Patent Term Extensions – A Lifeline to the Pharmaceutical Innovation

1. What are Patent Term Extensions? How do they differ from Supplementary Protection Certificates?

Under normal circumstances, a patent expires upon the completion of 20 years from its original filing date. However, in the pharmaceutical industry, owing to the long regulatory review periods, often the patentee is not able to avail the benefits of a granted patent until the drug is approved by the regulatory body. Consequently, a significant period is lost awaiting the drug approval. To compensate for this loss, patent term extension (PTE), generally for a maximum period of 5 years, is awarded to the patentee allowing him/her to enjoy the monopoly in the market for an extended time.

Patent term extensions are also known as supplementary protection certificates or SPCs in Europe. While there maybe a few differences between patent term extensions and supplementary protection certificates concerning the scope of the extension, however, frequently these are used interchangeably.

2. Why are patent term extensions applied for? How to apply for a patent term extension?

Patent term extensions are applied to compensate for the loss of time in getting the drug approval from the national regulatory authority of a country. The request for patent term extension is submitted with the country’s patent office which is examined for meeting the eligibility requirements.

3. How to calculate a patent term extension?

Generally, the term for which the patent would be extended is calculated by the following formula:

Market authorization (MA) date/Notice of compliance (NOC) date – patent filing date. If the period is more than 10 years, 5 years are added to the patent expiry date. If the period is less than 10 years, 15 years are added to the MA date. However, every country can have a slight modification depending on how the term of the extension is capped.

4. Are multiple extensions allowed on a patent?

In most of the countries, multiple extensions are not allowed on a single patent. However, Japan is an exception to it where multiple term extensions are allowed owing to differences in strengths, dosage forms or indications of drugs covered in the term extension. This makes the patent term extension scenario complex in Japan where multiple patent term extension expiries are considered while arriving at the loss of protection date for a particular drug.