What are the regulations on compensation for invention owners due to delayed marketing authorization of pharmaceuticals in Vietnam?
- Decree 65/2023/ND-CP: What are the regulations on compensation for invention owners due to delayed marketing authorization of pharmaceuticals in Vietnam?
- When is the registration procedure for delayed marketing authorization of pharmaceuticals in Vietnam?
- What is the application form for confirmation of initial registration of delayed marketing authorization of pharmaceuticals in Vietnam?
Decree 65/2023/ND-CP: What are the regulations on compensation for invention owners due to delayed marketing authorization of pharmaceuticals in Vietnam?
On August 23, 2023, the Government issued Decree 65/2023/ND-CP elaboration on several articles and implementation measures of the Law on Intellectual Property regarding industrial property rights, protection of industrial property rights, rights to plant varieties, and state management of intellectual property.
Accordingly, Article 42 of Decree 65/2023/ND-CP stipulates compensating owners of inventions for late issuance of marketing authorization of pharmaceutical products as follows:
- In case the procedure for first-time registration of marketing authorization of pharmaceutical products falls behind schedule according to Article 131a of the Law on Intellectual Property, after the marketing authorization is issued, within 2 months from the date the applicant submits the written request following Form No. 02 Appendix I of Decree 65/2023/ND-CP, authorities competent to issue marketing authorization of pharmaceutical products shall issue confirmation of the late issuance of marketing authorization, specifying the time delayed.
- If the owner of the invention patent has a written document following Form No. 03 Appendix I of Decree 65/2023/ND-CP enclosed with confirming documents of the authority competent to issue marketing authorization of pharmaceutical products on the late issuance of marketing authorization as prescribed in Clause 1 of this Article, the industrial property right authority shall notify the owner of compensation schemes and shall:
+ Exempt the owner from paying fees for the use of the invention patent during the time the procedure for registering marketing authorization of pharmaceutical products produced under such a patent is delayed during the processing of the request for validity maintenance;
+ Deduct the paid fees for the next processing of validity maintenance request if the fees for the use of the invention patent are paid during the delay;
+ Refund use fees to the owner of the invention patent within 3 months after receiving the valid application according to regulations in case the owner decides not to maintain the validity or the invention patent expires.
- Regarding pharmaceutical products produced under many invention patents, the owner shall be exempted from the use fees of every concerned invention patent.
What are the regulations on compensation for invention owners due to delayed marketing authorization of pharmaceuticals in Vietnam?
When is the registration procedure for delayed marketing authorization of pharmaceuticals in Vietnam?
In Article 131a of the Law on Intellectual Property 2005, supplemented by Clause 51, Article 1 of the Law on amendments to some Articles of the Law on Intellectual Property 2022, provides for compensation to patent owners for delays in granting marketing licenses for pharmaceuticals.
Compensation for invention owners due to delayed marketing authorization of pharmaceuticals
“1. When following procedures for maintaining the effect of the invention patent, the patent holder is not required to pay the fee for using the patent for the period of delay in marketing authorization of the pharmaceutical manufactured under the invention patent in Vietnam.
2. It will be considered that the marketing authorization process is delayed if the licensing authority does not issue any written response within 2 years from the date of receipt of the marketing application. The delay begins on the first day after the expiration of the aforementioned 2-year period and ends on the issuance date of the first written response.
3. A delay that is caused by the applicant or reasons outside of control of competent authorities will be excluded from the period of delay specified in Clause 2 of this Article.
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Accordingly, it will be considered that the marketing authorization process is delayed if the licensing authority does not issue any written response within 2 years from the date of receipt of the marketing application. The delay begins on the first day after the expiration of the aforementioned 2-year period and ends on the issuance date of the first written response.
In addition, a delay that is caused by the applicant or reasons outside of control of competent authorities will be excluded from the period of delay specified in Clause 2 of Article 131a of the Law on Intellectual Property 2005, supplemented by Clause 51, Article 1 of the Law on amendments to some Articles of the Law on Intellectual Property 2022
What is the application form for confirmation of initial registration of delayed marketing authorization of pharmaceuticals in Vietnam?
In Appendix I issued with Decree 65/2023/ND-CP, the application form for confirmation of initial registration of delayed marketing authorization of pharmaceuticals is prescribed as follows:
Download the application form for confirmation of initial registration of delayed marketing authorization of pharmaceuticals here.
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