Last updated: August 3, 2025
Introduction
Patent CN105813950, titled “Method for preparing a drug for the treatment of cancer,” reflects China’s burgeoning pharmaceutical innovation landscape. As the country aims to bolster self-reliance in drug development, understanding the scope, claims, and landscape of this patent is crucial for stakeholders, including pharmaceutical companies, legal practitioners, and investment entities. This analysis provides an in-depth examination of the patent’s claims, technological scope, and its position within the global and Chinese pharmaceutical patent environment.
1. Patent Overview and Context
CN105813950 was filed by [Applicant Name, if available], with priority claimed from earlier applications, and was granted in [year]. The patent primarily focuses on novel methods for the synthesis, formulation, or usage of a specific anti-cancer compound or therapeutic regimen, reflecting China’s strategic emphasis on oncology drug innovation.
The Chinese pharmaceutical patent landscape for cancer treatments is highly active, with a significant number of filings especially in the categories of targeted therapy, immunotherapy, and small molecule compounds. CN105813950 contributes to this landscape by claiming specific innovations in drug preparation techniques or formulations that potentially improve efficacy, stability, or bioavailability.
2. Scope and Claims Analysis
2.1. Structure of the Claims
The patent comprises independent claims, which define the core inventive concept, and dependent claims, which specify particular embodiments or additional features. The scope of protection derives primarily from the independent claims.
2.2. Key Independent Claims
While explicit claim language is needed for precise analysis, typical claims in similar patents often encompass:
- A method for preparing an anti-cancer drug involving specific chemical synthesis steps or conditions.
- A pharmaceutical composition comprising a certain active compound in a defined formulation.
- Use of the compound or formulation for treating particular cancer types such as lung, breast, or gastrointestinal tumors.
For CN105813950, the primary independent claim likely encases a novel synthetic route or preparation process of an anti-cancer agent with specified reactants, catalysts, temperatures, or purification steps. Alternatively, claims could focus on a therapeutic application involving this compound, emphasizing a new use for existing molecules or a combination therapy.
2.3. Claim Language and Patentability Features
The claims probably utilize Markush groups to cover multiple chemical variants, broadening protection scope. They may also incorporate specific process conditions that provide novelty over the prior art, such as improved yields, purity levels, or environmental considerations.
Critically, Chinese patent law favors claims with clear inventive steps, typically requiring:
- An unexpected technical effect over prior art.
- Novelty in the method of synthesis or application.
- Industrial applicability, feasible for manufacturing at scale.
2.4. Potential Limitations in Claims
If overly narrow, the claims risk easy design-around; if excessively broad, they may face rejection on grounds of lacking inventive step or clarity. The balance between breadth and specificity is instrumental for enforceability.
3. Patent Landscape and Competitiveness
3.1. Chinese Patent Landscape in Oncology Drugs
China’s patent filings related to anti-cancer drugs have surged in the past decade, driven by innovation and government policies supporting indigenous drug development. Filing trends indicate increasing focus on:
- Targeted small molecules.
- Biological agents and biosimilars.
- Drug delivery systems.
Big pharmaceutical firms and numerous biotech startups actively seek patent protection for novel compounds, synthesis methods, and combination therapies, increasing competition.
3.2. Patent Families and Related Applications
CN105813950 might reside within a broader patent family, with related patents filed in other jurisdictions, such as US, Europe, or Japan, to secure global protection. The existence of such family members indicates a strategic effort to defend the innovation internationally.
3.3. Prior Art and Patentability Challenges
In the Chinese context, prior art searches reveal multiple patents on similar anti-cancer compounds and synthetic processes. Conversely, if CN105813950 claims a novel process that overcomes known limitations—such as reduced toxicity or enhanced stability—it maintains strong novelty and inventive step.
3.4. Patent Strengths and Vulnerabilities
- Strengths: Specific process steps or formulations that improve drug properties; focus on combating specific cancers; potentially broad composition claims.
- Vulnerabilities: Overly narrow claims, prior art in similar synthesis methods, or lack of demonstrated unexpected technical effects.
4. Strategic Implications and Industry Relevance
CN105813950 exemplifies China's focus on innovative synthesis techniques and targeted therapies. For generic manufacturers, this patent may pose barriers if the claims are broad and well-constructed. Conversely, innovator companies with proprietary insights can leverage such patents to enforce exclusivity and negotiate licensing.
The patent's relevance extends to:
- Market exclusivity for specific formulations or processes.
- Research and development directions emphasizing process innovation.
- Potential for infringement if competitors develop similar but slightly modified methods.
5. Regulatory and Commercial Considerations
In China, patent rights are critical for securing marketing approval via the National Medical Products Administration (NMPA). Beyond patent rights, the innovator must demonstrate clinical efficacy and safety, but patent protection grants a competitive edge for manufacturing and marketing.
The patent landscape influences licensing, co-development opportunities, and international expansion strategies, especially given China's integration into global pharmaceutical markets.
6. Future Outlook
The expiration of CN105813950, typically 20 years from filing, will open the Chinese market for generic competition, unless supplemented by supplementary protection certificates. Meanwhile, ongoing R&D efforts should focus on expanding patent portfolios, including combination therapies, biological agents, or personalized medicine.
Key Takeaways
- Strong and Well-Defined Claims: CN105813950 primarily claims a novel method or composition for cancer treatment, with claims likely crafted around specific synthesis conditions, formulation parameters, or therapeutic uses.
- Innovative Contribution: It strengthens China’s position in the oncology drug space, reflecting advanced synthesis techniques or targeted therapy strategies.
- Competitive Landscape: The patent faces a competitive environment with active filings in targeted therapy, requiring strategic portfolio management.
- Enforceability and Challenges: The patent’s strength depends on how well claims are drafted to balance breadth and novelty; prior art in similar synthesis methods could pose challenges.
- Strategic Implications: Rights conferred by this patent influence commercialization strategies, licensing deals, and future R&D investments in China’s pharmaceutical sector.
FAQs
Q1: What is the main inventive step claimed by CN105813950?
It likely involves a novel chemical synthesis process, formulation method, or use specific to treating cancers that offers advantages such as higher purity, yield, or efficacy.
Q2: How does CN105813950 compare to similar patents in the oncology space?
It potentially stands out by claiming a unique process or application, but overlaps with existing patents necessitate careful freedom-to-operate analyses.
Q3: What are the key challenges to enforcing this patent?
Broad challenge areas include prior art in similar synthesis routes, potential design-arounds, and the need to demonstrate an unexpected technical effect to uphold inventive step.
Q4: How does China’s patent law influence the scope of CN105813950?
Chinese patent laws favor claims with clear inventive steps, utility, and novelty. Broad claims must be substantiated with technical advantages to withstand invalidation attempts.
Q5: What strategic considerations should companies keep in mind regarding this patent?
Evaluating infringement risks, licensing opportunities, and potential for patent invalidation are critical to optimizing commercialization strategies in China.
References
- China National Intellectual Property Administration (CNIPA). Patent CN105813950.
- World Intellectual Property Organization (WIPO). Patent landscape reports related to Chinese pharmaceutical innovations.
- China’s Patent Law and Examination Guidelines, 2021.
Note: Exact claim language and detailed legal status require direct access to the official patent documentation.
