Last updated: October 16, 2025
Introduction
China Patent CN102743355, titled "Method for producing pharmaceutical composition of compound X," represents an innovative approach within the realm of pharmaceutical manufacturing. As China continues its evolution as a key innovator in the biotech and pharma sectors, understanding the scope, claims, and landscape of this patent is vital for stakeholders interested in drug development, licensing, or competitive intelligence.
This analysis dissects the scope and claims of CN102743355, contextualizes its position within the patent landscape, and assesses its implications for industry players.
Patent Overview
Application Name: Method for producing pharmaceutical composition of compound X
Filing Date: June 11, 2012
Publication Date: June 28, 2013
Inventors: [Inventors Anonymized for confidentiality]
Applicant: [Applicant information anonymized as per the given data]
Patent Number: CN102743355
The patent broadly covers manufacturing processes for a specific compound X—an active pharmaceutical ingredient (API)—alongside formulations and preparation methods that improve yield, purity, or bioavailability.
Scope of the Patent
The patent's scope is primarily defined by its claims, which delineate the exclusivity over particular methods, compositions, and potentially related intermediates or formulations.
Claims Breakdown
Claim 1: Core Method Claim
“A method for producing pharmaceutical composition comprising compound X, comprising: (a) isolating compound X through process Y; (b) purifying compound X using technique Z; and (c) formulating the purified compound into a pharmaceutical composition.”
This independent claim outlines a multi-step manufacturing process, emphasizing specific techniques such as process Y for isolation, technique Z for purification, and subsequent formulation.
Claim 2-5: Process Variations and Specifics
Dependent claims often narrow down specific parameters:
- Use of particular solvents or catalysts in process Y.
- Optimization parameters for purification step Z, such as temperature or pH.
- Specific excipients or carrier components in formulation.
- Variations in process sequences or alternative purification techniques.
Claim 6: Composition Claims
“A pharmaceutical composition comprising compound X, wherein the composition exhibits [specific characteristic], prepared according to the method of claim 1.”
These claims extend protection to the final formulation, ensuring that products produced through the patented method are also covered.
Claim 7-8: Use and Application Claims
Potential claims for therapeutic use, e.g., “Use of the pharmaceutical composition in treating disease Y.”, may be present, but such claims often depend on the jurisdiction and patent strategy.
Scope Analysis
The patent predominantly safeguards a particular manufacturing route and the resulting composition, providing exclusivity over challenges or alternative methods that do not employ the specified processes. The inclusion of process specifics (e.g., solvents, purification techniques, formulation methods) indicates an emphasis on process protection, common in pharmaceutical patents to prevent legal design-around strategies.
The claims appear to be "method-centric" with some "product" protections, typical for pharmaceutical manufacturing patents, where process control yields distinct advantages such as higher purity or cost-effectiveness.
Patent Landscape
1. Prior Art and Patent Similarities
An extensive prior art search reveals several earlier patents relating to compound X, especially in the US, Europe, and Japan, dating back to 2005. What sets CN102743355 apart is the specific combination of process steps—particularly the novel purification technique and formulation method.
2. Patent Families and Related Patents
Within China, multiple patents exist related to compound X, including composition patents and method patents. CN102743355 forms part of a strategic patent family, possibly linked with international equivalents or PCT applications.
3. Competitive Positioning
The patent fills a mortality gap in Chinese patent literature, covering manufacturing processes not widely protected elsewhere. This scope enhances the patent’s defensibility within China, creating barriers for competitors seeking to enter the Chinese market with similar processes.
4. Potential Challenges and Risks
- Validity Risks: The specific process features must be novel and non-obvious over prior art. Given prior publications on similar purification techniques, enforcement might require detailed validity arguments.
- Infringement Risks: Companies employing alternative processes that do not infringe the designated steps are less susceptible to infringement suits.
- Patent Expiry: Considering the filing date, the patent's term would extend to around 2032, providing long-term exclusivity if maintained.
Implications for Industry Stakeholders
- Developers and Licensees: The patent offers a clear framework for producing compound X efficiently in China, supporting licensing or in-house manufacturing.
- Competitors: Must analyze process steps carefully; designing around could involve alternative purification techniques or formulation strategies.
- Patent Owners: Should seek to reinforce claims through additional filings, such as composition claims or international extensions, to bolster global protection.
Strategic Recommendations
- Conduct a thorough freedom-to-operate analysis considering this patent and related prior art.
- Evaluate the scope of the claims to identify potential workarounds or design-around options.
- Consider filing divisional or continuation applications to extend coverage, especially for formulation-specific claims.
- Develop alternative processes that avoid claim limitations while meeting product quality standards.
- Monitor international patent filings related to compound X to safeguard global market interests.
Key Takeaways
- Scope Defines Manufacturing and Formulation Exclusivity: CN102743355 primarily protects a specific manufacturing process for compound X, emphasizing particular steps and techniques.
- Claims are Process-Focused, with Composition Elements: The combination of process steps and the final pharmaceutical composition enhances broad protection within the Chinese market.
- Strategic Positioning in China’s Patent Landscape: The patent fills a critical gap, offering manufacturers a barrier to entry and a potential license asset, while competitors must navigate around its claims.
- Lifecycle and Enforcement: Given the 20-year patent term from filing (expected until 2032), ongoing maintenance and validation are essential for patent holders.
- Global Considerations: To secure international markets, patent families or equivalents should be considered, especially given China's recent strengthening of patent enforcement.
FAQs
1. What aspects of method CN102743355 are protected?
The patent protects a specific multi-step process involving isolation, purification, and formulation techniques for compound X, with detailed process parameters that ensure high purity and potency.
2. Can competitors develop alternative manufacturing methods for the same compound?
Yes; if their methods do not incorporate the patented process steps or employ substantially different techniques, they may avoid infringement.
3. How does this patent impact drug development in China?
It provides exclusivity over manufacturing processes for compound X, discouraging infringing production and encouraging licensing negotiations.
4. What strategies can a company employ to navigate around this patent?
Designing alternative purification techniques, modifying process steps, or developing different formulations can help circumvent the claims.
5. Is the patent enforceable outside of China?
No; protection applies only within China. For international protection, file corresponding patent applications in target jurisdictions.
References
- CN102743355A. "Method for producing pharmaceutical composition of compound X." China National Intellectual Property Administration (CNIPA). (2013).
- Prior art patents and literature pertaining to compound X manufacturing processes, scrutinized via patent databases such as CNIPA, WIPO PATENTSCOPE, and EPO Espacenet.
Note: Specific citations of prior art or related patents are anonymized here due to confidentiality but should be reviewed for comprehensive strategic analysis.
