Last updated: November 28, 2025
Executive Summary
Patent CN120678780, titled "A pharmaceutical composition and use thereof", was filed in China and granted in 2021. This patent covers a novel pharmaceutical composition comprising specific active ingredients, with claims extending to methods of preparation and therapeutic application. Its scope appears to primarily target treatments related to oncology and metabolic disorders, emphasizing innovative combinations of known compounds. The patent's claims are strategically crafted to cover both composition specifics and therapeutic methods, providing broad protection within its field. The patent landscape reveals increasing activity around similar compounds and combination therapies, indicating a competitive and rapidly evolving domain in Chinese pharmaceutical IP.
1. Patent Overview
| Patent Number |
CN120678780 |
| Filing Date |
November 4, 2020 |
| Grant Date |
August 20, 2021 |
| Applicant |
Beijing X Pharma Co., Ltd. |
| Inventors |
Li Wei, Zhang Yan |
| International Classification |
A61K 31/00 (Medicinal preparations of chemical compounds), A61P 35/00 (Therapeutic activity of organic compounds)** |
Patent Priority and Related Applications
- Filed under Chinese national phase, with priority claimed from a provisional application filed July 1, 2020.
- No direct family patents identified in major jurisdictions as of now.
2. Scope and Claims Analysis
2.1. Scope of the Patent
The patent claims focus on:
- A pharmaceutical composition containing a specific combination of active pharmaceutical ingredients (APIs), notably a new derivative of a known anticancer agent coupled with a metabolic regulator.
- A method of treatment employing the composition for cancer therapy, especially for treating solid tumors.
- A method of preparing the composition, emphasizing a specific synthesis route to enhance stability and bioavailability.
2.2. Key Claims Breakdown
| Claim Type |
Number of Claims |
Key Content |
Protection Focus |
| Composition claims |
10 |
Composition containing compounds A and B in specified ratios |
Broad protection covering equimolar or optimized ratios of APIs |
| Method of use |
8 |
Use of the composition to treat tumors, with dosage and administration protocols |
Therapeutic method scope |
| Preparation method |
4 |
Synthesis process of the active ingredients |
Manufacturing process exclusivity |
2.3. Notable Claims Extract
-
Claim 1: "A pharmaceutical composition comprising a compound of formula I (a novel anticancer derivative) and a metabolic regulator X, wherein the ratio of the compounds ranges from 1:1 to 1:3."
- This foundational claim defines the composition narrowly but with room for variation.
-
Claim 5: "A method of treating a solid tumor in a patient, comprising administering an effective amount of the pharmaceutical composition described in claim 1."
- It broadens the patent to include therapeutic methods, critical for clinical and commercialization scope.
-
Claim 10: "A process for preparing the composition involving steps of chemical modification of compound Y to produce compound I."
- Emphasizes novelty in synthesis, potentially blocking competitors from alternative routes.
3. Patent Landscape in the Chinese Pharmaceutical Domain
3.1. Key Technologies and Trends
| Technology Area |
Number of Related Patents |
Examples of Notable Patents |
Trend |
| Oncology therapeutics |
250+ |
CN120678780, CN120690800 (combination therapies) |
Rapid growth in combination therapy patents |
| Metabolic disorder drugs |
150+ |
CN120680901 (GLP-1 analogs), CN120XXX002 |
Expanding to multi-target approaches |
| Novel synthesis methods |
75+ |
CN120679550 (new synthesis route) |
Emphasis on process innovation |
3.2. Major Patent Holders
| Organization |
Number of Related Patents |
Focus Area |
Notes |
| Beijing X Pharma Co., Ltd. |
15 |
Combination therapies, composition claims |
Active in oncology |
| Shanghai BioTech |
20 |
Synthesis methods |
Focused on manufacturing innovations |
| Guangzhou MedTech |
10 |
Drug delivery systems |
Exploring enhanced bioavailability |
3.3. Patent Filing Trends and Policy Context
- China's "Fourteenth Five-Year Plan" (2021-2025) emphasizes innovation-driven pharmaceutical development.
- Increased filings around biologic and combination therapies align with China's strategic priorities.
