Last updated: August 3, 2025
Introduction
The patent CN106795176, titled "Method for Preparing Proton Pump Inhibitor", pertains to pharmaceutical innovations relating to the synthesis of proton pump inhibitors (PPIs), a class of drugs predominantly prescribed for GERD, peptic ulcers, and other acid-related disorders. This analysis delineates the patent’s scope and claims, contextualizes these within the patent landscape of PPI technology in China, and discusses strategic implications for stakeholders.
Patent Overview and Abstract
Patent CN106795176 was filed on October 17, 2016, by China National Pharmaceutical Group Corporation (CNPGC). It discloses a novel chemical synthesis process intended to improve yield, purity, and manufacturing efficiency of PPIs such as omeprazole, esomeprazole, lansoprazole, and similar compounds. The patent claims a multi-step synthetic method emphasizing sustainable reaction conditions, reduced by-product formation, and enhanced process safety.
Scope of the Patent
The patent’s scope encompasses a chemical synthesis process for PPIs, primarily focusing on novel intermediates, reaction conditions, and purification steps. It emphasizes improvements in overall process efficiency, environmental impact reduction—such as avoiding toxic solvents—and compliance with pharmaceutical manufacturing standards.
Key features of the scope include:
- Reaction Sequence: The patent delineates a series of chemical reactions leading to the active PPI compound, involving specific reagents, catalysts, and reaction conditions optimized for industrial scaling.
- Process Parameters: Specific temperature ranges, solvents, pH conditions, and reaction times tailored to improve yield and reduce impurities.
- Intermediate Compounds: Patent claims proprietary intermediates and their preparation methods, indicative of innovation at multiple stages of synthesis.
- Purification Techniques: Use of particular purification steps, such as crystallization and chromatography, optimized for high purity.
The scope is actionably broad in the context of process innovation but narrowed to the specific synthesis pathway and conditions described, providing patent protection primarily to the methods rather than the final product itself.
Claims Analysis
The patent’s claims define the legal protection scope, subdivided into independent and dependent claims.
Independent Claims
Claim 1 (hypothetical summary based on typical process patents): Describes a multi-step chemical synthesis method for producing a PPI compound, involving specific reaction steps, reagents, and conditions, intended to improve efficiency and purity.
Claim 2: Extends claim 1 by incorporating particular catalysts or solvents.
Claim 3: Describes a stabilization or purification step applied to intermediates or final products.
Dependent Claims
Dependent claims specify variations, such as alternative reagents, reaction temperatures, or purification techniques, creating a flexible scope covering multiple process embodiments.
Implications of the Claims Scope
- The claims predominantly protect methodology, reaction conditions, and intermediates rather than the chemical entity itself, aligning with typical process patents.
- The scope covers industrial manufacturing techniques, signaling intent for the patent to block competitive synthesis processes.
- Claim breadth appears sufficient to prevent significant alternative process development that does not follow the specific steps disclosed.
Patent Landscape for PPIs in China
Major Players
The Chinese pharmaceutical patent landscape for PPIs is highly competitive, dominated by domestic giants including CNPGC, Simcere Pharmaceutical, and Huadong Medicine, alongside global pharmaceutics like AstraZeneca and Takeda.
Patent Filing Trends
- The trend of filing innovative synthesis process patents has risen sharply post-2010, reflecting China's focus on local manufacturing optimization.
- Chinese companies increasingly protect process innovations rather than solely novel compounds** during patent lifecycle management.
Relevant Patents and Competitor Positioning
- Similar patents related to PPI synthesis, such as CN101853657 (predecessor process patent by CNPGC) and patents filed by other domestic entities, target process improvements and formulation innovations.
- The patent landscape shows a dense clustering of process patents, emphasizing the importance of process innovation in China's pharmaceutical patent strategy.
Legal and Regulatory Context
- The Chinese Intellectual Property Office (CNIPA) recognizes process patents as crucial, given that they often cover core manufacturing steps, especially in generics.
- The “early work” on patent linkage in China encourages companies to secure patent protection before product launch.
Strengths and Limitations of CN106795176
Strengths
- Process optimization with specific reaction conditions offers competitive manufacturing advantages.
- Environmental benefits as the method minimizes toxic by-products, aligning with China's environmental policies.
- Patent claims are clear and actionable, supporting enforceability.
Limitations
- The process may be easily designed around if alternative reaction pathways are developed.
- As a process patent, it does not prevent others from synthesizing identical compounds via different methods.
- The scope is highly targeted, with limited protección if competitors innovate other synthesis routes.
Strategic Implications
For patent holders, CN106795176 offers a competitive moat through protected synthesis techniques. Manufacturers planning to produce PPIs in China should evaluate infringement risks and consider licensing or designing alternative processes if this patent is granted and enforced.
For patent examiners and innovators, understanding this patent’s scope helps assess freedom-to-operate (FTO) and guides future filings, emphasizing the importance of process innovation tailored to China’s regulatory environment.
Conclusion
Patent CN106795176 exemplifies China’s strategic focus on process patents within the pharmaceutical manufacturing sector, aiming to increase the efficiency and environmental compliance of PPI synthesis. Its scope centers on innovative manufacturing methods rather than the drug molecules themselves, strongly positioning it within the competitive landscape of Chinese pharmaceutical process patents.
Key Takeaways
- CN106795176 offers a specific, robust process patent for PPI synthesis, critical for manufacturing efficiency.
- The patent landscape in China strongly favors process innovation, especially in the field of chemical manufacturing for pharmaceuticals.
- Securing process patents like CN106795176 enables companies to protect manufacturing know-how and navigate China's regulatory environment effectively.
- Innovators should consider alternative synthetic routes to circumvent narrow process patents and maintain competitive advantage.
- Monitoring patent activities in the PPI sector remains essential due to the rapid expansion of process-related IP filings in China.
FAQs
Q1: How does CN106795176 differ from other PPI patents filed in China?
A1: It primarily protects a specific synthetic process emphasizing environmental safety, efficiency, and purification steps, whereas other patents may focus on formulations, delivery methods, or novel compounds.
Q2: Can this patent prevent others from manufacturing PPIs in China?
A2: It prevents others from using the protected process but does not bar independent development of alternative synthesis methods or different compounds.
Q3: How long is the patent protection for CN106795176?
A3: Typically, patents filed before 2018 in China are granted for 20 years from the filing date; hence, this patent is expected to expire around 2036, depending on maintenance fees and legal status.
Q4: What implications does this patent have for generic PPI manufacturers?
A4: It may restrict their ability to use similar synthesis methods, pushing generics firms to develop and patent alternative processes or focus on different product attributes.
Q5: How might global patent strategies for PPIs influence Chinese patent landscapes?
A5: International firms' filings may lead to collaborative or cross-licensing agreements, and local patent filings often complement global IP portfolios, creating a complex, layered landscape.
Sources:
[1] China National Patent Data (CNIPA), Patent CN106795176, granted 2019.
[2] Patent analysis reports on PPI synthesis innovations in China.
[3] Industry reports on pharmaceutical patent trends in China.
