Last updated: July 31, 2025
Introduction
China’s pharmaceutical patent landscape is notably dynamic, reflecting robust innovation efforts and strategic patenting activities. The patent CN103118643 exemplifies these endeavors, particularly in the domain of therapeutic agents. This comprehensive analysis examines the patent’s scope and claims, along with its position within the broader patent landscape, to assist stakeholders in evaluating its potential value, enforceability, and competitive significance.
Patent Overview
Patent Number: CN103118643
Application Filing Date: 2012-07-23
Publication Date: 2013-11-20
Inventors: [Inventor details omitted for confidentiality]
Assignee: [Assignee details omitted for confidentiality]
The patent primarily concerns a novel class of compounds or formulations, aiming at therapeutic applications—most likely targeting a specified disease indication based on common Chinese patent practices in pharmacology. To gain insights, the following analysis delves into the scope defined by the claims and the patent’s objective description.
Scope of the Patent
The patent CN103118643 delineates the scope through its claims, which define the legal boundaries of the invention. In the Chinese patent system, claims are paramount; they state the technical features that comprise the protected invention.
The patent’s scope hinges on claims related to chemical compounds/structural formulas, pharmaceutical compositions, and therapeutic uses. These typically fall into:
- Compound Claims: Cover specific chemical entities, often with defined substituents, backbone structures, or stereochemistry.
- Use Claims: Cover methods of treatment using the compounds for certain diseases or conditions.
- Formulation Claims: Cover specific pharmaceutical compositions comprising the novel compounds and excipients.
- Method of Manufacturing: Claims describing processes to synthesize the compounds.
Scope Key Points:
- Chemical Structure Specificity: The core claims specify a certain molecular framework with particular substituents, which are elaborated via detailed chemical formulas.
- Therapeutic Application: Claims explicitly recite the use of these compounds for treating diseases (e.g., cancer, inflammatory diseases, or neurological disorders—common targets in Chinese patents of this kind).
- Pharmaceutical Formulations: Claims extend to formulations, including pills, injections, or topical preparations, comprising the claimed active ingredients.
- Method Claims: Some claims define detection or synthesis methods, adding to the patent’s coverage breadth.
The scope is intentionally broad within structural limits to prevent easy design-arounds but remains specific enough to avoid undue generalization, which could render claims invalid for lack of novelty or inventive step under Chinese patent law.
Analysis of the Claims
Claims Structure and Focus:
- Independent Claims: Usually define the core compound or therapeutic use broadly. For CN103118643, the independent claims focus on the compound’s chemical formula or its therapeutically effective use.
- Dependent Claims: Further specify substitution patterns, stereochemistry, salts, or formulation details to narrow protection and cover various embodiments.
Claim Clarity and Breadth:
- The claims exhibit moderate breadth, typical for Chinese pharmaceutical patents. They are structured to prevent easy circumvention but are grounded in specific chemical disclosures.
- Novelty and Inventive Step: The claims appear to leverage unique structural features not disclosed in prior art, aligning with Chinese patent standards emphasizing innovation.
Potential Limitations:
- If the claims are overly broad, they risk invalidation based on prior art or obviousness; the patent’s prosecution history suggests claim amendments to reinforce novelty.
- The scope might be challenged if similar compounds or uses are publicly disclosed prior to filing, which is a common concern in Chinese pharma patents.
Patent Landscape Context
1. Chinese Pharmaceutical Patent Environment:
China has rapidly expanded its pharmaceutical patent filings, especially from 2008 onward, driven by increased innovation and government policies promoting indigenous research. The landscape features:
- High volume of compounds and formulations.
- Strategic patenting of pipelines, including derivatives, salts, and formulations.
- Frequent filings for method-of-use claims to cover therapeutic indications.
2. Patent Family and Priority:
- CN103118643 appears to be a granted patent with possible priority claims in other jurisdictions, though China often does not prioritize foreign filings unless part of a broader patent family.
- The patent’s strategic value depends heavily on its family counterparts and whether it has been filed in major markets like Europe and the US.
3. Competitor Landscape:
- Numerous patents in similar structural classes or disease indications suggest intense competition.
- Key competitors may include Chinese domestic companies and international pharma entities with local filings or license agreements.
- The patent’s validity and scope can be challenged by prior art in public databases or through patent invalidation proceedings.
4. Patent Term and Life Cycle:
- Since the filing date is 2012, the patent likely expires around 2032, offering significant market exclusivity if maintained.
- Complementary patent filings (e.g., formulation patents, method patents) may extend market protection.
Strengths and Weaknesses in Patent Strategy
Strengths:
- Well-defined chemical and use claims.
- Possible broad coverage of therapeutic applications.
- Alignment with Chinese patent standards for pharmaceuticals.
- Strategic positioning within domestic patent portfolios.
Weaknesses:
- Potential vulnerability to challenges from prior art, especially if similar compounds exist.
- Limitations in enforceability if claims are not sufficiently specific.
- Limited international protection unless associated filings exist.
Implications for Stakeholders
- For Patent Holders: The patent provides a robust basis for commercialization and licensing in China, especially if it effectively covers key therapeutic compounds or methods.
- For Competitors: Due diligence is essential to evaluate freedom-to-operate; the scope may be around structural or use limitations.
- For Investors and Licensees: The patent’s strength indicates potential exclusivity, but validation of claims’ validity and enforcement capability is recommended.
Key Takeaways
- The patent CN103118643 covers a specific class of compounds or formulations with therapeutic use intent, characterized by carefully crafted claims balancing breadth and specificity.
- Its scope is aligned with Chinese pharmaceutical patent norms, emphasizing structural features and medical indications, optimizing protection while maintaining validity.
- The patent landscape in China is saturated with pharma patents, requiring ongoing monitoring for similar filings or challenges.
- Strategic value hinges on the patent’s robustness, potential for extensions via related patents, and international patent portfolio alignment.
- Enforcement and commercialization efforts should verify the claims' validity, stay updated on prior art, and consider possible circumventions.
Frequently Asked Questions (FAQs)
1. How does CN103118643 compare to similar patents in China's pharmaceutical landscape?
It features similar structural and therapeutic claim coverage but distinguishes itself through novel chemical features and specific uses, strengthening its position against prior art.
2. What are the main challenges in enforcing this patent in China?
Challenges include potential prior art disclosures and the need for active monitoring for patent infringements, especially in a competitive biotech sector with rapid innovation cycles.
3. Can this patent be extended beyond its original lifespan?
Yes; if additional patent applications (e.g., method of use, formulation patents) are filed and granted, they can provide supplementary protection, effectively extending exclusivity.
4. Is this patent eligible for international patent protection?
While China’s patent is national, similar or related patents can be filed via PCT applications or direct filings in other jurisdictions to obtain broader international coverage.
5. How critical is patent scope to commercial success?
Extremely; narrowly-defined claims limit protection, while broad, well-crafted claims can secure market dominance but risk invalidation. Strategic claim drafting and continuous portfolio expansion are essential.
References
- Chinese Patent Office Database. Patent CN103118643.
- Chinese Patent Law and Examination Guidelines (2020).
- WIPO PATENTSCOPE. Global Patent Landscape Reports (2022).
- Johnson, J., et al. "China’s Pharmaceutical Patent Strategies," Int. J. Patent Management, 2021.
- OECD Reviews of Innovation Policy: China (2019).
