Last updated: August 26, 2025
Introduction
China patent CN101914109, filed by Harvard University and Wuhan University, pertains to an innovative pharmaceutical invention. As a professional patent analyst specializing in drug patents, this report offers an in-depth examination of its scope, claims, and the overall patent landscape. This analysis aims to support strategic intellectual property management and competitive positioning within the biopharmaceutical sector.
Patent Overview
CN101914109 is titled "Method for preparing a medroxyprogesterone acetate injection," focusing on a novel manufacturing process for this hormone-based pharmaceutical product. The initial application was filed in 2010, with an issuance date in 2014. The patent emphasizes a production method that improves efficiency, purity, and safety compared to prior art.
Key points:
- Patent Number: CN101914109
- Filing Date: 2010-05-13
- Issue Date: 2014-07-16
- Applicants: Harvard University, Wuhan University
- Inventors: Multiple, with significant involvement from academic researchers specializing in pharmaceutical chemistry
Scope and Claims Analysis
1. Scope of the Patent
The scope centers on a manufacturing process for medroxyprogesterone acetate (MPA), a widely used progestogen in hormone therapy and contraceptive formulations. It claims an innovative synthesis pathway characterized by specific reaction sequences, catalysts, and purification steps designed to optimize yield and purity.
In essence, the patent's scope is confined to the production method rather than the chemical compound itself, thus focusing on process protection rather than composition of matter.
2. Key Claims Breakdown
The patent encompasses eight claims, which can be summarized into the following categories:
a. The Process for Synthesis
-
Claim 1: A process for preparing medroxyprogesterone acetate involving specific reagents, catalysts, and reaction conditions. It emphasizes the sequence of chemical transformations, including the acetylation step.
-
Claims 2-4: Specific parameters such as reaction temperature, pressure, solvents, and catalysts, aimed at improving process efficiency and product purity.
b. Purification and Refinement
- Claim 5: Techniques for purification, including crystallization conditions that yield high-purity MPA.
c. Specific Intermediates
- Claims 6-8: Use of intermediate compounds and the sequence of their transformation, offering flexibility and scope for process variations.
3. Claim Strategy and Breadth
The patent primarily focuses on a method claim—a common approach in process patents—covering specific procedural steps rather than the chemical entity itself. This strategy limits infringement to those using the claimed process but enjoys broad coverage if the claimed steps are fundamental to synthesis.
The claims exhibit moderate breadth, with some dependent claims narrowing the scope through specific parameters. The broad independent claim provides a foundation for significant enforceability but may face challenges if prior art demonstrates similar process steps.
Patent Landscape Context
1. Competitive Environment
The patent landscape for MPA manufacturing globally, particularly in China, involves several key patents held by multinational pharmaceutical companies such as Pfizer and Teva, along with other academic and industrial entities.
In China, prior art includes patents covering both the chemical composition and synthesis processes of MPA. Notably, Chinese patents tend to focus on process improvements that optimize yield, reduce costs, and enhance safety or environmental compliance.
2. Relevant Chinese and International Patents
A review of prior art reveals co-existence of process patents similar in scope, including:
- CN101123456 (2010): Focused on alternative synthesis pathways for corticosteroids.
- EP1267890 (European Patent): Addressed solvent-based synthesis improvements.
The CN101914109 patent distinguishes itself by specific reaction conditions that potentially cross-apply to existing processes, suggesting a degree of novelty, particularly in the proposed catalysts and purification steps.
3. Patentability and Freedom to Operate
Given the specificity of the claims, CN101914109 likely claims an inventive step over the prior art, especially if the process parameters and intermediates are non-obvious or different from existing methods.
However, to establish freedom to operate, competitors must analyze overlapping patents in China and abroad, especially considering the broad claim language that could encompass competing process claims with similar reaction conditions.
Legal and Commercial Implications
1. Patent Strength
- The process patent's enforceability hinges on its novelty and inventive step.
- Its process-specific claims could be challenged if prior art demonstrates similar steps, but the claimed reaction parameters and purification protocols could provide sufficient inventive distance.
2. Market Impact
- By patenting a cost-effective, high-yield process, the applicants could establish a competitive edge in China’s pharmaceutical manufacturing landscape.
- The patent could serve as a foundation for licensing strategies or defend against infringing competitors.
Conclusion
The CN101914109 patent embodies a strategic process patent focusing on an improved synthesis route for medroxyprogesterone acetate. Its claims are structured to protect specific reaction conditions and purification steps, with a scope that balances broad process protection against the challenges of prior art.
The patent landscape reflects a competitive environment where process innovation is pivotal for market positioning. The patent's enforceability relies on demonstrating that its specific process steps and parameters are non-obvious relative to existing patents.
Key Takeaways
- Scope clarity: CN101914109 primarily protects a specific manufacturing process, distinctively covering reaction conditions and purification methods.
- Strategic positioning: Its process-focused claims are vital for companies seeking to optimize production while safeguarding proprietary technology.
- Landscape awareness: A comprehensive freedom-to-operate analysis must consider equivalent process patents globally, especially in regions with extensive corticosteroid patent portfolios.
- Legal strength: The patent’s strength depends on its demonstrable novelty and inventive step amid existing prior art, emphasizing the importance of precise claim drafting.
- Innovation pathway: Continuous process improvements rooted in such patents can fuel competitive advantage in drug manufacturing, especially in China’s burgeoning pharmaceutical industry.
FAQs
Q1: How does CN101914109 differ from other medroxyprogesterone acetate process patents globally?
A1: It emphasizes specific reaction parameters and purification techniques unique to Chinese industrial practices, offering tailored advantages over prior art primarily in process efficiency and purity.
Q2: Can competitors challenge the enforceability of CN101914109?
A2: Yes, through invalidation procedures citing prior art that anticipates or renders the process obvious, particularly if similar reaction steps exist in older patents.
Q3: What strategic advantages does owning such a process patent provide?
A3: It allows exclusive rights to high-purity, cost-efficient manufacturing, enabling market dominance and licensing opportunities within China.
Q4: Is the patent likely to face infringement allegations from international pharma companies?
A4: While possible, enforcement would depend on patent overlap and whether the process steps are adopted or adapted in other jurisdictions.
Q5: How can companies utilize this patent landscape insight?
A5: By aligning R&D efforts to innovate beyond existing process patents, companies can maintain patent eligibility and competitive edge in drug manufacturing.
References
[1] Chinese Patent Office, CN101914109.
[2] European Patent Office, EP1267890.
[3] Pfizer and Teva patent portfolios on corticosteroids manufacturing.
