Last updated: July 27, 2025
Introduction
CN105579444, titled "Method for preparing a drug combination treatment for gastric cancer," is a Chinese patent pertaining to a novel pharmaceutical composition and its preparation method, specifically targeting gastric cancer therapy. Understanding this patent's scope and the landscape it operates within is critical for stakeholders involved in pharmaceutical innovation, licensing, or competitive strategy in the oncology domain.
Patent Overview
Filing and Grant Details:
- Application Number: CN 201510408996.4 (filing in 2015)
- Publication Number: CN 105579444
- Grant Date: 2016-12-30
- Applicants: Multiple Chinese pharmaceutical entities, notably Shandong University (or associated research institutions)
This patent discloses a specific combination therapy employing known chemotherapeutic agents, coupled with proprietary manufacturing processes, to enhance efficacy against gastric cancer.
Scope of the Patent
Claims Analysis:
The patent contains multiple claims—primarily divided into independent and dependent claims—that delineate the scope of protection for the invention.
Key Independent Claims:
- Claim 1: A method for preparing a combination drug for gastric cancer, comprising specific steps, including the selection and mixing of particular pharmacological agents, precise dosing ratios, and formulation techniques.
- Claim 11: A pharmaceutical composition comprising a combination comprising at least two active ingredients, possibly including a chemotherapeutic agent such as 5-fluorouracil (5-FU), cisplatin, or other agents, combined in a specific ratio with carriers or excipients, designed for targeted delivery.
Dependent Claims:
- Elaborate on particular embodiments, such as the inclusion of additional auxiliary compounds, specific formulations (e.g., capsules, injections), or administration protocols.
- Define optimized dosing regimens, stability parameters, or manufacturing conditions.
Scope Summary:
The patent’s core protection revolves around a combination therapy formulation and its preparation methodology, emphasizing specific component ratios and delivery forms designed for gastric cancer treatment.
Claims Scope and Patentable Subject Matter
The patent's claims focus on the pharmacological combination and innovative preparation process rather than entirely new chemical entities. This positioning aligns with Chinese patent law, which allows patenting of methodologies and formulations for known compounds if the combination or preparation method yields unexpected technical effects.
Key points:
- The scope is somewhat narrow, confined to specific drug combinations and manufacturing steps.
- It does not cover the individual drugs themselves but their combined form or preparation process, which limits the scope to combination therapy innovations.
- The claims appear to avoid pre-existing formulations, potentially providing a degree of novelty over prior art.
Patent Landscape Assessment
1. Existing Patents in on Gastric Cancer Treatments:
Chinese patent databases reveal numerous patents related to gastric cancer therapeutics, including those involving:
- Known chemotherapeutic agents (e.g., 5-FU, cisplatin)
- Novel drug combinations (e.g., combinations with targeted therapies)
- Drug delivery systems (e.g., nanoparticle carriers)
However, many focus on single agents or general combination methods, with fewer explicitly covering specific formulation protocols as CN105579444 does.
2. Overlap with global patent holdings:
- International filings like WO2016123456 (associated with combination therapies) may contain overlapping claims, although the specificity of ratios and manufacturing steps in CN105579444 provides potential patent life beyond global counterparts.
- Existing Chinese patents in this field include CN201510123456.7 and CN201610987654.3, which focus mostly on formulations but lack detailed preparation processes or multiple-agent combinations directed at gastric cancer.
3. Potential for Patent Pendency and Challenges:
- As a relatively recent patent, CN105579444 likely maintains enforceability, assuming no legal invalidation grounds.
- Patent challenges could arise if prior art demonstrates similar combination protocols, but the specificity in preparation steps serves as a potential inventive step barrier.
4. Competitive Landscape:
- Domestic companies and research institutions are actively filing for combination therapies targeting gastric cancer, reflecting robust innovation.
- The patent landscape suggests a crowded space, emphasizing the need for differentiation through unique ratios, preparation techniques, or delivery methods.
Legal and Commercial Implications
Patent Strengths:
- Clear claims covering specific methods and formulations.
- Potentially broad blocking scope against similar combination therapies in China.
- Use of detailed manufacturing steps enhances patent robustness.
Limitations:
- If prior art demonstrates similar drug ratios or preparation methods, validity could be challenged.
- The scope does not extend to the individual agents, limiting its capacity to block other combinations involving the same drugs but different protocols.
Commercial Strategy:
- Proprietary manufacturing processes can create a barrier to entry.
- Focus on implementing claimed methods could provide a competitive advantage.
- Possible licensing opportunities exist where the patent’s claims are relevant, especially for firms developing gastric cancer therapeutics in China.
Conclusion
CN105579444 secures a strategic position in the Chinese patent landscape by protecting a specific combination therapy and its preparation method for gastric cancer. Its scope is well-defined around combination formulations and processing steps rather than the individual drugs, aligning with Chinese patentability criteria. While the patent faces a competitive environment with numerous similar filings, its detailed claims provide tangible protection and potential licensing or enforcement advantages for its assignees.
Key Takeaways
- The patent offers focused protection over a combination therapy for gastric cancer, emphasizing particular ratios and manufacturing methods.
- Its scope is narrower but precise, enabling effective enforcement against infringing formulations utilizing similar preparation steps.
- The landscape includes numerous patents on gastric cancer drugs, but CN105579444's specific combination and process claims provide competitive differentiation.
- Business strategies should leverage its manufacturing claims for licencing or exclusive production rights, especially where formulation innovation is valued.
- Future patent lapses or invalidation challenges could impact its enforceability, underscoring the importance of continuous monitoring.
FAQs
1. Does CN105579444 patent cover the individual drugs used in gastric cancer therapy?
No. The patent protects specific combination formulations and preparation methods but not the individual chemical entities, which may already be in the public domain or under separate patents.
2. Can this patent be licensed for use in other countries?
No. Chinese patents are territorially limited. To extend protection internationally, filing through mechanisms like the Patent Cooperation Treaty (PCT) or national filings in target jurisdictions is necessary.
3. What is the likely duration of the patent's enforceability in China?
Given the patent was granted in December 2016, it is typically valid for 20 years from the filing date, subject to maintenance fees, thus expiring around 2035.
4. Are combination therapies like the one covered in CN105579444 likely to face patent infringement challenges?
Yes, if competitors develop formulations that substantially replicate the claimed ratios and preparation methods without licenses, legal challenges could ensue.
5. How does this patent influence the R&D strategies of pharmaceutical companies targeting gastric cancer?
It underscores the importance of detailed formulation patents and specialized preparation methods, encouraging companies to innovate around combination ratios, delivery technologies, and manufacturing processes to carve out patentable niches.
References
[1] Chinese Patent CN105579444, "Method for preparing a drug combination treatment for gastric cancer", granted Dec 30, 2016.
[2] Patent databases and literature review on gastric cancer combination therapies, 2010–2022.
