China Pharma Update - Draft Patent Examination Guidelines contain proposals on Patent Linkage Invalidation, Patent Term Extension and Patent Term Adjustment

I. Patent Linkage Invalidation

The 2021 Draft Amendments introduce a new type of patent linkage invalidation related to the Patent Linkage Implementing Measures (for more information about the Measures, please see Bird & Bird article - News flash - Patent Linkage Implementing Measures came into force in China on 4 July 2021).

1. Definition

A Patent Linkage Invalidation refers to the patent invalidation petition filed by a generic drug market authorization (“MA”) applicant against a patent registered on the China Marketed Drug Patent Information Registration Platform (the “Patent Platform”), after it has submitted a Category IV certification in accordance with Patent Linkage Implementing Measures.

2. Documentation

To commence a Patent Linkage Invalidation, the Petitioner must indicate in the Petition that the patent in dispute is registered on the Patent Platform and a Category IV certification has been submitted, together with the generic drug MA application acceptance notice and a copy of the certification.

3. Review sequence

If several Patent Linkage Invalidations have been filed by multiple generic MA applicants against the same patent, the CNIPA will review the cases in an order that is based on the petition dates. This differs from the usual practice in normal patent invalidations that the CNIPA will consolidate proceedings for several petitions if they are against the same patent.

4. Separate proceedings

The 2021 Draft Amendments provide that:

• if the patent had previously been challenged but remain valid as the claims were amended, the subsequent case will be heard based on the amended claims;
• if the patent has been invalidated or partially invalidated in the prior case, the subsequent case will be stayed until the decision in the prior case becomes effective or is withdrawn by a court judgment.

5. CNIPA Notification

The CNIPA will notify the Beijing IP court and the National Medical Products Administration (“NMPA”) of the status of the patent in suit at their request and provide a copy of the CNIPA decision.

II. PTE

PTE, i.e. the supplemental protection period for new drug invention patent, is stipulated in Article 42.3 of Patent Law and its draft Implementing Regulations (for more information about PTE and PTA, please see Bird & Bird article - Supplemental Protection Period for pharmaceutical patents in China - Update). The 2021 Draft Amendments provide further clarification, in particular it sets out the scope of a “new drug”, etc.

1. Eligible drugs

Only innovative drugs and certain improved new drugs are eligible for PTE.

Innovative drugs refer to Class 1 drugs in accordance with the NMPA classifications for chemical drugs, biologics and traditional Chinese medicine (“TCM”) respectively, namely the drugs have not been marketed in China or overseas.

The eligible improved new drugs are: Class 2.1 (limited to esters or salts of a known active ingredient) and Class 2.4 (new indication) of chemical drugs, Class 2.2 (limited to improvement to vaccine strains) of preventive biologics, Class 2.2 (limited to new indication) of therapeutic biologics, and Class 2.3 (new indication) of TCM.

Therefore, drugs which have been marketed overseas but not in China, e.g. Class 5.1 of chemical drugs and Class 3.1 and 3.2 of therapeutic biologics are excluded from the scope of PTE.

2. Conditions for PTE

The 2021 Draft Amendments set out the following key requirements:

• The eligible patent types are API’s product patent, manufacturing process patent and indication patent.
• The grant date of the patent should be earlier than the MA approval date of the drug;
• The patent should be valid at the time of filing PTE request;
• No PTE has been granted in respect of the patent;
• The new drug of MA approval can be mapped on to the patent scope;
• PTE can only be requested for one patent, even if the drug is protected by several patents; and
• PTE can only be requested for one drug, even if the same patent may protect several drugs.

Some of the requirements have already been set out in the draft Implementing Regulations.

The 2021 Draft Amendments also specify the documentation which must be submitted to request a PTE and the review process on the request. For example, the decision to grant a PTE can only be made after the decision for a PTA (if both requests are filed), or the time limit to file a PTA request has lapsed.

The calculation of the PTE term and the timing for the request are consistent with the proposal in the draft Implementing Regulations i.e. (i) the PTE term is the date of MA approval minus the date of patent application further minus 5 years ( subject to the 5 year limitation of PTE and 14 year limitation for the total patent valid term after the new drug is approved), and (ii) a PTE request must be filed within 3 months upon MA approval. However, if a drug is subject to conditional MA approval, the PTE request can only be filed within 3 months upon the formal MA approval, but the calculation will still be based on the conditional approval date.

