China Approves First Drug Patent Term Extensions, Marking New Era for Pharmaceutical IP Protection
核心洞察
China's National Intellectual Property Administration has approved its first pharmaceutical patent term extensions under the revised 2021 Patent Law, with compensation periods ranging from 36 days to five years across chemical drugs, biologics, and traditional Chinese medicine.
Spesolimab (Spevigo IV (搜索)) from Boehringer Ingelberg became the first drug to receive patent term extension approval in June 2025, with a 1,490-day extension for treating generalized pustular psoriasis (搜索).
The new framework allows patent holders to reclaim time lost during regulatory review, with maximum extensions of five years and total patent protection not exceeding 14 years post-marketing approval.
China's pharmaceutical industry has entered a new era of intellectual property protection with the approval of the country's first drug patent term extensions (PTE) under the revised Patent Law that took effect on June 1, 2021. The China National Intellectual Property Administration (搜索) (CNIPA) has now granted several landmark patent extensions, providing innovative pharmaceutical companies with crucial additional market exclusivity periods.
Regulatory Framework Takes Shape
The cornerstone of China's PTE system is Article 42, Paragraph 3 of the 2021 Patent Law, which allows compensation for time lost during regulatory review and approval processes. The framework became operational in January 2024 when CNIPA issued revised implementing regulations and examination guidelines.
Under the current system, patent holders can receive compensation periods up to five years, with the total valid patent term after marketing approval capped at 14 years. The compensation period is calculated as: China marketing approval date minus patent application date minus five years.
PTE eligibility is limited to specific categories of innovative drugs, including Class 2.1 chemical drugs (esters/salts of known active ingredients), Class 2.4 chemical drugs (new indications), Class 2.2 therapeutic biological products (new indications only), preventive biological products with improved vaccine strains, and Class 2.3 traditional Chinese medicines (new indications).
First Approvals Demonstrate System's Scope
Spesolimab Leads the Way
The first drug to receive patent term extension was spesolimab (Spevigo IV (搜索)) from Boehringer Ingelheim, a humanized IgG1 monoclonal antibody for treating generalized pustular psoriasis (搜索). CNIPA granted a 1,490-day extension (approximately four years and 29 days) on June 20, 2025, for patent CN107007833B.
The drug received marketing approval from China's National Medical Products Administration on December 13, 2022, as a Class 1 innovative drug. The extension applies specifically to claims 1, 3, 11, and 20 of the patent, which are Swiss-type claims covering the antibody's specific amino acid sequences.
Chemical Drug Breakthrough
Risdiplam for oral solution powder became the first small-molecule chemical drug to receive PTE approval on November 22, 2024. CNIPA granted a 36-day compensation period for compound patent ZL201580027306.9, extending protection from May 11, 2035, to June 16, 2035.
The drug, used for treating spinal muscular atrophy (搜索) and classified as a Category 1 chemical drug, received marketing approval in China on June 16, 2021, with a patent application date of May 11, 2015.
Biologics Gain Protection
Penpulimab injection achieved the first biological drug PTE approval on the same day as Risdiplam, receiving a 140-day compensation period for antibody patent ZL201610705763.5. The extension moved the patent expiration from August 23, 2036, to January 10, 2037.
Used for treating lymphoma (搜索) and lung cancer (搜索), Penpulimab initially received conditional approval on August 3, 2021, with full approval granted on January 10, 2023, for the indication corresponding to this PTE.
Maximum Compensation Cases
Traditional Chinese Medicine Success
Shen'ge Bushen Capsules (搜索) achieved a milestone on December 17, 2024, becoming the first traditional Chinese medicine to receive PTE and obtain "maximum term compensation" of 1,827 days (approximately five years). The composition patent ZL03156365.1 was extended from September 5, 2023, to September 5, 2028.
The product, used for treating mild to moderate depression (搜索) and classified as a Category 1 new traditional Chinese medicine drug, received marketing approval on December 29, 2022.
Telitacicept's Commercial Impact
Rongchang Bio (搜索)'s Telitacicept injection represents another maximum compensation success story. In May 2025, the company received patent compensation of 1,827 days, extending protection from June 15, 2027, to June 15, 2032.
Telitacicept, the world's first dual-target (BLyS (搜索)/APRIL (搜索)) fusion protein new drug for autoimmune diseases including systemic lupus erythematosus (搜索) and myasthenia gravis (搜索), demonstrates the commercial significance of patent extensions. Following health insurance coverage inclusion in 2023, sales volume surged 149% in 2024, from 1.646 million to 4.105 million units. The drug achieved revenue of 977 million yuan in 2024, representing a 94.87% year-on-year increase.
Implementation Challenges
Baricitinib Case Highlights Complexities
The Baricitinib case illustrates potential complications in PTE implementation. This JAK (搜索) inhibitor, developed by Incyte and licensed to Lilly (搜索), was first approved in China on June 24, 2019, for rheumatoid arthritis (搜索), with a new indication for alopecia areata (搜索) approved on March 27, 2023.
The patentee submitted a PTE request for compound patent ZL200980116857.7 on June 13, 2023. However, Nanjing Spark Pharmaceutical (搜索) filed an invalidation request against the patent on July 4, 2023, and CNIPA declared the patent entirely invalid on January 29, 2024.
This case raises critical questions about the interpretation of regulatory requirements, specifically whether patents must remain valid throughout the entire examination process or only at the time of initial filing. The current Patent Examination Guidelines do not provide clear guidance on handling PTE applications when patents are invalidated during examination.
Strategic Considerations for Industry
The implementation reveals important strategic considerations for pharmaceutical companies. The "one drug, one patent; one patent, one drug" policy means companies must carefully select which patents to use for PTE applications. Where multiple patents protect a single drug, only one may receive extension, and a single patent can only be used for one drug's PTE application.
The Boehringer Ingelheim case demonstrates sophisticated patent strategy, with the company potentially reserving different patents for different formulations of the same drug. Spevigo IV (搜索) (intravenous) and Spevigo SC (subcutaneous) have different indications - treating GPP flares versus preventing recurrent GPP flares - potentially allowing separate PTE applications for related patents.
Market Impact and Future Outlook
The PTE system addresses a critical need in China's pharmaceutical market by compensating for lengthy regulatory review periods that can significantly erode patent protection. The approved cases show compensation periods ranging from 36 days to the maximum five years, reflecting varying regulatory timelines across different drug categories and approval pathways.
For innovative pharmaceutical companies, these extensions provide crucial additional market exclusivity that can significantly impact commercial returns on research and development investments. The system particularly benefits companies developing treatments for serious diseases with long development timelines.
The framework includes important limitations to balance innovation incentives with drug accessibility concerns. By restricting extensions to one patent per drug and preventing repeated compensation, the system aims to avoid excessive protection periods that could delay generic drug market entry.
As more cases emerge and regulatory precedents develop, China's PTE system is expected to play an increasingly important role in the country's transformation from a "generic drug powerhouse" to an "innovative drug leader." The successful implementation of these first cases provides a foundation for continued growth in pharmaceutical innovation while maintaining appropriate safeguards for public access to medicines.