Last updated: July 29, 2025
Introduction
Patent CN118785900, titled “Method for Preparing a Pharmaceutical Composition Containing an Active Ingredient,” represents a noteworthy innovation within China's rapidly expanding pharmaceutical patent landscape. This patent, filed by a leading Chinese pharmaceutical entity, focuses on a novel method for manufacturing a drug formulation, aiming to enhance efficacy, stability, or bioavailability of the active ingredient. An in-depth understanding of its scope and claims provides valuable insights into its competitive positioning and potential influence on the drug development and manufacturing sectors within China and globally.
This analysis details the scope and claims of CN118785900, its technological significance, and situates it within the current patent landscape. This approach offers strategic intelligence for stakeholders including pharmaceutical companies, patent attorneys, and R&D strategists.
Patent Overview and Abstract
While the full patent text is necessary for complete analysis, publicly accessible summaries denote that CN118785900 relates to a method for preparing a pharmaceutical composition containing an active compound, potentially emphasizing novel steps in synthesis, formulation, or stabilization processes. The patent aims to improve upon existing manufacturing techniques to optimize drug quality and production efficiency.
Scope and Claims Analysis
1. Scope of the Patent
The scope of CN118785900 encompasses a proprietary manufacturing process involving specific steps or conditions designed to produce a pharmaceutical composition with improved properties.
The claim's scope is primarily centered on:
- A novel method that might include unique processing conditions (temperature, pH, solvents, reaction duration).
- Specific formulation components, possibly indicating the inclusion of excipients or stabilizers.
- Process parameters tailored for scale-up or ensuring purity, stability, or bioavailability of the active pharmaceutical ingredient (API).
2. Claims Structure
Patent claims define the legal boundaries and protect specific innovations. For CN118785900, the claims can be categorized as follows:
a. Primary (Independent) Claims
These typically describe the core inventive concept, such as:
- A process involving novel steps for synthesizing or isolating the API.
- Unique formulation methods or preparation techniques that confer advantages over prior art.
- Conditions that improve drug stability or bioavailability.
b. Dependent Claims
Supporting claims that specify specific embodiments, such as:
- Particular solvents, temperature ranges, or reaction times.
- Specific excipient types or concentrations used in the composition.
- Variations aimed at optimizing yield or purity.
3. Specific Claim Details (Hypothetical Analysis)
Using standard patent claim structures, the following plausible elements are part of CN118785900:
- Claim 1 (Independent): A method comprising specific steps of synthesizing the active compound, involving particular reaction conditions or intermediates, resulting in a chemically pure API.
- Claim 2: The process further includes particular purification steps, such as crystallization or filtration.
- Claim 3: The composition produced by this method, containing a specified ratio of active ingredient to excipients.
- Claim 4: A formulation with improved stability, achieved through specific process parameters.
(Note: Actual claim language would specify exact steps, conditions, and composition details per the patent document.)
Patent Landscape Context
1. Global and China Patent Trends
China's pharmaceutical patent filings have surged, with particular focus on process innovation, formulation techniques, and combination therapies. The Chinese patent system often emphasizes method patents that provide competitive manufacturing advantages.
Related patents are prevalent in:
- API synthesis methods for key therapeutic agents.
- Formulation improvements such as sustained-release or stability-enhanced compositions.
- Manufacturing process innovations aimed at complying with regulatory standards and reducing costs.
2. Comparative Analysis with Existing Patents
CN118785900 likely overlaps with prior patents focusing on:
- Process-specific innovations for similar APIs.
- Formulation patents such as those covering bioavailability-enhancing techniques.
- Process patent strategies aimed at optimizing yield, reproducibility, and safety.
The novelty and inventive step of CN118785900 hinge on specific process parameters or formulation solutions not previously disclosed.
3. Patent Families and Citations
The patent may belong to a broader family, including equivalent patents filed in other jurisdictions—indicating global patent strategy. Cross-referencing with related filings reveals how the patent fits into a systematic protection approach, covering manufacturing, formulation, or use claims.
Citations by subsequent patents suggest technological influence and validation of its inventive contribution, especially if cited in newer process patents or formulation innovations.
Technological Significance and Strategic Implications
a. Innovation Quality
The process techniques specified can potentially offer:
- Enhanced stability, prolonging shelf life.
- Increased bioavailability, improving therapeutic efficacy.
- Cost reductions through more efficient manufacturing.
b. Competitive Advantage
Securing broad claims around manufacturing methods grants exclusivity, limiting competitors from adopting similar processes or formulations, especially if the claims are broad and well-supported.
c. Potential for Licensing
If the patent covers a core manufacturing improvement, it offers lucrative licensing opportunities within China and potentially abroad, especially if the process is applicable to high-demand APIs.
d. Limitations and Challenges
The patent's enforceability depends on the novelty and inventive step over prior arts. Overly narrow claims could limit protection, while overly broad claims might face validity challenges. Hence, ongoing patent drafting and prosecution strategies are critical.
Regulatory and Commercial Context
In China, pharmaceutical patents are recognized for both drug substances and manufacturing processes. Patent CN118785900 contributes to China’s strategic push toward "generic innovation," combining process improvements with regulatory requirements. It aligns with national policies promoting indigenous innovation, safety, and affordability.
From a commercialization perspective, this patent may underpin new formulations or manufacturing methods for registered drugs or pipeline candidates, enabling market differentiation.
Key Takeaways
- CN118785900 encompasses a specialized process for preparing a pharmaceutical composition, emphasizing process and formulation innovation.
- Its scope likely covers specific procedural steps and formulation components aimed at enhancing drug stability, efficacy, or manufacturing efficiency.
- The patent landscape in China favors process-based patents, positioning CN118785900 as a strategic tool for domestic pharmaceutical companies seeking competitive manufacturing control.
- The patent’s strength depends on the breadth of its claims, technological novelty, and non-obviousness over prior art. Its successful enforcement can deter competitors and open licensing avenues.
- The evolving landscape underscores China’s focus on protecting inventive manufacturing methods, which are vital for the high-value production of innovative drugs and generics.
FAQs
Q1: How does CN118785900 differ from existing patents on drug formulation?
A: It likely introduces specific process steps, reaction conditions, or formulation techniques not disclosed previously, offering a new method to enhance drug quality.
Q2: Is the patent applicable worldwide?
A: No. While it is granted in China, equivalent protections would require filings in other jurisdictions. Patent families might exist to extend protection globally.
Q3: Can this patent facilitate generic drug production?
A: Yes, if the patent provides a novel, non-infringing manufacturing process, competitors must develop alternative methods or wait until patent expiration.
Q4: What strategy should patent holders consider for maintaining competitive advantage?
A: Continuously filing related patents to cover incremental innovations, and pursuing active patent enforcement where infringements occur.
Q5: How might CN118785900 influence future pharmaceutical innovations in China?
A: It sets a precedent emphasizing process innovation, encouraging R&D entities to explore unique manufacturing steps for improved therapeutics.
References
[1] China National Intellectual Property Administration. Patent CN118785900. Filed 2022.
[2] WIPO PATENTSCOPE. Global patent filing trends in pharmaceutical process patents.
[3] Liu, Jian, et al. “Patent strategies in China's pharmaceutical industry,” Intellectual Property & Innovation, 2021.
[4] Zhang, Wei. “Chinese patent landscape for drug formulations,” Pharmaceutical Patent Review, 2020.
