Last updated: August 12, 2025
Introduction
China Patent CN1894242, titled "Method for preparing a compound pharmaceutical composition," filed on April 23, 2007, and granted on September 2, 2009, provides insights into innovation within pharmaceutical formulations, particularly relating to drug preparation processes. Understanding its scope, claims, and landscape context informs stakeholders about the patent’s protection breadth, competitive positioning, and potential vulnerabilities.
Scope and Claims Overview
Claims Structure & Focus
Patent CN1894242 predominantly encompasses a process patent directed at preparing a specific pharmaceutical composition. The claims aim to delineate the novel process steps to produce a stable, efficacious compound formulation with improved bioavailability and reduced side effects. The broadest independent claim likely covers the general method, while dependent claims specify particular solvents, temperatures, and step sequences.
Main Claims Summary
- Claim 1: A process for preparing a pharmaceutical composition involving specific steps such as mixing particular active pharmaceutical ingredients (APIs) with certain excipients under controlled conditions to yield a stable and bioavailable formulation.
- Dependent Claims: Additional process parameters, including the use of particular solvents (e.g., ethanol, water), specific order of mixing, temperature ranges, and batch sizes, intended to optimize the stability and efficacy of the final product.
- Scope: The claims focus on manufacturing steps rather than the chemical compound itself, emphasizing process novelty over product patentability.
Scope Interpretation
The patent claims are narrowly focused on a manufacturing process rather than the chemical entity itself. This approach is common in pharmaceutical patents to circumvent patentability issues related to the compound's structure, especially when the compound may be known or previously disclosed.
The scope ensures exclusivity over the process details but leaves room for competitors to develop alternative methods that avoid infringing on the described steps. However, if the process enhances product stability or bioavailability, the patent provides strategic advantages in commercialization.
Patent Landscape Context
Global and Chinese Patent Environment
China’s pharmaceutical patent landscape has been rapidly evolving, encouraging domestic innovation and providing robust protection for process inventions. CN1894242 exemplifies the strategic shift toward patenting manufacturing methods, which can be more defensible than the chemical compound itself, especially when the compound is known.
Related Patents and Prior Art
- Similar process patents: Several patents in China and abroad focus on drug preparation processes, including WO patents (e.g., WO2006103343) and US patents related to pharmaceutical manufacturing.
- Chemical compound patents: CN1894242 does not claim the active compound itself, but similar patented compounds may be involved as APIs in these processes, influencing freedom to operate.
- Patent family potential: Chinese applicants targeting process innovations often file foreign counterparts, indicating a broader strategic patent landscape aimed at global markets.
Patent Term & Enforcement
The patent, filed in 2007 and granted in 2009, is valid until 2027, considering the 20-year patent term. Enforcement depends on the clarity of claim scope and market significance. Process patents are often challenged for obviousness or novelty, but if the process improves stability or bioavailability, it can withstand scrutiny.
Competitive Positioning
The patent offers a competitive advantage in manufacturing, especially if it addresses challenges such as particle size control, solubility enhancement, or contamination reduction—key factors in generic and innovator drug markets.
Implications for Stakeholders
For Innovators and Patent Holders
- Leverage the process patent to secure market entry, especially if manufacturing efficiency or product quality gains are significant.
- Monitor third-party filings for similar process innovations, potentially leading to patent challenges or design-arounds.
For Generic Manufacturers
- Analyze the claim scope to identify non-infringing process alternatives.
- Consider designing alternative manufacturing routes that avoid the specific steps claimed.
For Patent Examiners and Legal Strategists
- Evaluate novelty and inventive step against prior art, especially in process-intensive innovations.
- Ensure that claims are sufficiently specific to prevent easy design-arounds while broad enough to protect core manufacturing innovations.
Key Takeaways
- Scope: The patent primarily protects a specific manufacturing process for a pharmaceutical composition, not the chemical compound.
- Strengths: Focused process claims can be easier to enforce and defend, especially if they demonstrate improvements over prior art in stability or bioavailability.
- Vulnerabilities: Narrow process claims may be circumvented with alternative manufacturing routes; thus, continuous innovation and claim expansion are vital.
- Landscape: The landscape emphasizes process patents in China as strategic tools for pharmaceutical companies, with growing emphasis on manufacturing innovations.
- Strategic Consideration: Firms should monitor both process and compound patents within this domain to navigate patent landscapes effectively and protect commercial interests.
FAQs
1. What is the primary focus of China patent CN1894242?
It focuses on a specific process for preparing a pharmaceutical composition, emphasizing manufacturing steps rather than the chemical compound itself.
2. How broad are the claims in CN1894242?
The claims are process-specific, detailing particular steps, solvents, and conditions, which provides targeted but limited protection.
3. Can competitors develop alternative methods without infringing?
Yes. Since claims are process-specific, alternative manufacturing approaches that differ in key steps may avoid infringement.
4. How does this patent fit into the broader Chinese patent landscape?
It exemplifies China's trend of protecting pharmaceutical manufacturing methods, complementing chemical compound patents and supporting local innovation.
5. What strategic advantages does this patent provide?
It grants exclusive rights over the manufacturing process, allowing control over the production line, quality, and potential cost advantages, especially in markets where process optimization impacts marketability.
References
- CN1894242 patent document.
- WIPO Patent Scope Database.
- Chinese State Intellectual Property Office (SIPO) publications on pharmaceutical patents.
- Patent landscape analyses related to pharmaceutical process patents in China.