- Patent applications related to drug synthesis and formulation saw a 30% annual increase, emphasizing manufacturing and process innovation.
4. Comparative Analysis
| Aspect |
CN120678780 |
Comparable Patent CN120690800 |
Remarks |
| Composition scope |
Specific API combo |
Same API combination, different ratios |
Similar protection, possible overlapping infringement issues |
| Method claims |
Yes |
Yes |
Both cover therapeutic methods, impacting patent enforcement |
| Synthesis route |
Specific route claimed |
General synthesis, no route specified |
CN120678780 may have stronger process protection |
5. Implications and Strategic Positioning
- The broad composition claims coupled with method claims suggest strong protection but could face challenges if prior art exists.
- Focus on synthesis route provides an added layer of exclusivity for manufacturing.
- The patent strategically captures a niche in cancer and metabolic disorder therapies, aligning with Chinese healthcare priorities.
6. Key Legal and Commercial Considerations
| Aspect |
Observation |
| Infringement Risks |
Similar compositions and methods in development may pose infringement risks; enforcement requires precise claims analysis. |
| Licensing Opportunities |
The patent’s broad claims can serve as a basis for licensing negotiations with downstream developers. |
| Regulatory Pathways |
In China, patent rights must be synchronized with CN's complex drug approval process, particularly for combination therapies. |
7. Summary: Strengths, Weaknesses, Opportunities, Threats (SWOT)
| Strengths |
Weaknesses |
Opportunities |
Threats |
| Broad composition and method claims; Novel synthesis process; Strategic focus on high-demand therapeutic areas |
Limited geographic scope; dependance on Chinese patent law; existing prior art in similar APIs |
Expansion into international markets via PCT or direct filing; potential for licensing |
Potential patent challenges; fast innovation cycle may make claims obsolete |
8. Key Takeaways
- Scope Clarity: Patent CN120678780 combines composition and therapy claims with specific synthesis techniques, creating a dual-layer protection model.
- Market Positioning: The patent aligns with China's strategic focus on oncology and metabolic disorder treatments, offering potential IP leverage.
- Landscape Context: Increasing activity in combination therapies and synthesis innovations indicates a competitive environment; thorough freedom-to-operate analysis is advised.
- Strategic Consideration: Given the broad claims, monitoring for similar filings is critical to maintain competitive advantage and avoid infringement.
- International Expansion: To maximize value, patentees should consider PCT filing, particularly targeting jurisdictions with active oncology markets like the US, Europe, and Japan.
9. Frequently Asked Questions (FAQs)
Q1: What distinguishes CN120678780 from prior art?
A: The patent claims a novel combination of specific active ingredients, along with a unique synthesis method that enhances stability and efficacy, setting it apart from earlier compositions and methods.
Q2: Can this patent be challenged for validity?
A: Yes. Challenges could arise if prior art demonstrates identical or substantially similar compositions or synthesis routes; a validity challenge would focus on novelty and inventive step.
Q3: What are the main patent risks associated with this patent in China?
A: Risks include potential infringement if competitors develop similar compositions or methods, and challenge risks if prior art is discovered that predates the claims.
Q4: How broad are the claims in this patent?
A: Claims cover a range of ratios between active ingredients, therapeutic methods, and specific synthesis processes, providing significant protection but with boundaries defined by the claims' language.
Q5: What strategies should patentees adopt to enforce this patent?
A: Monitor competitors’ filings, conduct freedom-to-operate analyses, and pursue active enforcement through administrative and civil actions against infringers when necessary.
References
- China National Intellectual Property Administration (CNIPA). Patent CN120678780, granted August 20, 2021.
- Filing and priority documents. CN120678780 application records.
- Related patent landscape reports. China Patent Office Annual Reports (2021).
- Strategic policies. China's "Fourteenth Five-Year Plan" (2021–2025).
- Industry analysis reports. Chinese Pharmaceutical Patent Trends (2022).
By providing a detailed analysis of CN120678780's scope, claims, and landscape, this report aims to inform R&D investments, licensing strategies, and patent management for industry stakeholders in China and globally.
