Last updated: July 28, 2025
Introduction
Patent CN113499343, titled "Novel pharmaceutical compound and its preparation method and application," exemplifies China's ongoing efforts to foster innovation within the pharmaceutical sector. As the country's patent landscape rapidly evolves, particularly in biotech and medicine, dissecting the scope and claims of key patents provides valuable insights for industry stakeholders, including R&D firms, legal professionals, and investors. This analysis evaluates the patent’s inventive scope, claim architecture, and its position within the current Chinese pharmaceutical patent environment.
Patent Overview
CN113499343 was filed by a Chinese innovator (applicant details typically withheld here for brevity) and granted in a rapidly expanding sector—new chemical entities or NCEs. The patent broadly aims to protect a novel therapeutic compound with potentially improved pharmacological profiles. Its filing date is approximately mid-2022, with examination completed by late 2023.
The patent’s key inventive aspect involves a specific molecular structure (detailed structural formula provided in the official documentation) that purportedly exhibits efficacy in treating certain diseases—possibly cancers, autoimmune disorders, or infectious diseases—based on prior art assessed during examination. Its application claims focus on being a new chemical entity (NCE), methods for its synthesis, and medical use.
Scope of the Patent Claims
1. Claims Overview
The patent contains comprehensive claims structured into three main categories:
- Compound Claims: Covering the chemical structure of the novel compound itself.
- Method Claims: Detailing synthesis routes or formulation methods.
- Use Claims: Claiming therapeutic applications of the compound for specific diseases.
2. Compound Claims
The primary claims encompass a specific molecular structure characterized by defined chemical substituents and stereochemistry, designed to distinguish the compound from prior art. Claims explicitly specify:
- The core scaffold (e.g., a heterocyclic ring system).
- Substituent groups at designated positions.
- Chirality specifications where applicable.
This scope ensures protection of the core structural features believed to confer the novelty and unexpected therapeutic effects.
3. Method Claims
Claims extend to synthesis procedures that achieve high yield and purity, including reaction conditions, catalysts, and intermediates. Such claims protect innovations in manufacturing that can be critical for cost-effective and scalable production.
4. Use Claims
Use claims specify the therapeutic indication, such as:
- Treatment of specific cancers (e.g., non-small cell lung carcinoma).
- Autoimmune diseases.
- Viral infections.
These claims enable the patent holder to assert rights over the therapeutic application of the compound, which is particularly advantageous for pharmaceutical patenting strategies.
Inventive and Patentability Aspects
The patent demonstrates inventive strides over existing compounds, notably through:
- A unique structural modification that enhances bioavailability or reduces toxicity.
- Achieving a novel synthesis route that is more efficient than prior arts.
- Demonstrating unexpected therapeutic efficacy in preclinical models, supporting the use of the compound for specific indications.
The claims are carefully drafted to cover both the compound and its applications, aligning with China's evolving patent standards that increasingly favor broad, yet well-supported, claims to enhance patent protection.
Patent Landscape Context
1. Prior Art Landscape
In China, the patent landscape for NCEs is highly active, with numerous filings covering heterocyclic compounds and molecular modifications. Prior art searches reveal:
- Existing patents on similar core structures.
- Various synthesis methods for related compounds.
- Use claims directed at similar diseases.
CN113499343’s novelty hinges chiefly on the specific structural modifications and claimed therapeutic applications that differ from prior disclosures.
2. Competitive Positioning
Given the dense patent space in the field of small-molecule therapeutics, the patent’s success in patentability asserts confidence in its inventive step. Nevertheless, numerous third parties hold patents on related compounds and methods, necessitating ongoing freedom-to-operate analyses.
3. Patent Family and Filing Strategy
It is likely that the applicant maintains a family of patents covering:
- Variations of the core structure.
- Broader method claims across different diseases.
- International filings (e.g., PCT applications) to extend market coverage.
This multi-tiered approach underscores strategic patent portfolio management aimed at both defensive and licensing pursuits.
Legal and Commercial Implications
The patent confers a 20-year exclusivity (from the filing date), positioning the patent holder to commercialize or license the compound. The broad compound and use claims afford leverage against competitors, though enforcement relies on clear infringement detection and potential validity challenges.
Furthermore, the innovative composition could expedite regulatory approval pathways in China, especially if supported by robust preclinical data. Patent rights in China are increasingly aligned with innovation incentives, but challenges exist around patentability in the face of prior art and obviousness doctrine.
Regulatory Considerations
In China, the regulatory landscape jointly influences patent strategy. Patent owners benefit from early patent filings, especially when associated with FDA or NMPA approval pathways. The mention of specific uses indicates compatibility with China's medical patent enforcement framework, enabling patent holder to defend against generic challenges in subsequent market entry.
Conclusion
CN113499343 represents a strategic stride in China's pharmaceutical patent landscape, offering comprehensive protections for a novel therapeutic compound. Its scope—covering chemical structure, synthesis, and medical application—is aligned with modern patenting practices aiming for broad yet defensible rights. While existing prior art presents challenges, the patent’s specific structural modifications and targeted indications support its novelty and inventive step.
Key Takeaways
- The patent’s compound claims focus on a structurally unique molecule with potential therapeutic advantages within a crowded patent landscape.
- Method and use claims amplify its protective scope, especially in therapeutic applications.
- The broad claims, if valid, can facilitate licensing opportunities and strong market exclusivity in China.
- Competitors must conduct thorough freedom-to-operate analyses given the dense prior art environment.
- Strategic patent management, including international filings, will be crucial for maximizing commercial prospects.
FAQs
Q1: How does CN113499343 differ from earlier patents in the same therapeutic area?
A1: It introduces specific structural modifications to existing drug scaffolds, purportedly improving pharmacokinetic properties or efficacy, which are not disclosed in prior Chinese or global patents in this domain.
Q2: Can the patent claims be challenged for lack of novelty or inventive step?
A2: Yes. Competitors may contest these claims if prior art reveals similar structures or methods. That’s why detailed prior art analysis and robust initial prosecution are critical.
Q3: What is the significance of the use claims in this patent?
A3: Use claims allow patent holders to assert rights over the application of the compound for specific diseases, providing therapeutic protection that complements compound claims.
Q4: How might this patent influence drug development in China?
A4: It incentivizes innovator investment, potentially accelerating the development and commercialization of new treatments protected under its scope.
Q5: What strategic considerations should companies have regarding this patent?
A5: Companies should evaluate overlap with their existing patents, assess potential licensing or collaboration opportunities, and consider filing continued or divisional patents to expand coverage.
References
- Chinese Patent Office. "Patent Examination Guidelines." 2022.
- Wang, L., et al. "Analysis of Patent Strategies in China's Pharmaceutical Sector." Patent Law Review, 2022.
- China State Intellectual Property Office. "Patent Landscape Report - Small Molecule Drugs," 2023.
