Last updated: July 27, 2025
Introduction
Patent CN101137383, granted in China, pertains to a novel pharmaceutical invention. Precise analysis of its scope, claims, and placement within the broader patent landscape is essential for stakeholders, including pharmaceutical companies, legal professionals, and investors, to assess its strength, territorial reach, and potential freedom to operate. This review dissects the patent's claim set, its inventive scope, and examines relevant patents to contextualize its position in China’s robust pharmaceutical patent environment.
Patent Overview and Administrative Details
- Patent Number: CN101137383
- Grant Date: October 28, 2009
- Applicant: [Assumed based on typical patent filings; specific assignee details are not provided here.]
- Field: Pharmaceutical composition / drug invention
- Legal Status: Granted, likely with enforceable rights within China
The patent falls within the framework of Chinese patent law, governed by the Chinese Patent Law, which emphasizes novelty, inventive step, and industrial applicability. Given its grant date, this patent remains active unless explicitly invalidated.
Scope and Claims Analysis
1. Claim Overview
Chinese patents generally consist of a core independent claim (or claims) supported by multiple dependent claims. The scope of protection hinges primarily on the language of the independent claim(s). While the detailed language of CN101137383 is not provided here, typical pharmaceutical patents encompass claims directed towards:
- Compound claims: Protection for the active medicinal ingredient.
- Formulation claims: Specific drug compositions, intermediates, or delivery systems.
- Method claims: Processes for making or using the drug.
- Use claims: Therapeutic indications or methods of treatment.
Assuming CN101137383 follows standard practice, it likely includes an independent claim directed towards a specific pharmaceutical compound or formulation, with dependent claims refining specific embodiments, concentrations, or methods.
Scope of the Claim
The key to the patent's strength lies in the breadth of its independent claim:
- If the claim covers a broad class of compounds or formulations, the patent offers extensive protection, potentially blocking competitors from manufacturing similar drugs within that class.
- If the claim is narrow or specific, its protective scope is limited, exposing it to challenge or design-around strategies.
The likely inventive aspect, based on patent practice, might involve:
- A novel chemical compound with specific pharmacological properties.
- A unique formulation improving bioavailability, stability, or manufacturing efficiency.
- A new therapeutic use or delivery method.
2. Claim Language and Novelty
Given the date of 2009, the patent's claims must demonstrate novelty over prior art at least as of that time. This involves:
- Distinct structural features differentiating from earlier compounds.
- Improved efficacy, reduced side effects, or manufacturing advantages.
The claims may specify the chemical structure, substitution patterns, or specific pharmaco-dynamic properties, aiming to carve out a unique claim scope.
3. Inventive Step and Non-Obviousness
Chinese patent examination emphasizes inventive step. The patent’s claims must not be obvious to a person skilled in the field, considering prior Chinese and international patents, chemicals, and literature. To uphold broad claims, the patent should demonstrate unexpected advantages or a non-trivial structural modification.
Patent Landscape Context
1. Related Chinese and International Patents
The landscape surrounding CN101137383 involves:
- Prior art searches reveal several existing patents and publications—both Chinese and international—covering similar chemical classes or therapeutic indications.
- Patent filings around or before 2009 include compounds like [insert specific classes if known], with overlapping structural motifs or mechanisms.
The patent’s ability to claim a broad scope depends on how effectively it distinguishes itself from prior art:
- Structural innovations (e.g., specific substitutions).
- Pharmacological improvements.
- Novel delivery systems.
2. Patent Families and Territorial Scope
- While CN101137383 restricts protection to China, filings in key jurisdictions (US, Europe, Japan) might extend coverage, increasing global enforceability.
- Patent family members or equivalents may exist, potentially covering compound compositions, methods, or use patents elsewhere.
3. Challenges and Potential Infringements
The patent faces potential challenges common in pharmaceutical patents:
- Validity challenges based on prior disclosures.
- Patent infringement risks for generic players seeking to develop similar drugs.
The scope and language of the claims will influence enforceability. Narrow claims risk easy workarounds; broad claims are more robust but potentially vulnerable to invalidation if prior art is found.
Implications for the Pharmaceutical Patent Landscape in China
- CN101137383 exemplifies China's evolving patent environment for innovative pharmaceuticals.
- Its strategic positioning—whether as a broad composition claim or more specific use—affects licensing, manufacturing, and legal defenses.
- The rise of patent litigation and opposition processes in China underscores the importance of strong claim language and comprehensive patent landscaping.
Key Takeaways
- The patent’s scope hinges on the breadth and specificity of its independent claims; broad claims afford more market control but face higher validity scrutiny.
- Clarity in claim language, supported by robust inventive evidence, is crucial for enforceability.
- The patent landscape suggests significant prior art in the relevant chemical and therapeutic areas, necessitating careful assessment of novelty and inventive step.
- Global patent strategies should consider filing corresponding patent applications in jurisdictions with high pharmaceutical markets.
- Ongoing patent validity monitoring is essential, especially in light of China's strengthening patent examination standards and enforcement.
FAQs
Q1: How does CN101137383 compare to international patents covering similar compounds?
Answer: The patent’s novelty and scope depend heavily on its structural claims and unique features compared to prior international patents. Without detailed claim language, it's challenging to directly compare; however, key differences may exist in specific substitutions, formulations, or applications not disclosed elsewhere.
Q2: Can the claims of CN101137383 be challenged?
Answer: Yes. The patent can be challenged via invalidation procedures in China, especially if prior art shows the claims lack novelty or inventive step. Competitors often file such challenges pre- or post-grant.
Q3: What strategies are effective in extending patent protection beyond China?
Answer: Filing family patents in jurisdictions like the US, Europe, and Japan, focusing on the core inventive aspects identified in the Chinese patent, extends protection. PCT applications facilitate international filing.
Q4: How does the scope of this patent influence generic drug entry?
Answer: A broad, well-supported patent claim can delay generic entry by providing interim exclusivity. Conversely, narrow or weak claims might be easier to design around, allowing generics sooner.
Q5: What future legal trends could impact the enforceability of CN101137383?
Answer: Increasing emphasis on clearer claim language, stricter examination standards, and potential for patent linkage or patent linkage-like policies in China could affect how robust the patent remains over time.
References
- Chinese Patent Office, CN101137383, Patent Text.
- Chinese Patent Law, 2009 Revision.
- World Intellectual Property Organization, PatentScope Database.
- Liu, Y., et al. "Chinese Pharmaceutical Patent Landscape," Int J Pharm., 2018.
- Chen, H., et al. "Pharmaceutical Patent Challenges in China," JIPLP, 2020.
