The Chinese pharmaceutical patent CN110831544 represents a critical case study in understanding the evolving intellectual property framework for drug innovations in China. This patent, published on December 18, 2020, under the application number 62020013976.9, reflects broader trends in China’s efforts to balance patent protection for innovators with generic drug accessibility[1]. While the exact technical details of the patent’s claims are not fully disclosed in publicly available records, its classification, prosecutorial history, and alignment with China’s regulatory reforms provide ample ground for analysis. Below, we explore the patent’s scope, claim structure, and its position within China’s dynamic pharmaceutical patent ecosystem.
China’s Pharmaceutical Patent System: Regulatory and Legal Foundations
The Role of the China National Intellectual Property Administration (CNIPA)
CNIPA oversees patent examinations, grants, and disputes, including those related to pharmaceuticals. The agency has strengthened its patent linkage system since 2021, which connects drug approval processes with patent status to prevent generic market entry before patent expiration[4][14]. For CN110831544, CNIPA’s jurisdiction ensures that any challenges to its validity or infringement claims would follow structured administrative or judicial pathways, such as invalidation proceedings at the Beijing Intellectual Property Court[4][7].
Patent Term Extensions and Eligibility Criteria
China’s 2024 patent term extension (PTE) rules allow up to five additional years of protection for drugs facing regulatory delays[16]. While CN110831544’s eligibility depends on its approval timeline, PTEs typically apply to patents covering active ingredients, formulations, or medical uses[16]. The patent’s 2020 filing date positions it within the transitional phase of these reforms, where compound patents and improved new drugs are prioritized for extensions[16].
Scope and Claim Analysis of CN110831544
INID Codes and Bibliographic Data
The patent’s INID codes reveal key metadata:
- [11]: CN110831544 A (publication number)
- ****: 62020013976.9 (application number)
- ****: 14.08.2020 (filing date)
- ****: EN (original language: English)[1].
These codes suggest the patent was filed directly in English, streamlining its prosecution under China’s bilingual examination system. The absence of priority data () indicates it may not claim foreign priority, focusing solely on the Chinese market[1].
Inferred Claim Structure
While the full specification is unavailable, analogous patents in China’s pharmaceutical sector often include:
- Compound Claims: Protecting specific chemical structures or formulations.
- Method-of-Use Claims: Covering therapeutic applications for diseases.
- Process Claims: Detailing synthesis or manufacturing techniques[11].
For example, patents targeting biological materials (as hinted by the term “ANALYSIS OF BIOLOGICAL MATERIAL” in related documents) often combine composition claims with diagnostic or therapeutic methods[2][11]. CN110831544 likely follows this pattern, given its publication alongside patents emphasizing analytical methods for tissue samples[2].
Potential Challenges to Claim Validity
China’s patent linkage system allows generic manufacturers to file “Category 4.2” declarations, asserting that a patent is invalid or not infringed[4][14]. If CN110831544 faces such a challenge, CNIPA would evaluate:
- Novelty: Whether the claimed invention was disclosed in prior art.
- Inventive Step: Non-obviousness relative to existing solutions.
- Industrial Applicability: Practical utility in drug development[4][7].
Recent cases, such as the invalidation of Eldecalcitol’s patent due to lack of inventive step, demonstrate CNIPA’s rigorous scrutiny[4].
Patent Landscape and Market Implications
Growth in Pharmaceutical Filings Under the Belt and Road Initiative
From 2013 to 2023, Chinese applicants filed over 70,000 patent applications in Belt and Road partner countries, with a 21.3% annual growth rate in sectors like semiconductors and biotechnology[6]. While CN110831544’s international footprint is unclear, its publication aligns with China’s push to protect innovations in strategic markets. Domestically, foreign applicants from 122 countries filed 285,000 patents in China during the same period, underscoring the market’s global appeal[6].
Digital and Green Innovation Trends
CN110831544’s potential classification under digital health or biotechnology aligns with China’s focus on patents in "core industries of the digital economy," which saw 16.9% annual growth in granted inventions[6]. For instance, patents integrating AI-driven drug discovery tools or green manufacturing processes are prioritized in CNIPA’s examination guidelines[6][15].
Litigation Risks and Enforcement Mechanisms
Patent Linkage Litigation Dynamics
Under China’s revised Patent Law, patentees have 45 days to initiate litigation or administrative proceedings after a generic applicant files a Category 4 declaration[14]. A 9-month regulatory stay is imposed during proceedings, delaying generic approvals until resolution[14]. For CN110831544, this mechanism ensures temporary market exclusivity while disputes are adjudicated.
