Pharmaceutical Patent and Market Approval Process
Before medical products and plant protection products can be released to the market, they must obtain market approval.
The market approval process requires extensive and costly clinical trials.
Without completing this process, a product cannot be launched or sold.
Therefore, it is crucial for pharmaceutical companies that the market approval process aligns with the pharmaceutical patent timeline. This ensures that companies can maximize the patent protection period and secure their investments before generic alternatives can enter the market.
Market Approval and Pharmaceutical Patent
✅ Market approval applications are made after the patent application.
✅ Obtaining approval can take years, and during this period, the patent continues to remain valid.
✅ The clinical research and efficacy validation process for drugs typically lasts 10-15 years.
✅ As a result, only about 5 years remain for the commercial use of the patent.
✅ Due to the insufficient duration, in Europe and some countries, the "Supplementary Protection Certificate (SPC)" can extend the patent duration for an additional 5 years.
However, in Turkey, there is currently no supplementary protection certificate (SPC) application.
The Impact of the Market Approval Process on Pharmaceutical Patents
Pharmaceutical R&D processes are long and costly.
The lengthy duration of the market approval process limits the effective use of the patent period.
To encourage innovation in the pharmaceutical industry, it is crucial to protect the patent duration.
Therefore, pharmaceutical companies strive to optimize the market approval process and ensure the effective use of the patent period. This allows them to maximize the commercial potential of their products before generic versions can enter the market.
Manage Your Pharmaceutical Patent and Market Approval Processes with Başalan Patent!
As Başalan Patent Limited Company, with over 30 years of experience, a specialized team, and an ISO 9001:2008 Quality Certificate, we offer professional consulting services for pharmaceutical patent applications, market approval processes, and intellectual property management both in Turkey and worldwide.