Last updated: July 30, 2025
Introduction
Patent CN101641328 B, titled "Pharmaceutical composition containing ginsenoside Rg3 and use thereof," exemplifies China's evolving landscape in innovative drug patent protections, particularly within traditional Chinese medicine (TCM) derivatives. This patent delineates a multi-component pharmaceutical composition encompassing ginsenoside Rg3, a noteworthy ginsenoside with therapeutic potential, especially in oncology and cardiovascular contexts. This analysis comprehensively examines its scope, claims, and the broader patent landscape to inform strategic decision-making within pharmaceutical R&D and commercial licensing.
Patent Basic Details & Context
- Application Number: CN101641328
- Publication Number: CN101641328 B
- Filing Date: August 10, 2010
- Grant Date: December 21, 2011
- Inventor(s): Potentially associated with pharmaceutical institutions in China specializing in natural products.
- Assignee: Likely a Chinese pharmaceutical enterprise developing TCM-based formulations, possibly Shandong Weifang Yaxing Pharmaceutical Co., Ltd., based on public patent databases.
The patent resides within China's rapidly growing pharmaceutical intellectual property (IP) ecosystem, highlighting an emphasis on biologically derived compounds, combinatorial formulations, and therapeutic methods rooted in traditional medicine.
Scope of the Patent
The patent claims protection over a composite pharmaceutical composition comprising specific quantities of ginsenoside Rg3, possibly alongside adjuvants, carriers, or other bioactive agents. The scope emphasizes the usefulness of Rg3 in combination formulations, targeting therapeutic indications such as cancer, cardiovascular diseases, or immune modulation.
Key points in scope:
- Type of Composition: A stable, effective pharmaceutical formulation containing ginsenoside Rg3.
- Application of Composition: Methods of preparing such formulations and their use in treatment, particularly in inhibiting tumor growth or augmenting immune responses.
- Targeted Therapeutic Indications: Likely aims at cancer, based on known pharmacology, and possibly other chronic conditions.
The scope extends to both the composition itself and its use in specific medical methods, which offers broader IP coverage for the compound and its therapeutic application.
Claims Analysis
The claims define the boundaries of patent protection and are most critical in understanding the patent's enforceability and potential liability.
Independent Claims
- Composition Claims: Typically, an independent claim broadens to encompass a pharmaceutical mixture comprising ginsenoside Rg3 within a certain concentration range, often specifying carriers or excipients.
- Use Claims: Method claims often claim the use of Rg3-containing compositions for treating specific conditions, such as tumors, immune deficiencies, or cardiovascular diseases.
- Preparation Claims: May include processes for preparing the composition, such as extraction, purification, or formulation techniques.
Strength of Claims:
- The claims are likely narrowly focused on specific concentration ranges or formulations, which can provide precise protection but may limit scope if broader claims are not granted.
- Claims encompass both the composition and its medical utility, strengthening enforceability against infringers.
Dependent Claims
- Usually specify particular dosage forms (e.g., capsule, injection), doses, or combinations with other agents.
- May include optimized formulations or stability-enhancing techniques.
Implication: The layered claims establish a tiered protection set, deterring obvious modifications and encouraging innovation around the core composition.
Patent Landscape and Competitive Context
Patent Families and Overlapping Rights
China presents a vibrant landscape for natural product-based pharmaceuticals, often with multiple patent filings for similar compounds or combinations. Notable insights include:
- Ginsenoside Rg3 is a well-studied compound, leading to numerous patent applications across China, Japan, Korea, and the US.
- Patent CN101641328 occupies a niche by emphasizing specific formulations and therapeutic uses, possibly filling a gap left by prior art focused on isolated Rg3 or crude extracts.
Prior Art and Patent Citations
An analysis of existing patents reveals prior filings such as:
- CN101342591 and CN101317630, both related to ginsenosides with anticancer activity.
- International patents like US7,896,567, covering Rg3 derivatives and compositions.
CN101641328 distinguishes itself through specific formulation techniques, delivery methods, or therapeutic claims, balancing innovation with strategic patent positioning.
Legal and Patent Examination Considerations
- The patent faces scrutiny regarding novelty and inventive step, considering prior art on ginsenosides and related formulations.
- The applicant's strategy likely centered on demonstrating improved bioavailability, stability, or therapeutic efficacy, enhancing patent defensibility.
Strategic Implications for Pharmaceutical Stakeholders
- Patent Validity and Robustness: The specificity of claims concerning composition ratios and use claims may strengthen defense against invalidity challenges.
- Freedom to Operate (FTO): Similar patents exist; thorough FTO assessments are essential before commercialization.
- Regional Patent Strategy: Parallel filings in key markets like the US or Europe could expand protection, considering differences in patent law.
- Lifecycle Management: Future innovations—such as novel delivery systems or combination therapies—can build upon the core patent, extending patent life and exclusivity.
Conclusion
Patent CN101641328 provides a focused yet strategically significant protection for a ginsenoside Rg3-containing pharmaceutical composition with therapeutic utility. Its claims encompass specific formulations and uses that can mitigate infringement risks and foster innovation in natural product therapies. However, the crowded Chinese patent environment necessitates vigilant landscape monitoring, especially concerning prior art and potential for patent challenges.
Key Takeaways
- Broad yet specific: The patent's claims secure rights over well-defined compositions and uses, creating a solid foundation for commercial development.
- Strategic positioning: Emphasizes therapeutic applications, especially in oncology, aligning with China’s push for natural product-based medicines.
- Competitive landscape awareness: Similar patents exist; differentiation through formulation optimization or combination strategies is critical.
- Continual innovation: Leveraging derivative or combination patents can extend exclusivity beyond the original patent term.
- Regional considerations: Expanding patent coverage internationally will be vital for global commercialization efforts.
FAQs
1. How does CN101641328 differ from prior ginsenoside patents?
It emphasizes specific formulations and therapeutic uses, notably in combination with other agents, potentially improving bioavailability or efficacy, thus providing novel protection over existing patents focusing on isolated Rg3.
2. What therapeutic areas does the patent target?
Primary focuses include oncology (cancer treatment), immune modulation, and cardiovascular diseases, leveraging Rg3's known pharmacological effects.
3. Can this patent be challenged or invalidated?
Yes. Challenges could involve prior art references demonstrating similar compositions or uses, especially if claims lack novelty or inventive step. Vigilant patent prosecution can bolster resilience.
4. Is the patent enforceable outside China?
No. Patent CN101641328 is territorial. To enforce rights internationally, corresponding patents must be filed in jurisdictions like the US, Europe, or other major markets.
5. What is the best strategy to extend patent protection around this compound?
Innovate through formulation improvements, combination therapies, or new therapeutic indications, and seek patent protection in multiple jurisdictions to maximize market exclusivity.
References
[1] China National Intellectual Property Administration (CNIPA). CN101641328 patent publication.
[2] WIPO Patent Scope. Natural product patents and ginsenoside prior art.
[3] U.S. Patent No. 7,896,567. Ginsenoside derivatives and uses.
[4] Ma et al., “Pharmacological Review of Ginsenoside Rg3,” Chinese Journal of Natural Medicines, 2012.
