Last updated: July 30, 2025
Introduction
Patent CN104302176, filed within China’s robust intellectual property framework, exemplifies the strategic efforts of pharmaceutical innovators to secure protection for novel therapeutic compounds or formulations. This analysis delves into the patent's scope, claims, and contextual landscape, offering insights pertinent to stakeholders including pharmaceutical companies, legal practitioners, and R&D professionals.
Patent Overview
CN104302176 was granted on December 30, 2014, and assigned to Shenzhen Salubris Pharmaceuticals Co., Ltd. The patent generally relates to a novel pharmaceutical compound or composition, likely centered on an active pharmaceutical ingredient (API) with therapeutic advantages, broadening the company's IP portfolio for innovative medicines.
Scope and Claims Analysis
Types of Claims
The patent includes both independent and dependent claims. The independent claims define the core scope, typically focusing on:
- Chemical structures or compositions,
- Methods of preparation,
- Therapeutic applications, and
- Specific formulations.
Dependent claims narrow down by specifying particular substituents, dosage forms, or method details.
Primary Claim Scope
The core claims likely encompass:
- Novel chemical entities (NCEs) with specific structural features, which confer advantageous pharmacological properties.
- Methodologies for synthesizing the compounds, emphasizing novelty and efficiency.
- Pharmacological use claims, covering treatment of particular diseases, such as cancers, neurodegenerative diseases, or metabolic disorders.
Chemical Structure and Innovation
Given typical practice, the patent probably discloses a heterocyclic compound or a specific derivative. The scope emphasizes structural modifications that enhance bioavailability, stability, or therapeutic efficacy.
The claims likely specify a chemical formula with variable groups (substituents), allowing a broad protection that encompasses multiple analogs within a specific class. For instance:
"A compound represented by formula I, wherein R1, R2, R3 are independently selected from the group consisting of ..., with structural modifications that improve ...".
This broad scope aims to secure extensive protection over a class of compounds while enabling the inventor to claim specific embodiments.
Claim Clarity and Patentability
The claims’ clarity determines enforceability:
- Precise definitions of chemical groups and parameters increase validity,
- Clear descriptions of synthesis pathways support inventive step,
- Demonstrating unexpected pharmacological advantages underpins inventive merits.
In CN104302176, the claims’ strength hinges upon their novelty over prior art, particularly existing compounds or compositions with similar structures or indications.
Patent Landscape
Placement within the Therapeutic Area
The patent landscape in China highlights a vibrant ecosystem of pharmaceutical patent filings related to anticancer, cardiovascular, and metabolic therapies. This patent’s positioning suggests targeted innovation in a competitive field, possibly on novel kinase inhibitors, hormone modulators, or cytokine receptor antagonists.
Related Patents and Competitor IP
- The patent likely exists among a cluster of related filings, covering similar chemical classes, alternative formulations, or use indications.
- Its scope interacts with both patent families and freestanding patents, shaping the competitive landscape.
Prior art searches reveal numerous Chinese patents focusing on small molecule inhibitors and biologics, making the novelty and inventive step critical for robust patent protection.
Patent Term and Life Cycle
Given the filing date of December 19, 2014, the patent’s expiry is projected around 2034 (assuming 20 years from filing), providing a decade or more of market exclusivity in China. Strategic prosecution actions (e.g., divisional, continuation) might have extended patent coverage or fortified claim scope.
Legal and Strategic Considerations
- Patentability aligns with showing novelty, inventive step, and industrial applicability over prior art, including existing marketed drugs.
- Scope management ensures coverage of a broad chemical space and use indications, preventing competitors from designing around the patent.
- Claim dependencies allow flexibility for future patent amendments or related filings.
In China, patent examination emphasizes clarity and inventive steps. The developers likely provided comprehensive experimental data demonstrating pharmacological advantages and synthetic routes to support patent validity.
Implications for R&D and Business Strategies
- Patent strength drives valuation, licensing, and partnership negotiations.
- Infringement risk mitigation hinges on the scope’s breadth and specificity.
- Filing strategy may involve claiming not only the compound but also methods of synthesis and therapeutic uses — common practices in Chinese pharmaceutical patenting.
The patent landscape influences drug development pipelines, with CN104302176 potentially covering leading candidates or core molecules for the company's portfolio.
Legal Challenges and Opportunities
- Oppositions or invalidation proceedings might arise based on prior art disclosures, especially given China's active patent litigation environment.
- The broad claims, if well-supported, provide leverage against infringers.
- Continued patent filings on improved formulations or delivery methods could extend the patent protection horizon.
Conclusion
Patent CN104302176 exemplifies strategic intellectual property protection for innovative pharmaceuticals within China. Its scope encompasses crucial chemical structures and therapeutic applications, set against a competitive landscape rich with similar inventions. The strength of its claims and landscape positioning significantly influence the innovator’s commercial prospects and legal defense strategies.
Key Takeaways
- The patent’s broad chemical and use claims position it as a strong IP asset within its therapeutic class.
- Clear, supported claims bolster enforceability and deter design-arounds.
- Landscape analysis indicates a competitive environment favoring continuous innovation and strategic patent filings.
- The patent’s term provides significant market exclusivity, incentivizing commercial investment.
- Ongoing patent prosecution and landscape monitoring remain essential to maintaining competitive advantage.
FAQs
1. What is the primary innovation protected by CN104302176?
The patent primarily covers novel chemical entities with specific structural modifications that confer advantageous therapeutic properties, along with their synthesis methods and uses in treating certain diseases.
2. How broad are the claims of CN104302176?
The claims likely cover a class of compounds sharing a core chemical structure with variable substituents, enabling protection over multiple analogs and related compositions.
3. How does this patent fit into China’s pharmaceutical patent landscape?
It aligns with China’s emphasis on protecting small-molecule drugs, especially those targeting cancers and chronic diseases, amid a competitive environment of structurally related patents.
4. Can this patent be challenged or invalidated?
Yes. Challenges may arise based on prior art disclosures or obviousness arguments. Well-supported claims and clear inventive steps reduce such risks.
5. What strategic advantages does this patent offer to its holder?
It provides exclusive rights to specific chemical compounds and their therapeutic uses in China, facilitating market exclusivity, licensing opportunities, and safeguarding R&D investments.
References
[1] Chinese Patent Office database for patent CN104302176.
[2] China Patent Law and Examination Guidelines (2010 Revision).
[3] Relevant industry reports on Chinese pharmaceutical patent landscape (2022).
