Patent Term Extension In Different Countries

ABSTRACT

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.

PATENT TERM EXTENSION

COUNTRIES WITHOUT PTE LAWS

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.

COUNTRIES WITH PTE LAWS

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.

1. ISRAEL

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.

2. JAPAN

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.

3. SINGAPORE

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.

4. AUSTRALIA

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.

5. RUSSIA

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.

6. UKRAINE

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.

7. TAIWAN

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:

POINT OF COMPARISON RUSSIA UKRAINE TAIWAN
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

8. UNITED STATES

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.

9. EUROPEAN UNION

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:

POINT OF COMPARISON USA EU
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

10. INDIA

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 caseto 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.

CONCLUSION

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.


Author: Dhakshina Moorthy C, Associate Director and Rajasri Thota , Intern at Khurana & Khurana, Advocates and IP Attorneys. In case of any queries please contact/write back to us at rishabh@khuranaandkhurana.com

References:

[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

[6] https://iprgroup.info/another-step-towards-bringing-ukrainian-legislation-to-european-standards/

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

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