Estados Unidos de América

Sudáfrica

Patentes (incluida la protección de variedades vegetales)

Please describe the manner in which South Africa protects test data submitted with applications for marketing approval of pharmaceutical and agricultural chemical products against (a) disclosure and (b) unfair commercial use in accordance with Article 39.3 of the TRIPS Agreement, including protection against the direct or indirect reliance on such data to support later-filed applications. Are there any circumstances under which such test data would not receive protection against disclosure and unfair commercial use?

Specific provision is made for the preservation of confidentiality in regard to information submitted by an applicant for purposes of the registration of a pharmaceutical substance or an agricultural chemical in the following manner: 5.1 Medicines and Related Substance Control Act No. 101 of 1965: Section 34 provides as follows: "Preservation of secrecy 34. No person shall, except for the purpose of the exercise of his powers or the performance of his functions under this Act, or for the purpose of legal proceedings under this Act, or when required to do so by any competent court or under any law, or with the written authority of the Director General, disclose to any other person any information acquired by him in the exercise of his powers or the performance of his functions under this Act and relating to the business or affairs of any person, or use such information for self gain or for the benefit of his employer." 5.2 Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act No. 36 of 1947: Section 17 provides as follows: "Preservation of secrecy 17. Any person who discloses except to the Minister or to any other person for the purpose of the performance of his duties or the exercise of his functions under this Act or when required to do so by any court or under any law, any information acquired by him in the exercise of any duty or function under this Act, in relation to the business or affairs of any other person shall be guilty of an offence and liable on conviction to a fine not exceeding five hundred pounds or imprisonment for a period not exceeding twelve months." Unfair commercial use is not addressed expressly, except for the prohibition on self gain or any benefit to the employer in the Medicines Act. The circumstances under which such information could be disclosed are set out in the two sections quoted above.