Patent Term Adjustment vs Patent Term Extension

The Duration of a Patent

Patents are typically granted for a fixed term, often ranging from 15 to 20 years from the filing date or allowance date. However, the exact duration varies depending on the jurisdiction and type of patent. Utility patents and plant patents are valid for 20 years from the filing date of the patent application. Design patents are only valid for a period of 15 years from the date of filing. This means the innovation that is the subject of an issued patent is only legally protected for the specified duration of time. The right to sue an infringing party is based on this period.

Utility patents are the only type of patents that require maintenance fees in order to stay active after patent issuance. If the maintenance fees are not kept up with, the patent application will become abandoned, and the issued patent will be entered into the public domain. Read more information on maintenance fees in our patent maintenance article.

What Happens after the Specified Term Elapses?

You cannot renew a patent in the United States. Once the specified term expires, the patented invention enters the public domain, becoming freely useable for all. Public domain, in the field of patents, refers to all of the inventions and innovations that are no longer patent protected and are therefore open for public use without permission or cost. Patents that can be found in the public domain are often referred to as “public domain patents.”

Once a patent enters the public domain, it can no longer be protected by patent law. Inventions and innovations found in the public domain are permitted to be built on, expanded on, or replicated. The public is free to use public domain works any way they choose.

Important Note: A utility patent can enter public domain prior to the specified period of validity if the patent maintenance fees are not paid on time.

Carson Patents

Patent Term Extension vs Patent Term Adjustment

Patent Term Extension (PTE) and Patent Term Adjustment (PTA) are often used interchangeably, although there is a slight difference between the two. PTE compensates patent owners for delays caused by a regulatory review process. PTA compensates patent applicants for delays caused by the USPTO during the patent application process. Both PTE and PTA are designed to lengthen the term of a non-provisional patent past the original term of 20 years (or 15 years for a design patent).

Patent Term Extension in the United States

Although a patent cannot be renewed in the United States, there exists a way to extend the term of a patent for special cases. Certain events can delay a patent application from maturing into an issued patent. When delays are caused by the United States Patent and Trademark Office (USPTO), the time lost can be regained through Patent Term Extensions (PTE) under 35 U.S.C. 156 (Hatch-Waxman Act 1984).

PTE under 35 U.S.C. 156 enables the owners of patents that claim certain human drug products, medical device products, animal drug products, veterinary biological products, and food or color additive products to restore to the terms of those patents some of the time lost while awaiting premarket Government approval for the products from a regulatory agency. Under this Act, owners of patents that claim specific human drug products, animal drug products, biological veterinary products, medical device products, and food or color additive products in their patent application can restore the time it took awaiting premarket government approval of the products from a regulatory agency, the Food and Drug Administration (FDA).

The maximum term of extension is 5 years. While both the USPTO and FDA participate in calculating PTE, the USPTO has the final say on the term extension amount. Any term extension granted under the statute is applied from the original expiration date of the patent, including any PTE. In the United States, a patent is eligible for an extension of the term only if all of the following conditions are met:

1. The application contains at least one claim covering the approved drug product;
2. The patent is not expired;
3. The patent has never been extended prior; and
4. A complete and timely PTE application is submitted to the USPTO.

Patent Term Adjustment in the United States

The USPTO has categorized the main reasons for a delay in the patent application process into 3 types:

Type A: Occurs when the USPTO fails to reply to the patent applicant or their patent practitioner within the specified time period.

Important Note: According to U.S. patent law, the USPTO must issue the first office action within 14 months from the filing of a patent application. Any following office actions must be issued within 4 months from the receipt of an applicant office action response.

Type B: Occurs when the prosecution period of a patent application exceeds three years, excluding any time consumed by requests for continued examination (RCE), secrecy orders, interferences, or applicant-requested delays.

Important Note: The USPTO estimates the standard prosecution period of a patent application to be three years from the date of the filing of the application to the issue of the patent.

Type C: Occurs due to an interference/derivation proceeding, the imposition of a secrecy order, or a successful appellate review.

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.