Life Sciences Horizons Brochure 2025 - Flipbook - Page 76
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2025 Horizons Life Sciences and Health Care
China’s patent linkage system: Key features and practical implications
China’s pharmaceutical patent linkage system,
introduced through reforms starting in 2021, has
evolved rapidly, with numerous administrative rulings
and civil judgments shaping its development. We have
identified the following key features of the system:
Patent information registration platform. China’s Marketed
Drug Patent Information Registration Platform (the
“Platform”), akin to the U.S. Orange Book, requires drug
marketing authorization holders (MAHs) to register patents
within 30 days of receiving the MAH certificates. The Platform
links Chinese patents for originator drugs to the MAH system
(hence the name “patent linkage”), allowing innovators to
register patent information related to their approved drugs.
The National Medical Products Administration (NMPA)
conducts only formal examinations, while MAHs are
responsible for the accuracy of the information published on
the Platform. Courts and the China National Intellectual
Property Administration (CNIPA) will reject cases involving
ineligible patents (e.g., chemical drug crystal forms) or if the
drug’s technical solution falls outside patent scope.
Patent declaration requirements and timeline risks.
Similar to the U.S. system, China requires generic applicants
to notify MAHs of patent declarations and provide supporting
evidence. For Type IV declarations (invalidity or noninfringement claims), MAHs have 45 days from the public
disclosure of the drug marketing application to initiate civil
litigation or request administrative adjudication. However,
MAHs face risks due to (a) the lack of penalties for delayed
notifications from generic applicants; and (b) the fact that the
45-day window starts from the public posting date, not when
MAHs are notified.
Dispute resolution mechanisms. Patent holders can resolve
disputes over patent infringement through civil litigation
at the Beijing Intellectual Property Court or administrative
adjudication at CNIPA. Civil litigation offers interim
injunctions if a case is not resolved within nine months,
whereas CNIPA’s process is quicker and benefits from
technically trained examiners.
For innovative pharmaceutical companies and patent holders
operating in China, the key takeaways are:
Timely registration: Register patents promptly on the
Platform to ensure access to the early dispute resolution
mechanism and protect rights effectively.
Strategic patent selection: Choose patents carefully to avoid
ineligible types and ensure the patent covers the drug’s
technical solution.
Vigilant monitoring: Monitor public notifications of generic
drug applications to manage litigation or administrative
adjudication timing effectively.
Appropriate dispute resolution: Select the best dispute
resolution method based on the case’s specifics to protect
patent rights.
Suyu Yuan
Partner
Hogen Lovells Fidelity
Jiayu Deng
Paralegal
Hogan Lovells Fidelity
