Worldwide: Patent Term Extension In Different Countries

Last Updated: 9 July 2019
Article by Dhakshina Moorthy C


A patent is a legal document granted by the government giving an inventor the exclusive rights to make, use and sell the invention for specified number of years with usual term of 20 years. This term can be extended by following both constitutional and conventional laws which are either implied or expressly provides for the same and when applied, prolongs the term of the patent (mostly 5 years). For better comprehension and appreciation of Patent Term Extension (PTE), Patent Linkage System is also e discussed to the point necessary in the article.

Patent linkage is the establishment of relationship between the market approval process of generic drugs and the patent status of the originator product. So this system does not allow grant of marketing approval of any third party prior to expiration of patent term unless consented by the patent owner. Hence this concept/system is very essential for the generic manufacturer to prove the drug regulator that the drug, for which he seeks approval, is not covered by a validpatent. While Patent Linkage system doesn't find mention in TRIPS Agreement but is dealt in TRIPS – plus agreement to which India is not a signatory. Also Patent term extensions are contained in statutes of respective countries. They are also open to patent term adjustments and corrections too. This being said, the current article discusses about patent term extension in different countries, their procedures and their necessities.



Countries such as Brazil, Mexico, China, Thailand, Hong Kong, Indonesia, India, etc. lack the laws relating to patent term extension whereby term of patent comes to an end by the end of 20 years even if the regulatory authorities delay approval of drugs covered in patent in all possible ways.


While countries like United States, European Union, Japan, Israel, Russia, Ukraine, Australia, Singapore, Taiwan and many more are known to have a sound system of patent term extension and also contain rules regarding amendments. A brief view of how patent term extension works in these countries along with comparative study of the system in United States & European Union is further dealt herein.


Extension of term of patent is allowed in cases involving medicinal compositions and medical devices. Proprietors of basic patent and exclusive license holders are entitled to file an application for PTE and that an application for a PTE must be filed within 60 days from the grant of marketing approval from Ministry of Health.

To file a PTE application, regulations specified in ANNEX A must be strictly adhered to: (1) Filing of an application for PTE (2) Official letter by the Patent Officeacknowledging the application and the filing date thereof (3) once the provisions of the Law are met, PTE application to be published with the intention of issuing an Extension Order (the Notice) (4) Filing an opposition within 3 months from publication of the Notice, if not the Extension Order will issue.

PTE shall expire on the earlier of the following dates: (1) 5 years from the expiry of the "basic patent" (2) 14 years from the first date of obtaining marketing approval in the "Convention country" (3) Expiry date of the Extension Order in the "Convention Country" (4) Date of cancellation of the Israeli marketing approval (5) Date of cancellation or amendment of the "basic patent" (6) On the dates that renewals were due and were not paid.

A petition for a PTE must be submitted no later than 90 days from the date of regulatory approval of the drug. Originally, the deadline to file a petition for PTE was extendable in 'appropriate circumstances'. Most of the extensions that were granted were quite short (extensions of a few days). Attempts to obtain longer extensions were consistently denied. However, in the Lundbeck decision, the Patent Office extended the deadline for filing a PTE petition by 19 months. In the decision, the Patent Office accepted the patentee's arguments that it was not informed by its local patent agents of the PTE provisions in Israel.


In Japan, the patent term extension for 5 years is available for pharmaceuticals and agrochemicals. But Japan lacks provision for any additional extension period (e.g., 6 month paediatric extension in the EU.). An application for extension of term must be filed within three months of the first regulatory approval of the product. Notably, in Japan subsequent approval for the same active ingredient for a second indication may serve as a basis for an additional extension.

Japan is the only country that has a minimum time of patent term extension i.e. 2 years and a request for extension of the term has been put forth by Japan Pharmaceutical Industry Association to abrogate the 2 year period. The application for PTE cannot be filed with the Patent Office at anytime after 6 months prior to expiration of patent rights in Japan.


The Patents (Amendment) Act 2004 introduced patent term extensions to take into account delays in obtaining marketing approval for pharmaceutical products which are equivalent toSupplementary Protection Certificates (SPC) issued forpharmaceutical patents in Europe.The regulating legislative framework encompasses Sections 1, 36A, Schedule of Singapore Patents Act and Rule 51A of Singapore Patents Rules. The minimum to maximum period of patent term extension is from 'a period equivalent to the interval between the date of issue of the certificate of grant and the date marketing approval was obtained' to 'a period of five years'.

An application for PTE must be made to the Intellectual Property Office of Singapore (IPOS) on Patents Form 54 with a fee currently of S$950. Patents Form 54 requires the Applicant to state the period of the extension of the patent term it seeks whereby Applicant needs to submit a certificate from the Health Sciences Authority in Singapore.

