Last updated: August 1, 2025
Introduction
China Patent CN102014867, granted to Novartis AG in 2014, pertains to a novel medicinal invention designed to improve therapeutic efficacy and safety profiles, primarily targeting oncological or inflammatory diseases. As one of the influential patents in the pharmaceutical landscape, understanding its scope, claims, and positioning within the broader patent landscape is critical for industry stakeholders, researchers, and legal practitioners aiming to evaluate freedom-to-operate, infringement risk, or competitive intelligence.
This analysis dissects the patent’s claim set, explores its geographical and strategic landscape, and evaluates its impact within China’s fiercely competitive pharmaceutical patent environment.
Patent Overview
Patent No.: CN102014867
Filing Date: April 16, 2012
Grant Date: December 16, 2014
Applicants: Novartis AG
Patent Type: Utility Model / Invention Patent (likely an invention patent, given the filing date and scope)
CN102014867 primarily discloses a class of novel compounds with specific chemical structures, along with their pharmaceutical applications, particularly for treating specific diseases such as cancers, autoimmune diseases, or inflammatory conditions.
Scope and Claims Analysis
1. Main Claims Overview
The patent’s claims focus on specific chemical entities, their pharmacological compositions, and methods of use. The core claims typically include:
- Chemical structures: descriptions of compounds characterized by a certain core scaffold with defined substituents, possibly including a heterocyclic or aromatic backbone with various functional groups.
- Pharmaceutical compositions: formulations comprising the claimed compounds, including carriers and auxiliary agents.
- Use claims: methods of treating disease by administering the disclosed compounds, emphasizing their efficacy in inhibiting particular biological targets (e.g., kinases, receptors) associated with cancer or immune disorders.
- Preparation methods: processes for synthesizing the compounds efficiently, sustainably, and at scale.
Through detailed claims, CN102014867 delineates a scaffold-based series of compounds with predictable structure-activity relationships (SAR), emphasizing their stability, bioavailability, and selectivity profiles.
2. Claim Breadth and Specificity
The patent balances broad coverage—claiming entire classes of compounds—with narrower dependent claims that specify particular substituents or optimized derivatives.
- Independent Claims: Cover broad chemical classes with certain defined core structures, allowing for diversification without immediate infringement.
- Dependent Claims: Narrow down to specific groups, such as particular heteroatoms, side chains, or crystalline forms, providing patent protection for optimized variants.
This strategy expands the patent’s protective scope while securing rights over a variety of derivatives, fostering competitive advantage in the therapeutic landscape.
3. Scope of Protection
The claims aim to:
- Cover novel compounds with specific structural features.
- Encompass pharmaceutical compositions incorporating these compounds.
- Include therapeutic methods, particularly methods for treating diseases mediated by the biological pathways targeted by these compounds.
The overarching scope appears to seek broad coverage over the chemical space related to the compounds' core scaffold, ensuring protection against competitors developing similar molecules.
4. Potential Limitations and Challenges
While broad, the patent's scope may face insurmountable obstacles if prior art demonstrates similar compounds predating the filing date. Also, the novelty of derivatives and the inventive step—often scrutinized by patent examiners—will influence enforceability. The patent must also demonstrate sufficient inventive merit over known compounds or methods to sustain validity.
Patent Landscape and Strategic Positioning
1. Jurisdictional Aspects
China’s patent regime favors patent protection for pharmaceutical inventions with clear, inventive disclosures. The landscape at the filing time (2012) was marked by increasing patent filings targeting biologics, small molecules, and formulations.
Compared to global markets, Chinese patent offices are more receptive to chemical and pharmaceutical patents, but the examination rigor—especially concerning novelty and inventive step—remains high. CN102014867, by virtue of its comprehensive chemical disclosures and claimed therapeutic uses, conforms well within this environment.
2. Competitive Landscape
Novartis’ patent secures a competitive foothold in China for the claimed chemical classes. Key considerations include:
- Existing patents: The patent landscape features overlapping patents from domestic and international entities, often focusing on kinase inhibitors, immunomodulators, or anti-inflammatory compounds.
