The Taiwan Intellectual Property Office Proposes Draft Amendments to the Patent Examination Guidelines The Taiwan Intellectual Property Office (TIPO) has recently proposed draft amendments in specific areas such as patent term extension calculations and who qualifies as an interested party in a patent invalidation. The main points are as follows: For patents relating to pharmaceutical inventions, if a regulatory approval shall be obtained in accordance with the Pharmaceutical Affairs Act or the Rare Disease and Orphan Drug Act for the exploitation of the patent, the patentee may apply for a patent term extension for the period in which the inventions cannot be exploited due to the absence of a regulatory approval. According to the Patent Examination Guidelines, the period from the day after the date of receiving the Notice for Collecting the Approval to the day of actually collecting the approval should be deducted from the term to be extended.  Therefore, the patentee should submit a document of proof regarding the date of receiving the Notice for Collecting the Approval. Concerning the topic of an interested party in a patent invalidation, an interested party is now specified as a legally interested party, i.e. a party whose rights or legal benefits are directly impaired due to any controversy surrounding the patent right or the right to apply for a patent. If the invalidation petitioner provides a document of proof to establish such interest, as long as the patentee does not argue against it and the examiner does not foresee any problems, it is unnecessary to investigate the existence of such interest.  However, if the patentee doubts the existence of the...