Asia Patent Alliance

Patent Term Extension for Pharmaceutical Inventions

 

 

In this issue we will focus on extending the term of patents in the pharmaceutical field. 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

 

Japan Korea
Eligible Applicant Patentee Patentee

Eligible candidates

(individual to receive approval for

pharmaceuticals production)

Patent right holder, holder of non-exclusive

registered right to work, holder of standard

implementation right to work

Patent right holder, holder of non-exclusive

registered right to work, holder of standard

implementation right to work

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))

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

Handling 6 months before

patent right term expires

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))

No prescribed for is required in Korea
Eligible Patent Rights

Patented inventions which were inoperable for

necessity to obtain an approval or other

disposition.

Patented inventions which were inoperable for

necessity to obtain an approval or other

disposition.

Documents Required

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.

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.

 

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).