Data Exclusivity in Pharmaceutical Drug Products

Masters Thesis from the year 2007 in the subject Law - European and International Law, Intellectual Properties, Marmara University (EUROPEAN UNION INSTITUTE), course: DEPARTMENT OF EUROPEAN UNION LAW, language: English, abstract: Data exclusivity in pharmaceuticals is one of the best protection systems among other type of regulatory drug product exclusivities such as patent protection, patent term extension and some other type of marketing exclusivities. Data exclusivity provides the right holder protection on his undisclosed information, in particular the results of tests in humans and animals and clinical trials which are given to the national authorities in order to obtain marketing approval for the drug product for which the application is made. In this regard data exclusivity means that, the second applicant can not use or rely on that data during the exclusive time period in order to obtain marketing approval for the same drug product which was already granted marketing approval first time. Like the second applicant, national regulatory authorities also can not rely on that data in order to grant marketing approval to the second applicant for the same drug product during that exclusive time period. By this reason data exclusivity differs from other type of drug product marketing exclusivities since marketing exclusivity in pharmaceutical drug products may last after data exclusivity time period expires like in the EU system. In the EU normally, while there is 8 year data exclusivity, marketing exclusivity is 10 year. Also data exclusivity differs from patent protection. In part one; firstly the focus is on the regulatory drug product exclusivities and then data exclusivity generally. In part two; data exclusivity is analyzed extensively in international law, in the EU law, in the U.S. law and lastly in Turkish law.