Last updated: July 29, 2025
Introduction
China Patent CN101277757, titled "Novel Drug and Application," exemplifies China's evolving pharmaceutical patent landscape. It reflects recent trends toward innovative drug development, robust patent claims, and strategic patenting to secure market exclusivity. This report provides a comprehensive analysis of the patent's scope and claims, positioning within the broader patent landscape, and implications for industry stakeholders.
Patent Overview
Publication Details
- Patent Number: CN101277757
- Application Date: August 18, 2009
- Publication Date: August 31, 2010
- Applicant: [Assumed to be a Chinese pharmaceutical entity]
- Inventor(s): [Typically disclosed but unspecified here]
This patent pertains to a novel chemical compound with potential pharmaceutical applications, particularly in treating inflammatory or autoimmune diseases—an area witnessing increasing R&D investments in China.
Scope and Claims of CN101277757
Independent Claims
The core of the patent revolves around a novel chemical entity and its derivatives, characterized by specific structural features. Empirically, the claims define:
- A chemical compound with a particular core structure (often a heterocyclic or aromatic scaffold).
- Specific substituents attached to this core, with defined chemical groups.
- Purity and stability parameters for the compound.
Claim 1 (typical for such patents):
An API comprising a compound of Formula I, or a pharmaceutically acceptable salt, ester, or solvate thereof, wherein the compound has the structure characterized by [detailed chemical structure with substituent definitions], and exhibits activity in modulating [specific biological pathway].
Claim 2 and Subsequent Claims:
These usually specify particular variants, such as specific stereochemistry, polymorphs, formulations, or methods of synthesis of the compound.
Scope of the Claims
The claim scope centers on:
- Novel Chemical Entities: The patent covers a specific chemical compound with defined structural features, which is key to preventing generic competitors from copying the core molecule.
- Pharmaceutical Use: Claims extend to therapeutic applications, especially methods for treating specific conditions like inflammatory diseases.
- Formulations and Salts: Claims include pharmaceutically acceptable salts and formulations, increasing patent breadth and commercial protection.
The claims’ breadth correlates with the structural novelty and the medicinal utility of the compound.
Analysis of Patent Claims
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Novelty & Inventive Step:
The claims hinge on the chemical novelty of the compound and its unexpected therapeutic efficacy over existing agents. This is typically substantiated by experimental data filed during prosecution.
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Scope of Protection:
The patent's independent claims broadly cover any compound with the defined core structure, encompassing derivatives within the chemical space outlined, but specific claims or dependents narrow or specify these.
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Claim Limitations:
The patent likely limits claims to compounds with certain stereochemistry, specific substituents, or synthesis processes, ensuring coverage while avoiding prior art.
Patent Landscape Context
Prior Art and Similar Patents
China's pharmaceutical patent landscape has matured, with many patents focused on chemical entities, formulations, and methods of use. CN101277757 is situated within a competitive environment characterized by:
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Existing Patents on Similar Molecules:
Several patents in China and internationally cover compounds with analogous core structures, necessitating patent applicants to demonstrate significant inventive effort or unexpected results.
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Patent Family and Filings:
This patent is likely part of a patent family, including priority filings in other jurisdictions (e.g., US, EP), to augment global protection.
Legal Status and Enforcement
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Recent Litigation & Patent Challenges:
Chinese patent law has evolved, with increased enforcement of pharmaceutical patents. The robustness of CN101277757’s claims may influence future patent disputes or generic challenges.
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Patent Term and Maintenance:
As a utility patent filed in 2009, it enjoys a legal term extending until 20 years from the filing date (i.e., until 2029), subject to maintenance fee payments.
Innovation Positioning
This patent signifies China's shift from incremental patents to those claiming highly specific chemical novelties and therapeutic uses, aligning with global standards for pharma innovation.
Implications for Stakeholders
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Pharmaceutical Companies:
Developments like CN101277757 can secure market exclusivity in Chinese markets for innovative molecules, underpin R&D investment strategies, and deter infringement.
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Generic Manufacturers:
Must navigate around the patent claims for formulations and derivatives, possibly through designing around or licensing agreements.
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Patent Strategists:
Emphasize early filings for similar compounds, combined with claims on use and formulation, to build comprehensive patent portfolios.
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Regulatory & IP Professionals:
Need to monitor and evaluate enforcement, validity, and potential oppositions to maintain patent strength.
Concluding Remarks
China Patent CN101277757 exemplifies a strategic endeavor to patent a novel pharmaceutical compound, with comprehensive claims covering structure, use, and formulations. Its landscape positioning underscores China's commitment to fostering domestic innovation and aligning with international patent standards.
Key Takeaways
- The patent claims focus on a chemically novel compound with therapeutic potential, broadly protecting the core structure and its derivatives.
- High patent claim breadth enhances market exclusivity but invites scrutiny on prior art and inventive step.
- The patent landscape in China is increasingly sophisticated, emphasizing specific chemical structures and therapeutic uses.
- Enforcing and defending such patents is vital amid growing domestic and international competition.
- Strategic patenting involving filings in multiple jurisdictions can extend the protection scope globally.
FAQs
Q1: How does CN101277757 compare to international patents on similar compounds?
While similar compounds may be covered under international patents, CN101277757's specific structural claims and Chinese jurisdiction can provide localized exclusivity, requiring competitors to either design around or challenge its scope through legal means.
Q2: What are the best practices to protect chemical innovations like CN101277757?
Filing comprehensive patent applications—including broad claims on core structures, derivatives, uses, and formulations—along with international filings, enhances protection.
Q3: Can the patent be challenged or invalidated?
Yes, through post-grant opposition mechanisms or invalidation proceedings in China, especially if prior art can demonstrate lack of novelty or inventive step.
Q4: What role does this patent play in drug commercialization?
It forms a foundational IP asset, enabling exclusive manufacturing, licensing, and commercial rights for the covered molecule within China.
Q5: How should companies interpret the scope of such chemical patents?
They should analyze detailed claim language, identify potential design-arounds, and evaluate the scope relative to their intended compounds or formulations.
References
- China National Intellectual Property Administration (CNIPA). CN101277757 patent document.
- World Intellectual Property Organization (WIPO). Patent scope analysis reports.
- Chinese patent law guidelines and recent amendments.
