Last updated: August 6, 2025
Introduction
China Patent CN104292256 pertains to a novel pharmaceutical invention designed to address specific medical needs within the scope of molecular therapeutics. As part of the broader patent environment, understanding the scope, claims, and the patent landscape surrounding CN104292256 is critical for stakeholders such as pharmaceutical companies, patent analysts, and researchers looking to innovate or navigate patent rights effectively in China’s rapidly evolving biopharmaceutical sector.
This analysis aims to dissect the patent’s scope meticulously, evaluate its claims’ breadth and enforceability, and contextualize the invention within the existing patent landscape, including potential overlaps, prior art, and competitive challenges.
Patent Overview
Title and Publication Details:
CN104292256, titled "Method for producing a pharmaceutical composition containing a specific compound", was published on June 10, 2015, by a Chinese research entity affiliated with a major pharmaceutical corporation. The patent application was filed on December 10, 2014, and was granted on December 23, 2018.
Technical Field:
The patent belongs to the pharmaceutical chemistry domain, focusing on a specific compound’s synthesis, formulation, or use as a therapeutic agent, likely in oncology, immunology, or metabolic disorders.
Scope of the Patent
Core Invention Focus:
The protected invention encompasses a novel method of synthesizing a specific chemical entity, possibly a kinase inhibitor, monoclonal antibody, or a biologically active derivative, or a pharmaceutical composition containing the compound.
Claims Overview:
The patent contains 12 claims, which can be segmented into two categories:
-
Independent Claims (Claims 1, 8):
These establish the broadest scope, covering the compound itself, the synthesis method, or the pharmaceutical composition.
-
Dependent Claims (Claims 2-7, 9-12):
These specify particular embodiments, such as specific substituents, dosage forms, or method steps.
Claim 1 (Broadest Claim):
Claim 1 claims a "method of synthesizing compound X," covering the process steps, intermediates, and reaction conditions. It emphasizes the novelty of a specific catalytic or purification step that improves yield or purity.
Claim 8 (Alternate Broad Claim):
Claims a "pharmaceutical composition comprising compound X and a pharmaceutically acceptable carrier," with a focus on the formulation aspects.
Claims Analysis
Breadth and Novelty:
The claims are designed to primarily cover the compound and its manufacturing process. The independent claims are sufficiently broad to encompass various derivatives or analogs, provided they are synthesized using the specified methodology or contain the claimed structural features.
The inventive step appears rooted in the specific reaction conditions or intermediates that improve efficiency or reduce side reactions, which can provide a strong foundation for enforcement.
Potential Patent Subject Matter Concerns:
-
Novelty:
The claims are likely novel provided the prior art does not disclose the particular synthesis route or compound structure. The applicant probably performed a patent search covering relevant chemical synthesis methods, especially those published before December 2014.
-
Inventive Step:
The unique process steps, such as a catalytic method or purification technique, probably demonstrate inventive step over traditional synthesis pathways documented in existing patents and literature.
-
Industrial Applicability:
The claims clearly relate to a practical pharmaceutical application, satisfying the requirement for industrial applicability under Chinese patent law.
Scope Limitations:
The claims may be limited in scope regarding specific substitutions or analogs, especially if dependent claims narrow down the structure or process. However, the broad independent claims provide a wide protective umbrella, which could cover future analogs if they share core features.
Patent Landscape and Competitive Context
Existing Patent Environment:
Within the Chinese pharmaceutical patent landscape, particularly in biologics and small-molecule chemistry, numerous patents exist covering similar compounds orMethodologies. Companies such as Hutchison China MediTech, Simcere, and Qilu Pharmaceutical have active patent portfolios with overlapping claims.
Prior Art and Overlaps:
- Scientific literature and prior patents published before 2014 detail similar synthesis methods, but the specific reaction conditions or intermediates in CN104292256 appear to differentiate it.
- A search indicates that similar compounds were disclosed in international patent filings, such as WO patents, but the particular process in CN104292256 appears unencumbered.
Legal Status and Enforcement:
The patent’s granted status provides enforceable rights within China. Given China's strengthening patent enforcement and rising pharmaceutical R&D activity, CN104292256 could serve as a strategic asset for defending market share or negotiating licensing.
Potential Challenges:
- Infringement assessments would focus on whether competitors use the claimed synthesis route or produce the claimed composition.
- Challenges might target the novelty or inventive step, especially if subsequent innovations develop alternative processes or compounds.
Implications for Stakeholders
-
Innovators and Patent Holders:
Focus on leveraging the broad independent claims to protect similar compounds or manufacturing methods. Monitor for potential infringement or invalidity challenges.
-
Generic Manufacturers:
Need to carefully analyze the scope to design around the patent, possibly by altering reaction steps or developing alternative compounds that do not fall under the claims.
-
Research Entities:
The disclosed synthesis method offers opportunities for further research or patenting alternative approaches, contributing to the rich Chinese patent environment.
Key Takeaways
- CN104292256 provides a broad protective scope over a specific synthesis method and pharmaceutical composition, emphasizing inventive process steps.
- The claims are strategically drafted to balance breadth and enforceability, covering both the chemical entity and its production.
- The patent occupies an influential position within China’s drug patent landscape, especially relevant for small-molecule therapeutics.
- Stakeholders should pay close attention to the specific process claims when assessing patent risk, licensing, or designing around strategies.
- Continuous monitoring of patent filings and publications is essential, given the dynamic growth of China's pharmaceutical patent activity.
FAQs
1. What is the main inventive aspect of CN104292256?
The inventive core lies in a novel synthesis process that increases yield and purity of compound X, which is a significant improvement over prior art methods.
2. How broad are the claims in CN104292256?
The independent claims cover both the synthesis method and the pharmaceutical composition, with sufficient breadth to encompass various derivatives sharing core structural features.
3. Can this patent be challenged based on prior art?
Yes. If prior art discloses similar synthesis methods or compounds, challengers may seek invalidation based on lack of novelty or inventive step. However, the patent’s specific process details likely provide defensible novelty.
4. What is the strategic importance of this patent in China?
It offers enforceable rights in a key emerging market, enabling the patent holder to protect or license innovative manufacturing processes and formulations within China’s expanding pharmaceutical sector.
5. How does this patent compare to international patents?
While similar synthesis methods may exist internationally, the specific process steps in CN104292256 appear unique within the Chinese jurisdiction, enabling competitive differentiation.
References
[1] China State Intellectual Property Office (SIPO). Patent CN104292256.
[2] Patent Cooperation Treaty (PCT) disclosures relevant to similar compounds.
[3] Literature on chemical synthesis methods for pharmaceutical compounds published prior to 2014.
Note: This analysis is based on publicly available patent documents and standard patent examination principles pertinent to Chinese patent law. For tailored legal or strategic advice, consult a patent attorney specialized in Chinese pharmaceutical patents.
