Pharmaceutical Patent Term Extension and Data Exclusivity in Singapore
Patent term extension: The requirements
Singapore permits an extension of term of up to 5 years for a patent which includes “any substance which is an active ingredient of any pharmaceutical product”.
In order to apply for an extension it must be shown that there was “unreasonable curtailment” of the opportunity to exploit the patent caused by the process of obtaining marketing approval with the Singaporean Health Services Authority for the pharmaceutical product.
The pharmaceutical product must also be the first product which uses the substance as an active ingredient to obtain marketing approval.
In addition, the patent must have not previously been granted an extension of term.
Patent term extension: The details
What is a pharmaceutical product?
A pharmaceutical product is defined as “a medicinal product which is a substance used wholly or mainly by being administered to a human being for the purpose of treating or preventing disease”.
There are a number of exclusions in the definition of “pharmaceutical product”, including substances used solely for diagnosis or testing, or as a device or instrument; traditional or homeopathic medicines; quasi-medicinal products; medicated oils or balms; foods, food additives or food supplements; and any substance which occurs naturally in a plant, animal or mineral.
What is unreasonable curtailment?
To meet the unreasonable curtailment requirement, marketing approval for the product must have been obtained after grant of the patent, and the time between filing for marketing approval and the date marketing approval was obtained from the Health Services Authority must have been more than 2 years.
What is the scope of protection provided?
During any period of extension the scope of protection conferred by the patent only applies to the substance which is the active ingredient of the pharmaceutical product for which marketing approval was granted.
Data exclusivity: The facts
Data exclusivity refers to a defined period of protection for data provided by an innovator company to a regulatory agency to prove the safety, quality and efficacy of a product. During the period of protection competitors cannot benefit or reply on the data when seeking approval of an equivalent product.
Singapore provides a 5 year data exclusivity period which commences on the date that approval for the product is granted by the Health Services Authority.
Patent term extension and data exclusivity: The reality
In Singapore, marketing approval for products submitted to the Health Services Authority are typically based on product dossiers already approved in Europe or the US. Accordingly, it usually takes less than 2 years to receive regulatory approval for a pharmaceutical product in Singapore and extensions of pharmaceutical patents are therefore not commonplace. This means that in reality, when a patent has expired, the data exclusivity provisions generally provide more practical protection to an innovator company.