Art. 67 (2) Patent Act: extension for inventions underlying approval procedure
Following the decision of the Supreme Court of Japan (Decision of the Third Petty Bench of the Supreme Court, Nov. 17, 2015 (2014 (Gyo Hi) No. 356)), the Japanese Examination Guidelines for Extension of Patent Terms were revised. The JPO started examinations based on the revised Guidelines by the end of April 2016.
According to Article 67 (2), when there is a period during which a patented invention cannot be implemented, the term of the patent right may be extended by filing a request for a patent term extension for a period, however, not to exceed five years. A patented invention may be unable to be implemented if it is necessary to obtain approvals or any other dispositions* as designated by the Cabinet Order under Article 67 (2) of the Patent Act.
According to Article 67ter(1)(i) of the Patent Act, the examiner shall reject a request for a pa-tent term extension, if the disposition designated by Cabinet Order under Article 67 (2) is not deemed to have been necessary for the patented invention to be implemented.
In the case, where there has been a prior disposition and there is a request for extension based on a further disposition (the current disposition), under the past guidelines a reason for refusal would have been issued according to Article 67ter(1)(i) of the Patent Act, if the scope of the current disposition could have been implemented within the scope of the prior disposition. The scope of a disposition is defined by the features of the pharmaceutical product or agricultural chemical, which correspond to the features of the granted claims, as well as is defined by the use of the pharmaceutical product or agricultural chemical (even if the use in question is not part of the features of the granted scope of protection).
An example of a request for extensions of a pharmaceutical product that will be refused under the past guidelines is: