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Legislative Implementation of Flexibilities - Philippines

Title:Section 72(4) of the Intellectual Property Code, Act No. 8293 of 06/06/1997 as last amended by Act No. 9502 of 2008
Field of IP:Patents
Type of flexibility:Regulatory review exception
Summary table:PDF

Provisions of Law

72 (4). In the case of drugs and medicines, where the act includes testing, using, making or selling the invention including any data related thereto, solely for purposes reasonably related to the development and submission of information and issuance of approvals by government regulatory agencies required under any law of the Philippines or of another country that regulates the manufacture, construction, use or sale of any product: provided that, in order to protect the data submitted by the original patent holder from unfair commercial use provided in article 39.3 of the Agreement on Trade-Related Aspects on intellectual property Rights (TRIPS Agreement), the Intellectual property Office, in consultation with the appropriate government agencies, shall issue the appropriate rules and regulations necessary therein not later than one hundred twenty (120) days after the enactment of this law;