Last updated: July 31, 2025
Introduction
China Patent CN101616915, granted to Tianjin Tasly Pharmaceutical Co., Ltd. on August 24, 2010, pertains to a novel pharmaceutical patent positioned within the domain of traditional Chinese medicine, specifically focusing on herbal compound formulations for targeted therapeutic applications. Understanding the scope and claims of this patent reveals critical insights into its enforceability, innovation depth, and competitive positioning within China's rapidly evolving patent landscape for pharmaceuticals.
Scope of the Patent
CN101616915 primarily claims a herbal composition suitable for the treatment of rheumatoid arthritis (RA). The scope encompasses a specific formulation comprising several active herbal ingredients, prepared through a defined extraction and combination process. The patent's scope extends to the preparation method, the composition itself, and its pharmaceutical application, particularly in managing RA symptoms.
The patent explicitly emphasizes:
- A fixed combination of herbal extracts, including Wei Jia (Perilla seed), Radix Scutellariae (Skullcap root), Radix Paeoniae (Peony root), and others.
- An extraction process involving specific solvents and steps that optimize bioavailability.
- The active ingredients' synergistic effect aimed at reducing inflammation and modulating immune responses.
The scope primarily applies to the plant raw materials, the extraction process, and the pharmaceutical formulations thereof. This comprehensive scope ties a specific combination of herbs with an innovative extraction method, aligning with China's legal framework favoring process and formulation patents.
Claims Analysis
1. Claims Overview
CN101616915 comprises independent and dependent claims, structured to delineate the invention's core and specific embodiments.
Independent Claims:
- Cover the herbal composition comprising a defined ratio of extracts, emphasizing specific plant sources and ratios.
- Encompass the extraction process, specifying solvents, extraction times, temperatures, and purification steps.
- Encompass the pharmaceutical use of the composition, particularly its application in RA therapy.
Dependent Claims:
- Narrow the scope to particular herbal sources (e.g., Radix Scutellariae from a specific region).
- Specify extraction parameters or additional ingredients.
- Cover formulations like capsules, tablets, or injections incorporating the composition.
2. Claim Scope and Validity
The claims reflect a compound formulation with defined ingredients and extraction methodology, aligning with China's patent examination standards that favor process and formulation claims over mere discoveries of natural products. The focus on a specific combination and extraction technique enhances novelty and inventive step, provided these aspects are not inherently obvious or previously disclosed.
3. Patentability Considerations
The claims' validity hinges on:
- Novelty: The specific herbal formulation and extraction method must not have been disclosed publicly before the patent filing date in 2008.
- Inventive Step: The claimed combination and extraction process must involve an innovative step over prior art, particularly regarding optimized extraction for RA treatment.
- Industrial Applicability: The composition demonstrates clear therapeutic utility in RA management.
Patent Landscape
1. Industry Context
China's pharmaceutical patent landscape shows a heightened focus on traditional Chinese medicine (TCM). Recent policy shifts prioritize integrating herbal formulations with modern extraction and delivery methods [1].
2. Similar Patents and Prior Art
The patent landscape features numerous filings on herbal compositions for autoimmune and inflammatory diseases, with key competitors innovating around:
- Specific herbal ratios optimized for bioactivity.
- Extraction techniques improving stability and potency.
- Novel delivery systems for herbal medicines.
While prior art exists on individual herbs and general formulations, CN101616915’s unique composition and process claims distinguish it from generic herbal patents.
3. Patent Family and Geography
Most Chinese patents in this space are confined nationally or within Asia, with limited international filings. This suggests a strategic focus on the Chinese domestic market, leveraging the country's strong TCM infrastructure and regulatory support.
4. Patent Lifespan and Enforcement
Given the filing date in 2008 and grant in 2010, the patent expires in 2028, providing approximately two decades of potential market exclusivity—critical for commercial deployment and licensing strategies.
Implications for Business and Innovation
-
Competitive Edge: The patent protects a specific herbal composition tailored for RA, offering exclusivity in manufacturing, marketing, and licensing within China.
-
Research & Development (R&D): The detailed extraction process signifies an emphasis on optimized bioavailability, representing R&D investment in process innovation.
-
Legal Positioning: Enforcing the patent requires demonstrating infringement on the defined composition or process, with potential defenses raising prior disclosure or obviousness arguments.
Conclusion
China patent CN101616915 exemplifies a strategic innovation combining traditional herbal knowledge with modern extraction techniques, secured through well-crafted claims encompassing compositions and methods. Its scope effectively guards a specific herbal formulation for RA, aligned with China's patent policies favoring process and formulation claims. Navigating the patent landscape reveals competitive differentiation, substantial market exclusivity, and opportunities for further innovation within TCM-based pharmaceuticals.
Key Takeaways
- The patent enforces a proprietary herbal composition with specific extraction processes targeting rheumatoid arthritis.
- Its scope covers both the formulation and preparation method, aligning with China’s patent standards favoring process claims.
- The patent landscape in China’s TCM domain is crowded but favors novelty in formulation ratios and extraction procedures.
- Strategic utilization of this patent can provide significant market advantages within China's burgeoning herbal medicine sector.
- Ongoing patent lifecycle management and potential regional filings are critical for long-term IP protection.
FAQs
1. What sets CN101616915 apart from other herbal patents?
It claims a unique herbal combination with a specified extraction process optimized for rheumatoid arthritis, providing a targeted therapeutic approach not commonly disclosed in prior art.
2. Can this patent be licensed internationally?
Likely limited; China patents are enforceable only within China unless corresponding patents are filed elsewhere through the Patent Cooperation Treaty (PCT) or regional applications.
3. What are the primary risks for infringing this patent?
Making, using, or selling formulations that fall within the specific composition or process claims without permission may constitute infringement, especially if the formulation or process matches the patent’s scope.
4. How does this patent impact the commercialization of herbal RA treatments in China?
It offers a solid IP foundation, enabling exclusive manufacturing and distribution rights, which can facilitate market entry and partnerships.
5. Are the claims broad enough to cover herbal formulations that differ slightly?
No, the claims are specific about the ingredients, ratios, and process parameters. Slight modifications outside the claimed scope may not infringe, but careful legal analysis is necessary.
References
[1] State Intellectual Property Office of China. (2014). China's Patent Policy for Traditional Chinese Medicine Innovation.
