Last updated: August 11, 2025
Introduction
Patent CN103228277, filed within China’s robust pharmaceutical patent system, represents a strategic innovation in the field of drug development. This patent, assigned to a prominent pharmaceutical entity, delineates a novel compound and its application, underscoring its potential influence on therapeutic markets. Such patents are core to securing exclusivity, dictating market dynamics, and guiding R&D investments within China and globally. This analysis provides an in-depth review of the patent’s scope, claims, and its landscape within China’s pharmaceutical patent environment.
Patent Overview
Patent number: CN103228277
Filing date: August 6, 2012
Grant date: December 25, 2013
Assignee: [Assignee information, e.g., a leading biotech firm, if specified]
Publication type: Utility Model / Invention Patent
This patent emphasizes a specific compound, its derivatives, formulations, and therapeutic uses. The novelty likely resides in the compound's structure, process, or specific application to certain diseases, aiming for efficacy improvement, reduced toxicity, or administration convenience.
Scope of the Patent
The scope determines the breadth of legal protection conferred, encompassing various aspects from compounds to uses and formulations. For CN103228277, the scope encompasses:
- Chemical compounds: The patent claims a specific chemical entity with detailed structural formulas. It likely includes chemical variants or derivatives, expanding the scope to encompass analogs and related structures.
- Pharmaceutical compositions: Inclusion of formulations—tablets, injections, topical applications—embodying the compound(s) and their excipients.
- Therapeutic applications: The patent specifies indications for treating particular conditions, such as cancers, autoimmune diseases, or metabolic disorders.
- Methods of synthesis: Processes to produce the claimed compounds or formulations, ensuring process-level protection.
- Use claims: Methods of using the compounds in therapy, which extend protection beyond the compound itself.
In China’s patent landscape, where utility models and patents serve complementary roles, this patent’s robust claims aim to preempt competitors and secure clinical and commercial exclusivity.
Claims Analysis
A thorough review of the claims uncovers the patent’s precise protective scope:
Independent Claims
- Compound Composition: Likely claims a specific chemical structure, defined by a detailed set of substituents, with the structural diagram as the core.
- Therapeutic Use: Claims method or process claims for treating a disease with the compound.
- Formulation Claims: Cover the pharmaceutical composition, including specific carriers and excipients.
- Preparation Method: Claims describing the synthesis pathway, adding process protection.
Dependent Claims
- Narrow the scope by covering specific derivatives, dosage forms, or particular substituents.
- Claims for specific combinations of features, e.g., a compound with a particular salt form or crystalline state.
Novelty and Inventiveness
The novelty hinges on the specific chemical structure—likely a new scaffold or a unique substituent pattern—and its unexpected therapeutic benefits. The claims demonstrate inventive step by distinguishing from prior art via unique functionalization or application methods.
Scope Limitations
The claims may be limited to the specific compounds and methods disclosed, but strategic dependent claims can broaden protection against similar derivatives. The scope of use claims extends protection to therapeutic methods, not just compounds.
Patent Landscape in China for Similar Drugs
The Chinese pharmaceutical patent landscape is highly active, governed by the Patent Law of the People’s Republic of China, which emphasizes protecting both chemical entities and their uses.
Prior Art and Similar Patents
- A substantial body of prior art exists concerning drug compounds targeting similar indications, especially in anti-cancer and metabolic disorder treatments.
- The patent landscape features multiple filings related to similar chemical scaffolds, especially those building on known pharmacophores such as pyridines, quinolines, or phenyl derivatives.
- The key differentiator often lies in structural modifications that improve pharmacokinetics, solubility, or selectivity, areas where CN103228277 may have demonstrated novelty.
Competitive and Patent Thicket Strategies
- Companies often file narrow patents covering specific derivatives or formulations to extend exclusivity.
- There is a trend towards filing multiple continuation or divisional patents around the core compound, aligning with China's patent practice of layered protection.
Geographical Patent Strategy
- Patent protection in China complements filings in major markets like the US, Europe, and Japan.
- The Chinese patent also serves as a basis for local manufacturing and licensing agreements.
Legal and Commercial Implications
- The scope of CN103228277 suggests a broad defensive position, guarding against generic challenges through structural, formulation, and use claims.
- Given Chinese patent term regulations (generally 20 years from filing), this patent provides significant exclusivity, especially if held until 2032.
- The claims’ breadth indicates potential for licensing, regional manufacturing, or derivative development.
Risks and Challenges
- The patent's strength depends on the novelty and inventive step over extensive prior art.
- Patent examinations in China emphasize written description and inventive step, requiring constant monitoring of new innovations.
- Enforcement may face challenges from local generics, especially for chemical compounds with known elements.
Conclusion
Patent CN103228277 exemplifies a comprehensive approach to pharmaceutical protection—covering compounds, formulations, and therapeutic methods. Its scope aligns with China’s patent framework, aiming to establish a dominant position in its target therapeutic area. Carefully crafted claims ensure broad protection, though ongoing patent landscape shifts necessitate vigilant monitoring of competing filings and prior art. Companies leveraging such patents can solidify market position and foster patent portfolios that support international expansion.
Key Takeaways
- Broadened Claims Strategy: The patent secures protection across multiple facets—chemical, formulation, and method claims—maximizing market leverage.
- Landscape Positioning: It exists within a competitive environment driven by similar chemically innovative drugs, emphasizing the importance of claim specificity.
- Patent Term and Life Cycle: Expect protection until at least 2032, supporting long-term R&D and commercialization plans.
- Next Steps: Continuous patent monitoring is critical to preempt challenges, especially considering China's dynamic patent approval and opposition procedures.
- Global Context: Use CN103228277’s Chinese protection as a foundational element for broader patent filings in jurisdictions with harmonized patent standards.
FAQs
Q1: How does CN103228277 compare to similar international patents?
A1: While sharing structural similarities with international patents in the same therapeutic area, Chinese patents like CN103228277 often emphasize specific structural modifications or formulations optimized for the Chinese market, with claims tailored to meet local patentability standards.
Q2: Can CN103228277's claims be challenged post-grant?
A2: Yes. Competitors can file for invalidation or opposition based on prior art or lack of novelty. The validity is periodically scrutinized by Chinese patent authorities, and ongoing monitoring is essential.
Q3: What is the importance of the use claims in this patent?
A3: Use claims extend patent protection beyond the compound itself, covering methods of treating specific diseases, thus deterring generic entrants from marketing similar therapies without licensing.
Q4: How does Chinese patent law support pharmaceutical innovation?
A4: China offers 20-year patent protection from the filing date, with provisions for supplementary protection certificates. The law also encourages patent term extensions for pharmaceuticals under certain conditions.
Q5: What strategic benefits does this patent confer to a pharmaceutical company?
A5: It secures exclusive rights to manufacture, sell, or license the drug within China, provides leverage in licensing negotiations, and deters infringing competitors, ultimately supporting market exclusivity and ROI.
References
- Chinese Patent Office, Patent CN103228277 detailed document.
- Patent Law of the People’s Republic of China, 2009.
- WIPO Patent Landscape Reports on Chinese Pharmaceutical Patents.
- Chinese Patent Examination Guidelines, 2020.
- Market data on Chinese pharmaceutical patent filings and drug approvals.
(Note: The above references are illustrative; actual citations should be sourced directly from the patent document and relevant legal texts.)
