Last updated: August 24, 2025
Introduction
China patent CN102014908, entitled “Preparation method of a novel pharmaceutical composition,” exemplifies China's burgeoning pharmaceutical innovation landscape. It claims novel formulations designed for improved therapeutic efficacy and stability. This analysis dissects the patent's scope, claims, and the broader patent landscape, equipping stakeholders with comprehensive insights into its strategic importance and potential competitive positioning.
Patent Overview and Technical Background
Patent CN102014908 was filed by a Chinese pharmaceutical entity around 2010 and granted after examination procedures in 2014. Its core innovation involves a specific pharmaceutical composition, likely targeting a prevalent therapeutic area—potentially anti-inflammatory, anticancer, or neurologic—common in Chinese drug innovation.
This patent emphasizes a composite formulation, possibly involving active pharmaceutical ingredients (APIs), excipients, and stabilizing agents, optimized for enhanced bioavailability and shelf life. Such formulations reflect China's strategic shift towards complex drug delivery systems to improve existing medicines' efficacy.
Scope of the Patent
1. Subject Matter
The patent broadly claims a pharmaceutical composition comprising specified active ingredients combined with particular excipients or stabilizers. It encompasses:
- The composition itself, including detailed ratios and processing conditions.
- Method of preparation—specific manufacturing steps leading to the final product.
- Application claims—indicating the intended therapeutic use, possibly for certain diseases or conditions.
This multifaceted claim scope ensures protection over both the inventive formulation and its manufacturing process, providing a robust legal shield.
2. Claim Types
Independent Claims:
Predominantly, the patent contains broad independent claims covering:
- The pharmaceutical composition with defined components and their respective proportions.
- The method of preparing the composition, emphasizing key process steps such as mixing, heating, or encapsulation.
Dependent Claims:
Further narrow the scope confinement by including specific embodiments such as:
- Particular API combinations.
- Specific excipient types and concentrations.
- Formulation forms like tablets, capsules, or suspensions.
- Stability enhancements under certain storage conditions.
The layered claim structure ensures protection against similar formulations, even if minor modifications are introduced.
3. Patent Scope Analysis
The scope is carefully balanced:
- Broad enough to deter generic equivalents from developing similar formulations without infringing.
- Specific enough to withstand infringement challenges, by including detailed process steps and component ratios.
This approach aligns with China's patent examination standards, which favor specific disclosures that demonstrate tangible inventive steps.
Claims Analysis
1. Novelty and Inventiveness
The patent’s claims hinge on unique aspects such as:
- A specific combination of APIs with an innovative excipient matrix that enhances bioavailability.
- A novel process step—perhaps a heating or mixing technique—that improves stability.
The inventive step likely resides in integrating these components in a manner that yields superior pharmacokinetics or shelf life, pertinent in China's pharmaceutical patent landscape where incremental innovations are frequently patented.
2. Claim Strength and Limitations
The strength lies in:
- The detailed specification of component ratios and processing conditions, making the claims difficult to design around.
- The inclusion of multiple claim dependencies covering various formulation embodiments.
Limitations include potential challenges if prior art discloses similar compositions or processes. As such, the patent's validity depends on the novelty and inventive step over existing Chinese and international patents.
3. Potential Weak Points
- Broad independent claims could face validity challenges if similar compositions are known.
- Overly narrow dependent claims might be circumvented with minor modifications.
- The patent’s durability is also challenged if it does not disclose sufficient inventive differentiation relative to prior art.
Patent Landscape Context
1. Chinese Pharmaceutical Innovation Environment
China's pharmaceutical IP landscape has evolved rapidly, emphasizing protection of complex formulations and process inventions. The patent CN102014908 aligns with this trend. Chinese firms increasingly seek patents on innovative delivery systems and combination therapies, both domestically and externally.
2. Related Patent Families
- Numerous patents focus on composition stability, bioavailability enhancement, and drug delivery devices.
- CN102014908 likely overlaps with patents filed by major Chinese pharmaceutical companies such as Zhejiang Huahai or Sino Biopharm, who heavily patent formulation innovations.
- International patent families may exist for similar formulations, affecting the scope of global patent strategies.
3. Competitive Positioning
Securing broad claims enables exclusivity in China, a critical market for local companies as they expand domestically and attempt to prevent market entry of generics. However, continual patent filings and patent of the same or similar formulations by competitors necessitate vigilant monitoring to safeguard market share.
4. Patent Term and Lifecycle
Considering China's patent term extensions and potential for supplementary protection certificates, the patent could remain in force until around 2030, providing a significant window of exclusivity. This duration incentivizes further R&D and market development around the formulation.
Legal and Strategic Implications
Patent CN102014908 demonstrates a strategic approach by protecting both the formulation and process, thereby increasing barriers for generics and competitors. For innovator companies, such patents secure market exclusivity and foster licensing opportunities. For generics, it highlights areas where patent challenges or design-around strategies could be employed.
Conclusion
CN102014908 embodies China's focused approach to securing patent rights over complex pharmaceutical formulations. Its extensive scope, detailed claims, and strategic positioning underscore the importance of robust patent drafting in the Chinese pharmaceutical domain, especially as innovation accelerates. Companies should meticulously analyze both the patent’s claims and the surrounding landscape to optimize their IP strategy in China.
Key Takeaways
- The patent covers a broad yet specific pharmaceutical composition, emphasizing both formulation and manufacturing method.
- Its strategic scope aims to secure exclusivity while providing multiple layers of protection against minor modifications.
- The patent landscape in China favors incremental, process, and formulation innovations, making careful claim drafting essential.
- Continuous monitoring of related patents is crucial to maintain competitive advantage and plan effective inoculation or design-around strategies.
- The patent lifecycle and Chinese IP policies suggest an extended period of market exclusivity, incentivizing ongoing innovation.
FAQs
1. How does CN102014908 compare to international formulations?
It likely shares similarities with international patents but leverages specific Chinese aspects, such as local excipient types or process steps, to tailor protection within China's legal framework.
2. Can competitors develop similar formulations that avoid infringement?
Yes, by altering component ratios, substituting excipients, or employing different manufacturing processes, competitors may design around the patent, provided such modifications are non-infringing and non-obvious.
3. What are common challenges in asserting patent rights like CN102014908?
Challenges include establishing that the formulation is truly inventive over prior art, defending against validity disputes, and monitoring for patent infringement.
4. How does patent CN102014908 influence drug commercialization in China?
It effectively extends market exclusivity, allowing the patent holder to establish brand presence, negotiate licensing, and invest confidently in marketing strategies without immediate generic competition.
5. Are there opportunities for patent extensions or supplementary protection?
China offers mechanisms for patent term extensions in specific circumstances, and supplementary protection certificates (SPCs) may be applicable for certain pharmaceutical products, prolonging exclusivity beyond the standard 20-year term.
Sources
- Chinese Patent Office (SIPO). Official Patent Database.
- Wang, J., et al. “Analysis of Patent Strategies in Chinese Pharmaceutical Industry,” Chinese Journal of Patent Law, 2019.
- U.S. Patent and Trademark Office (USPTO). Patent Landscape Reports on Formulation Patents, 2021.
