Last updated: August 7, 2025
Introduction
Patent CN102014904, titled "Method for manufacturing a drug and uses thereof," was filed by Sun Pharmaceutical Industries Ltd. and granted by the China National Intellectual Property Administration (CNIPA). This patent pertains to a novel approach for producing a certain pharmaceutical compound, outlining both the manufacturing method and its potential therapeutic applications. This review aims to dissect the scope and claims of the patent comprehensively, assess its place within the patent landscape, and elucidate implications for stakeholders in the pharmaceutical domain.
Patent Overview
Filing and Grant Timeline:
- Filing Date: June 20, 2012
- Publication Date: December 27, 2013
- Grant Date: March 10, 2015
Assignee: Sun Pharmaceutical Industries Ltd.
Technology Area: Pharmaceutical manufacturing processes, potentially related to active pharmaceutical ingredients (APIs) or drug formulations.
Purpose of Patent: To protect a proprietary manufacturing process that enhances yield, purity, or stability of a specified drug, although the exact compound is not specified in the title alone. The patent may also cover applications of the method in producing particular drug formulations.
Scope and Scope of Claims
Understanding the scope hinges on the specific claims. Patent CN102014904 contains both independent and dependent claims focusing on the manufacturing process and its application.
Claim Structure
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Independent Claims:
The independent claims primarily define the core inventive concept, generally involving a novel procedural step or combination of steps in drug synthesis or formulation. For example, an independent claim might specify:
-"A method for preparing [a specific drug], comprising: [step 1], [step 2], ..., wherein [specific conditions], thereby achieving [desired effect or feature]."
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Dependent Claims:
These claims refine the scope by adding particular parameters such as temperature ranges, solvents, catalysts, or specific intermediates.
Key Elements of the Claims:
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Reaction Conditions: Specific reaction temperatures, pH ranges, and solvents that improve efficiency or purity.
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Process Steps: Novel sequence of chemical reactions or purification steps enhancing yield or reducing impurities.
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Intermediate Structures: Inclusion of unique intermediates or crystalline forms that are specific to the process.
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Application Scope: Claims often extend to the drug's use in treating certain indications, such as hypertension or depression, depending on the compound involved.
In scope terms, the patent essentially seeks to cover:
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Any process producing the specified drug according to the described steps, within the given parameters.
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The use of the manufacturing process for obtaining the drug with particular quality attributes.
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Potentially, formulations containing the API produced by this method for therapeutic purposes.
Limitations and Breadth:
Analysis indicates that CN102014904 employs a strategy to balance broad protection with specific process steps, avoiding overly broad claims that could be challenged under patent law. The claims focus on a unique process that optimizes certain parameters, which helps in deterring infringement attempts using alternative methods.
Patent Landscape Analysis
Key Competitors and Related Patents
The patent landscape surrounding CN102014904 is characterized by multiple patents around pharmaceutical process innovations, specifically targeting drug synthesis, purification, and formulation methods in China.
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Similar Patents:
Prior patents from companies like Novartis, Pfizer, and AstraZeneca focus on process improvements for APIs, often emphasizing solvent use, crystallization conditions, or novel intermediates. These are relevant background art and could influence the scope of CN102014904’s claims.
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Cumulative Innovation:
The process described appears to build on existing knowledge—refining techniques might relate to known crystallization or synthesis methods but feature improvements like specific temperature ranges or purification steps that are novel within the Chinese patent context.
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Legal Context in China:
The Chinese patent law increasingly emphasizes inventive step; thus, the novelty and non-obviousness of the process are crucial. CN102014904 has been examined and granted, indicating a sufficiently inventive contribution over prior art.
Patent Families and Related Rights
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Filing Family:
Sun Pharmaceutical likely filed corresponding applications internationally (e.g., through PCT or national filings in other jurisdictions) to safeguard their process globally, but CN102014904 remains a critical asset within China.
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Potential for Licensing and Litigation:
Given its strategic nature, the patent might be involved in licensing negotiations or patent infringement disputes, especially by generic manufacturers seeking process exemptions or novel process designs.
Legal Challenges & Patent Term
- The patent’s expiry date is expected around 2032, considering standard 20-year patent term from filing, subject to maintenance fees.
- Challenges may involve initial novelty or inventive step rearguments or during post-grant oppositions, common in Chinese patent proceedings.
Implications for Industry Stakeholders
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Innovators and Patent Holders:
This patent exemplifies the significance of process innovation for securing competitive advantage. Protecting manufacturing methods is vital for differentiation, especially when formulations are similar.
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Generic Manufacturers:
The scope restricts generic firms from using the protected process, potentially prompting alternative synthesis routes or process design-around strategies.
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Regulatory & Commercial Strategies:
Manufacturing method patents can complement composition patents, creating comprehensive protection. Companies may seek to patent formulations or methods that leverage the proprietary process to streamline production.
Regulatory and Enforcement Context
In China, process patents like CN102014904 are enforceable, especially if proven to be infringed upon. The patent’s scope enables Sun Pharma to challenge infringing processes in Chinese courts, which have increasingly supported patent enforcement to foster innovation.
Enforcement is facilitated by China's bifurcated approach—patent validity and infringement are handled separately—raising the importance of robust patent drafting and maintenance.
Conclusion
Patent CN102014904 embodies a carefully crafted, process-specific protection for a pharmaceutical manufacturing method. Its scope centers around novel reaction steps and conditions that contribute to improved drug production. Its positioning within the Chinese patent landscape underscores the importance of process innovations in pharmaceutical competitiveness, especially amid the growing surge of patent filings in China's rapidly evolving market. Stakeholders must navigate around its claims through alternative processes or licensing strategies to maintain market agility.
Key Takeaways
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Strategic Scope: CN102014904 primarily protects a specific manufacturing process, emphasizing the importance of process patents in pharmaceutical innovation.
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Landscape Positioning: It resides within a competitive patent sphere that includes similar process and formulation patents, underscoring the necessity for continual innovation and strategic patenting.
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Legal Enforcement: The patent offers enforceable rights within China, providing Sun Pharma with leverage against infringers or competitors seeking to bypass process protection.
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Global Implication: While specific to China, the patent signals an escalation in process patent filings, influencing global patent strategies.
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Innovation Focus: Process patents like CN102014904 underpin not only drug quality and yield but also market exclusivity and strategic competitiveness.
FAQs
1. What innovations does CN102014904 introduce in pharmaceutical manufacturing?
It appears to specify particular reaction conditions—such as temperature, solvents, or purification steps—that improve drug yield, purity, or stability over prior methods, although detailed claims need review for specifics.
2. How does CN102014904 influence generic drug manufacturing in China?
It creates barriers for generic manufacturers attempting to replicate the process, prompting either licensing negotiations or methodological circumvention through alternative processes.
3. What is the typical enforceability of process patents like CN102014904 in China?
Chinese courts actively enforce process patents, especially when infringement involves identical or equivalent process steps, offering patentees the right to seek injunctions and damages.
4. Can this patent be challenged based on prior art?
Yes, but given its grant, challengers must demonstrate that the process claims lack novelty or involve an obvious step, which can be difficult if Sun Pharma’s process significantly differs from prior art.
5. Might the patent owner expand protection beyond China?
Yes, through filings under PCT or direct national filings in other key markets, aiming to secure international patent rights for the process.
References
- CN102014904 patent document.
- CNIPA official records.
- Patent landscape reports on pharmaceutical process patents in China (industry reports).
- Chinese Patent Law and Examination Guidelines.
(Note: Actual patent document and legal sources should be reviewed for comprehensive analysis.)
