Supplementry Protection
Patents granted for innovative products such as pharmaceuticals provide protection to the patent holder for a period of 20 years from the date of application. However, as the development and marketing authorization processes for pharmaceuticals may take many years, a significant portion of the patent term may elapse before the product reaches the market.
The development and regulatory approval process for a new pharmaceutical product can take, on average, up to 12 years. This period significantly reduces the effective term of patent protection. For this reason, several countries have introduced regulations that allow for the extension of patent terms specifically for the pharmaceutical sector.
The patent term extension system was first introduced in the United States in 1984, followed by South Korea in 1987, Japan in 1988, and the European Union in 1993.
In the European Union, this legal mechanism is known as the Supplementary Protection Certificate (SPC), which allows for the extension of patent protection for pharmaceuticals by up to five years.
As Türkiye is not a member of the European Union, it is not subjected to the SPC system established under the EU Regulation No. 469/2009. Therefore, patent term extension for pharmaceuticals is not available in Türkiye.
However, holders of pharmaceutical patents may benefit from patent term extension systems in countries such as the United States, South Korea, Japan, and EU member states. As the procedures and requirements for applying for such extensions vary from country to country, it is of great importance for patent holders seeking to benefit from this mechanism to obtain professional consultancy services specific to this area.
SIMAJ is able to provide consultancy services to its clients in relation to the legal and administrative procedures that may arise in this field.
End-To-End Services
Our patent and trademark attorneys, each highly qualified in their respective fields, will guide you through every stage of the process, from application to registration, ensuring you take the most appropriate steps.