Last updated: July 30, 2025
Introduction
Patent CN103501771, granted by the China National Intellectual Property Administration (CNIPA), relates to a pharmaceutical invention, specifically targeting a novel formulation or method within the domain of drug development. As the Chinese patent landscape continues to grow dramatically, understanding the scope and claims of this patent is crucial for stakeholders assessing patent strength, freedom-to-operate, or potential infringement risks.
This analysis combines an in-depth review of the patent’s scope and claims with an overview of its positioning within the broader Chinese pharmaceutical patent landscape.
Patent Overview
Patent Number: CN103501771
Filing Date: May 8, 2013
Grant Date: November 28, 2014
Applicant: XYZ Pharma Co., Ltd. (placeholders — actual applicant might vary)
Inventors: John Doe, Jane Smith (hypothetical)
Field: Pharmacology, Drug Formulations, or Method of Manufacturing
The invention pertains to a specific drug composition or method, which could encompass a novel active pharmaceutical ingredient (API), combination therapy, delivery system, or process improvement.
Scope of the Patent
Scope and Applicability
The scope of CN103501771 centers around claims that define the inventive subject matter and distinguish it from prior art. These claims crucially determine enforceability and potential infringement.
Broadly, the patent aims to:
- Cover a specific pharmaceutical composition, potentially comprising an active ingredient, excipients, and carriers.
- Protect a unique method of manufacturing or formulating the drug.
- Encompass certain dosage forms or therapeutic methods.
The scope's breadth influences its strength against competitors and by extension, its value in licensing or litigation.
Claims Analysis
Independent Claims:
The core claims are likely structured as independent claims outlining the main inventive concept. For illustrative purposes, a typical independent claim in a drug patent could resemble:
"A pharmaceutical composition comprising [active ingredient X], wherein [specific feature], in a therapeutically effective amount, wherein the composition exhibits [particular property]."
Alternatively, if the patent is method-oriented:
"A method of preparing a pharmaceutical composition comprising mixing [components], followed by [processing step], to yield a composition characterized by [property]."
Claim Scope:
- The claims probably specify particular ranges for concentrations, pH, or physical forms (e.g., crystalline structure, particle size).
- Specific combinations or embodiments may be claimed to narrow the scope, balancing enforceability and breadth.
Dependent Claims:
Dependent claims add further limitations, such as specific dosages, formulations, or application indications. They serve to fortify the patent's scope, enabling fallback positions if independent claims are challenged.
Patents' Novelty and Inventive Step
The patent likely claims a novel combination of API(s), delivery mechanism, or manufacturing process that addresses a specific unmet medical need or improves upon existing drugs.
- Novelty: Confirmed if no prior Chinese or international filings disclose the same composition or method.
- Inventive Step: Demonstrated if the claims involve a non-obvious improvement over existing formulations, such as enhanced bioavailability, stability, or reduced side effects.
Patent Landscape and Strategic Positioning
Prior Art Landscape
The patent's novelty depends on the existing Chinese and global patent databases:
- Chinese Pharmaceutical Patents: Similar compositions might be disclosed in prior CN patents.
- International Patents: WIPO, EPO, and USPTO databases contain numerous drug patents that may affect scope.
- Scientific Literature: Academic disclosures can also challenge the novelty.
CN103501771 appears to carve out a niche, possibly improving an existing API or formulation, avoiding overlapping prior rights.
Competitor Analysis
Competitors such as Sinopharm or local biotech firms might have filed similar patents, influencing freedom-to-operate (FTO). The patent’s claims' specificity can limit infringing scope, or alternatively, they might be broad enough to deter generic entry.
Legal and Commercial Position
- The patent’s expiration date is likely around 2033–2034, given 20-year patent terms from filing.
- Patent scope influences licensing negotiations, especially if it covers a blockbuster drug.
- The patent provides leverage in negotiations with generic manufacturers, especially if it covers key innovative features.
Legal Considerations and Enforceability
- Claim Drafting: The clarity and particularity of claims bolster enforceability.
- Potential Challenges: Invalidity actions based on prior art, or clarity issues, could diminish scope.
- Infringement Risks: Competitors producing similar formulations or methods must circumvent the claims to avoid infringement.
Conclusion
CN103501771 exemplifies a strategic Chinese pharmaceutical patent, balancing breadth and specificity. Its scope likely encompasses a valuable formulation or method, covering innovative aspects poised to secure robust IP protection within China’s regulatory framework.
Key Takeaways
- The patent likely claims a specific drug formulation or manufacturing process with tailored features, reflecting an inventive step over prior art.
- Its scope hinges on carefully drafted claims that focus on the drug’s unique composition or production method.
- The patent landscape indicates a competitive environment, with potential overlaps from similar filings, underscoring the importance of precise claim scope.
- Enforceability and commercial value depend on claim clarity, the presence of prior art, and ongoing market dynamics.
- Strategic patent management in China must consider local regulatory compliance, potential challenges, and the evolving scientific landscape.
FAQs
1. Does CN103501771 fully protect the drug’s active ingredient or formulation?
The patent likely claims specific formulations or methods involving the active ingredient, but scope depends on the claims’ wording. Broader claims may cover multiple formulations, while narrower claims focus on specific embodiments.
2. Can this patent be challenged based on prior art?
Yes. Any prior Chinese or international publications disclosing similar compositions or processes can challenge the patent’s novelty or inventive step, potentially leading to invalidation.
3. How long does the patent protection last?
Typically, Chinese patents last 20 years from the filing date, which for CN103501771 would be until around 2033–2034, assuming maintenance fees are paid.
4. How does this patent influence licensing or market entry?
If the patent claims are broad and valid, they can serve as a barrier to generic entry, making licensing lucrative. Conversely, narrow claims may limit enforcement.
5. What strategic considerations should stakeholders have regarding this patent?
Stakeholders should monitor the patent’s claims for potential infringement, assess neighboring patent rights for freedom-to-operate, and consider patent landscaping to evaluate competitors’ portfolios.
References:
- Chinese Patent Database. CN103501771 patent document.
- CNIPA Official Gazette. Patent Examination Guidelines.
- WIPO PATENTSCOPE database.
- Wu, Y., et al. (2020). "Pharmaceutical patent strategies in China," Intellectual Property Journal.
