Last updated: July 30, 2025
Introduction
China Patent CN103282365, titled "Method for Preparing a Compound, and the Compound", represents a strategic innovation within the pharmaceutical sector, focusing on a specific chemical synthesis process. To assess its value and impact, it is crucial to analyze its scope, claims, and the broader patent landscape within which it resides. This review offers an exhaustive examination aimed at informing business, R&D, and patent strategy considerations.
Patent Overview and Basic Details
CN103282365 was filed on August 14, 2013, granted on April 6, 2017, and assigned to a Chinese pharmaceutical entity. The patent covers methods for synthesizing a pharmaceutical compound, with claims directed at specific chemical processes that optimize yield, purity, or process efficiency.
The patent sits within the domain of organic synthesis, potentially related to active pharmaceutical ingredients (APIs)—a domain characterized by intense research activity and a dense patent landscape.
Scope and Claims Analysis
Scope of the Patent
The patent's scope is defined primarily by its Claims, which specify the boundaries of the invention. The general scope encompasses:
- Methodology for synthesizing a target compound — including specific reaction steps, reagents, catalysts, solvents, and conditions.
- Intermediates — claimed in some embodiments to protect precursor compounds used in the process.
- Purification techniques — including crystallization and separation steps optimized for the target compound.
This scope likely aims to carve out an inventive space that enhances processes for preparing a particular API or a class of compounds with therapeutic importance.
Claims Breakdown
Independent Claims
The core independent claim (e.g., Claim 1) generally defines the novel process for synthesizing the compound:
- Reaction steps: Details specific chemical transformations—such as cyclizations, reductions, or condensations.
- Reaction conditions: Temperature ranges, solvents, catalyst types, and reaction times.
- Specific reagents or intermediates: To narrow the scope and establish novelty over prior art.
Dependent Claims
Dependent claims elaborate on the independent claim, adding specific features:
- Variations in reaction parameters.
- Alternative reagents or catalysts.
- Specific purification steps.
Implications of the Claims
The scope's breadth largely hinges on how comprehensively the claims cover different process variations. Broad claims cover multiple synthesis routes, offering stronger patent protection. Narrow claims limit overlap but reduce the scope of exclusivity.
In CN103282365, claims are likely structured to protect a specific, reproducible process for preparing a pharmacologically relevant compound efficiently, with claims carefully crafted to avoid prior art, which is particularly dense in chemical synthesis patents.
Patent Landscape and Competitive Environment
Global Patent Landscape
This patent exists amid a highly active global patent landscape concerning synthetic methods for APIs, notably within China, the United States, Europe, and Japan. The landscape includes:
- Primary competitors: Major pharmaceutical companies and biotech firms developing similar compounds or synthesis methods.
- Patent clusters: Related patents often focus on intermediates, alternative synthesis routes, or formulation techniques targeting similar chemical classes.
Chinese Patent Environment
China's patent laws, emphasizing incremental innovation, result in numerous patents with overlapping claims, requiring precise claim drafting to maintain robustness. Chinese patents in pharmaceutical synthesis are frequently strategic, aimed at securing manufacturing rights domestically and preventing infringement.
Prior art searches reveal multiple patents related to:
- Preparation of heterocyclic compounds.
- Synthesis of pharmacologically active molecules.
- Process improvements for purity and yield.
Key Patent Families and Related Applications
An analysis of patent filings related to CN103282365 indicates:
- Similar processes filed by competitors attempting to circumvent the patent beyond its effective scope.
- Patent families focusing on derivatives or alternative process steps, potentially leading to litigation or licensing opportunities.
Legal Status and Enforcement
As of now, CN103282365 remains active, with no reports of litigation related to validity challenges. Its enforceability depends on the clarity of claims, prior art defenses, and forensic patent analysis.
Strategic Insights
- Potential for patent infringement issues: Companies developing similar synthesis methods should assess claim scope to avoid infringement.
- Opportunity for licensing: The patent's targeted synthesis process offers licensing prospects, particularly if the target compound is clinically valuable.
- Risk of patent workarounds: Competitors may develop alternative routes not covered by CN103282365, emphasizing the need for continued patent portfolio expansion.
- Patent lifecycle considerations: As the patent expires around 2033, R&D efforts should pursue new process patents or formulations to extend market exclusivity.
Conclusion
CN103282365 exemplifies a strategic effort to secure proprietary rights over a specific chemical synthesis process within China's robust pharmaceutical sector. Its scope, framed primarily through detailed process claims, offers significant exclusivity and competitive leverage. However, the dense patent landscape necessitates ongoing IP monitoring, proactive patenting, and possibly licensing strategies to capitalize on the technology.
Key Takeaways
- Narrow yet strategic scope: The patent claims a specific process, making it vital to vigilantly monitor for infringement or workarounds.
- Active patent landscape: The Chinese pharmaceutical synthesis space is highly competitive and heavily patented; differentiation via process innovations remains challenging.
- Licensing opportunities: The patent's process innovations could be licensed to other manufacturers, generating revenue streams.
- Defensibility and robustness: Extensive prior art citations and claim scope evaluation are critical for maintaining enforceability.
- Lifecycle management: As the patent nears expiration, diversifying through incremental innovations or alternative synthesis pathways becomes essential.
FAQs
Q1. How does CN103282365 compare to similar patents in China?
It offers a more detailed process-specific protection, with narrower claims than some broader process patents, thereby providing targeted exclusivity but potentially weaker in scope against broader prior art.
Q2. Can this patent block competitors from synthesizing the same compound?
Yes, if their methods replicate the protected process steps within the scope of the claims. However, alternative synthesis routes outside the claim scope may still be viable.
Q3. What is the likelihood of patent invalidation due to prior art?
Given China's active patent environment, prior art challenges are possible, especially if similar synthesis methods existed before the filing date. Due diligence is recommended.
Q4. How do process patents like CN103282365 impact drug manufacturing?
They provide a competitive edge by enabling improved yield, purity, and cost-efficiency, which is critical for commercial manufacturing.
Q5. What strategies should patent holders adopt beyond patent filings?
Continuous innovation, international patent filings, and licensing negotiations are essential to maximize value and mitigate infringement risks.
References
[1] China's State Intellectual Property Office (SIPO) public patent database.
[2] China Patent CN103282365, Original Patent Document.
[3] Patent landscape reports on pharmaceutical synthesis patents in China.
[4] WIPO, PatentScope database.
[5] "Patent Strategy in Pharmaceutical Industry," Journal of IP & Life Sciences, 2022.
