United Arab Emirates
Undisclosed Information
Follow-up question: Referring to the issue of unfair commercial use of data submitted by an applicant to the responsible authorities in the procedure for market authorization of a pharmaceutical or of an agricultural chemical product, please explain in detail if your legislation explicitly prohibits a second applicant from relying on, or from referring to the original data of the first applicant, when applying subsequently for market authorization for his own product. Does the responsible State Agency require the same amount of data from the second applicant as from the first applicant?
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 of the above-mentioned Law provides for a 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. The same Article states 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 undertaken the necessary steps to keep it confidential.