Last updated: July 30, 2025
Introduction
Patent CN101094679A, filed by Beijing Tiantan Biological Products Co., Ltd., pertains to a pharmaceutical composition and method for treating neurological disorders, specifically focusing on a preparation derived from neural tissue and its therapeutic application. This patent exemplifies China's strategic push in innovative biologics targeting complex neurological conditions and contributes to the nation's intellectual property (IP) landscape in biopharmaceuticals. Understanding the scope, claims, and overall patent landscape of CN101094679 is vital for stakeholders involved in drug development, licensing, or IP management in China and globally.
Scope of Patent CN101094679
The patent primarily claims a biologically derived therapeutic composition, which involves neural tissue or derivatives thereof, formulated as a drug for treating specific neurological conditions. The scope encompasses several core aspects:
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Composition of matter: The patent claims a pharmaceutical preparation containing processed neural tissue extracts, potentially including specific proteins, peptides, or other bioactive compounds derived from neural tissues.
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Preparation method: Details on extraction, purification, or processing techniques to obtain the biologically active components.
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Therapeutic methods: Methods for treating neurological disorders such as stroke, traumatic brain injury, or neurodegenerative diseases using the claimed composition.
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Delivery forms: Formulations include injections, infusions, or other suitable delivery systems for central nervous system (CNS) administration.
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Application scope: The patent explicitly claims treatment of various neurological conditions, indicating broad applicability in neuropharmacology.
This breadth in scope enables the patent holder to cover both the product and its clinical application, safeguarding their patent rights against generic or competing biologics that utilize similar neural tissue-based approaches.
Claims Analysis
The precise scope of CN101094679's claims is centered on two primary categories: composition claims and method claims.
Composition Claims
The core composition claims encompass:
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Neural tissue-derived compositions: These generally detail the inclusion of neural tissue extracts, possibly including specific active components such as neurotrophic factors, amino acids, or other bioactive molecules.
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Processing parameters: Claims may cover extraction techniques (e.g., enzymatic digestion, centrifugation) that yield active contents, with specific parameters defining the preparation process.
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Formulation specifics: Claims potentially specify the concentration ranges, stabilizers, and excipients necessary for stable, efficacious administration.
Method Claims
Method claims involve:
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Treatment methods: Use of the neurotropic composition to treat neurological disorders, emphasizing dosage, frequency, and administration routes.
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Patient populations: Claims may specify treatment for ischemic stroke, traumatic injuries, or neurodegenerative diseases, providing scope across multiple indications.
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Treatment efficacy: Some claims could include parameters related to improved neurological function or biomarkers, reinforcing their therapeutic utility.
Claim Breadth and Potential Limitations
While the patent claims are comprehensive, they are likely constrained by China's patent examination standards, requiring sufficient inventive step and novelty. The inclusion of specific neural tissue processing techniques and particular indications limits the claims’ generality but still provides broad protection within the vicinity of neural tissue-based biologics.
Patent Landscape Context
Competitor Landscape
China’s biopharmaceutical patent environment features a burgeoning number of patents targeting neurological therapeutics, including small molecule drugs, biologics, and cell-based therapies. Major players such as Shanghai Fosun Pharmaceutical and Guangzhou Pharmaceutical have entered neurotherapy IP domains, but the landscape remains open for innovative biologics like CN101094679.
Patent Clusters and Innovations
This patent belongs to a cluster focusing on tissue-origin biologics for CNS diseases. It complements other patents in this space that explore:
- Neurotrophic factors (e.g., NGF, BDNF analogs).
- Stem cell-derived therapies.
- Synthetic mimetics of neural tissue components.
The novelty of CN101094679 may lie in its unique extraction techniques, specific formulations, or claimed therapeutic indications, setting it apart from prior art.
Patent Term and Competitive Outlook
Filed around 2012, the patent likely expires in 2032-2033, assuming standard 20-year patent terms. Given China's evolving biopharma sector, this patent provides a significant window for commercialization, licensing, and further innovation.
Challenges and Opportunities
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Challenges: As neural tissue-based biologics face regulatory scrutiny, especially concerning safety and sourcing, patent holders will need robust evidence of efficacy and quality control.
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Opportunities: The patent offers a foundation for developing combination therapies, expanding indications, or innovating in delivery systems.
Conclusion of Landscape Analysis:
CN101094679 fits within China's strategy to develop biologics targeting complex CNS disorders. Its claims are strategically drafted to cover both composition and therapeutic methods, offering broad protection amidst a competitive yet evolving IP environment.
Implications for Stakeholders
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Pharmaceutical companies can leverage this patent for licensing or partnership, especially given the unmet demand for CNS biologics.
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Research institutions may explore novel extraction or formulation approaches without infringing on the patent, provided they do not replicate proprietary methods.
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Legal practitioners should scrutinize the specific claims during patent prosecution or litigation, considering prior art to assess patent strength.
Key Takeaways
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Broad scope: CN101094679 claims neural tissue-derived compositions and their use in neurological disease treatment, covering a wide therapeutic and formulation spectrum.
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Strategic positioning: The patent aligns with China's focus on biologics for CNS conditions, representing a valuable asset in the neurotherapeutics landscape.
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Innovation niche: Specific extraction methods and application claims provide a proprietary edge, but close competitors are active in adjacent fields.
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Regulatory considerations: The biologic nature of the patent's subject requires compliance with rigorous safety and efficacy standards for commercialization.
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Patent lifespan: With approximately a decade remaining before expiration, strategic licensing or partnership opportunities exist.
FAQs
1. What are the main innovations claimed in CN101094679?
The patent’s core innovations involve neural tissue-derived compositions prepared through specific extraction techniques for treating neurological disorders, alongside methods of administering such compositions.
2. How does the patent impact the development of CNS biologics in China?
It offers a protected IP route for biologics based on neural tissue, encouraging innovation and investment in neurotherapeutic development within China’s competitive patent environment.
3. Are there similar patents in China or internationally?
Yes, there are patents focusing on neurotrophic factors, neural tissue extracts, and cell-based therapies. However, the specific extraction methodologies and therapeutic applications claimed in CN101094679 distinguish it within this landscape.
4. What are the potential challenges in commercializing this patented technology?
Regulatory approval, sourcing high-quality neural tissue, ensuring consistent manufacturing, and addressing safety concerns represent significant hurdles.
5. Can this patent be licensed outside China?
Yes, but licensing depends on international patent family filings, patent prosecution status, and jurisdiction-specific IP laws. Usually, patent owners pursue patent protection in key markets globally for broader commercialization.
References
- Patent CN101094679A document, available via CNIPA database.
- China's Patent Law and Guidelines for Patent Examination.
- Industry reports on biologic therapeutics for CNS diseases in China.
- Patent landscape analyses of biopharmaceuticals targeting neurological disorders.
This analysis underscores the importance of CN101094679 within China's burgeoning neurobiological therapeutics IP landscape, revealing strategic protection measures for neural tissue-derived biologics and their broad therapeutic claims.
