At a November 11, 2026, briefing in Beijing, the Beijing Intellectual Property Court reported on five years of cases under China’s drug patent-linkage system, which connects generic-drug approval to patents on originator medicines. The system took effect in June 2021 to address patent disputes before generic drugs reach the market.
Vice-president Song Yushui said the court, which has centralized first-instance jurisdiction over these cases nationwide, had accepted 382 patent-linkage cases—358 civil and 24 administrative—and concluded 369. More than 90% involved foreign parties, according to the court.
Under the system, a generic manufacturer can file a “Category IV” declaration asserting that a relevant patent is invalid or that its product does not infringe it. If the originator company brings a case within 45 days, the drug regulator places the generic application under a time-limited approval stay while the dispute is addressed.
The court said the average first-instance duration for drug patent-linkage cases fell to 101 days in 2025, and more than 80% of its cases of this kind have been concluded within five months. It aims to complete both instances of litigation within the nine-month waiting period applicable to chemical generic-drug registration applications.
The court also presented cases illustrating the limits of patent-linkage litigation. In a palbociclib case, it dismissed an originator company’s suit because a patent registered for a capsule could not be treated as registered for the generic applicant’s tablet. In a vonoprazan fumarate tablet case, it found that a generic applicant had withheld necessary technical evidence without justification and ruled that the product’s technical solution fell within the patent’s scope.
Other rulings addressed patents declared invalid by China’s National Intellectual Property Administration, changes to a generic drug’s technical proposal during review, and how broad chemical-structure claims known as Markush claims should be assessed. The court said its published cases are intended to clarify the rules for pharmaceutical patent disputes.
Source: m.thepaper.cn (originally published 2026-11-11 16:21 UTC+8)
