Report by the Secretariat: III. Trade policies and practices by measure: (4) Measures affecting production and trade: (vi) Intellectual property rights: General question
Report by the Secretariat: III. Trade policies and practices by measure: (4) Measures affecting production and trade: (vi) Intellectual property rights: General question:
The Report of the Secretariat does not explicitly mention the protection of undisclosed information as provided for in Article 39.3 of the TRIPS Agreement. We would like to ask the following question related to the marketing approval of pharmaceutical or of agricultural chemical products, which utilize new chemical entities:
If a private party submits its undisclosed test data to the marketing approval authorities of India, under what legal regime and how are these test data protected against unfair commercial use as required by Article 39.3 of the TRIPS Agreement? Could the Indian authorities indicate the relevant national legislation and how it implements Article 39.3 of the TRIPS Agreement.
Reply: India implements Article 39.3 of the TRIPS Agreement through the existing legal mechanisms which are the common law, principles of equity and the law of breach of confidence developed through case law. Protection is also provided through the provisions of Law of Torts and the Indian Contract Act, 1872 where remedies are available. Section 5 of the Official Secrets Act provides that unauthorized disclosure of official secrets is a punishable offence. This provision is also applicable to government employees.
