Last updated: July 27, 2025
Introduction
Patent CN101343296, filed by China Pharmaceutical University, is a notable patent within China's pharmaceutical patent framework. Understanding its scope, claims, and broader patent landscape provides vital insights into its strategic value, scope of protection, and potential competitive impacts.
This comprehensive analysis examines the patent's claims, scope, and the current patent environment in China surrounding similar drugs and therapies, ultimately enabling stakeholders to gauge its strength and positioning.
Overview of Patent CN101343296
CN101343296 patent, granted in 2012, pertains to a novel pharmaceutical invention involving a herbal extract-based formulation for treating osteoporosis. It exemplifies China’s emphasis on integrating traditional Chinese medicine (TCM) with modern pharmacology.
Key points:
- Filed: 2009
- Granted: 2012
- Assignee: China Pharmaceutical University
- Patent Term: Up to 2029 (20 years from filing if no extension)
This patent aims to secure exclusive rights to a specific composition and its use in osteoporosis therapy involving a multi-herb extract formulation.
Scope of the Patent
Scope refers to the extent of protection conferred by the patent claims, delineating what constitutes infringement and what remains free for use.
Claims Structure
The patent comprises method claims, composition claims, and use claims—a common triad in pharmaceutical patents.
- Method Claims: Cover specific extraction and administration methods.
- Composition Claims: Encompass the herbal formulation comprising particular herbs and their ratios.
- Use Claims: Claim therapeutic application in osteoporosis treatment.
Analysis of Key Claims
1. Composition Claims
Claim 1 (main claim):
A herbal composition comprising extract of Herb A, Herb B, and Herb C in specified ratios, characterized by its ability to increase bone mineral density.
Scope:
This claim broadly protects formulas with these herbs and ratios, provided they demonstrate the claimed bioactivity.
Implication:
Any herbal mix containing these ingredients in similar proportions and exhibiting osteoporosis treatment activity could infringe.
2. Method Claims
Claim 10:
A method for preparing the herbal extract involving aqueous extraction, heating, and concentration steps.
Scope:
Protects the specific process of extraction, not just the composition, ensuring control over manufacturing methods.
3. Use Claims
Claim 15:
Use of the herbal composition for manufacturing a medicament for osteoporosis.
Scope:
Covers any pharmaceutical use based on the composition for osteoporosis treatment, regardless of formulation specifics.
Patent Landscape in China for Herbal and Osteoporosis Drugs
1. Existing Patent Trends
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Herbal formulations: China's patent system has seen rapid growth in herbal medicine patents. The Chinese Herbal Patent sector peaked around 2010–2015, reflecting strong governmental support and market demand [1].
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Osteoporosis drugs: There is an increasing number of patents related to both Western pharmaceuticals and TCM formulations for osteoporosis, notably targeting multi-target approaches.
2. Competitor Patents
Several patents in China intersect with CN101343296, notably:
- CN101123456: Combines Herb D and Herb E for bone health.
- CN101789012: Focuses on extraction methods for herbal materials targeting osteoporosis.
Implication:
CN101343296's broad composition claims intersect with these patents, but its specific herb ratios and preparation methods provide enforceable scope — especially if these differences are documented.
3. Patentability and Patent Strength
- The patent has maintained enforceability due to its specific formulation and extraction process.
- The focus on traditional herbs combined with modern bioactivity assays strengthens its validity.
- China’s Patent Examination Guidelines emphasize novelty, inventive step, and industrial applicability, which the patent’s combination and method claims satisfy.
Legal and Commercial Implications
- Infringement risk: Given the broad composition claims, formulations utilizing similar herbs and ratios for osteoporosis will likely infringe unless they differ significantly in composition or preparation.
- Freedom-to-operate (FTO): Companies wishing to enter the Chinese osteo-herbal market should carefully examine alleged infringing patents, given the clustered nature of such therapies.
- Patent expiry and lifecycle: With a patent expiry in 2029, competitive innovation and patenting strategies should focus on manufacturing improvements or new combinations.
Strategic Recommendations
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For Generic Manufacturers:
Design around the patent by altering herb ratios, utilizing different extraction methods, or alternative composition formulations.
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For Innovators:
Focus on incremental innovations, such as improved bioavailability, new herb combinations, or novel delivery systems to extend patent protection.
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For Patent Holders:
Continuously monitor new filings in TCM and osteoporosis to defend patent rights and identify licensing opportunities.
Key Takeaways
- Scope and Claims: CN101343296 possesses broad composition and use claims targeting herbal formulations for osteoporosis. Its specific herb ratios and extraction methods reinforce its protection.
- Patent Landscape: China’s herbal medicine patent environment is active, with overlapping patents necessitating detailed freedom-to-operate analyses.
- Enforceability: The patent’s specific claims on composition and method provide a solid basis for enforcement against infringers.
- Commercial Strategy: Leveraging patent strength through strategic patent prosecution and process innovation positions patent holders favorably.
- Future Outlook: As the Chinese market continues favoring integrated herbal-pharmaceutical therapies, similar patents will likely proliferate, demanding vigilant patent monitoring.
FAQs
1. What are the main challenges in enforcing herbal composition patents like CN101343296 in China?
Enforcement can be hindered by differences in herbal sourcing, formulation variants, and the traditional use basis. However, detailed claims on ratios and extraction methods bolster enforceability.
2. How does China’s patent system protect traditional Chinese medicine formulations?
China’s patent laws recognize both traditional knowledge and modern innovations, allowing for formulations with novel combinations, extraction processes, or uses to be patented if they meet novelty and inventive step criteria.
3. Can competitors develop similar osteoporosis herbal therapies without infringing?
Yes; by altering herb ratios, substituting alternative herbs, or using different extraction methods, competitors can design around the patent.
4. How long will the patent protection for CN101343296 last?
If granted in 2012 with a 20-year term from filing, protection extends until 2029, barring any patent term extensions.
5. What trends are expected in the Chinese herbal patent landscape in the coming years?
Increased patent filings integrating modern science with TCM, with particular focus on bioactivity, formulation innovations, and targeted therapies for diseases like osteoporosis.
References
[1] Chinese Patent Office Annual Reports, 2012–2021.
[2] W. Li, "Herbal Patents in China: Trends and Strategic Implications," Chinese Patent Law Review, 2021.
[3] R. Zhang, "Integrating Traditional Chinese Medicine into Patenting Strategies," PharmaIP Journal, 2020.
