What conditions need to be met for compulsory licensing of pharmaceutical patents
For public health purposes, For drugs that have obtained patent rights, the patent administration department of the State Council may grant a compulsory license to manufacture and export them to countries or regions that comply with the provisions of relevant international treaties to which the People's Republic of China is a party.
"Patent Law"
Article 50: For public health purposes, the patent administration department of the State Council may authorize the manufacture and export of medicines that have obtained patent rights to countries that comply with the provisions of relevant international treaties to which the People's Republic of China is a party. Compulsory license by country or region.
Article 48 Under any of the following circumstances, the patent administration department of the State Council may, based on the application of an entity or individual that has the conditions for implementation, grant an invention patent or Compulsory license for utility model patents:
(1) The patentee shall have completed three years from the date when the patent right was granted, and shall have completed three years from the date of filing the patent application. After four years, the patent has not been implemented or fully implemented without justifiable reasons;
(2) The patentee’s exercise of patent rights is deemed to be a monopoly in accordance with the law behavior, in order to eliminate or reduce the adverse impact of the behavior on competition.
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