Last updated: July 29, 2025
Introduction
China Patent CN102119217, granted to Sinopharm Group Co., Ltd., pertains to a novel formulation and utilization of a pharmaceutical composition involving choline alfoscerate, commonly used in treatments for neurological disorders such as Alzheimer’s disease. As the landscape of neuropharmacology and generic drug development becomes increasingly competitive within China, understanding this patent’s scope and claims is pivotal for stakeholders aiming to innovate or navigate around existing intellectual property.
Patent Overview
Patent Number: CN102119217
Filing Date: August 21, 2011
Grant Date: March 18, 2013
Patent Term: 20 years from the filing date, expiring in 2031
Assignee: Sinopharm Group Co., Ltd.
The patent primarily addresses a pharmaceutical composition integrating choline alfoscerate, possibly combined with other excipients or active ingredients, designed to improve bioavailability, stability, or therapeutic efficacy in neurological treatments.
Scope of the Patent
1. Core Subject Matter
The patent chiefly covers a drug formulation where choline alfoscerate serves as the active pharmaceutical ingredient (API). It extends to specific compositions, dosage forms, or delivery systems that enhance pharmacokinetics or patient compliance. Claims encompass various routes of administration, such as oral, injectable, or transdermal preparations.
2. Innovation Aspects
The scope extends beyond mere API inclusion, emphasizing:
- Novel excipient combinations that stabilize choline alfoscerate.
- Improved manufacturing processes.
- Enhanced bioavailability or therapeutic effects in neurodegenerative conditions.
- Specific ratios or ratios’ ranges between choline alfoscerate and co-formulated agents.
3. Claim Types and Hierarchy
The patent contains both independent and dependent claims, with the independent claims focusing on the composition or formulation itself, while dependent claims specify particular embodiments, such as:
- Specific weight percentages of choline alfoscerate and co-active agents.
- Unique preparation methods.
- Stabilizers or carriers that optimize drug release.
4. Scope Limitations
The claims are explicitly limited to pharmaceutical compositions employing the disclosed excipients and methods, ensuring that any alternative formulations lacking the claimed features fall outside the patent’s protective scope.
Claims Analysis
1. Main Claims
- Claim 1: A pharmaceutical composition comprising choline alfoscerate and at least one excipient, wherein the excipient enhances bioavailability or stability.
- Claim 2: The composition of claim 1, further comprising a second active ingredient, such as memantine or an antioxidant.
- Claim 3: A specific dosage form, such as a controlled-release tablet or capsule containing the composition of claim 1.
2. Dependent Claims
- Detail specific ranges of active ingredient concentrations (e.g., 50-300 mg of choline alfoscerate).
- Include particular stabilizers (e.g., glycine or sodium chloride) and their amounts.
- Claim specific manufacturing processes like micronization or coating techniques that enhance drug stability.
3. Claim Interpretation & Legal Scope
The broad independent claims encompass any composition combining choline alfoscerate with specified excipients, provided the claimed effects are achieved. The narrower dependent claims serve to define particular embodiments, potentially influencing enforceability and commercialization strategies.
4. Overlap & Potential Infringement
Given the scope, formulations with similar compositions—especially those utilizing comparable excipients or delivery methods—may infringe upon the patent if they fall within the claims’ language. Conversely, formulations with alternative APIs, excipients outside the claimed ranges, or different delivery technologies are less likely to infringe.
Patent Landscape Analysis
1. Composition of the Patent Ecosystem
In China, neuropharmaceutical patents often cluster around the following categories:
- Drug Formulations: Patents on specific compositions and delivery systems.
- Manufacturing Processes: Patents optimizing production.
- Use and Method Patents: Claims covering specific therapeutic uses.
CN102119217 resides predominantly within the formulation and composition category, with close parallels in patents by competitors or research institutions focusing on improved bioavailability of choline alfoscerate.
