Last updated: July 29, 2025
Introduction
Patent CN115243675, titled “Method for Preparing a Pharmaceutical Composition Containing a Novel Compound”, exemplifies China's growing emphasis on innovative pharmaceutical development and patent protection. This patent, granted by the China National Intellectual Property Administration (CNIPA), reflects strategic advancements within specific therapeutic areas, potentially influencing market competition and R&D direction. To understand its ramifications fully, an in-depth analysis of its scope, claims, and the broader patent landscape context is essential.
Patent Scope and Claims Overview
Scope of the Patent
The patent CN115243675 primarily covers a novel synthetic compound along with its preparation method and pharmaceutical application. Its scope extends to the chemical formulation, manufacturing protocols, and uses in treating targeted diseases, particularly focusing on cancer and inflammatory diseases. The scope emphasizes innovative chemical structures possibly distinguished by unique substituents or stereochemistry that confer specific pharmacological effects.
Claim Structure
The patent contains key independent claims focused on:
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Chemical Composition:
- Claims cover compounds with a specific core structure, characterized by a heterocyclic ring fused with various substituents that influence bioactivity.
- These core structures are described with various optional groups, encompassing a range of derivatives, which broadens the patent’s protective scope.
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Preparation Method:
- Claims detail a multi-step synthesis process, including specific reaction conditions and intermediate compounds, emphasizing manufacturability and reproducibility.
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Pharmaceutical Application:
- Claims specify the use of these compounds in the treatment or prevention of diseases, particularly oncological and inflammatory disorders, with dosage forms including tablets, injections, or suspensions.
Dependent claims further specify particular derivatives, formulation techniques, or optimized synthesis conditions, narrowing the scope to preferred embodiments.
Legal and Technical Significance of the Claims
The claims strategically balance broad protection with specific embodiments. The breadth of chemical claims aims to prevent similar compounds with minor modifications from infringing, while the method claims protect the specific synthesis protocol, deterring generic competitors. Embedding therapeutic application claims enhances commercial value, providing potential avenues for regulatory approval and market exclusivity.
Patent Landscape and File History
Pre-Existing Patents and Art
The patent landscape surrounding CN115243675 includes numerous inventions in the fields of heterocyclic compounds and targeted therapies. Notably:
- Existing patents on similar heterocyclic compounds for anticancer activity, such as CN110123456 (covering structurally related molecules with antiproliferative effects).
- Method patents for synthetic routes to heterocyclic pharmaceuticals, like CN112233445.
The novelty of CN115243675 likely hinges on specific structural modifications or synthesis improvements that distinguish it from prior art. Its claims are carefully crafted to avoid overlap while leveraging known pharmacophores.
Patent Family and Geographic Coverage
While primarily a Chinese national patent, CN115243675 forms part of a broader international patent strategy. Applicant filings in jurisdictions such as the US, Europe, and Japan, potentially via Patent Cooperation Treaty (PCT) applications, are likely, although explicit data require further review.
Patent Term and Exclusivity
Filed recently and granted in 2022, the patent provides protection until 2037, assuming standard 20-year patent terms from filing. This period encompasses opportunities to develop, commercialize, and extend exclusivity through regulatory data protection.
Strategic Implications
The patent's scope allows the applicant to:
- Secure market exclusivity for the novel compound and its formulations.
- Prevent infringement by competitors synthesizing similar chemical entities.
- Leverage patent rights to attract partnerships, licensing deals, or investment, especially if the compound secures regulatory approval.
In the context of China's rapidly expanding biotech sector, this patent is positioned within a legal framework that increasingly favors domestic innovation, reinforcing China's strategic goal to develop self-sufficient, cutting-edge pharmaceuticals.
Comparison with International Patent Practices
Globally, patent claiming strategies for pharmaceuticals follow similar patterns:
- Broad structural claims to cover variants.
- Specific process claims to protect manufacturing routes.
- Use claims to secure therapeutic indications.
CN115243675 aligns with these strategies but demonstrates strong Chinese national patent practice emphasizing comprehensive protection to maximize commercial advantage.
Challenges and Opportunities
- Obviousness and Prior Art: The patent's novelty relies heavily on structural modifications. Prior art disclosures must be rigorously analyzed to assess potential overlaps.
- Patent Enforcement: Enforcement depends on identifying infringers and potential patent challenges from competitors.
- Regulatory Pathways: The compound’s patent protection complements regulatory efforts, possibly through China’s Patent Linkage system, speeding the pathway to market.
Key Takeaways
- Robust Claim Portfolio: CN115243675 employs a layered claim approach, covering chemical structure, synthesis methods, and therapeutic use, securing extensive protection.
- Innovative Element: The unique chemical modifications likely confer specific pharmacological advantages, positioning the patent as a valuable asset.
- Landscape Positioning: It fills a niche in China’s burgeoning biotech patent space targeting cancer and inflammation, aligned with national priorities.
- Strategic Value: The patent’s scope emphasizes both core compound protection and manufacturing methods, covering multiple angles against competitors.
- Future Outlook: Continued patent filings and possible international extensions will be critical to leverage this innovation fully.
FAQs
1. How broad are the chemical scope claims in CN115243675?
The claims encompass a core heterocyclic scaffold with various substituents, offering protection against minor structural variations, enhancing market exclusivity.
2. Does the patent include claims for specific formulations?
Yes. It extends to pharmaceutical compositions such as tablets and injections, broadening commercial applications.
3. How does this patent compare with similar international patents?
It aligns with global practices of combining compound, process, and use claims but emphasizes protection tailored to China's patent landscape and regulatory environment.
4. Can these claims be challenged post-grant?
Yes. Competitors may file invalidation requests citing prior art, especially if structural similarities or synthesis methods are revealed.
5. What strategic advantages does this patent provide for R&D?
It secures exclusive rights to novel compounds and their manufacturing methods, facilitating investment, partnership, and regulatory approval processes.
References
- CN115243675. China National Intellectual Property Administration. (2022).
- Prior art database searches. Chinese Patent Office records, 2015-2022.
- International Patent Landscape. WIPO PATENTSCOPE, 2023.
- Regulatory pathways in China. China Food and Drug Administration, 2022.
- Patent claiming strategies in pharma. WIPO World Patent Report, 2021.
This analysis aims to help stakeholders understand the strategic and legal positioning of CN115243675 within China's pharmaceutical patent ecosystem, informing decision-making processes in R&D, licensing, or competitive intelligence.
