On April 25 this year the China National Drug Administration (CNDA) published a proposed draft on Implementing Measures for Pharmaceutical Trial Data Protection. The measures prevent other drug manufacturers from relying on earlier trial data to receive sales approval without permission from the owner of the earlier trial data. The proposed draft extends the trial data protection term to up to 12 years compared with that of up to 6 years previously. During the protection term, the CNDA will not approve marketing of the same drug[i] from a third party without permission of the owner whose drug gets a trial data exclusivity, except if the third party independently runs a trial and collects trial data. Continue Reading China plans to increase market exclusivity term for pharmaceuticals based on improved pharmaceutical trial data protection
The State Council of China announced in April this year a plan to extend patent protection for up to five years for innovative drugs due to regulatory delay. However, the State Council has not disclosed specific rules nor timetable for same. Meanwhile, in May this year, China and the United States issued a joint statement in the economic and trade consultations, which clearly indicated that China would advance revisions on Patent Law, and it is speculated that revisions related to the above-mentioned patent term extension for drugs will be potentially reflected in the revised Patent Law[i].
It is likely that the patent term extension will only apply to patent applications filed after the revised Patent Law is in force. Revisions in the Patent Law will probably complete late this year, and the implementation of the patent term extension will probably begin in early next year. In addition, if a patentee of a patented drug product only applies for regulatory approval in China or if it only receives regulatory approval overseas but not in China, the patent term extension may not be available. The maximum term extension is 5 years, not to extend total remaining patent term beyond 14 years[ii].
Patent term extension will presumably apply to both foreign and domestic pharmaceutical companies. Drugs developed in China or overseas will also probably entitled to patent term extension. Also, yet to be determined, whether each drug patent is entitled to a single patent term extension (e.g., if a patent is relevant to two different drugs that underwent regulatory approval, is only one extension allowable?), and if only one patent per drug is entitled to the extension.
We can expect opposition from Chinese generic drug manufacturers as this will delay their ability to supply new generic drugs. However, foreign drug companies with new drugs should benefit with longer patent monopolies.