CHINA Law and Practice Contributed by: Binxin Li, Guangzhen Shang, Yue He and Lesley Wang, LeanWill Law Firm
the National Intellectual Property Administration and the National Healthcare Security Administration on Strengthening Intellectual Property Protection in the Field of Centralised Pharmaceutical Procurement, the following is required. • Enterprises participating in centralised procure ‑ ment or applying for online listing of pharmaceuti ‑ cals and medical consumables shall determine that the relevant products do not infringe another’s IP. If patent infringement disputes arise after the selec ‑ tion results are announced or online procurement transactions occur, the applying enterprise shall bear the corresponding liability. • If patent infringement disputes arise, centralised procurement agencies may advise the relevant par ‑ ties to seek resolution through intellectual property authorities, or to file lawsuits in the people’s courts. • If infringement is established by the relevant authorities (court/IP office), the centralised procure ‑ ment agencies shall refuse listing or promptly delist related products, in accordance with laws and regulations. Regarding pricing, during the annual adjustment peri ‑ od for the National Reimbursement Drug List (NRDL), companies may negotiate with the healthcare insur ‑ ance authorities regarding the inclusion of their drugs in the list and their pricing. For patented innovative drugs, the healthcare insurance department cannot force price reductions by introducing generic drugs before the patent expiries, allowing brand drug own ‑ ers to keep pricing leverage for investment return. For MAs, the China Patent Linkage system links the patent status of brand drugs with the MAAs of generic drugs. To be specific, for generic drugs not launch ‑ ing before the expiry of the registered patent (ie, Type 3 declaration), an approval shall be granted by the NMPA and the generic drugs can only be launched to the market after the expiry of the corresponding patent. For generic drugs that are under a Type 4 dec ‑ laration but are found by the authority to fall within the protection scope of the registered patent, the MAA shall be held during the patent term and transferred to the administrative approval stage right before the expiration of the patent term.
For Type 4 declarations, procedure wise, where a pat ‑ entee or an interested party objects to the declaration, it may file a complaint before the Beijing IP Court or before the CNIPA, or both, within 45 days from the publication date of the declaration on the Platform for Marketed Drugs. For generic drugs, a nine-month suspension period will begin upon the NMPA’s receipt of a copy of the official patent linkage case acceptance notice. The first generic drug applicant that successfully invali ‑ dated the patent and obtained an MA shall be granted up to 12 months’ market exclusivity (but not exceed ‑ ing the original patent term) for its generic drug, which means the NMPA shall not approve any other generic drugs during such exclusivity period from the date of approval of the first generic drug. The China Patent Linkage system covers patents for active pharmaceutical ingredients (APIs), for pharma ‑ ceutical compositions containing APIs, and for phar ‑ maceutical uses (including second use). Manufactur ‑ ing process patents are not included.
3. Biosimilar Market Entry 3.1 Infringing Acts See 2.1 Infringing Acts . 3.2 Data and Regulatory Exclusivity
According to the new Draft Measures for the Imple ‑ mentation of Drug Regulatory Data Protection (Provi ‑ sional) (Draft for Comments) issued by the NMPA in March 2025, a six-year protection period is available for innovative vaccine and biological products, and a three-year protection period is available for improved ones. However, the protection scope for biological products excludes bioavailability, bioequivalence and vaccine immunogenicity data. Different from generic drugs, biosimilars are excluded from data protection. 3.3 Acceptable Pre-Launch Preparations See 2.3 Acceptable Pre-Launch Preparations .
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