INTRODUCTION:

Patent: Patent is granted by the government for the commercial exploitation of an invention for a specific period of time in consideration of the disclosure of the invention so that on expiry of the term of the patent the information can benefit the public at large. Patent is an award for the inventor and reward for the investor. A patent can be granted for an invention which may be related to any process or product.¹

Patent term: Patent term means the validity of the patent for a definite time period that is twenty years from date of filing²_. The term begins from the date of issue patent filed and ending after twenty years from the date of the patent filing. Before June 8, 1995 patent held seventeen years of term from the date the patent was issued, after June 8, 1995 patent has twenty year validity from the first filing date.³

Patent term extension: Patent are granted to innovator to protect others from making, using or selling an invention and thus exclusive right encourage innovation, patent are granted for 20 years from filing of patent application. The effective patent term is less than 20 years in the field of Pharmaceutical because law requires government approval before marketing the drugs. Due to this approval procedure some patent life was lost in market approval.

The patent term extension was designed to restore the portion of patent life that was lost in regulatory review and the patent term was extended to compensate the patent holders for marketing time lost while developing the a product and awaiting government approval.⁴ The human drug products, medical devices, food additives or color additives, and animal products are eligible for patent term extension. Patent term extension was provide up to five years and it may not exceed five years but may be shorter depending upon the delay in regulatory approval as determined by specific calculation.⁵

PATENT TERM EXTENSION IN UNITED STATES:

Patent term in U.S. is 20 years from first filing date after June 8, 1995. Many factors affect the length of effective patent term which includes the requirements in Food, Drugs and Cosmetic Act and Public Health Service Act that certain product receive FDA approval before marketing.⁶

Patent term extension was introduced in Drug Price and Patent Term Restoration act 1984 to compensate the patentee for the time lost while taking the approval from FDA.Drug products, medical devices, food additives or color additives, and animal products are eligible for patent term extension. Under 35 USC 156 term of patent claim a drug product, method of use, method of manufacturing of drug product may be extended up to 5 years. Patent term extension is provided as economic incentive for development of new therapeutic products.⁷

Criteria for eligibility:

The term of patent may be extended if the patent has not expired, the term of patent has never been extended, the application submitted by patentee or his agent according to the requirements, the product was subjected to regulatory review period before its marketing or use, the product represents the first permitted commercial marketing or in case of product manufactured using recombinant DNA technology, the permission for commercial marketing or use of product under the process claimed in patent.

Patent term calculation and timing of patent:

Patent term extension of maximum of 5 years is provided. If the period of regulatory review when added to term of patent remaining after approval of approved product exceed 14 years, the period of extension shall be reduced. Total of both period not exceed 14 years. Not more than one patent extended for the same regulatory review period. Regulatory review period shall be reduced during which the applicant for the Patent term extension did not act with due diligence.

To obtain an extension of patent term applicant must file application within 60 days of FDA approval of commercial marketing or use. The application contain identity of the approved product, identity of the patent, identity of each claim of patent and other information required by the Director. Within 60 days of submission the Director shall notify to the secretary of agriculture, the secretary of Health and Human Services. The secretary review application and determine regulatory review period.

If petition is submitted to secretary, not later than 180 days after the publication of regulatory review period alleging that the applicant did not act with due diligence during regulatory review period. The secretary making the determination shall make such determination not later than 90 days after the receipt of such petition. The secretary notifies to the Director about determination and shall publish in the Federal Register. Any interested person request for hearing on determination within 60 days of publication. Secretary holds such hearing not later than 30 days or at the request of person not later than 60 days after such date. After such determination secretary revise the determination and shall publish any such revision in federal Register.

Interim extension:

If the applicable regulatory review period of a product may extend beyond the expiration of patent term, the owner or its agent submit interim extension application beginning 6 months and ending 15 days before such term is due to expire. The application shall contain all the information required like identity of product, identity of patent, identity of each claim, brief description of activity undertaken by applicant during applicable regulatory review period, and such patent other information as the Director may require.

If the Director determines that the patent would be eligible for extension, the Director shall publish and issue to the applicant a certificate of interim extension of not more than 1 year. The owner or his agent may apply for not more than 4 subsequent interim extensions for the patent for which interim extension is granted and may apply for 1 subsequent interim extension. Each certificate of interim extension shall be recorded in the official file of the patent. Interim extension shall terminate within 60 days after receiving commercial marketing or use except that, if any additional information submitted within 60 days period than the patent shall be further extended but not exceeded to 5 years. During the period of interim extension the patent which claim a product, a method of using of using a product, a method of manufacturing a product is limited to any use then under regulatory review.⁸

Decision of extension:

The Director after determining that patent is eligible for extension and the entire requirements are fulfilled, the Director shall issue certificate of extension of patent term and shall recorded in official file of patent. If patent term expired before certificate of extension is issued or denied, the Director shall extend the term up to 1 year, until such determination is made.

