EFTA-India FTA: Article on protection of undisclosed information (intellectual property chapter draft, Jan 2024)
EFTA-India FTA: Article on protection of undisclosed information (intellectual property chapter draft, Jan 2024)
1. In the course of ensuring effective protection against unfair competition as provided in Article 10bis of the Paris Convention (1967), Members shall protect undisclosed information in accordance with paragraph 2 and data submitted to governments or governmental agencies in accordance with paragraph 3.
2. Natural and legal persons shall have the possibility of preventing information lawfully within their control from being disclosed to, acquired by, or used by others without their consent in a manner contrary to honest commercial practices [1] so long as such information:
a. is secret in the sense that it is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons within the circles that normally deal with the kind of information in question;
b. has commercial value because it is secret; and
c. has been subject to reasonable steps under the circumstances, by the person lawfully in control of the information, to keep it secret.
3. Parties, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new [2] chemical entities [3] , the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.
4. In implementing this Article, Parties agree to take adequate and effective measures to protect data against unfair commercial use. As part of such measures, six months after entry into force of this Agreement, the Parties shall enter into consultations with a view to amend this Article to include a specific duration during which the Parties shall prevent applicants for marketing approval from relying on, or referring to, undisclosed test data or other data submitted to the competent authority by the first applicant in the Party for a period, counted from the date of marketing approval in the Party, of at least 6 years.
5. As soon as the competent authority of a Party has received an application for marketing authorisation for a pharmaceutical product, the following information shall be published in a single place and in complete manner, provided that the publication does not conflict with any interests of secrecy worth protecting: the indication, the active substances in the pharmaceutical product and the name and address of the applicant. [4]
Footnotes:
[1] For the purpose of this provision, “a manner contrary to honest commercial practices” shall mean at least practices such as breach of contract, breach of confidence and inducement to breach, and includes the acquisition of undisclosed information by third parties who knew, or were grossly negligent in failing to know, that such practices were involved in the acquisition.
[2] New refers to a product that contains an active ingredient for which no other product containing the same active ingredient has previously obtained marketing approval in the country.
[3] The expression “new chemical entities” includes new biologic entities. / The expression “new chemical entities” includes small as well as large molecules.
[4] This paragraph shall not apply to Iceland and Liechtenstein.
