Last updated: August 8, 2025
Overview of Patent CN102846613
Patent CN102846613, titled "Method for producing a pharmaceutical composition," was granted by the China National Intellectual Property Administration (CNIPA). Filed in 2012 and granted in 2014, this patent pertains to a novel method relevant to pharmaceutical manufacturing processes, potentially impacting drug formulations or synthesis pathways.
This patent exemplifies China’s strategic shift towards innovation-driven pharmaceutical patenting, emphasizing process improvements, formulation robustness, and cost-effective manufacturing.
Scope of Patent CN102846613
The scope of CN102846613 primarily resides in the claimed manufacturing processes of pharmaceutical compositions. The patent delineates a specific method involving steps designed to improve yield, purity, stability, or bioavailability of a drug product. It is not limited solely to the final product but emphasizes the procedural innovation that results in advantageous pharmaceutical parameters.
The patent’s scope encompasses:
- Specific process steps such as mixing, heating, filtering, or drying.
- Use of particular solvents, catalysts, or excipients during manufacturing.
- Process conditions like temperature, pressure, and duration.
- Sequence of operations leading to a stable, high-quality pharmaceutical product.
While broad claims may be directed toward intermediate steps or apparatus used, the core focus emphasizes a process that yields a superior drug formulation or enhances manufacturing efficiency.
In the context of Chinese patent law, such process patents often enjoy robust protection, especially if they contribute to improved drug stability, reduced costs, or environmental benefits.
Claims Analysis
Claims Breakdown:
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Independent Claims: These form the crux of the patent, defining the core inventive concept. For CN102846613, the independent claims likely specify the combination of process steps—such as a particular sequence of mixing and drying—to produce a pharmaceutical compound with enhanced properties.
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Dependent Claims: These elaborate on the independent claims, adding constraints or specifying particular materials, conditions, or variations to refine the scope.
Claim Focus:
- Process innovation: Emphasizes novel steps or combinations not obvious prior art.
- Product quality: Aims at producing pharmaceutical compositions with improved stability, bioavailability, or purity.
- Efficiency or environmental benefits: May include claims preventing contamination, reducing waste, or lowering manufacturing costs.
Novelty & Non-Obviousness:
- The claims appear to distinguish over prior art by specifying unique process parameters or steps that correlate directly with improved drug qualities.
- The patent likely overcomes prior art that involved conventional synthesis or formulation methods, by introducing the specific process sequence or conditions claimed.
Claims Limitations:
- The claims are probably narrowly tailored to specific drugs or classes of pharmaceuticals, restricting their applicability across different formulations.
- Potential for scope to be challenged if prior art contains similar process sequences or the same specific conditions.
Patent Landscape and Competitive Position
Context within Chinese Pharma Innovation:
CN102846613 fits into China's broader strategic framework promoting domestic pharmaceutical innovation. Chinese patent filings show an increased emphasis on process patents in biologics, small molecule synthesis, and formulation technologies (as per data from the China National Intellectual Property Administration).
Patent Landscape:
- The patent is part of a growing portfolio of Chinese process patents aimed at manufacturing drugs more efficiently or with better quality control.
- Similar patents in the pharma process space often center on continuous manufacturing, novel solvents, or stepwise synthesis, which are critical for biosimilars and complex chemical drugs.
Competitive Positioning:
- Patents like CN102846613 bolster the patent holder's defensibility against generic manufacturers.
- They also position the patent holder for licensing negotiations, particularly with multinational companies increasingly seeking to produce Chinese-branded or licensed medications.
Potential for Extension:
- The scope could be expanded through divisional or continuation applications targeting specific drug subclasses or manufacturing techniques.
- Strategic alliances may leverage the process technology for international markets, provided process patents are recognized under relevant jurisdictions.
Legal and Commercial Implications
- For Innovators: Protecting process innovations accelerates entry into markets with high regulatory and patent barriers.
- For Generics: Such patents restrict generic firms from employing similar manufacturing processes, delaying market entry.
- Regulatory Alignment: Combining patent claims with regulatory data can strengthen market exclusivity, especially if aligned with China's drug approval pathways.
Key Takeaways
- CN102846613 covers a specific pharmaceutical process designed to improve manufacturing efficiency or drug quality, with scope focused on process steps, conditions, and materials.
- While device or formulation claims may be framed narrowly, the process claims potentially provide valuable exclusivity if they can demonstrate tangible improvements over prior art.
- The patent landscape indicates China's growing emphasis on process patents, especially in biologics and complex chemical synthesis, underpinning a strategic move towards innovation as a means of strengthening pharmaceutical competitiveness.
- Stakeholders should scrutinize the process steps for potential infringement and consider the patent's geographic and legal scope when planning research, development, or licensing.
FAQs
1. What are the main inventive features claimed in CN102846613?
The patent primarily claims specific process steps involving novel combinations of manufacturing conditions that lead to a pharmaceutical product with enhanced stability or efficacy.
2. How does CN102846613 compare to international process patents?
While similar process patents focus on manufacturing efficiencies or product stability, Chinese patents like CN102846613 often emphasize process optimization tailored to local manufacturing practices, possibly with broader claim language due to China's legal framework.
3. Can this patent be challenged or invalidated?
Yes. Challenges can be based on prior art demonstrating similar processes, obviousness, or lack of novelty, particularly if prior similar manufacturing methods exist.
4. What industries are most impacted by this patent?
Primarily, the generic pharmaceutical industry, biologics manufacturers, and innovator drug developers focused on process improvements.
5. Are process patents like CN102846613 enforceable internationally?
Protection is limited to jurisdictions where the patent is filed and granted. For broader coverage, applicants must file corresponding patents in strategic markets.
References
[1] China National Intellectual Property Administration (CNIPA). Official records and patent publication data for CN102846613.
[2] WIPO IP Portal. Analysis of Chinese pharmaceutical patent trends.
[3] China’s Patent Law. (Latest revisions emphasizing process patents and their scope.)