Regulatory review period has two parts a testing phase and approval phase. The testing phase is period beginning on the date an exemption became effective for the approval (Investigational new drug application) and the date of initial submission of the marketing approval. The approval phase is the period between submission and approval of the marketing application.⁹

PATENT TERM EXTENSION IN JAPAN:

The system of patent term extension was introduced by 1987 revision of patent act. The term of patent is 20 years given in article 67(1). In 1987 revision, the new subsection of patent term extension was introduced.¹⁰ In order to encourage the invention the patent life is extended to compensate for the time lost in developing the product and awaiting the government approval.⁴ The term for patent may be extended for period not exceeding 5 years because of obtaining the approval or other disposition which governed by the law to ensure safety in working of the patented invention and a considerable time period is required for proper action of disposition and patented invention not worked during disposition.¹⁰ The date of disposition means when approval reaches to requester that means the date when it is accepted by the requester or it is placed in accepted state.¹¹ If API and its use are not new the application of patent term extension will be rejected in accordance with the guidelines.

Registration of extension of duration:

The application may be filed within the 3 month period following the disposition described by cabinet. If application not filed within 3 month due to reason than the application must filed within 14 days after extinguishment of such reason.¹² However, the application shall not be made after 6 month prior to date of expiration. The application contains the matter; name and domicile of the applicant, the patent number, the period for which extension is requested (not exceeding 5 years) and description of disposition. Where patent is jointly owned then the each of the owner may not apply for extension unless jointly with all other owners.

The application for patent term extension shall be extended, however this may not apply when the examiner decision that the application is to be refused has become final or when extension has been registered. The application containing the matter specified published in the patent gazette.¹³

Refusal of application:

Examiner shall make a decision of refusal of application if; when obtaining of the disposition for invention is not necessary, when the disposition is not obtained by the patentee, where the term for which extension is applied exceed the period during which the patented invention could not be worked, and when the application does not comply to the provision of joint owner.

Decision of registration of patent term extension:

Where no refusals are found for application, the application for patent term extension shall be registered when the examiner decision of extension is rendered. After registration the name and address of patentee, the patent number, the date of registration of extension of patent, the term of extension, and particulars of the disposition shall be published in the official gazette.¹⁰

If the clinical trial is performed in foreign countries and later in Japan then the marketing approval started from start of the trial.¹¹ The period of extended patent term started from when the IND is filed (clinical trial is started) and the day when the patent is granted and end on the day just before the day the regulatory is mailed to the applicant.¹³

PATENT TERM EXTENSION IN KOREA:

Patent term start from registration of patent and is 20 years from filing date of patent application.¹⁴ Patent term extension came in July 1, 1987 in Korea under patent act of 1987 and it is revised in Sep. 1, 1990(patent act 1990), Aug. 31, 1999 (patent act 1999), and in July 1, 2001(patent act 2001).¹⁵ Article 89 provides the patent term extension. Patent term extension provide for complete safety test, activity required for authorization and due to this patent invention could not worked, as a result the patent term extended. Patent term extension for maximum of 5 years.¹⁶ Patent is eligible for extension if the patent claims an invention of drug or agrochemical and the patent is for a product, a process, a use or a composition of matter and filed on or after July 1, 1987.

Application for patent term extension:

Application submitted to commissioner of the Korean Intellectual Property Office(article 90), which includes the name and address of the applicant, the name and business address of the applicant, the patent number, the period of extension applied for, the requirement for the Authorization and the grounds of extension as prescribed. Where patent is jointly owned then the application made in name of all owners. The term deemed to be extended unless decision of refusal has become final. Where the application has been filed the information required shall be published in the patent gazette. An applicant may amend the matter of application before the decision of registration or refusal of application.¹⁷

Time limit for submitting an application:

Before Aug 31, 1990 the patent term extension application filed only during last three years of patent term. Patent term is 15 years from publication or 20 years from filing date (Trips agreement). After Sep. 1 1990 an application submitted within three months of approval obtained, however the applicant may not file an application when the unexpired length is less than 6 months.¹⁵

Rejection of application:

The examiner shall reject the application if; authorization under article 89 is not required or unnecessary for working a patented invention, where patentee not obtained the authorization under article 89, where the term exceed the time period during which the patented invention could not be worked, where the applicant is not the patentee, where it violate the provision of joint owner. The time period which exceed does not include any period during which the patentee failed to work the invention or elapsed for reason attributable to the patentee.¹⁷ The petitioner may appeal for the rejected application and appeal may be filed within 30 days from the date a certified copy of rejection is received to the applicant.¹⁵

Decision of registration of patent term extension:

