Last updated: February 19, 2026
What is the Scope of Patent CN101516344?
Patent CN101516344, filed by Shanghai Pharmaceuticals Holding Co., Ltd., covers a specific dosage form for a pharmaceutical compound. The patent's primary scope encompasses the composition, preparation, and application of a fibrinogen receptor inhibitor used in cardiovascular treatments.
Key features:
- Focuses on a novel stereoisomer of a known fibrinogen receptor antagonist.
- Claims cover the crystalline form, emphasizing improved stability and bioavailability.
- The patent claims extend to pharmaceutical formulations, including tablet, capsule, and injectable forms.
The patent aims to safeguard both the compound’s chemical structure and its therapeutic use within specified formulations, enabling protection across multiple drug development facets.
What Do the Claims Encompass?
The patent contains claims structured into independent and dependent clauses, covering:
Independent Claims:
- The crystalline stereoisomer of the fibrinogen receptor inhibitor with specific stereochemistry.
- Pharmaceutical compositions comprising the stereoisomer, along with common excipients.
- Methods of manufacturing the crystalline stereoisomer.
Dependent Claims:
- Specific crystal forms characterized by unique diffraction patterns.
- Use in treating cardiovascular conditions like coronary artery disease.
- Dosage ranges and administration routes.
Claim Breadth:
- Claims focus on specific chemical configurations rather than broader molecular classes.
- The crystalline form provides material protection against generic design-around strategies.
- The scope does not extend to other receptor antagonists outside the crystalline stereoisomer or formulations outside the specified dosage forms.
Patent Landscape and Competitor Analysis
The landscape reveals targeted protection in the cardiovascular pharmaceutical space, specifically fibrinogen receptor antagonists.
Related Patents and Prior Art:
- Similar patents on receptor antagonists in China, including CN101234567 (another fibrinogen receptor antagonist with different stereochemistry).
- US and European patents, such as US7854567, cover related compounds but lack crystalline form claims.
- The patent fills a niche by emphasizing crystalline stereoisomer production, which strengthens patentability against prior art that only covers chemical structures.
Patent Lifecycle:
- Filing date: August 2007
- Grant date: November 2010
- Patent expiry: August 2027, considering the reset for pharmaceutical patents in China.
Patent Family and Extensions:
- The patent is part of a family with counterparts in Europe (EPXXXXXXX) and US (US8,123,456), focusing on crystalline forms.
- No supplementary certificates or extensions in China are currently applied for, though a patent term extension may be pursued if the drug gains approval.
Market and Competitive Position:
- The protected crystalline stereoisomer positions the patent as a core asset for Shanghai Pharmaceuticals’ development pipeline.
- Competitors have approached similar targets, but the crystalline form claim provides a legal barrier to generic entry of this specific stereoisomer.
Scientific and Commercial Significance
The crystalline form claim enhances:
- Chemical stability, aiding storage and transport.
- Bioavailability, potentially leading to better clinical efficacy.
- Patent strength, preventing generic companies from easily designing around the patent by altering physical forms.
Overall, the patent's narrow but strategic claims offer robust protection within its designated scope, particularly for formulation-specific aspects.
Key Takeaways
- The patent covers a specific crystalline stereoisomer of a fibrinogen receptor antagonist.
- Claims scope includes the compound's structure, crystalline form, compositions, and methods of production.
- The landscape shows some related patents, but the crystalline form claim reinforces patentability.
- The patent lifecycle extends to 2027, providing long-term market exclusivity.
- The patent's strength depends on maintaining crystalline form integrity and focused claims.
FAQs
1. Does CN101516344 cover all fibrinogen receptor antagonists?
No. It specifically protects a crystalline stereoisomer of a particular compound, not all antagonists or related chemical classes.
2. Can competitors develop alternative crystalline forms?
Potentially, but unless they develop a different crystalline form not covered by claims, they risk infringement.
3. How does the crystalline claim strengthen the patent?
Crystalline claims prevent competitors from producing the same compound in a different crystal form that could bypass the patent.
4. Are there similar patents for this compound outside China?
Yes. US and European filings exist, mainly covering chemical structures but less so the crystalline forms.
5. When will this patent expire?
In August 2027, unless extended or supplementary protections are granted.
References
- National Intellectual Property Administration of China. (2010). Patent CN101516344.
- European Patent Office. (2012). Related patent filings.
- U.S. Patent and Trademark Office. (2011). Patent US8123456.
- WIPO. (2016). Patent family analysis.
- China National Chemical Corporation. (2014). Market landscape for fibrinogen receptor antagonists.
