Chương II Thông tư 44/2014/TT-BYT: Sở hữu trí tuệ đối với thuốc đăng ký

Chapter II

INTELLECTUAL PROPERTY RIGHTS TO REGISTERED DRUGS

Article 13. General rules

1. The applicant shall take responsibility for intellectual property pertaining to its registered drugs.

2. The applicant establishes intellectual property rights or looks up related intellectual property objects before applying for drug registration in Vietnam.

3. In case there is any dispute about intellectual property when the application is processed, the objector to the issuance of drug registration number subject to dispute must provide the conclusion of the intellectual property authority or intellectual property enforcement body on infringement of intellectual property rights. The Ministry of Health shall not issue drug registration numbers to the drugs which are subject to infringement of intellectual property rights of other individuals or organizations according to good basis.

4. In case there is any dispute about intellectual property rights after the drug registration number is issued, the Ministry of Health shall decide to revoke the registration number or suspend the sale of the drug as prescribed in Clause 6 Article 23 or Clause 2 Article 33 of this Circular at the request of holder of intellectual property rights or a third-party beneficiary and pursuant to the judicial decision or final conclusion of the intellectual property authority or the intellectual property enforcement body on infringement of intellectual property rights.

Article 14. Patents on registered drugs

1. Regarding a drug containing active ingredients which are under the period of intellectual property protection, the applicant may provide related legal documents on condition of protection and intellectual property rights (patent) on registered drugs (if any).

2. Within 02 years before the expiry date of the period of patent protection, the applicant may submit the application for registration of generic drug together with documents proving that drug protection period will expire soon and clarify the request in the application using the form No.6A/TT issued herewith.

Article 15. Data security applied to registration application

The applicant wishes to secure data on application for new drug as prescribed in regulations on data securities applied to registration application as prescribed in the Circular No. 05/2010/TT-BYT dated March 1, 2010 of the Minister of Health on guidance on pilot data securities pertaining to drug registration must clarify the request in the application using form No. 6A/TT issued herewith.

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