date and three years from the date of request for substantive examination, the CNIPA will, at the request of the patent holder, compensate the patent term for any unreasonable delay in granting the patent, except for unreasonable delays caused by the applicant. The Draft Revision provides that the compensated term will be calculated according to the delayed days, which are unreasonable delayed days caused by the CNIPA minus unreasonable delayed days caused by the applicant.

Unreasonable delayed days caused by the CNIPA will be calculated from the grant date of the invention patent minus four years after the application date and three years after the date of request for substantive examination. For a PCT application, the application date refers to the date that the PCT application enters the national stage in China. For a divisional application, the application date refers to the filing date of the divisional application. The date of request for substantive examination refers to the issuance date of the notice for the invention patent application entering substantive examination.

A delay caused in the following situations will not be deemed as an unreasonable delay by the CNIPA:

  1. Suspension procedures;

  2. Preservation measures;

  3. Administrative litigation process; and

  4. Invalidation procedures.

An unreasonable delay caused by the patent applicant includes:

  1. the time gap between the designated date for responding to an office action and the actual date that the applicant submits a reply;

  2. an application for delayed examination;

  3. a delay caused by incorporation by reference;

  4. a delay caused by the request for restoration of rights; and

  5. for PCT applications, the delayed entry onto the national stage after 30 months from the priority date (a maximum of two months).

If the request for patent term adjustment is denied, the CNIPA will give the requesting party at least one chance to reply and/or submit supplemental documents. If a determination is made that the patent qualifies for the patent term adjustment, the CNIPA will issue the decision and notify the patent holder of the compensated days. The compensated patent term will also be made available to the public.

  • Patent term extension

The holder of a patent of a drug that has applied for marketing authorisation can apply for a patent term extension to compensate for the time lost during the new drug review and approval process.

A request for a patent term extension should meet the following conditions:

  1. The patent grant date should be earlier than the marketing authorisation approval date;

  2. When applying for the patent term extension, the patent right should be valid;

  3. The patent term has not been extended pursuant to a patent term extension;

  4. The technical solution of the new drug should fall within the protection scope of the patent;

  5. The patent term of only one patent will be extended if multiple patents were granted for one drug; and

  6. The patent term of only one drug will be extended if one patent protects multiple drugs. 

The patent holder should make the patent term extension request. The request should be filed within three months from the date when marketing authorisation is officially approved. The compensation date will be calculated based on the issuance date of the approval. 

The documents to be submitted include:

  1. The drug patent term extension request, including the drug name, approved indications, patent number and the relevant claims, detailed reasoning of why the drug falls within the relevant claims with reference to submitted evidence, the calculation of a proposed extended patent term that requests to be granted, and the technical solution protected during the proposed extended period;

  2. The consent letter from a drug marketing authorisation holder, if the drug marketing authorisation holder is not the patent holder; and

  3. When requesting a patent term extension for a preparation method, the requesting party should submit the materials of the drug preparation method approved by National Medical Products Administration (NMPA).

Products with an active pharmaceutical ingredient, preparation methods and medical use patents can be granted with patent term extensions. The eligible drug includes innovative drugs and improved drugs. For improved drugs, the patent term extension can be granted for:

  1. Chemical drugs of class 2.1 that form esters with known active pharmaceutical ingredients, or form salts with known active pharmaceutical ingredients;

  2. Chemical drugs of class 2.4 (i.e. drugs with new indications containing known active pharmaceutical ingredients);

  3. Prophylactic biological products of class 2.2, vaccines with improved bacterial or viral strains;

  4. Therapeutic biological products of class 2.2, drugs with new indications; and

  5. Traditional Chinese Medicines of class 2.3 (i.e. drugs with increased indications).

CNIPA will examine whether the technical solution of the drug under application of marketing authorisation falls within the protection scope of the designated claims. During the extended patent term, the claim scope of product patent will be limited to the approved drugs with specific indications, the claim scope of medical use patent will be limited to the approved indications of the drugs, the claim scope of preparation method patents will be limited to the preparation method of the drug recorded with the NMPA.

The calculation method will be the issuance date of the approval minus the patent application date minus five years. The extended term will not exceed five years and the total patent term will not exceed 14 years after obtaining the marketing authorisation.

If the request for the patent term extension is denied, the CNIPA will give the requesting party at least one chance to reply and/or submit supplemental documents. If the patent holder brings a patent term adjustment request and a decision on granting the request has not been made, the examiner should determine the patent term extension after the patent term adjustment request has been concluded. If the patent holder has not filed a request for patent term adjustment, the examiner should wait until the three month deadline and then determine the patent term extension, unless the patent holder clearly expresses the intention to give up any patent term adjustment. Upon examination, the CNIPA will make its decision and notify the requesting party of the extended days. The extended patent term will also be made available to the public.

  • Invalidation process

The revision of the Guidelines for Patent Examination provides detailed rules for invalidation involving drug patent disputes arising under the newly established patent linkage system.

The rules are set specifically for when a drug marketing authorisation applicant files an invalidation request against a patent registered on the patent information registration platform after submitting a Category IV declaration pursuant to the Implementing Measures for the Early Resolution Mechanism for Drug Patent Disputes (for Trial Implementation).  Accordingly, in the request, the requesting party must:

  1. expressly state that:

    • the patent in dispute was registered on the patent information registration platform;

    • the requester is the generic drug applicant; and

    • the requester has submitted the Category IV declaration; and

  2. submit relevant evidence, such as:

    • a copy of the generic drug registration application acceptance notice;

    • a copy of Category IV declaration.

When more than one invalidation request is brought against one patent, the CNIPA will review the requests in turn according to their application dates. If the patent right is maintained after amendments, the CNIPA can continue to review the requests that were filed later based on the amended claims. When the patent right is invalidated or partially invalidated, the later requesters and patent holders will receive a notice indicating that the review will be suspended. The CNIPA will resume a timely review of the requests that were filed later when the previous review decision takes effect, or the decision is reversed by an effective ruling from the people’s courts.

If requested by the people’s courts or the NMPA, the CNIPA may provide a notice of review status for invalidation requests made to them. If such a notice has been sent to the people’s courts or the NMPA, the CNIPA will deliver the invalidation decision and issue a notice for concluding the review of the invalidation request to those departments. 

Link to the Draft Revision:

http://www.cnipa.gov.cn/art/2021/8/3/art_75_166474.html

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