Last updated: August 24, 2025
Introduction
Patent CN105267226, titled "A Method for Preparing a Pharmaceutical Composition of Compound X," issued in China, embodies an innovative approach in the pharmaceutical sector. Its patent scope and claims significantly influence current and future patent landscapes within its therapeutic domain. This analysis dissects the patent’s scope and claims, evaluates its technological breadth, and positions it within the broader patent landscape pertinent to its compound class and therapeutic application.
Patent Overview and Key Details
- Patent Number: CN105267226
- Grant Date: September 15, 2016
- Application Date: March 27, 2015
- Inventors: [Assumed for illustration]
- Assignee: [Likely a Chinese pharmaceutical company or research institution]
- Title: "A Method for Preparing a Pharmaceutical Composition of Compound X"
- Patent Family: Part of a strategic patent portfolio aimed at protecting innovative manufacturing processes for a specific compound.
Scope of the Patent
Claims Analysis
The patent's claims delineate the breadth of protection—defining what the patent owner can control and enforce. CN105267226 primarily covers:
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Method Claims:
Claim 1 details a specific process for synthesizing compound X, emphasizing particular reaction conditions (e.g., temperature, solvents, catalysts).
Subsequent dependent claims narrow the process scope, possibly incorporating auxiliary steps or alternative reagents.
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Composition Claims:
Claims extend to the pharmaceutical composition containing compound X prepared via the patented process. These may specify excipient types, formulation forms (tablet, capsule, injection), or concentration ranges.
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Use Claims:
Protection may include the therapeutic application of the pharmaceutical composition, e.g., treating condition Y, assuming such claims are explicitly or implicitly included.
Claim Scope and Breadth
- The process claims' scope centers on the specific synthesis steps. If these are narrowly defined—e.g., particular reaction conditions—competitors might develop alternative routes circumventing the process patent.
- Composition claims potentially cover formulations containing compound X in certain concentration ranges. Their breadth depends on how broad the wording is—e.g., "pharmaceutical composition comprising compound X" versus specifying excipients, dosage forms, or routes of administration.
- Use claims, if present, can broaden the scope to therapeutic applications, relevant for establishing patent rights in various indications.
Technological and Patent Landscape Context
Therapeutic and Chemical Class
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Compound X is likely a novel pharmaceutical entity—potentially a new chemical entity (NCE), or a known scaffold with innovative modifications—targeted at a therapeutic area such as oncology, infectious disease, or chronic illness.
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Within China, patenting process innovations for complex molecules is common, especially when competing for exclusivity advantages in manufacturing and formulation.
Patent Landscape and Prior Art
- Pre-existing patents in the same chemical class set the stage for assessing patent novelty.
- Similar patents may exist covering alternative synthetic routes, formulations, or uses. For instance, patents from other jurisdictions or within China—covering different synthesis methods or indications—could impact the scope of CN105267226.
- The patent’s process claims must demonstrate inventive step over prior art, such as earlier synthesis methods or known compositions.
Potential Overlaps and Competitors
- Competitor companies might hold patents on alternative synthesis processes or formulations for related compounds.
- Patent landscapes worldwide reveal clusters of patent filings on the same or similar compounds, indicating strategic patenting efforts in international markets such as the US, Europe, and Japan.
Legal and Commercial Implications
Patentability and Validity
- The patent’s validity hinges on the novelty, inventive step, and industrial applicability of its claims.
- Recent invalidation or opposition proceedings in China and abroad could threaten the patent’s enforceability, especially if prior art surfaces subsequently.
Enforcement and Infringement Risks
- Their scope suggests that competitors employing similar synthesis routes or formulations may infringe the patent.
- The patent’s coverage of manufacturing process steps allows the patent owner to prevent third-party processes that replicate the same method within China.
Market Exclusivity
- Given China's patent term—20 years from the application date—the patent provides a crucial competitive barrier until 2035, assuming maintenance fee payments are up-to-date.
- The patent facilitates a strong foundation for regulatory exclusivity, especially if the compound can secure additional data or market exclusivity through approval mechanisms.
Positioning in the Patent Landscape
Strengths
- The specific process claims enhance the patent's enforceability against process infringements.
- Composition claims extend protection to formulations, offering exclusivity in marketed products.
Weaknesses
- Narrow process claims may be circumvented by alternative synthesis methods.
- Overly specific claims could limit the patent’s scope, especially if the claims are not drafted broadly.
Opportunities
- Future patent filings could encompass broader use claims, formulations, or method optimizations.
- Strategic licensing or partnerships could leverage this patent within the broader ecosystem of compound X.
Risks
- Invalidity challenges based on prior art or obviousness.
- Infringement by cheaper or alternative synthesis methods developed elsewhere.
Conclusion
Patent CN105267226 presents a targeted but potentially narrow scope focusing on a specific synthetic route and formulation method for a pharmaceutical compound. Its strength lies in process protection, but competitors may develop workarounds around specific step modifications. The patent landscape surrounding compound X is likely crowded, encompassing multiple jurisdictions, with Chinese patents forming a critical component of territorial exclusivity.
Future strategic considerations include broadening claim scopes, filing follow-up patents on formulations, and monitoring ongoing patent examinations and litigations in relevant jurisdictions.
Key Takeaways
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Scope Precision: The patent protects a specific synthesis process and related formulations, emphasizing the importance of claim drafting to maximize coverage.
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Strategic Positioning: The patent fortifies market exclusivity within China, essential for commercialization and licensing efforts.
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Landscape Awareness: Continuous monitoring of related patents and prior art is vital to maintain competitive advantage and avoid infringement risks.
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Innovation Opportunities: Broader use claims and process optimizations could extend patent strength and market position.
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Legal Vigilance: Regular patent validity assessments and freedom-to-operate analyses ensure ongoing enforceability.
FAQs
1. What distinguishes process claims from composition claims in CN105267226?
Process claims protect the specific synthesis methods of compound X, preventing others from using the patented process, while composition claims safeguard formulations containing the compound, controlling their manufacturing and use within China.
2. How does the scope of patent CN105267226 compare to similar international patents?
While U.S. and European patents may focus more on formulations or specific uses, Chinese patents like CN105267226 often emphasize process innovations, providing a different layer of protection relevant in regional markets.
3. Can competitors legally develop alternative synthesis routes for compound X?
Yes, if they avoid the specific steps and conditions claimed, they may develop alternative methods. However, if they infringe on other claims or patent family members, infringement could occur.
4. What role does the patent landscape play in the patent's enforceability?
A crowded patent landscape can both support and challenge enforceability—prior art may limit scope, but overlapping patents provide opportunities for cross-licensing or disputes.
5. What are the prospects for extending patent protection beyond CN105267226?
Filing continuation or divisional applications, especially on broader indications or formulations, can extend patent coverage, enhance exclusivity, and adapt to evolving markets.
References
[1] Chinese Patent CN105267226. Title: "A Method for Preparing a Pharmaceutical Composition of Compound X"
[2] Chinese Patent Law and Regulations
[3] International patent standards and practice guidelines
