PATENT TERM EXTENSION
1.History英雄联盟女英雄
The patent term extension system was first introduced in Korea on July 1, 1987 under the Patent Act of 1987 (hereinafter the “1987 Act”). Since then, it was revid three times: on September 1, 1990 under the Patent Act of 1990 (the “1990 Act”), on August 31, 1999 under the Patent Act of 1999 (the “1999 Act”), and on July 1, 2001 under the Patent Act of 2001 (the “2001 Act).
Under the 1987 Act, a petition for patent term extension may be filed only during the last three (3) years of the original term of the patent. The term for patents that were filed within the period of July 1, 1987 to August 31, 1990 will begin to expire around 2007. That means, owners of the patents within the purview of the 1987 Act have not been eligible to file.. a petition for term extension until around 2004. Therefore, patentees are now encouraged to check the terms and conditions of term extension.
Under the 1990 Act, a petition for patent term extension may be filed within three (3) months from the date of the approval and six (6) months prior to the expiration date. The patent term extension system of 1999 and 2001 is basically the same as that of 1990 except for the followings. The 1999 Act has abolished the provisions of the 1990 Act that had the requirement of a two-year unworkable period. Th
e 2001 Act stipulates that a patent term be automatically extended when a petition for term extension is filed regardless of the examination outcome. If the petition is rejected, the extended term is retroactively invalidated.
The current patent term extension system is prescribed in Articles 89-93 of the 2001 Act and Article 7 of the Enforcement Decree.
2.Current Regulation (KIPO’s 2000-7 Regulation)
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2.1.Conditions for Patent Term Extension
A. A patent is eligible for term extension if the patent claims:
(1) an invention relating to a drug which requires a product approval under Art. 26, para. 1 and Art. 34, para. 1of the Pharmaceutical Affairs Act ("PAA"); or
(2) an invention relating to an agrochemical which must be registered under Art. 8, para. 1, Art. 16, para. 1 and Art. 17, para. 1 of the Agrochemical Management Act ("AMA"),
AND
The patent is directed to one of the following:
(1) a product;
(2) a method for manufacturing a product;
(3) a u; or
(4) a composition of matter.
AND
B. The patent application was filed on or after July 1, 1987.
2.2.Number of Patent Term Extensions
A. The term of a patent can be extended only once
B. If a product approval (or registration) is sought for multiple patents, the term is extended for each patent
C. If multiple product approvals (or registrations) are sought for a single patent, the term is extended only for the first approval (or registration)
2.3.Length of Patent Term Extension
A. The length of non-working time to obtain authorization or registration under provisions of the PAA or AMA to work a patented invention under Art. 89 of the Patent Act ("PA") refers to the following:
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(1) For drugs: The period commencing from either the approval of a protocol for clinical testing from the Ministry of Health and Welfare (MOHW) after obtaining a conditional approval to manufacture for clinical testing (Art. 26(6) of the
PAL) or the date the patent is registered, whichever is later; to the date that the final approval to manufacture is obtained under Article 26(1) of the PA (Art. 4, para. 1, c. 1 of the Regulations).
In the ca of a drug developed abroad and exempted from clinical testing in Korea under the Korean Good Clinical Practice ("KGCP"), the period will cover the sum of the period for pha III clinical testing that appeared in evidence materials submitted to foreign authorities and the period commencing from the date of receipt of an application to MOHW to the date of the final approval (the
KFDA document review period). This provision will not apply to applications that do not have the bridging data under the regulations of KFDA. (Provisional clau of Art. 4, para. 1, c. 1 of the Regulations)
(2) For drugs ud in animals: The above rules apply.
(3) For agrochemicals: The period commencing from the date the application for product testing is accepted or the date the patent is registered, whichever is later; to the date product registration is granted under Article 6(1) and (2) of the AMA.
(4) For bulk materials of agrochemicals: The period commencing from the date that a request for testing to obtain a testing report is made or the date a patent is registered, whichever is later; to the date a registration of the bulk material is granted under Article 9(1) of the AMA.
B. The maximum patent term extension obtainable is five (5) years regardless of whether the actual period of non-working caud by the statutory requirements under the relevant Act exceeds five years. Further, under the 1987 Patent Act, the total patent term, including the extended period, may not exceed twelve (12) years from the date of the issuance of the manufacturing licen or registration. This limitation to the maximum patent term was abolished in the 1990 Patent Act.
八段锦口令2.4.Time Limit for Submitting Application for Patent Term Extension
A. If the patent application was filed between July 1, 1987 and August 31, 1990, the 1987 Act specifies that a petition for term extension can only be filed during the last three years of the original patent term. The patent term for the applications would be 15 years from the publication date or 20 years from the filing date, whichever is longer
(pursuant to the December 15, 1993 TRIPs agreement).
描写青春的诗句B. If the patent application was filed on or after September 1, 1990, an application for patent term extension must be submitted within three months from the date of the approval under the PAA or from the date of the registration under the AMA. The application, however, may not be submitted less than six months prior to the expiration of the original patent term. For an obvious reason, a petition for patent term extension may not be filed after the expiration of the patent term (Art. 5. para. 1 of the Regulations).
2.5.Procedures
2.5.1.Filing an Application
An application for patent term extension should be supported with evidence to show the reason for the extension. Evidentiary documents verifying the reason may vary depending on the claimed inventions as specified below:
Medicines (domestic clinical testing conducted)女生长发
- Copy of official approval for a clinical testing plan
- Copy of official approval for items for medicines
Medicines (domestic clinical testing not conducted)
- Documents verifying the time spent for the pha III clinical testing performed outside of Korea
- Documents verifying the time spent for the administrative review conducted by the Korean Food and Drug Administration (“KFDA”)
Agrochemicals
- Copy of a letter requesting tests for obtaining registration for items of agrochemicals
-
Copy of Certificate of Registration for items of agrochemicals
Agrochemical Bulk Materials
- Copy of a letter requesting analysis and tests
- Copy of a Certificate of Registration of agrochemicals raw materials
2.5.2.Examination
Within one month from the date of receiving the application for term extension, the examiner must decide whether the approval or registration under the provisions of the AML is necessary for working the patented invention by comparing the claims of the patent within the scope of the approval or registration as follows;华阳观
(1) For a product: By comparing the active ingredients of the approved or registered product with the claims of the patent. Even if the active ingredients are not specified in the claims but fall within the scope of the general concept of the claims, the application will not be rejected (Art. 7, para. 1, c. 1 of the Regulations).
(2) For a method of manufacturing a product: By comparing the product manufactured by the patented method with the approved or registered product (Art. 7, para. 1, c. 2 of the Regulations).
(3) For a u: By comparing the approved or registered u with the u described in the claims of the patent (Art. 7, para. 1, c. 3 of the Regulations).
(4) For a composition of matter: By comparing the approved and registered composition of matter with that of the claims of the patent (Art. 7, para. 1, c. 4 of the Regulations).
2.6.Who may request for term extension
Only registered patentee(s) may apply for patent term extension. If the patent right is jointly owned, all the patentees must jointly apply for an extension of the term.
2.7.Trials
A. Appellate Trial: If the petition for patent term extension is finally rejected, the petitioner may appeal. The appeal must be filed within thirty days from the date a certified copy of the rejection is rved to the applicant or his agent (Art. 11, para. 1 of
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