9 July 2021
The China National Intellectual Property Administration (“CNIPA”) will now officially accept patent linkage cases according to the “Notice on the Acceptance of Patent Linkage Adjudication” (the “Notice”) because the “Administrative Adjudication Measures for Drug Patent Dispute Early Resolution Mechanism” (“Patent Linkage Administrative Adjudication Measures”) was issued and effective on 5 July 2021.
The key provisions in the Patent Linkage Administrative Adjudication Measures are set out as follows.
1. Case filing requirements
The CNIPA has established a Patent Linkage Administrative Adjudication Commission to handle patent linkage administrative adjudication proceedings.
(1) Parties
The Applicant can be the generic drug applicant or patentee/interested party. However, the generic drug applicant can only file a request if the patentee or interested party does not file patent linkage proceedings before the court or CNIPA within the prescribed 45-day timeline, which is in line with the Patent Linkage Implementing Measures.
The interested party can be the patent licensee or the registered drug marketing authorization holder (“MAH”). A MAH or an exclusive patent licensee can file the request on its own i.e. without the patentee, but a patent licensee of a sole licence agreement can only file the request on its own if the patentee does not file it.
If the patent is owned by multiple parties, the request must be filed by all the owners, unless the other co-owners explicitly abandon their substantive rights.
If the patentee/interested party files the request, the generic drug applicant will be engaged in the proceedings as Respondent. If the generic drug applicant files the request, the Respondent will be the patentee.
(2) Conditions
The request for an administrative adjudication must meet the following conditions:
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Respondent, the request and supporting facts and grounds must be properly set out;
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The patent in dispute has been registered on the China Marketed Drug Patent Information Registration Platform (the “Patent Platform”) in accordance with Patent Linkage Implementing Measures;
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The parties have not commenced any court proceedings relating to the same drug (this requirement is different from the Patent Linkage Judicial Interpretations, as pending administrative proceedings will not preclude subsequent patent linkage proceedings to come before the court);
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The request will only be for a determination of whether one generic drug submitted for marketing authorization (“MA”) falls within the scope of one patent.
(3) Documents
The following documents must be filed with the CNIPA:
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A prescribed Request Form (a template is set out in the Notice);
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Identity certificate of the Applicant;
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Information of the patent registered on the Patent Platform;
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The generic drug MA application published by the platform of Centre for Drug Evaluation (“CDE”) of National Medical Products Administration (“NMPA”);
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The “non-infringement” certification (i.e. the Category IV Patent Certification) and supporting documents of the generic drug applicant; and
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If the generic drug applicant submits the request, it shall also file the technical dossier of the generic drug (the confidential technical information can be filed separately).
2. Post filing
After the request has been filed, the CNIPA may make the following request/decision:
(1) Correction
If the Request Form is incomplete or is not in the prescribed format, or the documentation filed is insufficient, the CNIPA may require the Applicant to make corrections within 5 working days, otherwise the request will be rejected.
(2) Rejection
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The basic information of the Applicant and/or the patent information have not been included in the Request Form;
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The Respondent is not clearly identified;
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The Applicant or Respondent do not meet the qualification requirements;
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The patent in dispute is not registerable on the Patent Platform or the patent in dispute is not the same patent as set out in the Category IV Certification;
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The patent in dispute has been invalidated;
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The Request Form does not specify the patent claims or specific adjudication request;
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The Applicant does not set out the specific grounds it relies on;
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The request covers more than one generic drug or more than one patent; or
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Separate court proceedings have already been commenced on the same drug.
(3) Acceptance
If the request meets the requisite conditions, the CNIPA will accept the case within 5 working days, and the CNIPA will notify the Applicant and Respondent.
3. Proceedings
The CNIPA may, at the request of a party or on its own initiative, verify the relevant evidence with the drug regulatory authorities.
The CNIPA can make a determination based on paper submissions/evidence or at an oral hearing. If multiple requests are filed by the same party for multiple patents against the same drug, CNIPA may consolidate the proceedings.
If an oral hearing is required, the CNIPA shall notify the parties at least 5 working days before the date of the hearing: if the Applicant does not attend the hearing without good reason, the request will be deemed withdrawn; if the Respondent does not attend without good reason, CNIPA will issue a default ruling.
4. Findings
The CNIPA may make the following findings:
(1) Dismissal
If some of the patent claims have been announced invalid, the CNIPA will make a determination based on the valid claims. However, if all the patent claims have been invalidated, the CNIPA will dismiss the case.
(2) Mediation
The CNIPA may require the parties to attend mediation. If the mediation is successful, the CNIPA may issue a Mediation Agreement upon the application of the parties. If the mediation is unsuccessful, the CNIPA will make an adjudication on its own.
(3) Stay
Upon the application of the parties or on its own initiative, the CNIPA may stay the proceedings due to the death, disability, or dissolution of one party, force majeure or other appropriate reasons.
However, the CNIPA may not stay the proceedings based on an invalidation petition filed by a party.
(4) Withdrawal
The Applicant can withdraw the case before the CNIPA issues the decision. However, a withdrawal will be null and void if it is made after the CNIPA has issued the decision.
(5) Adjudication
If the CNIPA issues an administrative adjudication, it must state whether the generic drug falls within the patent scope and set out the reasons. The administrative adjudication will be submitted to the NMPA and published with the trade secrets redacted.
If a party is not satisfied with the administrative adjudication, it may appeal to the Beijing IP Court.
5. Other provisions
The Patent Linkage Administrative Adjudication Measures contain provisions such as the parties’ obligation regarding authenticity of documents and duty of confidentiality etc.
It is indicated that issues which are not addressed in the Patent Linkage Administrative Adjudication Measures may be dealt with in the “Patent Administrative Enforcement Measures” or CNIPA’s provisions on the adjudication of patent infringement.
Alison Wong, Partner, Bird & Bird
alison.wong@twobirds.com