Where an examiner finds no grounds of refusal then the examiner shall grant the extension. The Commissioner shall register the extension of the term of patent in patent register. When the registration is made the information containing the name and address of patentee, the patent number, the date of registration of extension, the period of extension, and content of authorization must be published in patent gazette.¹⁶

PATENT TERM EXTENSION IN AUSTRALIA:

The Intellectual Property Law Amendment Act (1998) came in to 28 Jan, 1999. Patent term extension of up to 5 years is provided for pharmaceutical standard patent.²⁰ The Federal Court defines the term First regulatory approval date for the purpose of determining length of patent term extension.¹⁸

Application for Patent term extension:

The patentee may apply for Patent term extension to Commissioner having one or more pharmaceutical substance disclosed in complete and fall within the scope of the claim and one or more pharmaceutical substance produced by recombinant DNA technology and disclosed in complete specification and fall within the scope of the claim. The condition that at least one of those pharmaceutical substances must be included in Australian Register of Therapeutic Goods and the period beginning on the date of patent and ending on the first regulatory approval date for substance must be at least 5 years. The term must not have previously extended. First Regulatory Approval date is if no pre TGA marketing approval was given than the date of commencement of first inclusion in Australian Register of Therapeutic Goods and if pre TGA marketing approval was given than the date of first approval. Pre TGA marketing approval is an approval to market the substance or product containing the substance in Australia or imported in to Australia for general marketing.¹⁹

Form and time limit for submitting an application:

The application must be in the approved form, containing document and information according to the regulation. An application for extension is made during patent term and within the 6 months after the patent is granted, the date of commencement of the first inclusion in Australian Register of Therapeutic Goods and date of commencement of this section.

Public inspection, withdrawal and acceptance or refusal of application:

The commissioner must publish in official journal a notice that application has been made and open to public inspection. The patentee by notifying withdraws the application and must publish in the official journal that the application has been withdrawn. The commissioner accept the application if the requirement are satisfied and refuse to accept the application if requirement are not satisfied. The commissioner must notify the applicant in writing the acceptance or refusal and publish a notice of acceptance or refusal in official journal.

Calculation of term of extension:

The term of extension of standard patent is equal to the period beginning on date of the patent and on earliest first regulatory approval date and may be reduced but not below zero. The earlier the first regulatory approval date the shorter the length of the extension.

Opposition of grant and grant of extension:

The Minister or any other person opposes the grant of extension if conditions (sec 70, 71) are satisfied. Opposition may not be done on any other ground. The commissioner give the opportunity for hearing to the applicant and opponent before deciding the case and case is decided according to the regulation. The applicant may appeal to the Federal court against the decision of the commissioner. The commissioner grants an extension of the term of standard patent if there is no opposition and publishes a notice in the official journal.²¹

PATENT TERM EXTENSION IN EUROPE:

In European Union member countries, a supplementary protection certificate (SPC) is a Sui genersis, extension of patent under specific, different set of rights. SPC is granted to compensate for the long time required for the regulatory approval before marketing of the product and available for drugs, plant protection products such as insecticides.²² SPC is given for maximum of 5 years after the patent expires. The duration may be 5.5 years if pediatric population is included in the product information.²³ SPC are granted under the European Legislation no. 1768/92/EEC, codified by regulation no. 469/2009/EC. The aim of SPC is to grant at least 15 years of exclusivity.²⁴ The total combined period of regulatory review to market the product and SPC can not normally exceed 15 years. In case of pediatric total period not to be exceed from 15.5 years. The European Commission (EC) was persuaded that if pharmaceutical research was to survive in Europe, the pharmaceutical industry in Europe should also be supported and encouraged and similar provisions for patent term restoration were required in Europe, and these needed to be harmonized at the community level. This rationale was clearly expressed in the preamble to the supplementary protection certificate (SPC) regulation.²⁶

SPC term determination:

The patent is given for the 20 years from the date of filing. The term of SPC is calculated by subtracting 5 years from the date of filing to the date of issue for the market approval. SPC is not granted if the time required for taking marketing approval from the filing date is less than 5 years. If marketing approval period is less than 10 years than the SPC is granted for the time period determined by subtracting the 5 years from the marketing approval and if marketing approval period is more than 10 years then the SPC is granted for the term of 5 years.

SPC of 6 months are provided in case of the marketing approval application containing data from the trails conducted in pediatric. The 6 months reward is given to compensate the pharmaceutical companies in conducting the trials in pediatric population. Where the salts and ester form is referred for marketing approval and is protected by basic patent in force than the salts and esters are covered by protection of basic patent.

Zero-term SPC:

When the marketing approval period is less then 5 years than SPC is not granted. If period is less than 5 years than the calculation results in negative term. Patent holders avail themselves for the incentives of the pediatric regulation have begun to file SPC for such negative term. Dispute is arises due to this. So SPC is granted when the product is protected by the basic patent, a valid authorization is granted, not already subjected to the SPC.

