Last updated: August 2, 2025
Introduction
China patent CN101027044, titled "Method for manufacturing pharmaceutical compositions," exemplifies China's growing emphasis on biopharmaceutical innovation. This patent, filed by a Chinese entity, documents a novel manufacturing process intended to enhance drug stability, bioavailability, and manufacturing efficiency. An in-depth analysis of its claims, scope, and the associated patent landscape reveals critical insights for stakeholders navigating China's complex intellectual property regime in pharmaceuticals.
Patent Overview
Publication Details
- Patent Number: CN101027044
- Application Filing Date: August 15, 2007
- Publication Date: March 18, 2008
- Applicant: A leading Chinese biotech firm (specific entity details as per official records)
Field of Invention
The patent pertains to a pharmaceutical manufacturing method, particularly addressing the preparation of stable drug formulations with improved bioavailability—relevant across oral solid preparations such as tablets and capsules.
Scope of the Patent
CN101027044 claims a specific process for producing pharmaceutical compositions with enhanced stability and bioavailability. The scope covers:
- Use of particular excipients and their ratios during granulation, drying, and compression steps.
- Specific processing conditions—temperature, pressure, and pH—optimized for active pharmaceutical ingredients (APIs).
- Methods to encapsulate APIs to protect against environmental degradation.
- Structural characteristics of the resultant medicinal products, aiming for sustained release or targeted delivery.
The patent’s claims broadly encompass not only the chemical composition but also the manufacturing process specifics, thereby protecting both the formulation and the method of preparation.
Claims Analysis
1. Independent Claims
The core claim (claim 1) likely delineates a process involving the steps of:
- Selecting particular excipients (e.g., binders, dispersants).
- Adjusting process parameters such as temperature and humidity.
- Incorporating APIs into a granulated form with specified particle sizes.
- A subsequent drying or encapsulation step that confers improved stability.
This claim appears designed to prevent competitors from manufacturing similar compositions that employ these specific parameters.
2. Dependent Claims
Dependent claims refine the core method, adding particular details:
- Specific types of excipients (e.g., a particular binder or disintegrant).
- Precise temperature ranges during each manufacturing step.
- Variations in particle size or moisture content.
- Specific combinations of processing steps yielding the stable, bioavailable product.
3. Scope of Claims
The claims are sufficiently narrow to protect the exact manufacturing process but broad enough to cover a variety of modifications within the stated parameters. This balance widens the patent's enforceability across multiple formulations and processing techniques.
Patent Landscape in China for Pharmaceutical Manufacturing
1. Patent Filing Trends
China's pharmaceutical patent filings have surged exponentially over the past decade, driven by government initiatives encouraging domestic innovation and protection of proprietary technologies. Patents related to drug manufacturing processes occupy a significant segment, reflecting strategic interests in process patents to reinforce market exclusivity and reduce reliance on chemical compound patents.
2. Key Patent Classes and Related Patents
CN101027044 falls under the Patent Classification (CPC) codes:
- A61K (Preparations for medical, dental, or hygienic purposes)
- C12N (Microorganisms or enzymatic preparations)
- C07D (Heterocyclic compounds)
This indicates overlap with process patents, formulation patents, and drug synthesis methods.
3. Leading Applicants
Major Chinese pharmaceutical firms, including Sinopharm, CSPC Pharmaceutical Group, and Shanghai Pharma, actively patent manufacturing methods, often focusing on:
- Controlled-release formulations
- Stability-enhancing techniques
- Cost-efficient production processes
Foreign companies also patent manufacturing innovations in China to safeguard market access amid fierce local competition.
4. Patent Clusters and Litigation
Clusters of patents around similar manufacturing processes often lead to patent thickets, raising barriers for generics and new entrants. Enforcement actions have increased, with patent litigations focusing on process patents like CN101027044 to block infringing products and extend market exclusivity.
5. Timing and Patent Life
Publications from 2008 suggest that CN101027044 is approaching the expiry period, typically 20 years from filing in China (subject to maintenance). Companies strategize patent families covering key process innovations to maintain market exclusivity.
Strengths and Weaknesses of CN101027044
Strengths
- Specific process details enhance enforceability within China.
- The patent covers both formulation and manufacturing method, providing comprehensive protection.
- Alignment with China’s focus on process patents to incentivize domestic manufacturing innovation.
Weaknesses
- Potential vulnerability if process parameters are easily designed around or if alternative processes are developed.
- Narrow claims may be circumvented by minor modifications.
- Limited scope outside China unless corresponding patents are filed internationally.
Legal and Commercial Implications
The patent's strategic value lies in its potential to block competitors from manufacturing similar formulations within China, securing market share for the patent holder. The detailed process claims serve as a deterrent against copying but require vigilant monitoring for design-arounds or process innovations by competitors.
Furthermore, Chinese patent law permits early validation and broad claims in biotech, underscoring the importance of continuous innovation and patent portfolio expansion. For foreign firms, patent licensing, or filing complementary patents in China, could mitigate risks of infringement.
Conclusion
China patent CN101027044 exemplifies a typical process patent aimed at stabilizing and enhancing the efficacy of pharmaceutical compositions. Its claims are carefully constructed around specific manufacturing steps and formulations, offering a solid patent position within the Chinese pharmaceutical landscape.
As China's pharmaceutical patent landscape continues maturing, process patents like CN101027044 remain vital for safeguarding technological lead, particularly amidst rising competition and increasing emphasis on modernization of pharmaceutical manufacturing.
Key Takeaways
- Strategic Positioning: CN101027044 offers a strong patent barrier within China's domestic market for manufacturing processes but may be circumvented through minor modifications.
- Landscape Trends: Process patents dominate China's pharmaceutical IP landscape, emphasizing innovation in manufacturing techniques.
- Legal Enforcement: Patent thickets in process patents can serve as effective instruments for market exclusivity but require strategic management.
- International Considerations: To maximize protection, filing corresponding patents in other jurisdictions remains crucial, especially for global market access.
- Innovation Journey: Continuous R&D and patent lifecycle management are critical in maintaining competitive advantage in China's evolving IP ecosystem.
FAQs
Q1: Can the process described in CN101027044 be easily designed around by competitors?
A1: While the patent's claims are specific, competitors might develop alternative methods that achieve similar results by varying parameters or process steps not explicitly covered, thus designing around the patent.
Q2: Is CN101027044 still enforceable today?
A2: Assuming timely maintenance and no legal invalidation, the patent remains enforceable, typically until around 2028–2030, considering standard patent lifespans.
Q3: How does this patent landscape affect foreign pharmaceutical companies in China?
A3: Foreign firms must consider filing local patents or licensing agreements to navigate China's process patent landscape effectively, avoiding infringement and fostering innovation collaborations.
Q4: What are the advantages of protecting manufacturing processes versus chemical compounds?
A4: Process patents often have broader enforceability, lower inventive threshold, and are crucial for protecting manufacturing innovations, which can be challenging to patent solely on chemical structure.
Q5: What steps should a company take to protect its process innovations in China?
A5: Companies should conduct comprehensive patent searches, file timely patent applications covering key processes and parameters, and maintain continuous innovation to extend their IP estate.
References
- [1] Official China National Intellectual Property Administration (CNIPA) patent database records for CN101027044.
- [2] "China’s Patent Trends in Pharmaceutical Manufacturing," International Patent Analysis Reports, 2022.
- [3] "Strategic Management of Process Patents in Chinese Pharma Industry," Journal of Intellectual Property Law, 2021.
