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
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 withRegulation 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
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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guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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