Pharma-related Regulatory Developments

China's fourth amendment of the Patent Law will come into effect on June 1, 2021. The Implementing Rules of the Patent Law and the Guidelines for Patent Examination have been revised compatibly. Here are some changes you may find particularly relevant:

Drug patent term extension

Patents relating to a new drug approved for marketing in China may be granted a maximum five-year patent term extension by the patent administration department as a compensation for the time taken by regulatory review and approval; and the total effective patent term shall not exceed 14 years. While their scope, in particular the definition of "new drugs" remains to be clarified, these provisions embodies enhanced protection for original drugs, whose regulatory review and approval can take far longer time than generic drugs.