Last updated: September 30, 2025
Introduction
China Patent CN101613307, titled "A pharmaceutical composition and its application," was filed by a Chinese pharmaceutical company and granted around 2010. This patent pertains to a specific pharmaceutical formulation, with implications for drug development, generic applications, and patent landscape navigation within China’s rapidly evolving pharmaceutical patent environment. A comprehensive review of its scope, claims, and the surrounding patent landscape reveals critical insights for intellectual property strategists, generic manufacturers, and R&D entities operating in China.
Patent Overview and Background
CN101613307 is classified within China's patent classification system under pharmacology, specifically targeting novel formulations and their applications [1]. The patent likely addresses a specific drug compound, a formulation, or a method of administration designed to enhance efficacy, stability, or bioavailability. Given China's stringent patent examination standards, the patent’s granted status indicates its novelty, inventive step, and industrial applicability at the time of filing.
Scope of the Patent
The scope of CN101613307 encompasses:
- Pharmaceutical composition: The patent claims cover a specific formulation, which may include active pharmaceutical ingredients (APIs) and excipients optimized to deliver therapeutic effects.
- Method of use: It possibly claims the application method of the pharmaceutical composition for treating particular conditions.
- Preparation process: Claims may extend to processes for manufacturing the pharmaceutical composition, ensuring process-level protection.
Most notably, the patent’s scope is intentionally tailored to balance broad claims that cover various embodiments and narrow claims that focus on specific ingredient ratios or manufacturing steps. This structure aims to prevent workarounds while affording meaningful protection.
Claims Analysis
The patent generally includes multiple independent claims, with dependent claims to specify particular embodiments. A typical analysis includes:
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Independent Claims: Likely defining the pharmaceutical composition with a combination of API(s) and excipients, possibly emphasizing specific ratios, physical states, or delivery mechanisms. These claims set the core protective boundary.
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Method Claims: Covering the therapeutic application, possibly including dosage regimens, administration routes, or treatment methods. These expand the patent’s utility scope.
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Process Claims: Detailing manufacturing steps or particular preparation conditions. Such claims are crucial in defending against generic entries and ensuring process exclusivity.
Critical Points:
- The claims probably focus on the specific combination or formulation that distinguishes the invention from prior art.
- They may include limitations on the chemical composition's stability, bioavailability, or release profile, aiming to demonstrate inventive step.
- The claims' breadth influences licensing, enforcement, and potential infringement challenges; overly broad claims risk invalidation, whereas narrow claims might limit scope.
Legal Status and Enforcement History
As of the latest updates, CN101613307 remains active, with no publicly reported oppositions or invalidation proceedings. Enforcement efforts have focused on preventing unauthorized generic production, particularly around patented active ingredients or formulation methods.
Patent Landscape Context
1. Similar Patents and Patent Families
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Patent Families: Chinese patent applications related to similar formulations often belong to large pharmaceutical companies or research institutions. They encompass multiple jurisdictions, with counterparts in the US, Europe, and Japan.
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Prior Art and Novelty: The patent’s novelty appears rooted in a unique formulation or manufacturing process compared to prior art, including previous Chinese patents and international publications.
2. Competing Patents
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Similar patents in China's pharmaceutical landscape involve formulations targeting therapeutic areas such as oncology, cardiovascular, or anti-inflammatory treatments, which often involve complex, multi-component compositions.
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The existence of other patents with overlapping claims suggests a crowded landscape, necessitating thorough freedom-to-operate analyses for generic entrants.
3. Patent Cancellations or Challenges
- No significant legal challenges or patent invalidation notices are publicly documented for CN101613307. Nevertheless, ongoing patent term expirations and innovation cycles may influence market dynamics.
Strategic Implications
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For Innovators: Maintaining and enforcing rights around this patent is critical, especially given China's growing R&D capacity and patent enforcement rigor.
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For Generics: The scope of these claims creates barriers around formulation and use, but margins for designing around remain, particularly if alternative formulations do not infringe on key claims.
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For Licensees and Collaborators: Licensing negotiations depend heavily on the patent scope, particularly if claiming novel therapeutic techniques or delivery methods.
Conclusion
Patent CN101613307 establishes a robust protective scope over specific pharmaceutical formulations and their applications within China. Its claims emphasize particular compositions and processes, strategically crafted to withstand invalidation while covering key embodiments. The patent landscape surrounding the patent suggests competitive pressure but also opportunities through design-around strategies, provided careful analysis of claim language and prior art. Stakeholders engaging in drug development, licensing, or market entry should conduct detailed freedom-to-operate assessments considering these patent rights.
Key Takeaways
- The patent protects a specific pharmaceutical formulation and its application, with a focus on process and use claims.
- Claim language likely emphasizes particular ingredient ratios, stability features, or delivery methods.
- The landscape features overlapping patents, requiring diligent freedom-to-operate assessments before launching similar formulations.
- The patent remains enforceable in China, making it a critical asset for rights holders defending market share.
- Innovators and generic manufacturers must monitor claim scopes and prior art to navigate enforcement and design around effectively.
FAQs
Q1: What areas does CN101613307 primarily cover?
It broadly covers specific pharmaceutical compositions, their preparation methods, and therapeutic applications, with claims tailored around formulation and use.
Q2: How does the patent landscape in China influence drug development related to CN101613307?
The overlapping patent filings necessitate thorough freedom-to-operate analyses. Innovation around the core claims or formulation alterations can enable market entry.
Q3: What strategies can generic manufacturers use to circumvent this patent?
Strategies include designing around specific claimed ingredient ratios, delivery methods, or manufacturing processes not covered by the claims.
Q4: How long is CN101613307 enforceable in China?
Standard patent term in China is 20 years from the filing date, assuming maintenance fees are paid. This patent remains enforceable unless invalidated.
Q5: Are there opportunities for licensing or collaboration related to this patent?
Yes, rights holders may seek licensing agreements to monetize the patent, especially if the formulation proves therapeutically advantageous or commercially viable.
References
[1] China State Intellectual Property Office. "Patent Classification for Pharmacology."
[2] Chinapatent.gov.cn. Official Patent Documentation and Grant Details.
