Does the time delay caused by the applicant count towards the time considered delayed in determining the pharmaceutical registration procedure?
Application for Confirmation of Delay in the Initial Drug Registration Procedure as Stipulated in Decree 65/2023/ND-CP
On August 23, 2023, the Government of Vietnam issued Decree 65/2023/ND-CP, detailing certain provisions and measures for the implementation of the Intellectual Property Law regarding industrial property, protection of industrial property rights, rights to plant varieties, and state management of intellectual property.
In Appendix I issued along with Decree 65/2023/ND-CP, regulations regarding the application for confirmation of delay in the initial drug registration procedure are specified as follows:
Download the application form for confirmation of delay in the initial drug registration procedure here.
Does the time delayed due to the applicant's fault count towards the determination of the drug registration procedure being considered delayed?
Does the time delayed due to the applicant's fault count towards the determination of the drug registration procedure being considered delayed?
Article 131a of the Intellectual Property Law 2005, supplemented by Clause 51, Article 1 of the Amended Intellectual Property Law 2022, provides for compensation to patent holders for delays in drug marketing authorization:
Compensation for Patent Holders for Delays in Drug Marketing Authorization
1. When performing the procedure to maintain the validity of a Patent, the Patent holder is not required to pay the protection certificate usage fee for the period during which the initial drug registration produced under that Patent in Vietnam is delayed.
2. The drug registration procedure is considered delayed if, after two years from the date of receipt of a complete registration dossier, the competent authority has not issued a first response to the dossier. The delay period is calculated from the first day after two years from the date the competent authority receives the complete dossier until a first response is issued.
3. The time delayed due to the applicant's fault or reasons beyond the control of the competent state authority is not included in the periods specified in Clause 2 of this Article.
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Thus, the drug registration procedure is considered delayed if, after a period of two years from the date of receipt of a complete registration dossier, the competent authority has not issued a first response to the dossier.
The delay period is calculated from the first day after two years from the date the competent authority receives the complete dossier until a first response is issued.
Additionally, the time delayed due to the applicant's fault or reasons beyond the control of the competent state authority is not included in the period specified in Clause 2, Article 131a of the Intellectual Property Law 2005, supplemented by Clause 51, Article 1 of the Amended Intellectual Property Law 2022.
What are the Regulations on Compensation for Patent Holders for Delays in Drug Marketing Authorization in Decree 65/2023/ND-CP?
Article 42 of Decree 65/2023/ND-CP provides for the compensation of patent holders for delays in drug marketing authorization as follows:
- In the case of delays in the initial drug registration procedure as stipulated in Article 131a of the Intellectual Property Law 2005, supplemented by Clause 51, Article 1 of the Amended Intellectual Property Law 2022, upon the authorization of the drug, within two months from the date the applicant makes a written request according to Form No. 02 in Appendix I of Decree 65/2023/ND-CP, the competent authority for drug marketing authorization will issue a confirmation of the delay period, clearly stating the delay period.
- If the Patent holder submits a written request according to Form No. 03 in Appendix I of Decree 65/2023/ND-CP along with the confirmation document from the competent authority for drug marketing authorization on the delay of the drug registration procedure for the drug produced under that Patent as stipulated in Clause 1, Article 42 of Decree 65/2023/ND-CP, the state authority managing industrial property rights will notify the Patent holder about the compensation plan and perform the following procedures:
+ Waive the usage fee of the Patent for the period during which the drug registration procedure produced under that Patent is delayed during the validity maintenance process.
+ If the Patent usage fee for that period has been paid, deduct the amount paid during the maintenance process for the next period.
+ If the Patent holder does not continue to maintain validity or the Patent expires, refund the Patent usage fee within three months from the date of receipt of the complete request dossier as stipulated.
- For drugs produced under multiple Patents, the usage fee waiver applies to all related Patents.
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