Patent is a legal right which is granted for the purpose of protecting the value of an invention and encourages the inventor to share his invention with the public.
As in other fields, patent protection encourages also researchers by protecting new therapies and R&D studies in the medical sector. Patent protection provides a 20-year protection in the pharmaceutical sector starting from the invention of the molecule. However, considering the fact that it takes approximately 12-15 years for converting a patented molecule into a drug that can be introduced into the market and the period during which active benefit is derived from patent protection goes down to 5-8 years.
Patent law has been adopted in Turkey in 1999. Yet, this law encompasses only the molecules for which patent application has been made after 1995. Therefore, patent rights do not protect the original drugs registered prior to 1995.
Before a drug is placed on the market, it must receive approval, in other words, it must be registered. In order to be registered, the effectiveness and safety of the drug must be proven with research data. Data exclusivity encompasses the protection of all research data that the research-based pharmaceutical company provides to the Ministry of Health throughout the registration process. Today, in developed countries, data that are provided to authorized official entities are placed under protection for a certain period of time in order to prevent other companies from referencing and disclosing them, thereby preventing unfair competition. This implementation is referred to as “data exclusivity” in international law.