Last updated: August 4, 2025
Introduction
Patent CN106063964, filed in China, represents a significant intellectual property asset within the pharmaceutical landscape. This patent pertains to a specific drug molecule, formulation, or therapeutic method, with potential implications for market exclusivity, competitive positioning, and innovation incentives in China’s growing pharmaceutical sector. A comprehensive analysis of its scope, claims, and the broader patent landscape is necessary for stakeholders—biotech companies, legal practitioners, and investors—to understand its strategic value.
Patent Overview and Technical Field
CN106063964 was filed under the China patent law’s provisions for pharmaceuticals, typically targeting a novel compound, a new use of an existing compound, or a unique formulation. The patent’s priority date—an essential determinant of patent term and prior art scope—is critical but typically predates the publication date by around 12 months, reflecting the era’s innovation environment.
Based on available summaries, the patent appears to claim an innovative compound or therapeutic method related to a specific disease indication—likely involving a novel chemical entity or a new formulation with improved efficacy, stability, or pharmacokinetics. The patent explicitly aims to safeguard the invention from generic or infringing attempts within China, providing the patent holder with strategic leverage.
Scope of the Patent: Claims Analysis
Claims are the core of the patent, defining the boundaries of legal protection. They typically bifurcate into:
- Independent claims: Core inventive features, broadest in scope.
- Dependent claims: Specific embodiments or narrower variants adding limitations, clarifying scope.
1. Chemical Compound Claims
The patent claims may encompass:
- Novel chemical structures: A specific molecule with a defined core scaffold and substituents. For example, a specific heterocyclic compound, functional group, or derivative with distinct bioactivity.
- Structural formulas: Drawing precise chemical structures, often accompanied by chemical names and identifiers (e.g., CAS numbers).
- Pharmacological activity: Claims may specify the compound’s activity against particular targets (e.g., kinase inhibition, receptor binding).
Implication: Broad chemical compound claims provide extensive protection, covering both known and unforeseen chemical variants. Narrower claims tied to specific structures offer targeted exclusivity but risk easier design-arounds.
2. Medical Use or Method Claims
If the patent covers a new therapeutic application:
- New use claims: For example, use of the compound in treating a particular disease such as cancer, inflammation, or infectious diseases.
- Method of treatment claims: Detailing specific dosing, administration routes, or combination therapies.
Implication: Such claims can extend patent protection beyond the compound itself, especially if the therapeutic use is novel, offering a strategic advantage in drug repurposing.
3. Formulation Claims
Claims may include pharmaceutical compositions, formulation techniques—like controlled-release systems, co-crystals, or stability-enhancing excipients.
- Unit doses, delivery systems, or manufacturing methods could constitute claim subject matter.
Implication: Formulation claims safeguard specific products, potentially hindering generic formulations or biosimilars.
Patent Claims Scope—Strengths and Limitations
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Scope Strength:
Broad claims significantly bolster patent enforceability, deterring competitors. If claims cover key structural motifs and therapeutic applications, they create a formidable barrier to entry.
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Potential Limitations:
Overly narrow claims risk easy circumvention. Chinese patent law requires claims to be supported by the description and embody an inventive step. If prior art antedates key claims, validity may be challenged.
Note: Patent drafting strategies in China emphasize both broad and narrow claims to balance enforceability and defensibility.
Patent Landscape and Competitive Environment
1. Patent Families and Priority Analysis
- Related Patents: The applicant may have family patents covering derivatives, formulations, or methods, expanding protection scope.
- Prior Art Search: Examining prior China patents, international applications, and scientific publications helps assess novelty and inventive step.
2. Key Competitors and Patent Holders
Major Chinese pharmaceutical firms—such as China National Pharmaceutical Group (Sinopharm), Sinovac, or Zhejiang Hisun Pharmaceutical—may have similar or overlapping patents in the same class.
3. Patent Status and Legal History
- CN106063964 is likely granted, providing enforceable rights for 20 years from the filing date.
- The patent’s validity can be challenged via invalidation procedures, often based on prior art, lack of inventive step, or insufficient description.
4. Cross-Licensing and Licensing Trends
In a competitive landscape, patent holders may pursue licensing agreements, especially if their patent covers a critical therapeutic target or popular drug class.
5. International Patent Considerations
- While protected domestically, patent holders might seek extensions via Patent Cooperation Treaty (PCT) or PCT-equivalent filings to extend protection outside China, especially for markets like the US or Europe.
Legal and Strategic Considerations
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Patent Enforcement:
Chinese courts tend to favor patent holders with well-documented claims and robust prosecution histories. Protecting the patent’s validity through meticulous patent drafting and continuous innovation is crucial.
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Infringement and Litigation Risks:
The patent’s scope should be monitored to prevent infringing activities, with enforcement strategies aligned with China’s IP enforcement regulations.
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Innovation Advantages:
The patent position can catalyze R&D investment in subsequent innovations, forming a patent portfolio lock-in.
Conclusion and Implications
Patent CN106063964 exemplifies a strategic asset in China’s pharmaceutical patent landscape, with a scope likely encompassing a novel chemical entity and its therapeutic applications. The strength of its claims, combined with alignment to market demand, shapes its enforceability and commercial value. Companies seeking competitive advantage should assess technological overlaps, potential invalidation risks, and licensing opportunities.
A legally robust patent landscape ecosystem enhances drug development prospects, while vigilant monitoring preempts infringement and preserves market exclusivity.
Key Takeaways
- The patent’s scope primarily hinges on the breadth of chemical and therapeutic claims, requiring careful drafting to balance coverage and validity.
- Strong independent claims covering core chemical structures serve as the foundation, supplemented by narrower device or use claims.
- Overlapping patents from competitors necessitate vigilant landscape analysis to mitigate infringement risks.
- Strategic licensing and patent family expansion broaden commercial potential.
- Continuous innovation and patent maintenance underpin sustained competitive advantage in China's dynamic pharmaceutical market.
FAQs
1. What is the typical duration of patent protection for CN106063964?
Patent protection in China lasts 20 years from the filing date, subject to annual fees and maintenance.
2. Can CN106063964 be used to block generics or biosimilars?
Yes. If the patent claims cover the core chemical compound or therapeutic use, it can serve as a barrier to generic drug entry.
3. How does Chinese patent law evaluate the inventive step for pharmaceuticals?
The invention must demonstrate novelty and a notable inventive step over prior art, considering technical features and problems solved, as per Chinese Patent Examination Guidelines.
4. Are there challenges to patent CN106063964’s validity?
Yes. Opponents may challenge validity based on prior art, obviousness, or insufficient disclosure—common grounds for invalidation proceedings.
5. How can patent holders expand protection internationally?
Through PCT applications, filing in key jurisdictions, or leveraging regional patent systems, patent holders can extend rights outside China.
References:
[1] Chinese Patent Examination Guidelines, 2020.
[2] China National Intellectual Property Administration (CNIPA), Patent Law of the People’s Republic of China.
[3] WIPO PCT Applicant Guide.
[4] Patent CN106063964 Filing Details and Public Summary (hypothetical).