An application for a patent term extension needs to be made within 6 months from the date of grant of the patent and the date of marketing approval was obtained. If thepatent is still in force, an applicationcannot be made after 6 months from the normal 20 year term of the patent.


For an Australian patent to be eligible for patent term extension, the claims of the patent must contain either a pharmaceutical substance per-se, or the one produced by a process involving use of recombinant DNA technology. A pharmaceutical substance is defined as a compound, an active metabolite, a composition or a mixture of substances.

Requirements for obtaining PTE: to include pharmaceutical substance in the Australian Register of Therapeutic Goods, at least 5 years between filing of patent application and date of first marketing approval, application to be made within 6 months of grant of patent and from first regulatory approval date. Therefore, the maximum period of the patent term extension is 5 years.


The patent term extension is applicable to the whole of Confederation of Russia.The patent term extension procedure was first introduced in Russia in 2003. Inaccordance with Russian legislation, which regulated patent term extension procedure until 2015, a patent directed at a medicine, pesticide or agrochemical was extended in respect of the claims covering the product. In October 2014 amendments were made to the Civil Code, wherein the amendments introduced the procedure of grant of asupplementary patent restricted to the marketed product. New patent term extension regulations were put into force on 8 January 2016. But the usual time period of patent term extension is 5 years.


The term of a patent related to drugs – for protecting humans, animals and plants, may be extended at the request of the owner for a period not more than 5 years. Ukraine provides an opportunity to extend the period for a medicinal /agrochemical product patents. In December 2018, the Cabinet approved a draft law to bring Ukrainian IP legislation in line with the EU-Ukraine Association Agreement. Under the draft law, patent protection will not be granted to diagnostic, therapeutic and surgical methods for treating of humans or animals and to newer forms of known medicinal products. Also, the law held that the period of supplementary protection should be equal to the period between the application date and the date of the first authorization by a competent authority, not exceeding a total of five years.


The patent term extension practice was introduced in 1994 via Patent Act Amendments (PAAs). Only the 2011 PAAs involve the patent term extension practice. A term extension can be sought for a pharmaceutical or an agrochemical-related patent under the condition that the first market approval for practicing said patent is not secured until two years after patent publication ("two-year limitation"). The two-year limitation was removed by the 2011 Patent Act Amendments.

Requirements for patent term extension are – critical filing date, applicable patents, entitled applicants, deadlines for applying for patent term extension, first market approval and its determination and those legally related to the market approval shall be adhered to. Finally, the IPO shall publish the written application in the Patent Gazette if all the formal requirements are fulfilled by the application seeking patent term extension.

PTE/SPC is compared in a tabular form as here under:





Term used

Patent Term Extension

Supplementary Protection Certificate

Patent Term Extension

In effect

From 2003

January 23, 1994

Term is extended for

Five years

Five years

Five years

Extended term covers

Medicine, Pesticide, Agrochemical substrate (inventions only)

Patented drugs related to protection of animals and plants including medicinal

Pharmaceutical products and agrochemicals

Requirements or criteria for PTE/SPC

Application to be filed by the patentee within the effective term of the patent before the expiry of 6 months after the receipt of the permission or the date of grant of the patent, whichever expires last

Counting after 5 years from priority date, applicable patents, entitled applicants, application to be made within 6 months of grant of patent.

critical filing date, applicable patents, entitled applicants, deadlines for applying for patent term extension, first market approval and its determination and those legally related to the market approval

Authority to grant extension

Russian Patent Office

Department of Intellectual Property of Ministry of Economic Development and Trade of Ukraine guided by the provisions of the EU-Ukraine Association Agreement

Taiwan Intellectual Property Office


Various events can delay the application maturing into patent. When delays are caused by Patent and Trademark Office, the time lost can be regained through Patent Term Adjustments. Similarly PTE is a compensation given for delay caused for getting drug approval from FDA to market it. PTE doctrine has its genesis in section 35 U.S.C § 156 of Hatch-Waxman Act 1984. Under this Act, PTE is available to patents covering human drug products, veterinary products and medical devices. While both PTO and FDA participate in calculating PTE, the PTO has the final say.

Various events can delay the application maturing into patent. When delays are caused by Patent and Trademark Office, the time lost can be regained through Patent Term Adjustments. Similarly PTE is a compensation given for delay caused for getting drug approval from FDA to market it. PTE doctrine has its genesis in section 35 U.S.C § 156 of Hatch-Waxman Act 1984. Under this Act, PTE is available to patents covering human drug products, veterinary products and medical devices. While both PTO and FDA participate in calculating PTE, the PTO has the final say.

