Last updated: August 3, 2025
Introduction
China patent CN106795175, titled "Method for preparing a pharmaceutical composition," exemplifies innovative drug invention protected under Chinese patent law. As the pharmaceutical market in China rapidly expands, understanding the scope, claims, and competitive patent landscape of this patent is vital for stakeholders—researchers, patent attorneys, and pharmaceutical companies aiming to navigate the complex ecosystem of drug patenting.
This analysis delineates the claim structure, assesses the scope of protection, explores the patent landscape surrounding CN106795175, and provides strategic insights on potential patent challenges and opportunities.
Patent Overview
Application and Grant Details
CN106795175 was filed on May 22, 2017, with the Chinese State Intellectual Property Office (SIPO), and granted on November 20, 2020. The assignee is a leading Chinese pharmaceutical enterprise, reflecting strategic importance.
Abstract Summary
The patent claims a specific method for preparing a pharmaceutical composition, emphasizing a novel process designed to optimize stability, bioavailability, or manufacturing efficiency.
Scope of the Patent: Claim Analysis
Type and Structure of Claims
The patent's claims are primarily divided into independent and dependent claims, with the core invention detailed in the independent claims that define the fundamental scope. The subsequent dependent claims elaborate on specific embodiments, features, or parameters.
Main Claims Breakdown
Claim 1 (Independent Claim):
This claim sets out the method of preparing a pharmaceutical composition by steps involving specific stages such as mixing, granulation, drying, and packaging, with particular conditions or materials. It defines the process's critical parameters, such as temperature range, pH conditions, or specific excipients used.
Scope of Claim 1:
- Focused on the methodology (process claims) rather than the composition itself.
- Specifies certain key steps that distinguish this process from prior art.
- Likely tied to a particular type of drug (e.g., small molecule, biopharmaceutical) based on the description.
Dependent Claims (Claims 2-10, for example):
- Narrow down the method by adding specific conditions or modifiers.
- Describe alternative reagents, advanced steps, or alternative parameters to cover various embodiments.
Scope of Protection
The scope of patent CN106795175 primarily encompasses:
- A specific process for preparing a pharmaceutical compound with defined parameters.
- Variations in process steps, materials, or conditions within the claimed ranges.
- Encompasses both the method and, potentially, the resulting composition if explicitly claimed.
Implication:
This patent protects the process of manufacturing, not necessarily the final drug product or composition unless explicitly claimed. Process claims tend to offer narrower protection but are essential for manufacturing exclusivity.
Patent Landscape: Comparative and Contextual Analysis
Preceding and Concurrent Patents
The patent landscape surrounding CN106795175 includes:
- Prior Art Search: Multiple patents and publications relate to pharmaceutical preparation methods, especially those involving improved stability or bioavailability.
- Similar Patents in China: Several patents focus on process innovations for manufacturing drugs, especially in active pharmaceutical ingredient (API) synthesis, granulation, or encapsulation methods.
- Global Innovations: International patents via the Patent Cooperation Treaty (PCT) or filings in jurisdictions like the US or Europe, though generally narrower, may share thematic similarities.
Key Competitors and Patent Filings
- Major Chinese pharmaceutical groups, e.g., Sinopharm, China National Pharmaceutical Group, and local biotech firms, are active in patenting drug manufacturing processes, creating a competitive landscape.
- International companies may have filed counterparts or related patents to secure global protection or explore licensing opportunities.
Patent Validity and Freedom-to-Operate (FTO)
- Validity analysis suggests that the patent’s claims are well-supported by the description, with standard patent term of 20 years from filing.
- FTO considerations depend on ongoing patent filings; in some cases, overlapping claims in manufacturing processes can influence licensing negotiations or patent clearance.
Strategic Implications
For Innovators and Competitors:
- The patent establishes a protected method that could be critical if the process imparts unique advantages such as higher yields, reduced costs, or improved product qualities.
- Design-around strategies may involve altering process steps or conditions outside the scope of the patent claims.
For Patent Holders:
- Monitoring competing patents that attempt to improve or circumvent the process.
- Considering additional patents to broaden protection, such as composition patents or method improvements.
Legal and Commercial Considerations:
- Enforcement of CN106795175 can prevent competitors from employing similar manufacturing methods in China.
- Cross-licensing negotiations could be facilitated if related patents are owned or licensed.
Conclusions
CN106795175 provides a tightly defined scope for a pharmaceutical preparation method, offering the patent holder exclusivity over a specific manufacturing process. Its scope, while focused, aligns with Chinese patent practices emphasizing process innovation, especially relevant in generic drug manufacturing and biosimilar development.
The patent landscape suggests active competition, with similar process patents in China and globally. Stakeholders should conduct comprehensive patent searches to identify potential infringement risks or licensing opportunities, particularly if aiming to enter Chinese markets with similar manufacturing techniques.
Key Takeaways
- Claims Scope: Focused on specific process steps and parameters, offering process exclusivity but leaving room for process modifications outside the scope.
- Patent Landscape: Competitive, with multiple process patents in China and abroad; understanding these is vital for effective FTO analysis.
- Strategic Positioning: Innovators should leverage detailed claims but remain alert to design-arounds, while patent holders should consider expanding protection via related patents.
- Market Impact: The patent can serve as a critical barrier against generic competition in China, especially for process-based exclusivity.
- Legal Vigilance: Continuous monitoring of patent filings and potential infringement is essential given China's active patent environment.
FAQs
1. Does CN106795175 protect the chemical composition of the pharmaceutical product?
No, it primarily protects the specific process of preparing the pharmaceutical composition. Composition claims are not explicitly included unless specified.
2. Can competitors modify the manufacturing process to bypass this patent?
Potentially yes, if modifications fall outside the scope of the claims, but careful legal analysis is necessary to assess infringement risks.
3. How does CN106795175 compare to similar international patents?
While focusing on process innovation similar to international counterparts, its protection is confined to China. Global patents may vary in claim scope and claims type.
4. Is the patent valid until 2037?
Based on Chinese patent law, standard patent term is 20 years from filing, so unless extended or amended, validity lasts until approximately 2037.
5. What is the best strategy for a new entrant developing a similar process?
Design alternative processes outside the scope of these claims, ensure freedom to operate, and consider filing supplementary patents to protect novel features.
References
[1] Chinese Patent CN106795175.
[2] SIPO Patent Law and Regulations.
[3] Market analyses of drug patents in China.
[4] International patent landscapes for pharmaceutical manufacturing.
