A pharmaceutical patent term is effective for less than 20 years. On average, it is 9 to 11 years because of the time elapsed between the patent application date and the beginning of the sales. Some sources indicate that it may take up to 14 years between the filing date of the patent application and the marketing of the product, including the registration to health authorities, quality control, launch and sales. Such delay hampers company investments as well as access to medicines.
The European Union addressed this problem in the 1990's allowing Member States to implement supplementary protection certificates (hereinafter the 'SPC') into their legal systems as in the USA and Japan. Italy and France implemented Certificates of Complementary Protection (CCP) which provided a longer protection term than that of the other Member States. As a result, it was more advantageous to produce and market new drugs in some Member States than those lacking similar provisions. Such differences ended up hindering the internal market in terms of pharmaceutical products. Thereby the Council Regulation (EEC) 1768/92 was regulated in an effort to secure harmonisation in regard to SPCs for medicinal products.
Accordingly, a patent term extension is granted in case that the first market authorisation for a medicinal product has been granted within 5 to 10 years after the filing date of the patent application. This means that a SPC cannot be obtained in case that the first market authorisation has been granted within 5 years from the filling date of the patent application. The additional protection term is limited with 5 years even in cases where the delay between filing of the patent application and the market authorisation exceeds 5 years. It should also be added that the overall protection (the SPC protection and the patent term added up together) cannot exceed 15 years from the date of the first marketing authorisation. The only exception is provided with Regulation (EC) 1901/2006 for medicinal products for paediatric use in certain cases. However, this will not be discussed herein this Article.
As known by many, a customs union was established between the European Economic Community and Turkey in 1995 by virtue of the Decision 1/95 wherein Turkey has undertaken to harmonise its legislation to the Community Law. Thereby the ambit of patent protection was expanded to all pharmaceutical products and processes; as a result, the patentability of all inventions was introduced into domestic law. The Turkish Law transitioned to the system in which the patent term was for 20 years from the filling date in line with international obligations stemming from the TRIPS Agreement and the like.
Turkey's EU Accession Negotiations was started in the following years wherein chapters concerning patent law emphasized the importance of the implementation of the SPCs. Chapter on the Intellectual Property Law of the Accession Negotiations recommended that Turkey is 'envisaged to comply with Regulation No. 1768/92 and Regulation No. 1610/96'; and the objective is 'encouraging research and development activities in the pharmaceuticals industry, where such activities are costly and time consuming, by means of furnishing additional protection periods.'
As a response, Turkey declared on the 9th Progress Plan that the SPC system would come into force after an undetermined time period from full accession. Meanwhile the government officials stated that all necessary adaptations would be considered in consultation with the European Commission during the accession process. However, in some cases the governmental authorities, such as the Turkish Ministry of Industry and Trade, pointed out to the negative affects which the SPCs might have on generic companies operating in the domestic markets since Turkey did not benefit from the mutual recognition procedure from which all other EEA countries do.
Despite all that, the Draft Law which will provide for essential amendments on the current legislation concerning patent rights does not cover SPCs. The reason for that may well be the above-stated concerns regarding mutual recognition procedure. The Draft Law has been included in the parliament agenda in 2013 and is still awaiting to be evaluated by the MPs.
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