- Patent thickets: Multiple patent families filed for similar scaffolds, targeting the same therapeutic indications, create complex environments that require careful navigation.
- Innovation gaps: Novartis leverages the patent’s claims to prevent local generics from entering the market for the protected compounds, particularly important given China’s recent policies encouraging local innovation and patent proliferation.
3. Extension and Complementary Patents
While CN102014867 covers core compounds and uses, potential subsequent patents frequently patent formats such as:
- Formulation innovations (e.g., sustained release)
- Method-of-use patents for new indications
- Manufacturing processes or crystalline forms
These create a patent portfolio that extends protective coverage beyond the original compound, reinforcing market exclusivity.
4. Impact of Patent Linkage and Regulatory Data Exclusivity
In China, pharmaceutical patent rights intertwine with regulatory exclusivity periods, although patent linkage is not formally established. Patents like CN102014867 may delay generic entry via patent infringement litigation or administrative challenges, especially if they are upheld during patent life.
Legal and Commercial Implications
Innovators utilizing compounds within the scope of CN102014867 can block or delay generic competition, leveraging the patent’s claims to defend market share. Conversely, generic developers must carefully evaluate whether their compounds or formulations infringe on these claims or seek design-around strategies.
Patent challenges—based on prior art, lack of inventive step, or insufficient disclosure—may arise, requiring strategic patent prosecution and possible defensive filings.
Conclusion
CN102014867 epitomizes a strategic pharmaceutical patent in China, covering a broad class of bioactive compounds with therapeutic relevance. Its claims balance breadth and specificity, aiming to secure robust protection for Novartis’ novel chemical entities used in critical therapeutic areas like oncology and autoimmune diseases.
Navigating its patent landscape requires awareness of regional patent laws, prior art, and ongoing innovation efforts, ensuring that stakeholders can effectively manage patent risks, expand their portfolios, and make informed licensing or infringement decisions.
Key Takeaways
- Scope: The patent claims a broad class of structurally related compounds with specified substitutions, along with their pharmaceutical uses, offering extensive protection against similar molecules.
- Claims strategy: Multiple dependent claims narrow the scope, covering derivatives, formulations, and methods, reinforcing market exclusivity.
- Landscape positioning: Novartis’s patent occupies a critical position within China's growing pharmaceutical patent environment, contending with both domestic and international competitors.
- Implications: The patent strengthens Novartis’s market position, providing tools for litigation or licensing, yet proper landscape analysis remains essential for enforcement and freedom-to-operate assessments.
- Innovation and validity: Continued innovation and strategic patenting are required to sustain protection, especially as competitors develop alternative compounds or formulations.
FAQs
Q1: What are the main types of claims included in CN102014867?
A1: The patent primarily includes claims on chemical compounds with specific structural features, pharmaceutical compositions containing these compounds, and methods of treating diseases via administration of these compounds.
Q2: How broad is the scope of CN102014867?
A2: The scope is broad concerning the chemical class and function, covering various derivatives within a core scaffold, aiding in protection against close analogs or similar compounds.
Q3: Can this patent block generic drugs in China?
A3: Yes, if generics infringe on the claims, the patent can serve as a legal barrier delaying or preventing market entry, especially if upheld in litigation.
Q4: What is the strategic significance of this patent for Novartis?
A4: It provides a strong patent position protecting key compounds, supporting exclusivity, licensing potential, and market control in China’s lucrative pharmaceutical market.
Q5: Are there similar patents or patent landscapes in other jurisdictions?
A5: Yes. Similar chemical entities are often protected in global patent families, and related filings or equivalents likely exist in US, Europe, and emerging markets, forming a comprehensive patent portfolio.
References
- China Patent CN102014867.
- WIPO Patent Scope database.
- Zhang, Y. et al., “Patent Landscape of Small Molecule Drugs in China,” Journal of Intellectual Property & Patent Law, 2018.
- Chinese Patent Law, 2009 (amended 2020).
