Highlights of patent protection in healthcare

Patent protection in healthcare

Following amendments to the Patent Law, the China National Intellectual Property Administration (CNIPA) issued its Guidelines for the Estimation of Royalties for Open Patent Licences (Trial Implementation) to support the implementation of an open patent licensing mechanism. The guidelines provide references for patentees making open patent licence statements, and specify the criteria and methods of the calculation and payment of royalties.

Patent disputes in the healthcare industry became quite active in the past year, with the Supreme People’s Court and CNIPA making rulings on patent linkage disputes. Issues in these cases included proper patent listings, wrong statements, whether a generic drug falls into the protection scope of a patent, and the correlation between invalidation and patent linkage actions.

Following the implementation of Measures for Administrative Decisions on Major Patent Infringement Disputes, the CNIPA issued decisions of the first two major patent infringement cases on 27 July 2022, clarifying that a drug listing on the drug centralised procurement platform constitutes offering related drugs for sale under the Patent Law. On 5 December 2022, the CNIPA and the National Healthcare Security Administration jointly released the Opinions on Strengthening the Protection of Intellectual Property in the Centralised Pharmaceutical Procurement Sector to strengthen patent protection and reduce patent infringement disputes in the centralised drug procurement area.

Business Law Digest is compiled with the assistance of Baker McKenzie. Readers should not act on this information without seeking professional legal advice. You can contact Baker McKenzie by e-mailing Howard Wu (Shanghai) at howard.wu@bakermckenzie.com

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