The Author, Rashi Bhatia is a 4th Year, BA.LLB (H) student at Mody University, Rajasthan. She is currently interning with LatestLaws.com.
INTRODUCTION
A patent is a legal document approved by the government giving an originator the exclusive rights to make, use and sell the invention for particular number of years with usual term of 20 years. This term can be comprehensive 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 there are two different arrangements regarding the patent term that is Patent Term Adjustment (PTA) and Patent Term Extension (PTE). Patent term Adjustment is to mitigate the loss of rights and term of patent life due to the USPTO prosecutorial delays under the doctrine of prosecution history laches for unreasonable and undue delay in prosecution. While Patent term extension may result due to any number of reasons including regulatory agencies approval or review processes,other than the USPTO prosecutorial delay. Also Patent term extensions are contained in statutes of respective countries. The current essay discusses about patent term extension and adjustment in various countries on International level.
COUNTRIES NOT HAVING PATENT TERM EXTENSION LAWS
There are various countries such as Brazil, China, Thailand, Hong Kong, Indonesia, etc. does not contain 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 system delay in the approval of drugs covered in patent in all possible ways.
COUNTRIES HAVING PATENT TERM EXTENSION LAWS
While countries like United States, European Union, Japan, Israel, Russia, Australia, Singapore, Taiwan and others are known to have a sound system of patent term extension and also contain rules regarding amendments. A brief discussion about the procedure of patent term extension in these countries.
RUSSIA
In Russia, The patent term extension is applicable to the whole of Confederation of Russia. The PTE came into practice first in Russia in the year 2003. According to the Russian legislation, which regulated PTE process until 2015, a patent directed at a medicine, pesticide or agrochemical was extended in value of the claims covering the product. In the October 2014, an amendments were added to the Civil Code, wherein the amendments introduce the procedure of grant of a supplementary patent limited to the marketed product. Lastly, The rules and regulations patent term extension in Russia were put into force on 8 January 2016. But the normal time period for PTE is 5 years.
ISRAEL
The term for patents in Israel is generally up to 20 years.Extension of term of patent is allowed in cases involving medicinal compositions and medical devices. Proprietors of necessary 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, rule and regulations specified in ANNEX A must be firmly adhered to:
- Filing of an application for PTE
- Official letter by the Patent Office acknowledging the application and the filing date thereof
- The provisions of the Law are met, PTE application to be published with the intention of issuing an Extension Order i.e. the Notice
- Filing an opposition within 3 months from publication of the Notice, if not the Extension Order will issue.
Earlier, PTE shall expire before the following dates:
(1) 5 years from the expiry of the “basic patent”
“Basic Patent” is defined as the patent that protects any material, a process for the production of a material, use of a material, a medical preparation that incorporates a material, a process for the production of a medical preparation that incorporates a material or medical equipment that requires a license in Israel.[1]
(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.
For, PTE Petition must be submitted no later than 90 days from the date of regulatory approval of the drug. firstly, the deadline to file a petition for PTE was extendable in ‘appropriate circumstances’. Most of the extensions that were established were quite for few days. Attempts to obtain longer extensions were consistently denied. In, the Lundbeck [2]decision, the Patent Office extended the limit for filing a PTE petition by 19 months. In the decision, the Patent Office acknowledged the patentee’s point of view that it was not well-versed by its local patent agents of the PTE provisions in Israel.
AUSTRALIA
An Australian patent to be entitled for patent term extension, the claim of the patent must contain either a “pharmaceutical substance per-se,” or more “pharmaceutical substances when produced by a procedure that involves use of recombinant DNA technology”. A pharmaceutical substance is defined as a compound, a composition or a mixture of substances and an active metabolite.
The requisite for obtaining the PTE: to incorporate pharmaceutical substance in the Australian Register of Therapeutic Goods, at least for 5 years between filing of patent application and date of first marketing consent, the application to be made within 6 months of grant of patent and from first regulatory approval date. Therefore, the limit of the PTE is 5 years not more than that.
JAPAN
The Japanese Patent Act states that the period of a patent right expires 20 yrs after the filing date of the Patent Application. The PTE is available for 5 years in pharmaceuticals and agrochemicals. But Japan does not contain any provision for any additional extension period like an e.g., 6 month paediatric extension in the EU. An application for extension of term must be filed within 3 months of the first regulatory endorsement of the product. It should be noted that in Japan following approval for the similar active ingredient for a second indication may provide as a source for an additional extension.
Japan is the country that has a minimum time of patent term extension i.e. 2 years and an appeal for extension of the term has been put forth by Japan Pharmaceutical Industry Association to abrogate the period of 2 years. The application for PTE cannot be filed with the Patent Office at any time after 6 months prior to expiration of patent rights in Japan.