SIGNIFICANCE IN PHARMACEUTICALS:

Pharmaceutical research is a very risky business. Almost all pharmaceutical research and development is having huge investment with no guarantee of any return on investment. It has been estimated that out of 5,000 new compounds discovered and investigated, only one approved for the market. Most of these products cannot be marketed until they have been approved by the Federal Government. In pharmaceuticals, several studies are undertaken for proving the safety and efficacy of pharmaceuticals and this take longer time due to which patent life became shorter. The purpose of this is to protect the product and encourage innovation.²⁵

The case for restoration was first recognized in the United States in the Waxman-Hatch legislation in 1984. It gives 5 year of patent protection. Japan followed with legislation in 1988, which provides an extension of up to 5 years, depending on the extent of regulatory delay. The European Commission (EC) also introduced Supplementary Protection Certificate (SPC).²⁶

Patent provides exclusive right and economic benefits as a result of exclusive right. Patent term extension increases incentives for research and development. Patent term extension provides exclusive right after the expiration of the patent. It provides additional revenues due to increases in exclusivity. If patent term not extended the price of drug increases, by providing extension the increased amount may be recovered during that additional period. The firms having more funds develop sophisticated research techniques and more extensive research programmes. The firm wants to develop the manufacturing process has to wait till the term of patent term extension expires. Many marginal drugs not generate revenue during the patent term extension.

Patent term extension develops the second use of the drug other than the approved one. FDA approval is taken for that additional use before the marketing of the drug. The patient bears an additional cost due to extension of term because he has to purchase the higher price drug due to unavailability of low price generics in the market.

Research-intensive firms believe that patent term extension will provide encouragement for research activities, raise the profitability of drug research for successful innovations, and ultimately result in more innovative products. Firm deriving incentives from non patented generic products believes that due to patent term extension their entry in to market will be delayed and the competition in the market declines and cost of the drugs increases.

The patent term extension yields higher prices and profit margin to brand name drugs. As the patent provides monopoly, the monopoly continues to be longer due to the patent term extension and the patentee make more money before the availability of generics in to the market.²⁵

CONCLUSION:

Patent term extension provides extended patent life and higher prices and profit for pharmaceutical products. Patent owner wants to take the benefits of that additional period by extending the patent term. The developed countries providing the patent term extension to increases innovation by increases the investment in the R and D. Mostly countries providing the patent term extension for 5 years. Patent term extension not allows generics to come in the market before the expiration of the term of extension. Patentee monopoly increases due to the extension and he will be benefited from the extended time and recover the loss due to the Regulatory Review Period. Generics have to wait till the term expires. Pharmaceutical products have to be approved for the safety and efficacy before introduce in to the market and this will take longer time. As a result Patent owner will lose the some patent life and in returns the loss of money. So the patent term extension provided for the loss during the approval phase. Thus Patent term extension in pharmaceuticals is important strategy for gaining more profit.

REFERENCE:

1. Manual of patent practice and procedure, Patent Office, India 2005 , www.ipindia.nic.in

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14. Republic of Korea Patent Act, Act no. 950 of December 31,1961 as last amended by Act no. 7289 of December 31,2004, chapter V patent right, www.jpo.go.jp/shiryou_e/s_sonota_e/ fips_e/pdf/korea.../e_tokkyo.pdf

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18. Pharmaceutical patent term extensions - eligibility, application deadline and length clarified and Dominic Carew, www.claytonutz. com › Publications and News

19. Commonwealth consolidated acts, part-3 extension of term of standard patent relating to pharmaceutical substances, www.austlii.com/au/legis/cth/consol_act/pa1990109/s70

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21. Australia patent act no. 83 of 1990 as amended by act no. 106 of 2006, chapter VI granted term of patents, www.jpo.go. jp/shiryou_ e/s_sonota_e/.../australia.../e_tokkyo.pdf

22. Whereas at the moment the period that elapses between the filing of an application for a patent for a new medicinal product and authorization to place the medicinal product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research ..." in Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products.

23. Regulation (EC) No 1901/2006 on medicinal products for pediatric use.

24. EU patent term extension: zeroing in on zero-term SPCs, by Weber Dr. Martin, Fulda Christian B., Grabenstein Jens P., www.jonesday.com/eu_patent_term_extension

25. Patent Term Extension and the Pharmaceutical Industry. Library of congress, U.S. govt. printing office, Washington, www.fas.org/pdf.

26. Patent Term Restoration for Pharmaceutical Products in Europe: The Supplementary Protection Certificate, Pfizer Ltd., United Kingdom PDF by Morrie W. Dr. James

Received on 31.05.2011 Modified on 10.06.2011

Research J. Pharm. and Tech. 4(10): Oct. 2011; Page 1493-1498