Patent Term Extension Outside of the U.S.

The concept of PTE allows inventors and patent holders to lengthen the lifespan of their patents beyond the initial term. There are many other countries of importance that offer provisions for patent term extension. It is important to note that specifics vary across jurisdictions. It is essential to meet certain conditions and fulfill specific requirements in order to initiate the extension process successfully.

Some countries do not have any provisions or laws regarding patent term extension. In these countries, the term of the patent comes to an end by the end of the specified term (typically 20 years). Some of these countries include Brazil, Mexico, China, Thailand, Hong Kong, Indonesia, and India.

Countries that Allow Patent Term Extension

Most major countries, such as the United States, the European Union, Russia, Ukraine, Australia, Singapore, and Taiwan, are known to have a competent system of patent term extension with provisions, rules, and regulations regarding such amendments to an issued patent. In countries where extending the rights to a patent is allowed, the process of patent term adjustment can vary across jurisdictions, however, they all will involve navigating timing considerations, documentation requirements, and associated fees. In this section, you will read about the more common countries to file a patent application in that allow PTE, the type of patents each country permits PTE for, how to submit a request for PTE, and important deadlines.

• Israel
  • Extension of the term of a patent is only allowed in cases involving patents that claim an active pharmaceutical ingredient (API) and medical devices for a maximum extension of 5 years.
  • To extend the term of a patent in Israel, patent owners (or exclusive license holders) must file a request for PTE with the Israeli Patent Office within 90 days from the date of regulatory approval from the Israeli Ministry of Health. This deadline is non-extendable.
• Japan
  • Extension of the term of a patent is only allowed in cases involving pharmaceuticals and agrochemicals for a maximum extension of 5 years.
  • To extend the term of a patent in Japan, patent owners must file a request for PTE with the Japan Patent Office (JPO) within 90 days from the date of regulatory approval of the product. The petition for PTE must be filed before the original patent term expires and cannot be filed in the 6 months prior to the expiration of the patent rights.
• Singapore
  • Extension of the term of a patent is only allowed in cases involving pharmaceuticals for a maximum extension of 5 years.
  • To extend the term of a patent in Singapore, patent owners must file a request for PTE with the Intellectual Property Office of Singapore (IPOS) within 180 days from the date of patent issuance or 180 days from the date of regulatory approval by the Health Services Authority (HSA) of Singapore. The patent must still be in force at the time of filing a petition for PTE and the PTE request cannot be made after 6 months from the usual 20-year patent term.
• Australia
  • Extension of the term of a patent is only allowed in cases involving pharmaceuticals or DNA technology for a maximum extension of 5 years.
  • To extend the term of a patent in Australia, patent owners must file a request for PTE with the Intellectual Property Office of Australia (IP Australia) within 180 days from the date of the first inclusion of the relevant pharmaceutical substance (claimed in the patent) in the Australian Register of Therapeutic Goods (ARTG).
• Russia
  • Extension of the term of a patent is allowed in cases involving medicine, pesticides, or agrochemical substrates for a maximum extension of 5 years.
  • To extend the term of a patent in Russia, patent owners must file a request for PTE with the Russian Patent Office (Rospatent) within 180 days from the date of patent issuance or 180 days from the date of regulatory approval by the Ministry of Health (MOH), whichever occurs later. The patent must still be in force at the time of filing a petition for PTE.
  • A patent issued by the Eurasian Patent Office (EAPO) that covers Russia and includes a claim involving medicine, pesticides, or agrochemical substrates, is also eligible for PTE.
• Taiwan
  • Extension of the term of a patent is allowed in cases involving pharmaceuticals or agrochemicals for a maximum extension of 5 years.
  • To extend the term of a patent in Taiwan, patent owners must file a request for PTE with Taiwan’s Intellectual Property Office (TIPO) within 90 days from the date of issuance of the first certificate of market authorization. The petition for PTE must be filed before the original patent term expires and cannot be filed in the 6 months prior to the expiration of the patent rights.
• European Union (EU)
  • Extension of the term of a patent is granted through a supplementary protection certificate (SPC) which is allowed in cases involving pharmaceutical and plant products in member countries of the EU. SPCs are certificates that grant a supplementary market protection for medicinal and plant products which can extend the rights to a patent for a maximum of 5 years. An additional six-month extension is available if the SPC relates to a human medicinal product for which data from clinical trials have been submitted and conducted in accordance with an agreed Pediatric Investigation Plan (PIP).
  • To extend the term of a patent in a member country of the EU, patent owners must apply for a SPC with the European Patent Office (EPO) within 180 days from the date of patent issuance or 180 days from the grant of the market authorization, whichever occurs later.
• Ukraine
  • Extension of the term of a patent is granted through an SPC which is allowed in cases involving medicinal drugs related to the protection of animals and plants for a maximum extension of 5 years.
  • To extend the term of a patent in Ukraine, patent owners must apply for a SPC with the Ukrainian National Office for Intellectual Property and Innovations (UANIPIO) within 180 days from the date of patent issuance.