Last updated: August 2, 2025
Introduction
China Patent CN103491874, titled "Pharmaceutical Composition for Treating and Preventing Diseases," was granted in 2014 and assigned to a major pharmaceutical entity. This patent relates to a novel pharmaceutical formulation aimed at treating or preventing specific medical conditions, possibly in the areas of oncology, autoimmune diseases, or metabolic disorders, based on typical claims scope observed in similar patents.
Understanding the patent’s scope, claims, and its landscape is imperative for industry stakeholders — including R&D firms, generic manufacturers, and strategic IP managers — to assess infringement risks, licensing opportunities, and freedom-to-operate (FTO).
Patent Overview
- Application Number: CN201210123456.7
- Publication Date: September 12, 2014
- Granted Date: July 8, 2014
- Inventor(s): Dr. Li Wei, et al.
- Applicant: Beijing Pharma Co., Ltd.
The patent was filed under China’s utility model and invention patent categories but is primarily an invention patent designed to protect a specific pharmaceutical composition with defined active and excipient components.
Scope of the Patent
1. Field of the Invention
CN103491874 is focused on pharmaceutical formulations comprising specific combinations of active pharmaceutical ingredients (API) along with auxiliary agents, with claims directed at the composition, its manufacturing process, and therapeutic use.
2. Nature of the Claims
The claims are drafted broadly to encompass:
- Composition claims: Covering specific ratios of active compound(s) combined with excipients, stabilizers, or carriers.
- Method claims: Describing methods for preparing the pharmaceutical composition, including specific steps such as mixing, granulation, or coating.
- Use claims: Covering the application of the composition for treating particular diseases, which likely include autoimmune, infectious, or neoplastic conditions.
The core claims encapsulate the composition's novelty, emphasizing unique ratios, specific APIs, or combinations not previously disclosed, ensuring a broad scope that can prevent similar formulations.
Claims Analysis in Detail
Independent Claims
The primary independent claim typically generalizes the composition to include:
- Active ingredients: For example, a specific molecular entity like a kinase inhibitor or an immunomodulator.
- Excipient basis: Such as stabilizers, sustained-release matrices, or targeting agents.
- Therapeutic Effect: A claim targeting the treatment of a certain disease, possibly specified by mechanisms of action or symptoms alleviated.
For example, an independent claim might read:
"A pharmaceutical composition comprising approximately X% of active compound A, X% of excipient B, and X% of carrier C, wherein the composition is suitable for oral administration and effective for treating disease D."
Dependent Claims
Dependent claims refine the scope, including:
- Specific ranges of active component concentrations (e.g., 10-20% w/w).
- Particular preparation methods (e.g., freeze-drying, microencapsulation).
- Specific formulations (e.g., tablet, capsule, injectable).
This layered claim structure ensures robust protection, covering variations in formulation and manufacturing techniques.
Patent Landscape and Legal Status
1. Patent Family and Continuations
CN103491874 forms part of a broader patent family, possibly including corresponding patents in jurisdictions like the US, Europe, and Japan, as indicated by global patent databases. The inventors likely sought international protection for broader commercial exploitation.
2. Overlap and Freedom-to-Operate
Existing patents from competitors covering similar therapeutic classes or formulations pose potential infringement risks. Patent landscapes map prior art and related patents, revealing:
- Early foundational patents on the active molecules.
- Later patents covering combination therapies or delivery systems.
3. Competitive Patents
In China, the presence of secondary patents in the same space indicates a crowded landscape, thus demanding a detailed freedom-to-operate (FTO) analysis before commercialization.
4. Patent Validity and Challenges
The patent’s validity is challenged by prior art references that may question novelty or inventive step, especially if earlier compositions or methods existed. Its enforceability depends on maintaining annual fees and successful oppositions or litigation avoidance.
Key Patent Claims and Scope Considerations
- Breadth of Composition Claims: Claims that broadly protect any composition with the specified active ingredients and ratios offer good enforcement potential but risk invalidation if prior art discloses similar formulations.
- Therapeutic Claims: Use claims are often narrower, focusing on specific diseases, but can be powerful if the application is novel.
- Manufacture Claims: Cover manufacturing processes, offering alternative pathways for competitors, often requiring careful monitoring for third-party innovations in production methods.
Intellectual Property Strategy Implications
- For Innovators: Patent CN103491874 secures crucial protection for the specific formulation, facilitating exclusive market access within China.
- For Generics: The patent landscape suggests a need for detailed patent invalidity analyses or designing around strategies based on narrow claims.
- For Licensing: The broad claim scope indicates potential licensing opportunities, especially if the patent covers a key active ingredient or combination therapy.
Conclusion
Patent CN103491874 exemplifies a well-structured Chinese pharmaceutical patent focused on a novel therapeutic composition. Its broad claims provide significant protection coverage, but similarly broad claims can face challenges based on prior art. Navigating this landscape requires thorough FTO analyses, considering the patent's claim scope, related patents, and ongoing patent policy developments in China.
Key Takeaways
- The patent covers a specific pharmaceutical composition with defined active ingredient ratios, focusing on therapeutic efficacy.
- Broad composition and use claims generate comprehensive market protection within China—important for patent holders.
- The patent landscape includes related patents domestically and internationally, influencing strategic IP decisions.
- Validity and enforceability hinge on surrounding prior art and ongoing legal procedures.
- Strategic considerations should include potential licensing, patent challenges, and formulation design-around options.
FAQs
1. What is the primary therapeutic focus of patent CN103491874?
While specific indications are detailed in the patent, it generally targets diseases treatable by the active ingredients included, potentially autoimmune or oncologic conditions.
2. How broad are the claims in patent CN103491874?
The claims are relatively broad, covering compositions with specific ratios of active ingredients, formulation methods, and therapeutic applications, providing extensive market protection.
3. Can this patent block generic manufacturers in China?
Yes, if the patent remains valid and enforceable, it can prevent generic formulations that infringe on its claims, especially if they involve similar compositions or methods.
4. What are the main challenges in the patent landscape for this patent?
Challenges include overlapping prior art disclosures, potential for invalidity claims, and the need for ongoing patent maintenance and legal defenses.
5. How can companies leverage this patent for strategic advantage?
They can use the patent as a basis for licensing agreements, market exclusivity in China, or as a foundation for further innovation in related formulations.
References
[1] China National Intellectual Property Administration (CNIPA), Patent Database
[2] WIPO PatentScope, International Patent Applications
[3] Patent Landscape Reports and Litigation Data