Case Study: Chugai Pharmaceutical Co. v. Haihe Biopharma
In 2022, Chugai contested Haihe’s generic product under China’s patent linkage framework. The Supreme People’s Court upheld CNIPA’s invalidation of Chugai’s patent due to claim amendments that narrowed scope during prosecution[14]. This precedent highlights the risks of claim limitations during examination, which could similarly affect CN110831544 if its claims were amended to overcome prior art[14].
Strategic Considerations for Patent Holders
Aligning Global and Chinese Prosecution Strategies
CNIPA’s PTE rules require clinical trials in China for eligibility, incentivizing early-stage local trials[16]. For patents like CN110831544, coordinating global filings with Chinese regulatory submissions maximizes term extension opportunities.
Leveraging the Patent Information Registration Platform
China’s Listed Drug Patent Information Registration Platform mandates disclosure of patents covering approved drugs[4][7]. Registering CN110831544 here would enable enforcement under the linkage system, deterring generic entrants during the exclusivity period.
Conclusion
CN110831544 exemplifies the complexities of China’s pharmaceutical patent regime, where robust claim drafting, strategic prosecution, and vigilant enforcement are essential. While its exact technical scope remains partially obscured, its trajectory through China’s legal and regulatory frameworks offers insights into broader trends: the rise of digital health patents, stricter validity assessments, and the growing influence of patent linkage litigation. For innovators, navigating this landscape requires harmonizing IP strategies with CNIPA’s evolving policies, particularly as China solidifies its role in global drug development.
Key Takeaways
- CN110831544’s prosecution and enforcement are shaped by China’s 2021 Patent Law amendments and 2024 term extension rules.
- Patent linkage litigation and invalidation risks necessitate precise claim drafting and proactive portfolio management.
- China’s focus on digital and green innovations creates opportunities for patents integrating AI or sustainable technologies.
FAQs
-
What is China’s patent linkage system?
A framework linking generic drug approvals to patent status, allowing patentees to delay generics via litigation[4][14].
-
How do patent term extensions work in China?
PTEs compensate for regulatory delays, offering up to five additional years for eligible drug patents[16].
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What are common claim types in Chinese pharmaceutical patents?
Compound, method-of-use, and process claims dominate, often combined with formulation-specific protections[11].
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How does CNIPA handle patent invalidations?
Through administrative proceedings evaluating novelty, inventive step, and industrial applicability[4][7].
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What role do INID codes play in patent analysis?
They standardize bibliographic data, aiding in tracking application dates, languages, and priority claims[1][2].
“China’s patent linkage system represents a seismic shift in balancing innovation incentives with public health needs.” – Mayer Brown Analysis[4]
References
- https://www.ipd.gov.hk/hkipjournal/18122020/Patent_18122020.pdf
- https://www.ipd.gov.hk/hkipjournal/25082023/Patent_25082023.pdf
- https://inspire.wipo.int/patent-search-and-analysis-system
- https://www.mayerbrown.com/-/media/files/perspectives-events/events/2022/05/chinas-pharmaceutical-patent-linkage-system.pdf%3Frev=e1dac49500454c12972137bf92fa1d1e
- https://curity.io/resources/learn/scopes-claims-and-the-client/
- https://english.cnipa.gov.cn/module/download/downfile.jsp?classid=0&showname=13-Patent+Landscape_+China+and+Belt+and+Road+Partner+Countries+%282013-2023%29.pdf&filename=fbd6219df7de4ef8a817581c038eb211.pdf
- https://www.law.berkeley.edu/wp-content/uploads/2024/10/Intro-of-Drug-Patent-Linkage-System-in-China_20241003_submitted-version.pdf
- https://curity.io/resources/learn/scopes-vs-claims/
- https://www.uspto.gov/web/offices/pac/mpep/s2751.html
- https://ipfdalaw.com/proving-patent-infringement-double-counting-pharmaceutical-ingredients-when-one-element-satisfies-two-claim-limitations/
- https://patseer.com/a-quick-guide-to-pharmaceutical-patents-and-their-types/
- https://www.uspto.gov/patents/search
- https://www.wipo.int/en/web/patentscope
- https://www.iptechblog.com/2023/08/patent-linkage-litigation-in-china-a-two-year-review/
- https://english.cnipa.gov.cn
- https://patentblog.kluweriplaw.com/2024/01/19/chinas-new-patent-term-extension-a-welcome-change-for-innovators/
Last updated: 2025-04-24
