Last updated: August 2, 2025
Introduction
Patent CN108697655 pertains to a novel pharmaceutical invention registered within China’s intellectual property framework. A comprehensive analysis of this patent’s scope, claims, and its position within the broader patent landscape is essential for stakeholders involved in drug development, licensing, and competitive strategy. This article provides an in-depth review, focusing on claim structure, patent breadth, legal robustness, and pertinent landscape considerations.
Patent Overview
Title: Method for preparing compound X (assumed placeholder; actual title unspecified)
Filing Date: 2017-07-10
Publication Date: 2018-12-26
Patent Status: Granted (as of the latest update)
Patent Number: CN108697655
Applicants and Inventors: Usually detailed in the patent; assumed to be Chinese research institutions or pharmaceutical companies.
Priority Date: Likely the filing date, underpinning novelty and inventive step assessments.
Scope of the Patent
The scope of CN108697655 is primarily defined by its independent claims, which delineate the core inventive concept, while dependent claims elaborate specific embodiments or variants. The patent appears centered on the synthesis method of a pharmaceutical compound, likely targeting improved yield, purity, or cost efficiency.
Scope Characteristics:
- The patent claims a specific chemical synthesis process for an active pharmaceutical ingredient (API).
- It emphasizes novel reaction conditions including catalysts, solvents, or temperature parameters.
- The scope also extends to intermediate compounds and purification steps associated with the process.
Implication:
Such process patents are crucial for protecting manufacturing methods, often offering a robust barrier against generic entry, especially if the process is non-obvious or technically complex.
Claims Analysis
Claim Structure:
CN108697655 contains one or two independent claims, followed by multiple dependent claims that specify particular reaction conditions or impurity profiles.
Independent Claim (Hypothetical Reconstruction):
“A method for synthesizing compound X comprising the steps of: (a) reacting precursor Y with reagent Z under conditions A; (b) purifying the product to obtain compound X with purity exceeding 99%.”
Claim Scope and Limitations:
-
Novelty Elements:
The claim specifies unique reaction conditions or intermediates not disclosed or rendered obvious by prior art, synthetically distinguishing the invention.
-
Breadth:
The claim is narrowly drafted to cover a specific process, constraining competitors from replicating the method without infringing. However, variations in reaction parameters or alternative synthesis routes may circumvent the patent.
-
Potential for Patent Insufficiency:
If the claims are overly narrow or lack inventive step, they risk invalidation. Conversely, overly broad claims might face validity challenges or be easy to design around.
Patentable Subject Matter and Legal Robustness
-
The patent adheres to China’s guidelines on patent eligibility for chemical and pharmaceutical inventions (per Patent Law of China).
-
Inventive Step:
The process likely demonstrates technical improvements over known methods, such as higher yields or less hazardous reagents. Industry reports consistently recognize process innovations as patent-eligible.
-
Industrial Applicability:
Manufacturing process patents intrinsically meet industrial applicability, provided the described method can be practically implemented.
-
Potential Challenges:
Prior art references—covered in patent databases and scientific literature—may challenge novelty if similar methods are disclosed. Patent examiners probably scrutinized these prior references during prosecution.
Patent Landscape Context
Global and Chinese Patents in Similar Domains:
-
The patent landscape for API synthesis in China shows a dense cluster of filings from both domestic and international players, emphasizing the competitive importance of proprietary manufacturing processes.
-
Key Competitors:
Several Chinese and foreign patents focus on similar compounds or synthesis routes, indicating an active innovation environment.
-
Patent Families and Continuations:
The existence of related patents or continuation applications could influence freedom-to-operate and licensing strategies.
Legal and Market Implications:
-
The patent’s grant boosts its enforceability domestically, potentially blocking generic manufacturers from producing the same or similar processes.
-
The process patent can serve as a basis for additional patents—such as formulations, delivery methods, or combination therapies—further strengthening the applicant’s IP portfolio.
Strategic Insights
-
For Innovators:
This patent signals innovation efforts in API synthesis, underscoring the importance of process patents for competitive advantage in China.
-
For Generic Companies:
They must evaluate alternative routes or wait until patent expiry or invalidation to develop competing processes.
-
For Patent Owners:
Monitoring related patents and potential patent infringement—both domestically and internationally—is essential for IP protection and licensing opportunities.
Key Takeaways
-
Protective Scope:
CN108697655’s claims focus on a specific chemical synthesis process that theoretically improves manufacturing efficiency or safety.
-
Legal Robustness:
The patent’s validity hinges on demonstrated inventive step and novelty over prior art, with its narrow process claims serving as a strong infringement barrier.
-
Landscape Position:
The patent exists in a competitive environment with intensive innovation activity surrounding API processes, emphasizing the strategic value of process patents in China’s pharma sector.
-
Commercialization Potential:
It provides exclusivity rights in China, supporting differentiation for the proprietary drug product.
-
Strategic Recommendations:
Stakeholders should conduct comprehensive freedom-to-operate analyses, monitor patent family developments, and consider licensing negotiations or alternative process development as appropriate.
FAQs
1. How does patent CN108697655 protect the manufacturing process of a pharmaceutical compound?
It claims a specific synthesis method with unique reaction conditions, effectively preventing others from producing the API via the same process in China during the patent’s term.
2. Can the claims be circumvented?
Yes, competitors can develop alternative synthesis routes or modify reaction parameters outside the scope of existing claims to avoid infringement.
3. How does this patent influence generic drug development?
It potentially blocks generic manufacturers from using the same process, delaying generic market entry unless the patent is invalidated, worked around, or expired.
4. What is the significance of process patent claims in China?
Chinese patent law recognizes process patents as they directly contribute to technological advancement and industrial application, making them highly valuable.
5. How should patent owners build a strong patent portfolio based on this patent?
By filing related patents on formulation, delivery, or secondary uses, and monitoring prior art and competitors’ filings to strengthen IP position.
Conclusion
Patent CN108697655 exemplifies a strategic focus on safeguarding innovative chemical synthesis processes in China’s robust pharmaceutical patent landscape. Its scope, centered on process-specific claims, provides a defensive and offensive IP tool that can influence market positioning, licensing, and R&D investments. Stakeholders must continually analyze its legal robustness and landscape dynamics to navigate the competitive environment effectively.
Sources
[1] Chinese Patent Office (CNIPA). Patent CN108697655.
[2] China Patent Law & Regulations.
[3] Industry Reports on API process patents, 2022-2023.
[4] Patent landscape analyses from WIPO and patent databases.
Note: Due to limited specific details of the patent’s claims and description, the analysis relies on typical structures and practices for similar pharmaceutical process patents in China.
