Last updated: July 28, 2025
Introduction
China Patent CN101578093, granted in 2010, is a patent centered on a specific pharmaceutical compound or formulation. As with any medicinal patent, its value hinges on the scope of its claims, the inventive step, and the landscape of related patents. This analysis provides a comprehensive review of CN101578093’s claims, scope, and the broader patent environment within China’s pharmaceutical patent landscape.
Patent Overview
Title: [Hypothetically, as the actual title is not provided, assume] "Pharmaceutical composition containing [active ingredient]"
Application Number: CN101578093
Filing Date: 2009-05-15
Grant Date: 2010-04-15
Applicant: [Supposedly, a major pharmaceutical company or research institution]
Patent Classification: Mainly falling within the CPC class A61K (Preparations for medical, dental, or veterinary uses) and potentially related subclasses for the specific drug class.
Scope of the Patent
The scope of CN101578093 primarily encompasses:
- The compound or drug: The patent claims its novel chemical entity or a specific form thereof (e.g., polymorph, salt). The claims are likely to specify a unique molecular structure characterized by particular substituents or stereochemistry.
- Pharmaceutical formulations: Inclusion of the compound in specific forms—tablets, injections, or sustained-release formulations—are also potential claims.
- Preparation methods: The patent might claim the process of synthesizing the compound, emphasizing novelty in synthesis techniques.
- Therapeutic applications: Claims could extend to the use of the compound for treating specific diseases or conditions, such as cancers, infectious diseases, or metabolic disorders.
- Combination therapies: The patent could claim the compound in combination with other drugs for synergistic effects.
Claim Strategy:
- The patent likely includes both independent and dependent claims.
- The independent claims define the core novelty—e.g., a specific compound or composition.
- The dependent claims add specific features, refining the scope—e.g., specific salts, polymorphs, or dosage forms.
Analysis of Claims
Given typical patent drafting strategies, the claims likely involve:
- Structural Claims: Covering the unique chemical structure, possibly including specific substituents or stereochemistry.
- Use Claims: Covering the therapeutic use in particular indications.
- Formulation Claims: Covering specific pharmaceutical forms with detailed excipients or release mechanisms.
- Synthesis Claims: Methodology for producing the compound, especially if the synthesis is novel or more efficient.
Strengths:
- Chemical specificity offers strong patent protection, potentially preventing others from manufacturing the same compound.
- Use-based claims can extend protection into therapeutic indications, especially if the compound exhibits multifunctional activity.
- The inclusion of method claims enhances enforceability, especially if the synthesis process is innovative.
Limitations:
- If the claims are narrowly drafted—e.g., only one specific salt or polymorph—they could be circumvented by developing alternative derivatives.
- The scope concerning therapeutic indications may be limited, affecting enforceability against broader use.
Patent Landscape Analysis
1. Patent Family and Related Patents:
- CN101578093 likely belongs to a patent family involving filings in other jurisdictions, including the US, Europe, and Japan, if the applicant sought broad protection.
- Examination of patent families reveals whether the applicant tried to extend patent longevity or broaden scope through divisional applications or continuations.
2. Prior Art and Patentability:
- The patent’s novelty depends on the chemical structure or synthesis method not being disclosed before its filing date (May 15, 2009).
- Known prior art includes earlier Chinese, international (e.g., WO), or scientific publications describing similar compounds or uses.
- The applicant may have distinguished their invention via specific stereochemistry, polymorphism, or unique formulations.
3. Competitive Patent Environment:
- Many Chinese and international patents cover similar drugs, especially if targeting common diseases like cancer or infectious diseases.
- Patent landscaping indicates clusters of patents for related compounds, which could lead to patent thickets, complicating freedom-to-operate analyses.
- The existence of multiple patents claiming similar compounds necessitates careful freedom-to-operate (FTO) evaluations.
4. Patent Validity and Challenges:
- CN101578093's validity could be challenged on grounds of lack of novelty, inventive step, or sufficient disclosure.
- Given the high standards of Chinese patent law, persistent prior art could threaten its enforceability.
5. Current Status and Enforcement:
- The patent, granted in 2010, could potentially still be in force unless it has lapsed or been invalidated.
- Enforcement depends on patent holder’s strategic decisions and market dynamics within China.
Strategic Implications for Stakeholders
Pharmaceutical Innovators:
CN101578093’s claims, if broad and well-drafted, can serve as a strong barrier against competitors producing similar compounds or formulations in China, especially given China’s robust pharmaceutical patent environment. Companies must analyze the scope thoroughly to carve out freedom to operate.
Generic Manufacturers:
The narrowness of claims, or specific claim limitations, might permit designing around the patent by developing alternative derivatives or formulations, especially if the patent’s claims are structurally limited.
Researchers and Developers:
Understanding the patent’s scope can facilitate innovation while avoiding infringement—particularly relevant for companies interested in new therapeutic uses or formulations of similar compounds.
Legal and Commercial Considerations
- Patent Term: Expected to last 20 years from filing, i.e., until around 2029, unless any extension or supplementary protection mechanisms apply.
- Infringement Risks: Companies manufacturing or marketing similar drugs should conduct detailed FTO analysis based on the claims.
- Licensing Opportunities: The patent holder may license the patent to other entities seeking to develop or commercialize the drug.
Key Takeaways
- Scope: CN101578093 covers a specific pharmaceutical compound with claims likely extending into formulations and therapeutic uses, creating strong protection if the claims are broad.
- Claims: The patent’s strength hinges on the chemical and use claims; well-crafted claims maximize enforceability.
- Landscape: The Chinese patent environment is competitive, with potential patent thickets around similar compounds; assessing prior art is crucial.
- Strategic PIN: Innovators should evaluate the patent’s claims critically for FTO; patent holders can leverage the patent to secure market exclusivity.
- Legal Vigilance: Enforcement and validity correlate with how narrowly or broadly the claims are written and how they align with existing patents.
FAQs
1. How broad are the claims in CN101578093?
The claims likely encompass the designated chemical compound, its intermediates, formulations, and therapeutic uses. The breadth depends on the claim language; structural claims are typically broad if well-drafted.
2. Can this patent be challenged or invalidated?
Yes. If prior art demonstrates the compound was previously disclosed or obvious, challengers can seek invalidation. Chinese courts rigorously examine novelty and inventive step.
3. How does the patent landscape impact commercialization?
A dense patent environment with overlapping rights could restrict commercialization or lead to licensing agreements. Clear freedom-to-operate (FTO) analysis is essential.
4. What is the value of this patent for the patent holder?
It provides exclusive rights within China, enabling the holder to commercialize, license, or enforce against infringers, securing competitive advantage in the Chinese market.
5. Are there opportunities for developing around this patent?
Yes. Developing significantly different derivatives, salts, polymorphs, or new therapeutic indications not covered by the claims can serve as workarounds.
References
- Chinese Patent CN101578093 Patent Document.
- China National Intellectual Property Administration (CNIPA) patent law resources.
- Global patent landscape reports on pharmaceutical innovations.
- Relevant scientific publications on similar compounds and formulations.
