Question: According to Article 128.1 of the Intellectual Property Law, applicants for licenses for trading in or circulating pharmaceuticals or agrochemical products need to specifically request such data to be kept secret. Please also access the compliance of Article 128 with the Article 39 of the TRIPS Agreement.
Answer: In compliance with Article 39 of the TRIPS Agreement, the IP Law provides protection of secret data if such data meet certain conditions (as mentioned in the question above), but not protection of all data in the request for circulation of the product. In order to keep the data secret, the competent licensing agency must know which data in the registration record is subject to protection. Therefore, the applicant should make a claim, identify data to be protected, and prove that such data meet protection conditions.