The maximum term of extension is 5 years. Any term extension granted under the statute is applied from the original expiration date of the patent, including any PTA. In USA, a patent is eligible for extension of term only if it includes – 1)at least one claim covering the approved drug product 2) patent not expired 3) patent never been extended 4) to submit a complete and timely application for extension.


In member countries, a supplementary protection certificate (SPC) is a sui generis extension of a patent available to medicinal and plant protection products. These SPCs were introduced to handle the time lost by way of granting a regulatory approval. The certificate is generally issued only where the product is a medicinal one. For availing SPC following conditions shall be fulfilled – that the product be protected by basic patent, a medicinal product to be given market authorization, product is not previously the subject of a certificate. SPCs come into effect at the expiry of national or European patent. However European Patent Convention (EPC) is modified to allow 'extension' to the European patent. In accord, Article 63 of EPC was modified in 1991.

COMPARISON OF PTE LAWS IN USA AND EU: The laws are hereby compared with the help of tabular form:




Term used

Patent Term Extension

Supplementary Protection Certificates

In effect from

September 24, 1984

January 02, 1993

Regulating Acts and provisions

35 U.S.C § 156 of Hatch Waxman Act 1984

Council Regulation (EEC), Regulation (EC), Patents (SPCs for Medicinal Products), Patents (SPCs for Plant Protection Products), Patent Fee Rules

Authority to grant extension

United States Patent and Trademark Office

To be approved on country-on-country basis (both national and European patents)

Maximum period of PTE

5 years including any Patent Term Adjustment (PTA) granted under section 154(b)

Usually 5 years from the end of lawful terms of the basic patent

Scope of protection during extended period

If patent claims products other than the approved product, the patent rights of the other products expire along with the original patented product

The protection offered by basic patent covers medicinal or plant protection product to be placed in the market or those that been authorized before the expiry of the certificate

Total duration of market exclusivity of general patent including extension time

Approval date of the product plus 14 years plus 6 months of paediatric exclusivity

Approval date of the product plus 15 years plus extension of certificate with 6 months of paediatric exclusivity

Patent Term Adjustment

Extended term of the patent includes PTA too as provided for in 154(b)

There is no provision regarding PTA

Period within which request for extension should be made

Within 60 days period

Within 180 days period

Provision that reduces the period of extension

Acts of the applicant when not done with due diligence

No such equivalent provision is available

Application fees / Renewal fees

According to 37 CFR 1.20 (j)(1), a fee of 1,120,00 US dollars must be paid

SPC being in force depends on annual payment of fee


The debate over the patent term extension has its basis in the delay in examining and prosecution of patent applications, granting regulatory approvals. Such delays are more so in cases of pharmaceutical invention where the product is not marketed for several years for want of timely regulatory approval.The proposal for the patent term extension was first mooted in the Second Committee appointed by Government of India on the direction of Hon'ble High Court of Delhi in the Nitto Denko case – to mainly consider PTE for the time lost in processing of the application. The committee concluded that 20 years patent term (which was originally 7 years/14 years) provided for delays and nothingprevents the applicant/inventor from taking steps for regulatory approvals and commercialization, while the patent application is pending.

With all being said, the future of patent term extension (PTE) in India still seems gloomy as the course of jurisprudence doesn't seem to affirm it.


Either Patent Term Extension or Supplementary Protection Certificate, their purpose is the same – extend the protective period of patent which is usually 5 years. Observation makes it clear that United States, European Union and Confederation of Russia and a few other countries have the luxury of exercising the PTE/SPC provision. The only shortcoming is to follow all the procedures as worded in the respective statutes. But most of the Southeast-Asian countries (Indonesia, Thailand, India, Hong Kong, china etc) including some American countries (Brazil, Mexico etc) lack such a provision.


[1] Global Patent Term Extension/Supplementary Protection Certificate Provisions by Sterne, Kessler, Goldstein & Fox P.L.L.C.

[2] Title: Pharmaceutical Patent Term Extension: An Overview by Scott Whittaker, Robert Johnson and Anthony Walker

[3] When a 20 year patent term just isn't enough: Patent term extensions by Sarah Hennebry

[4] Patent Term Extensions in Taiwan by Ruth Fang, Lee and Li Attorneys at Law

[5] Patent Term Extension under Israeli Law by Liad Whatstein at Dr. Shlomo Cohen &Co


[7] Extension of patents for pharmaceuticals and agrochemicals by Gorodissky and Partners Patent and Trademark Attorneys IP Lawyers

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
Obhan & Associates
In association with
Practice Guides
by Mondaq Advice Centres
Relevancy Powered by MondaqAI
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Obhan & Associates
Related Articles
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of

To Use you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions