United States of America
United Arab Emirates
Undisclosed Information
Follow-up questions: Please explain in detail how Article 39 of the 1992 Patent and Industrial Design Law No. 44 includes the protections that are required under Article 39.3 of the TRIPS Agreement. Specifically, please explain how the law ensures that a second comer will not be allowed to rely on data that is submitted to the regulatory authorities in support of a pioneer drug application, as required by the unfair commercial use provisions of Article 39.3 of the TRIPS Agreement.
The 1992 Patent and Industrial Designs law No. 44 defines in its Article 1 "know-how" as the technical information, data or knowledge that result from professional experience and are applicable in practice. Article 39 states that know-how shall be protected against any unlawful use, disclosure or communication by third parties unless it has been published or made available to the public. The same Article states clearly that in order to enjoy protection, the owner of the know-how shall take the necessary steps to preserve the confidentiality of its elements. Article 42 provides for provision ensuring that a third party will not be allowed to use, disclose or communicate any element of know-how without consent of its owner, stating that any of these acts shall be deemed an unlawful act, provided that the person committing the act was aware of the confidential nature of the know-how or could not have ignored such nature. Furthermore, the Bylaws of the 1992 Patent Law (the 1993 Decision No. 11 of the Ministerial Council) lays down procedures required to ensure the protection of know-how as well as its contracting aspects. As regards pharmaceutical products specifically, the law No. 4 of 1983 related to pharmaceutical institutions and pharmacy profession and its Bylaws provide for establishment of a Committee in charge of pharmaceutical registration and pricing. All the confidential information submitted to it must be kept confidential, provided that it is confidential and the owner has undertake the necessary steps to keep it confidential.