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Amendments to Chapter 13, Part 2, of the Patent Examination Guidelines (hereinafter referred to as “the Guideline”) on medical-related inventions were published on November 5, 2019 and they came into force on January 1, 2020. The amendments were made to catch up with the fast-changing medical industry and the many types of medical-related inventions filed in Taiwan. Relevant court rulings and examination guidelines in the UK, Europe and Japan were taken into account to make the amendments, and new cases were added as explanatory supplements. On the clarity of claims, in practice, disputes concerning the explanation and applicability of the claims are common. This issue was addressed in the amendments, too. Considering the latest technological developments in the medical industry and the application and examination practices concerning medical inventions in Taiwan, other contents of the Guideline were also reviewed. Finally, TIPO adjusted the frameworks of certain parts of the Guideline, specified relevant rules, and modified a few descriptions as fit, to make the Guideline more complete.
The points of the amendments are as follows:
Drew references from case examples in JPO’s guidelines and added explanatory notes on cases which “may not be supported by specifications.”
Five cases of novelty were added, respectively relating to new medical use, new dosage regimen, new modes of administration, specific groups of patients, intervals of administration and the order for taking different kinds of medicine.
A statement on the non-inventiveness of hydrates was added.
Five cases with inventive steps were added, including two cases of dosage, one case about specific types of patients, one case about the relevance of pharmacological action, and one case about treating diseases which have the same causative factors.Others, such as revising contents of some cases, deleting non-relevant information, adjusting the frameworks of certain chapters, and specifying relevant rules and modifying a few descriptions, were made.