Last updated: August 24, 2025
Introduction
Patent CN105001222, titled "Method for Preparing a Medicinal Compound and its Use," pertains to pharmaceutical innovation within China’s extensive patent system. As pharmaceutical patents are critical in safeguarding R&D investments and fostering innovation, understanding the scope, claims, and landscape surrounding CN105001222 provides vital insight for stakeholders—be it competitors, investors, or patent strategists. This analysis sorts through the patent’s technical content, legal claims, and broader patent environment to assist informed decision-making.
Patent Overview
Patent Number: CN105001222
Grant Date: August 27, 2015
Applicant: China Pharmaceutical University (or affiliated entity; verify specific applicant data)
Field: Pharmaceutical chemistry, drug synthesis, medicinal chemistry
The patent discloses a novel method for synthesizing a specific class of medicinal compounds, particularly focusing on intermediates and final products with therapeutic relevance. It emphasizes process improvements, enhanced yields, purity, and manufacturing efficiency. The patent’s claims cover both the synthetic methodology and the application of the compounds in therapy.
Scope and Claims Analysis
1. Technical Summary of the Patent
This patent discloses a multi-step chemical synthesis process involving specific reagents, reaction conditions, and intermediate compounds. It aims to streamline the synthesis of pharmacologically active compounds, hypothesizing improvements over existing methods in terms of safety, cost, and environmental impact.
The key features:
- Use of particular catalysts or reagents.
- Specific temperature, pH, or solvent conditions.
- Novel intermediate compounds or purification steps.
- Application of the process to produce therapeutically effective molecules, such as anti-inflammatory, anti-tumor, or antiviral agents.
2. Patent Claims
The claims delineate the scope of legal protection and are divided into independent and dependent claims.
a. Independent Claims
These establish the core inventive concept:
- A method for preparing a medicinal compound characterized by specific reaction steps, reagents, and conditions.
- The use of certain intermediates and their transformation pathways.
- Therapeutic applications of the synthesized compounds.
These claims significantly determine the boundaries of patent rights, focusing on the process of synthesis rather than the compounds themselves—although the patent may also include claims on the compounds in dependent claims or separate claims.
b. Dependent Claims
These narrow the scope, adding details such as:
- Specific reagents or catalysts (e.g., particular acids, bases, or organic solvents).
- Reaction temperatures and times.
- Purification techniques like crystallization or chromatography.
- Variations of reaction pathways or alternative intermediates.
This layered claim structure designates the broadest patent coverage with specific fallback options.
3. Claim Scope and Patent Strength
The scope primarily covers the process for synthesizing the medicinal compounds, which provides an effective patent barrier against competitors attempting different methods. Given the focus on synthesis steps, this patent likely seeks to prevent third-party manufacturing of the same compounds through alternative routes.
However, if the patent includes claims on the compounds themselves, it would offer additional protection, especially if these compounds are subject to further patenting for their therapeutic use.
4. Legal and Strategic Considerations
- Novelty and Inventiveness: The patent’s claims hinge on specific reactions or intermediates that differ from prior art, assuming comprehensive examination by Chinese patent authorities.
- Reach: The claims are specific enough to prevent others from easily designing around the patent through different synthesis routes.
- Potential Limitations: If similar process patents exist, patent infringement may occur only if process steps or reagents are identical or equivalent.
Patent Landscape and Competitive Environment
1. Domestic and International Patent Landscape
China's emerging pharmaceutical sector has seen a proliferation of process patents like CN105001222, often focusing on efficient synthesis, new intermediates, and therapeutic applications. Key points:
- Patent Clusters: Several Chinese patents cover similar compound classes with overlapping synthesis methods (e.g., CNxxxxxxx series).
- Global Patent Counterparts: Internationally, similar patents are filed under the Patent Cooperation Treaty (PCT), notably in jurisdictions like the US, Europe, and Japan. However, patent scope and claim language vary significantly depending on regional patent laws.
2. Patent Family and Prior Art
Analysis indicates that patents citing or citing CN105001222 include:
- Related process patents with overlapping reaction schemes.
- Compound patents that claim the chemical entities obtainable via this process and their therapeutic uses.
- Methodology improvements that modify specific reaction parameters for enhanced yields or environmental considerations.
The patent landscape reveals fierce competition among Chinese applicants in process innovations, with many patents claiming incremental improvements or alternative pathways.
3. Patent Validity and Challenges
- Potential for Patent Infringement: Companies manufacturing similar compounds using comparable methods risk infringement if claims are broad and well-maintained.
- Challenges: Prior art searches reveal some overlaps with existing process patents, possibly leading to invalidation arguments or licensing negotiations.
4. Strategic Implications
- For Innovators: Securing broad claims on process steps offers strong barriers but requires vigilance regarding existing patents.
- For Competitors: Designing around such patents involves developing alternative synthesis routes, potentially challenging the novelty or inventive step.
- For Patent Holders: Expanding claims to cover compounds and their specific uses can fortify patent protection.
Regulatory and Commercial Considerations
China’s evolving drug patent environment emphasizes ensuring process and product patents align with regulatory approvals. Patent CN105001222, by covering essential synthesis steps, can facilitate smooth pathway approval, provided the process is reproducible and complies with GMP standards.
Furthermore, such patents bolster licensing or partnership opportunities within China’s burgeoning biotech sector.
Key Takeaways
- Focused Scope: CN105001222 centers on a novel, efficient chemical synthesis process, with claims primarily on manufacturing steps for therapeutic compounds.
- Strong Defensive Tool: Its detailed claims provide robust IP protection, potentially blocking competitors working with similar processes.
- Patent Landscape: The Chinese patent space for drug synthesis is highly competitive, with overlapping patents necessitating strategic landscape navigation.
- Leverageability: Patent holders can extend protections with compound claims or therapeutic use patents, maximizing market exclusivity.
- Regulatory Synergy: Process patents like CN105001222 can streamline Chinese drug approval pathways, adding commercial value.
FAQs
Q1: Does CN105001222 cover the chemical compounds themselves or the process of making them?
A1: The patent primarily covers the process (synthesis method), although the claims may extend to the compounds if explicitly included or within dependent claims.
Q2: How does this patent compare to similar foreign patents?
A2: While similar process patents exist internationally, CN105001222's specific reaction conditions and intermediates provide tailored protection within China, with variations depending on regional patent laws.
Q3: Can competitors develop alternative synthesis methods to bypass this patent?
A3: Yes, designing different reaction pathways or using alternative reagents may circumvent the patent, provided those routes do not infringe on the specific claims.
Q4: What is the significance of this patent for the pharmaceutical company's R&D strategy?
A4: It provides a protected route for manufacturing specific therapeutic compounds, potentially reducing costs and enabling faster market entry.
Q5: Are there any challenges to enforcing this patent?
A5: Enforcement depends on evidence of infringement, the scope of claims, and potential prior art challenges, necessitating vigilant monitoring and legal preparedness.
References
- Chinese Patent Database, CN105001222.
- World Intellectual Property Organization (WIPO), Patent Cooperation Treaty (PCT) data.
- Chinese patent law and regulation standards.
- Industry reports on pharmaceutical patent strategies in China.
- Comparative analysis of drug process patents in China and abroad.
This comprehensive analysis forms a foundation for strategic decision-making regarding CN105001222, offering clarity on its scope, landscape positioning, and enforcement potential in China’s pharmaceutical patent arena.
