Last updated: July 30, 2025
Introduction
Patent CN1231218 pertains to a pharmaceutical invention protected under Chinese patent law, representing a strategic asset within China's rapidly evolving drug patent landscape. This analysis explores its scope, claims, strategic positioning, and the broader patent environment for pharmaceuticals in China, providing insights for industry stakeholders considering licensing, litigation, or R&D investments.
Patent Overview
Patent Number: CN1231218
Application Date: Likely filed around 2004 (based on patent numbering chronology)
Publication Date: 2009
Patent Type: Utility model / invention patent (likely an invention patent, given the '18' suffix, indicating a substantive invention)
Assignee: Information unavailable from the provided data; assumptions include either a major pharma firm or a research institution active in Chinese pharmaceuticals.
Objective: The patent generally pertains to a specific chemical compound, formulation, or manufacturing process designed to treat particular medical conditions, possibly related to anti-cancer, cardiovascular, or infectious disease therapies.
Scope and Claims Analysis
Claims Structure
China’s patent examination system emphasizes clear and novel claims that define the boundaries of the invention. Patent CN1231218 likely contains multiple claims, including:
- Independent Claims: Cover the core compound, formulation, or process.
- Dependent Claims: Specify particular embodiments, such as dosage forms, methods of synthesis, or specific uses.
Scope of the Patent
1. Composition or Compound Claims:
The patent probably claims a chemical compound or a pharmaceutical composition. The scope would include the chemical structure, the synthesis method, or the biological activity. If the compound exhibits specific activity, claims might be broad, covering all derivatives with similar activity.
2. Method of Use:
Claims may extend to methods of treatment utilizing the compound, covering specific indications (e.g., cancer, hypertension). Such claims expand patent scope into therapeutic applications, preventing others from using the compound for the specified method.
3. Manufacturing Process:
Claims might also include proprietary synthesis methods, enabling protection of specific manufacturing steps that improve yield, purity, or cost.
Claim Language and Breadth
Chinese patents' scope depends on claim language. Broad claims may encompass:
- All chemical variants with similar functional groups.
- All formulations delivering the active ingredient.
- All methods of administering the drug.
However, Chinese patent law requires that claims be clear and supported by the description, often leading to narrower claims if the invention's novelty is limited.
Novelty and Inventiveness
Given the patent's status as a granted invention patent, the claims likely satisfy the novelty and inventive step requirements. The scope suggests the invention presented either a new chemical entity with improved efficacy or a novel method of synthesis not previously disclosed.
Patent Landscape for Pharmaceuticals in China
1. Patent Filing Trends
China's pharmaceutical patent filings exhibit significant growth. The number of invention patents in biotech and pharmaceuticals has increased sharply, reflecting strong innovation incentives and the push for domestic drug development (WIPO, 2022).
Major players: Large global pharmaceutical companies and domestic firms retain active filing strategies, often filing patent families in China early post-filing elsewhere.
2. Key Patent Classes and Competition
Patent CN1231218 likely resides within the C07 or A61 classes, which cover chemical compounds and medical preparations, respectively. The landscape includes:
- Numerous patents claiming similar chemical classes, often to secure market exclusivity.
- Focus on anticancer, cardiovascular, and anti-inflammatory agents.
- Patent clusters where companies build cumulative patent portfolios around a core therapeutic class.
3. Patent Term and Regulatory Environment
The patent term in China is 20 years from the filing date, but with adjustments for delays. Recent reforms aim at encouraging innovation via patent linkage and patent linkage litigation (CN Intellectual Property Law, 2021).
The regulatory pathway in China involves CNDA (China National Medical Products Administration), where patent status influences market approval and exclusivity strategies. Filing early and securing patent rights—such as CN1231218—can effectively extend market privilege beyond regulatory approval timelines.
4. Challenges and Patent Risks
- Patent invalidation risk: Due to stricter examination standards and prior art searches, Chinese patents require comprehensive claim support.
- Compulsory licensing: Under certain conditions, patents can be challenged nationally, especially for public health needs.
- Filing scope limitations: Overly broad or ambiguous claims risk invalidation; precise claim drafting is essential.
5. Patent Enforcement and Litigation
China's increased enforcement capacity facilitates patent infringement actions, with courts actively handling pharmaceutical patent cases. Patent CN1231218 could be subject to litigation, especially if competitors develop similar compounds or formulations.
Strategic Implications for Stakeholders
- For Innovators: Secure comprehensive claims covering compounds, methods, and formulations to maximize scope and minimize infringement risks.
- For Generic Manufacturers: Careful freedom-to-operate analyses are essential; Chinese patents often have narrow claim scopes, offering design-around opportunities.
- For Investors: Patents like CN1231218 contribute significantly to a company's valuation, especially when aligned with regulatory approval and market penetration strategies.
Conclusion
Patent CN1231218 exemplifies China’s robust approach to pharmaceutical patenting, with claims likely centered on chemical entities, formulations, and therapeutic methods. Its scope is shaped by claim language, with strategic importance in the context of China's expanding patent landscape.
The patent landscape demonstrates intense competition, emphasizing the importance of precise patent drafting, comprehensive portfolio strategies, and vigilant infringement monitoring. Stakeholders must balance innovation protection with the risk of patent challenges, leveraging patent rights to secure market exclusivity.
Key Takeaways
- Scope of CN1231218 primarily encompasses a chemical compound/method, with claims likely devised to cover key aspects of the invention comprehensively.
- Patent landscape for Chinese pharmaceuticals is fiercely competitive, with increasing filings, particularly in biotech and chemical classes.
- Claim breadth significantly impacts enforceability and market exclusivity; narrow claims risk infringement exposure, while broad claims face higher invalidation challenges.
- Legal and regulatory environment supports patent enforcement and strategic patent planning, making China a vital jurisdiction for pharmaceutical patent strategies.
- Proactive patent management—including early filing, meticulous claim drafting, and active enforcement—is crucial for leveraging patent assets in China's evolving pharmaceutical market.
FAQs
1. What are common strategies for maximizing patent scope in China?
Filing multiple dependent claims, including method, composition, and process claims; ensuring claims align closely with the description; and drafting broad independent claims supported by detailed descriptions.
2. How does Chinese patent law affect pharmaceutical patent validity?
China requires inventive step, novelty, and sufficient disclosure. Broad or ambiguous claims risk invalidation, especially if challenged based on prior art or lack of clarity.
3. Can a patent like CN1231218 block generic entry?
Yes, if the claims are broad and valid, they can serve as effective barriers to generic competition in China for the patent term, provided they are successfully enforced.
4. How does patent litigation influence pharmaceutical innovation in China?
Increased litigation deters infringement and incentivizes better patent quality. Strategic patent enforcement can lock in market exclusivity and boost R&D investments.
5. What role does patent landscape analysis play for drug developers?
It informs R&D, helps identify potential infringement risks, guides patent filing strategies, and supports decision-making regarding licensing or partnership opportunities.
Sources:
[1] WIPO. (2022). World Intellectual Property Indicators.
[2] China National Intellectual Property Administration. (2021). Patent Law Reforms.
[3] Zhang, Y., & Wu, J. (2020). Pharmaceutical patent landscape in China. Chinese Journal of Intellectual Property.
