CHINA Law and Practice Contributed by: Binxin Li, Guangzhen Shang, Yue He and Lesley Wang, LeanWill Law Firm
3.4 Publicly Available Drug and Patent Information See 2.4 Publicly Available Drug and Patent Informa- tion . 3.5 Reimbursement and Pricing/Linkage Markets Reimbursement and pricing for biologics or biosimi ‑ lars are basically the same as outlined in 2.5 Reim- bursement and Pricing/Linkage Markets , but there are some differences in terms of patent linkage: • the nine-month suspension period and the market exclusivity awarded based on a successful patent challenge are not applicable to biosimilars; and • the patent type qualified for patent linkage is lim ‑ ited to sequence patents and use patents.
The calculation of PTA is based on the actual days of unreasonable delay during examination, referring to the interval between the date that meets the require‑ ment of four years from the patent filing date and three years from the substantive examination request filing date, and the grant date of the patent, minus both reasonable delay and applicant-caused unreasonable delay days. As to the PTA decision issued by the CNIPA, the pat ‑ entee or an interested party (eg, a defendant in related patent infringement dispute) is entitled to apply for a judicial review against the decision. PTE To make up for time consumed by MAA examination for a novel drug, the CNIPA may extend the term of certain patents that cover approved drugs upon the application of the patentee. The following types of invention patents related to novel drugs are eligible for PTE: • a product patent for the API; • a manufacturing process patent for the API; and • a use patent for the API. An application for PTE shall meet the following require ‑ ments: • the patent grant date shall be earlier than the drug approval date; • the patent is valid when the PTE application is filed; • the patent has not previously been granted any extension of term; • the technical solution of the new drug falls into the protection scope of the patent; • if one drug is covered by two or more patents, only one patent can be used for the PTE application; and • if a patent covers two or more drugs, the PTE application can be filed for one drug only. The underlying requirements can be summarised as “one drug, one patent”. These requirements – par ‑ ticularly the “one drug, one patent” rule – would bring some challenges to patent portfolio management,
4. Patent Term Extensions for Pharmaceutical Products
4.1 Supplementary Protection Certificates Both Patent Term Adjustment (PTA) and Patent Term Extension (PTE) are available in China. PTA To compensate for unreasonable delay during the examination of certain patents, PTA has been intro ‑ duced in China. Only invention patents meeting the following criteria are eligible for PTA: • invention patents granted more than four years after the patent filing date and after three years from the date of filing a request for substantive examination; and • invention patents not filed and granted under the situation of Article 9.1 of the Patent Law (ie, twin- filing). PTA is not automatically granted by the CNIPA when granting a patent. The patentee shall file an applica ‑ tion for PTA within three months from the patent grant date. The CNIPA will review the PTA application and determine whether and how the patent term could be adjusted.
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