Patent term extension

Patent term extension

The extension of patent term is available for human pharmaceuticals, as well as animal drugs and agricultural chemicals. .

Because the extension is a provision to compensate for the patent term that has been eroded due to the delay of a regulatory approval, it is allowed in only case that a patent fulfills all the following requirements i)-iii):

  1. a regulatory approval (=allowance) from the Japanese Health, LabourandWelfareMinistry was necessary to work the patent, therefore the request of investigation was asked before or after the grant, (please refer to the illustration below: types 1 and 2)
  2. the regulatory approval (=allowance) was received from the Japanese Health, LabourandWelfareMinistry after the grant, and
  • due to the delay of the above approval, the patent could not be carried out (=patented products could not be produced or sold).

* type 0 : A request of investigation is asked before the grant and the allowance was also received before the grant.  In this case no extension is available.

type 1 : A request of investigation is asked before the grant and the allowance was received thereafter.  The extension term is calculated from the grant.

type 2 : A request of investigation is asked after the grant and afterward the allowance was received.  The extension term is calculated from the request of investigation.

 

extension duration

If a patent fulfills all the requirements above, the patent can be extended for 5(five) years at the maximum.  The extension duration corresponds with the term that the patented products could not have been sold because of the absence of a regulatory approval.

 

request for extension

If your patent(s) meet(s) the requirements, you may request for the extension of patent duration by submitting evidence which shows the reception of a regulatory approval from the Japanese Health, Labour and Welfare Ministry.

 

notes

Please note that the extension of patent duration is strictly limited to the case above, therefore the other reasons, such as a delay of the examination inside the JPO will never be considered.

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