SINGAPORE
In Singapore through the Patents Amendment) Act, 2004 introduced patent term extensions to take into description delay in obtaining marketing approval for pharmaceutical products which are equal to Supplementary Protection Certificates (SPC) issued to pharmaceutical patents in Europe. The regulating legislative framework enclose the Sections 1, Schedule of Singapore Patents Act that is 36 A and Rule 51A of Singapore Patents Rules. The minimum to maximum period of patent term extension is from ‘a period equal to the interval between the date of issue of the certificate of grant and the date marketing approval was obtained’ till the period of 5 years.
An application for PTE must be prepared in the the Intellectual Property Office of Singapore (IPOS) through the Form 54 with a fee presently of $950. The Form 54 of Patent requires the Applicant to mention the period of the extension of the patent term it seeks whereby Applicant needs to put forward a certificate from the Health Sciences Authority in Singapore. The application for a PTE requests to be made within 6 months from the date of grant of the patent and the date of marketing consent was obtained. If the patent is still continues, an application cannot be made after period 6 months from the normal 20 year term of the patent.
UKRAINE
The term of a patent connected to drugs – for protecting humans, animals and plants, may be extendable at the request of the holder for a period not more than 5 years. This country provides an occasion to extend the period for a medicinal /agrochemical product patents. In December 2018, the Cabinet approves to draft law to bring Ukrainian IP legislation in line with the EU-Ukraine Association Agreement. Under the law, patent protection will not be granted to surgical, diagnostic and therapeutic methods for treating of humans or animals and to recent forms of known medicinal products. Also, the law added that the period of supplementary protection should be equal to the period between the application date and the date of the first authorization by an experienced authority, not exceeding a whole of 5 years.
UNITED STATES
The diverse events can delay the application maturing into patent. When delays are caused by Patent and Trademark Office, the lost time can be regain through Patent Term Adjustments. similarly, PTE is a compensation given for delay caused for getting drug approval from Food and drug administration to market it. PTE is the doctrine has its origin in section 35 U.S.C § 156 of Hatch-Waxman Act, 1984. Under the Act, PTE is offered 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 not at all been extended
4) To submit a complete and timely application for extension.
EUROPEAN UNION
In member countries, patents are granted by either the capable national authorities or the European patent office. A supplementary protection certificate (SPC) is an essential extension of a patent available for the protection to medicinal and plant protection products.
The Regulation defines:
Medicinal Products as any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals.
Plant Protection Products as active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to:
- protect plants or plant products against all harmful organisms or prevent the action of such organisms, in so far as such substances or preparations are not otherwise defined below;
- influence the life processes of plants, other than as a nutrient (e.g. growth regulators);
- preserve plant products, in so far as such substances or products are not subject to special Council or Commission provisions on preservatives;
- destroy undesirable plants; or
- destroy parts of plants, check or prevent undesirable growth of plants.
These SPCs were introduced to handle the time lost by way of conceding a regulatory approval. The certificate is usually issued only where the product is a medicinal one. For availing SPC following terms and conditions shall be fulfilled – that the product be protected by necessary patent, a medicinal product to be given market authorization, product is not formerly the subject of a certificate.
SPCs come into effect at the end of national or European patent. On the other hand European Patent Convention (EPC) is modified to allow ‘extension’ to the European patent. In accord, Article 63 of EPC was modified in 1991.
INDIA
The discussion over the patent term extension has its basis in the delay in examining and prosecution of patent applications, granting regulatory approvals. Such delay are more so in cases of pharmaceutical invention where the product is not marketed for numerous years for want of timely regulatory approval.The suggestion for the patent term extension was first put in the terms of reference of Second Committee appointed by the Government of India on the direction of Hon’ble High Court of Delhi in the Nitto Denko case[3] – main aim for considering PTE for the time lost in processing of the application.
The committee concluded that 20 years patent term which was originally 7 years or 14 years provided for delays and nothing prevent the applicant/inventor from taking steps for regulatory approvals and commercialization, while the patent application is pending.
The future of patent term extension (PTE) in India still seems dim as the course of jurisprudence doesn’t seem to affirm it.
CONCLUSION
I want to conclude by saying that we should consider Either Patent Term Extension or Supplementary Protection Certificate, their rationale is the same – extend the protective period of patent which is usually 5 years. It is clear after observation that United States, European Union and Confederation of Russia and a few other countries have the luxury of exercising the PTE/SPC and PTA provision. The only shortcoming is to follow all the processes 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.
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