Articles
IP-Related Aspects in Drug Registration in Vietnam

31 - 05 - 2010
By Nguyen Thi Hong Anh*

The current Pharmaceutical Law requires registration with the Drug Administration of Vietnam (DAV) before a drug can be distributed in the territory. There are three pertinent IP-related rights in the drug registration process: trademark, patent and data security.

If a trademark is applied to a drug in an application for product registration, such application must be accompanied by a copy of a certificate of trademark registration or a trademark search result from the National Office of Intellectual Property (NOIP). An official decision on the formal acceptance of the relevant trademark application issued by the NOIP may also be accepted as evidence of the applicant's rights to the trademark.

Applicant for a drug registration is not required to submit to the DAV any evidence to proving patent rights to the drug or proving non-infringement of other's patent rights. Owners of patent rights in Vietnam are, however, entitled to notify the DAV and the DAV will refer to such patent rights in examining drug registration applications. Information about active ingredients patented in Vietnam that have been notified to the DAV is published at http://www.dav.gov.vn/Default.aspx?tabid=60.

Data security is provided for in Circular No. 05/2010TT-BYT dated 01 March 2010, that was recently promulgated by the Ministry of Health, and replaced Decision No 30/2006/QD-BYT. Effective on 15 April 2010, the circular makes clinical drug test data subject to data security if it satisfies the following conditions:

(i) The clinical drug test data is for a finished drug containing a new active ingredient. A finished drug is a drug that has completed all stages of production. A new active ingredient is an active ingredient that has neither been granted registration for circulation in Vietnam or elsewhere more than 12 months prior to the filing date.

(ii) The data must be deemed to be a business secret under the current Law on Intellectual Property.

(iii) The data must be the result of an investment of significant effort.

(iv) A request for securing the data must be properly lodged with the DAV.

Note that the security of clinical drug test data in an application dossier for registration of a drug will be refused if securing such data may have serious effects for the public health or if the drug is denied product registration.

Upon determining eligibility for data security, the first in time application preempts all subsequent applications containing the secured clinical drug test data for 5 years from the grant of the product registration. An exception exists where the applicant of the subsequent application dossiers obtains a letter of consent from the owner of the secured clinical drug test data or proves that the clinical drug test data included in the subsequent application was independently created. Information about drug registration with data security is published at http://www.dav.gov.vn/Default.aspx?tabid=60.

(*) Please contact the author at anh.nguyen@indochinecounsel.com or our partners if you wish to have more information or specific advice for the topic of this article.
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