Chương II Thông tư 22/2009/TT-BYT: Sở hữu trí tuệ đối với thuốc đăng ký

Chapter II

INTELLECTUAL PROPERTY FOR REGISTERED DRUGS

Article 14. General principles

1. Drug registration establishments shall take responsibility for issues relating to intellectual property of drugs registered for circulation.

2. The Ministry of Health encourages drug registration establishments to establish intellectual property rights or inquire about related intellectual property objects before registering the circulation of drugs in Vietnam.

3. If there arises an intellectual property-related dispute in the course of consideration for the grant of a circulation registration number, the party objecting to the grant of a registration number for the disputed drug shall supply infringement-related conclusions of the intellectual property state management agency or the agency functioning to enforce intellectual property rights. The Ministry of Health may refuse to grant a registration number for the drug if having sufficient grounds for believing that the drug, once granted a registration number, is likely to infringe upon protected intellectual property rights of other individuals or establishments.

4. If there arises an intellectual property-related dispute following the grant of a circulation registration number, the Ministry of Health shall, at the proposal of the holder of intellectual property rights or a third party with related interests and based on the court verdict or infringement-related final conclusions of the state management agency in charge of intellectual property or agency functioning to enforce intellectual property rights, decide to suspend the circulation or withdraw the circulation registration number of the drug concluded as infringing upon intellectual property rights.

Article 15. Inventions related to registered drugs

1. For drugs containing active ingredients still in the period of intellectual property protection, registration establishments may supply legal documents relating to the protection and intellectual property rights (patent) of registered drugs (if any).

2. Within 2 years before the expiration of the invention protection duration for a drug, the drug registration establishment may submit a dossier of registration for circulation of generic drugs, enclosed with documents evidencing that the validity duration of the protected drug is going to expire, and shall clearly state its request in the registration application (made according to a set form).

Article 16. Data confidentiality for registration dossiers

Drug registration establishments that wish to have data in their new drug registration dossiers kept confidential shall comply with the Health Ministry's regulations on data confidentiality for drug registration dossiers and clearly state such request in their registration applications (made according to a set form).