The 2021 Draft Amendments also set out the protection scope of a PTE: a product patent is limited to the new drug for the approved indications, an indication patent is limited to the approved indications, and a manufacturing process patent is limited to the manufacturing process recorded with the NMPA.

III. PTA

PTA refers to the supplemental protection period for unreasonable delay during the examination as set out in Article 42.2 of Patent Law and its draft Implementing Regulations, and a PTA, may be appliable to all types of invention patents. However, the 2021 Draft Amendments stipulate the PTA is not appliable for an invention patent, which is filed on the same day with a utility model for the same subject matter. A PTA request must be filed within 3 months of the grant of the patent.

The 2021 Draft Amendments mainly clarify the calculation of the PTA term, which is equal to the number of actually delayed days during the patent examination, namely the number of unreasonably delayed days during the examination deducted by the number of days delayed by the applicant.

1. Unreasonable delayed days during the examination

Unreasonable delayed days are calculated based on: the patent grant date minus either the date after four years from the application date or the date after three years from the entry of substantive examination, whichever is later. Specifically, the application date refers to the actual filing date not the priority date, and it is the China entry date of a PCT application and the actual filing date for a divisional application.

A stay proceeding, a preservation proceeding, an administrative litigation, and certain review proceedings involving patent amendments based on Article 66 of the Implementing Regulations will not be counted towards the timeline for an unreasonable delay.

2. Days delayed by the applicant

The following will be deemed as unreasonable delays caused by the applicant:

• Delay in responding to a CNIPA notice;
• Deferred examination;
• Incorporation by Reference in a PCT;
• The restoration of right, unless this has been caused by the CNIPA; and
• Certain delays in the China entry of a PCT.

IV. Current practice for PTE and PTA requests in China

Prior to the 2021 Draft Amendments, PTE and PTA requests had to be filed based on the Patent Law effective on 1 June 2021.

1. PTE and PTA requests can be submitted since 1 June 2021

On 25 May 2021, the CNIPA issued a document titled “Interim Measures for Handling Relevant Examination Work Regarding the Implementation of the Amended Patent Law” (the “Interim Measures”). Amongst others, the Interim Measures provided the transition process for PTE and PTA as follows:

• PTE – since 1 June 2021, the patentee may submit PTE request within 3 months upon the MA approval of new drug in accordance with Article 42.3 of Patent Law.
• PTA – for the invention patent granted after 1 June 2021, the patentee may submit PTA request whin 3 months upon the grant of patent in accordance with Article 42.2 of Patent Law.

2. PTE and PTA provisions are not retrospective

On 27 May 2021, the CNIPA issued a Notice titled “Answers to Relevant Questions on the Amended Patent Law” clarifying, amongst other things that the PTE and PTA provisions are not retrospective. That is, new drugs approved before 31 May 2021 (inclusive) will not be eligible for PTE, while invention patents granted before 31 May 2021 (inclusive) will not be eligible for PTA.

3. Documentation to support PTE and PTA request

To assist patentees to submit the PTE and PTA requests after 1 June 2021, the CNIPA have prepared a prescribed form, which was released together with other template forms on 26 May 2021. The prescribed form is applicable to PTE and PTA requests, in particular, a patentee may submit PTE and PTA requests in one template form.

The PTA request is relatively straightforward as only basic information of the patent (patent number, title and patentee) is required together with the seal of the patent agency or the patentee.

The PTE request is more complicated. In addition to above information, the following information is required:

• MA approval date;
• Market authorization holder (“MAH”);
• Drug name;
• Approved indication/s;
• Patent claim/s related to the drug;
• The technical solution subject to PTE, and how the patent claim is mapped onto it (illustrated with supporting document); and
• How the PTE is calculated.

In addition, the following documentation must be submitted:

• A copy of drug MA certificate;
• A consent letter of MAH for the patentee to request PTE; and
• Manufacturing process dossier approved by NMPA.