Patent Term Extension or Supplementary Protection Certificate
Are you interested in extending the effective term of your patent?
How to extend the effective term
As a patent owner, you may be interested in extending the effective term of your patent on drugs or other products that require marketing authorization before market launch. This can be achieved through a Patent Term Extension (PTE) or Supplementary Protection Certificate (SPC) depending on the region.
To ensure the best protection for your product, it is important to consider the possibilities for extension already during the preclinical studies and clinical trials. Our team can help you develop a strategy for exploiting the extension opportunities and ensure all formal requirements are met.
Country specific rules
Different rules apply in various countries, and we can assist you in navigating the regulations and applying for PTEs and/or SPCs. In the EU and EEA, for example, the extension can be granted for a period between the filing of the patent application and receipt of the first marketing authorization approval minus 5 years, with a maximum extension of 5 years. In the USA, a patent can be extended based on the time spent by the FDA on regulatory review, with a maximum extension of 5 years after the expiry of the ordinary patent term.
China, Japan, and Korea also offer PTE options for up to 5 years, while in India it is not possible to obtain such an extension.
Contact us to learn more about PTEs and SPCs
Contact our experts to learn more about PTEs and SPCs and how we can help you obtain an extension of the exclusivity for your drug or other products in different markets