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The duration of a patent is 20 years from the filing date. However, because legal regulations require testing and examination for production and sale of pharmaceutical products to ensure safety, some patented inventions may be inoperable, despite validity of the patent right. Such safety disposition requirements etc may result in shortening the duration of the patent right.
In light of the problem above, it is possible to extend the patent term by up to five years through application for registration of patent term extension.
Requirements for Extension Registration
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Japan |
Korea |
| Eligible Applicant |
Patentee |
Patentee |
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Eligible candidates
(individual to receive approval for
pharmaceuticals production)
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Patent right holder, holder of non-exclusive
registered right to work, holder of standard
implementation right to work
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Patent right holder, holder of non-exclusive
registered right to work, holder of standard
implementation right to work
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| Application Period |
Within 3 months of the disposition (approval
of pharmaceuticals, same as below).
However, submission is not possible after the
term of the patent right has expired (Patent Law
Article 67bis(3))
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Within 3 months of the disposition (approval
of pharmaceuticals, same as below).
However, submission is not possible after the
term of the patent right has expired
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| Handling 6 months before
patent right term expires
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A day before 6 months prior to expiration of the
original patent term, if determined that the
applicant cannot obtain disposition, extension
of the patent term is only possible if a prescribed
form is submitted (Patent Law Article 67 bis-bis
(1))
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No prescribed for is required in Korea |
| Eligible Patent Rights |
Patented inventions which were inoperable for
necessity to obtain an approval or other
disposition.
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Patented inventions which were inoperable for
necessity to obtain an approval or other
disposition.
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Documents Required
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1) Proof of the disposition for implementation
of patented invention. 2) Proof of inoperable date
of disposition. 3) The name and domicile or
residence of applicant.
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1) Proof of the disposition for implementation
of patented invention. 2) Proof of inoperable date
of disposition. 3) The name and domicile or
residence of applicant.
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If an application for registration extension is filed, the patent right will be deemed extended. Afterwards, as the result of a JPO examination, either decisions for refusal will become final or registration extension will be made (Patent Act Article 67bis(5))
The essence of legal regulations such as the Pharmaceutical Affairs Act lies in regulation of the sales and production of specific products. This means that the specific products or methods of application are vital for assessment.
Thus, when several dispositions relate to the same product (the product and its use), only the earliest disposition is eligible for registration extention. For example, if a different production method or dosage is later approved for the same medication, extension will not apply. Thus it is not necessarily guaranteed that the patent term will be revived for production methods and dosage forms of medication, even if the patent right cannot be operated.
If several patent rights apply towards the same disposition, the term of each of the individual patent rights will be extended. In the event that there are separate substance patents, usage patents, and process patents, the term of each patent will be extended. Again, if several dispositions apply to a single patent right, extension is approved for each individual invention. For example, if one patent right has various active ingredients or effects/advantages, extension applies for each individual disposition.
Effect of patent right in the case of duration extension
Even if the patent term is extended, it does not provide exclusive rights to the entire range of the patent right. Exclusive rights are only provided for “items that apply to the decision of extension” or, if specific use is designated during assessment, “items utilized for such use.” This is because inventions that do not apply to the disposition do not require the effects of patent right extension.
（Effect of patent right in the case of duration extension）
Article 68-2 Where the duration of a patent right is extended (including the case where the duration is deemed to have been extended under Article 67-2(5)), such patent right shall not be effective against any act other than the working of the patented invention for the product which was the subject of the disposition designated by Cabinet Order under Article 67(2) which constituted the reason for the registration of extension (where the specific usage of the product is prescribed by the disposition, the product used for that usage).
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