The Japan Patent Office has announced the following news, which relates to a partial change to the Pharmaceutical and Medical Device Act (PMD Act) and patent term extensions.
A new pharmaceutical approval system has been introduced into the PMD Act on May 20, 2022, which, under certain specific conditions, provides immediate approval for pharmaceuticals in the case of an emergency. An emergency approval under the new system would be subject to a disposition providing grounds for registration of a patent term extension under the Patent Law.
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(written in Japanese only)