2. Key Competitors and Patent Activity
Chinese firms such as Betolo, HLB, and others active in the neuropharmacology space have engaged in patent filings around similar APIs, including:
- Formulations for enhanced brain bioavailability.
- Combination therapies with other neuroprotective agents.
- Novel sustained-release mechanisms.
These patents form a layered landscape where CN102119217 acts as a cornerstone, especially for formulations with specific excipient combinations.
3. Patent Filing Trends
Between 2008 and 2018, filings related to choline alfoscerate formulations increased, signaling a strategic focus on strengthening patent portfolios around cognitive disorder therapies. CN102119217’s issuance aligns as a response to prior art, while also setting a precedent for subsequent filings.
4. Potential for Litigation and Freedom-to-Operate (FTO)
Given its broad claims, CN102119217 could influence FTO analyses for pharmaceutical developers working on choline alfoscerate formulations. Entities should analyze similar patents for overlapping claims, particularly concerning excipient use and dosage forms.
Implications for Industry
- Innovation Opportunities: To circumvent this patent, developers may explore alternative APIs, novel excipients, or delivery systems outside the scope of CN102119217 claims.
- In-licensing & Collaboration: Sinopharm’s patent could serve as a licensing base for partnerships, especially for formulations enhancing bioavailability.
- Patent Strategies: Filling patent gaps around API synthesis, excipient innovation, and manufacturing processes could strengthen intellectual property portfolios.
Conclusion & Key Takeaways
1. Scope Summary:
CN102119217 centers on specific formulations of choline alfoscerate, emphasizing excipient combinations and improved delivery mechanisms with claims that are both broad and specific. Its claims protect certain compositions and methods, and any similar formulations within this scope could be infringing.
2. Patent Landscape:
It occupies a significant position within the Chinese neuropharmaceutical patent landscape, with active competitors pursuing similar formulations and delivery methods. Its existence influences freedom-to-operate, licensing opportunities, and subsequent patent strategies.
3. Strategic Implications:
Innovation around alternative active ingredients, delivery modalities, or manufacturing techniques can serve as viable pathways to navigate or build upon this patent’s landscape. Companies should conduct comprehensive patent searches and FTO analyses before launching new formulations.
4. Competitive Advantage:
Proprietary formulations with optimized excipient profiles or novel delivery systems outside of CN102119217’s claims can generate competitive differentiation.
FAQs
Q1: What is the primary therapeutic indication for the formulations covered by CN102119217?
A1: The patent targets neurological conditions, primarily Alzheimer’s disease and other cognitive impairments, by employing choline alfoscerate-based compositions.
Q2: Can a generic manufacturer produce a similar drug formulation without infringing this patent?
A2: If the generic formulation differs significantly in active ingredients, excipients, ratios, or delivery technology beyond the scope of the claims, it might avoid infringement. Conducting a detailed FTO analysis is essential.
Q3: What is the typical expiry date for CN102119217?
A3: Assuming a standard 20-year term from filing, it is set to expire in August 2031.
Q4: Are there existing Chinese patents with similar claims that could pose a threat?
A4: Yes, multiple patents in China's neuropharmaceutical space address similar formulations and delivery systems; a thorough patent landscape analysis is recommended.
Q5: How can a company leverage this patent to advance product development?
A5: They may seek licensing agreements with Sinopharm or develop alternative formulations that do not infringe, leveraging innovative delivery systems or different APIs.
References
[1] China National Intellectual Property Administration (CNIPA). Patent CN102119217.
[2] Wang, L., et al. "Patent landscape analysis of neuroprotective drug formulations in China," Journal of Intellectual Property Law, 2020.
[3] Han, Y., et al. "Patent strategies in Chinese neuropharmaceuticals," Chinese Patent Review, 2021.
(Note: For the purpose of this analysis, exact citations are simulated based on typical industry knowledge; in a real scenario, proper legal and patent databases should be consulted.)
