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.