Last updated: August 3, 2025
Introduction
China Patent CN103402499, filed by a leading pharmaceutical innovator, presents a comprehensive patent centered around a novel therapeutic compound. This patent, published in 2013, extends the strategic patent coverage of a new drug candidate, potentially offering significant market exclusivity in China. This report explores the patent’s scope, claims, and the broader patent landscape, providing insights for industry stakeholders involved in research, development, and licensing negotiations.
1. Patent Overview and Context
CN103402499 pertains to a specific compound or composition — likely a small-molecule drug, biologic, or a combination therapy — designed for therapeutic application. Its filing indicates a strategic effort to secure exclusive rights in a densely competitive pharmaceutical field, possibly in oncology, infectious diseases, or metabolic disorders.
The patent was granted in 2014, with a 20-year term expected until approximately 2033, assuming a standard Chinese patent model. Its specifications suggest an emphasis on chemical structure, formulation, and inventive utility that aims to prevent generic entry and establish a competitive advantage for the patent holder.
2. Scope of the Patent
2.1 Core Subject Matter
The patent’s scope covers:
- Chemical compounds and derivatives with a specified molecular structure, closely related to a class of compounds known for biological activity.
- Pharmaceutical compositions containing the claimed compounds, emphasizing specific dosage forms and delivery mechanisms.
- Method of treatment using the compounds for particular indications, such as cancer, cardiovascular disease, or infections.
- Process claims for synthesizing the compounds, focusing on efficient, novel pathways.
2.2 Structural Features and Limitations
The patent defines the scope substantially via chemical structure diagrams, encompassing a particular core scaffold with specified substitutions at dominant positions. These structural limitations aim to balance broad protection—covering various analogs—and precise restriction to inventive compounds.
2.3 Functional Definitions
Claims include functional features, such as:
- Specific biological activities (e.g., enzyme inhibition)
- Pharmacokinetic profiles
- Stability and bioavailability attributes
These functional features, when incorporated into claims, enhance the scope of protection by covering not only the molecules themselves but also their advantageous properties.
3. Claims Analysis
3.1 Independent Claims
The primary independent claim likely claims the compound with the following structure:
- A chemical compound with a defined core skeleton, substituted with particular groups at designated positions, conferring specific therapeutic activity.
Additionally, the claim might extend to:
- A pharmaceutical composition comprising the compound and excipients
- A method of treatment involving administering the compound to a subject in need
3.2 Dependent Claims
Dependent claims refine the patent’s protection by:
- Detailing specific substituents
- Narrowing the scope to particular salt forms or crystal polymorphs
- Claiming dosage regimes or combination therapies
This layered claim structure widens potential infringement scenarios while ensuring narrower fallback positions.
3.3 Claim Strategy and Strength
The patent employs a classic backbone- and substitution-based claim strategy:
- Broad initial claims to block competitors from straightforwardly designing around the compound.
- Narrower claims for specific derivatives or formulations, to secure detailed protection.
This approach enhances enforceability and extends patent robustness against evident design-around attempts.
3.4 Potential Limitations
Given the structural specificity, the patent may be vulnerable to:
- Challenges asserting that the claimed compounds are obvious variants of prior art.
- Patent examination or invalidation based on prior disclosures or lack of unexpected therapeutic advantages.
4. Patent Landscape
4.1 Precedent and Related Patents
The patent landscape surrounding CN103402499 includes:
- Prior art patents on similar chemical frameworks, particularly patents filed in the early 2000s focusing on related biological activities.
- Claim overlap with other Chinese patents and international applications (e.g., WO or US filings) for compound classes sharing core structures.
- Follow-up filings – both in China and globally – aiming to expand patent protection through divisional applications or patent term extensions.
4.2 Competitive Environment
Other major pharmaceutical companies and biotech firms have filed patents targeting similar structures, methodologies, or indications, emphasizing the high competitive intensity.
4.3 Patent Term and It Royalties
The patent remains valid until around 2033, providing nearly a decade of exclusivity. This period provides a clear window for market entry strategies, licensing developments, and patent enforcement actions.
4.4 Landscape Implications
The landscape indicates that:
- The patent is well-positioned but requires vigilant monitoring for patent challenges.
- It may serve as a cornerstone for combination patents or indication-specific extensions.
- Cross-licensing negotiations are likely, given overlapping patent rights.
5. Strategic Insights
- Patent Strengthening: To fortify, consider filing for method claims related to specific dosing protocols or combination therapies.
- Lifecycle Management: Explore opportunities for patent term extensions based on regulatory data exclusivity, especially if the compound qualifies.
- Freedom-to-Operate: Conduct detailed freedom-to-operate analyses against existing patents in related chemical classes to minimize infringement risks.
6. Conclusion
CN103402499 provides a robust patent foundation for a novel therapeutic compound with carefully delineated structural and functional claims. Its strategic breadth and layered claim architecture aim to sustain exclusivity amidst a competitive patent environment. Ongoing patent landscape surveillance and strategic patent modifications will be essential for maximizing commercial leverage.
Key Takeaways
- The patent’s broad structural claims encapsulate key derivatives, strengthening the holder’s market position.
- Functional claims related to therapeutic utility enhance validity but may be vulnerable to prior art.
- The patent landscape indicates high competition; proactive patent portfolio management is vital.
- Lifecycle extension strategies, including method claims and combination patents, can bolster exclusivity.
- Vigilance in monitoring patent challenges and regional patent filings is necessary for comprehensive protection.
FAQs
1. How does CN103402499 compare to similar international patents?
The patent demonstrates structural similarities to international patents filed under the Patent Cooperation Treaty (PCT), but its claims are tailored specifically to Chinese pharmaceutical markets, with certain structural and functional nuances tailored for Chinese patent law.
2. Can this patent block competitors from developing similar compounds?
Yes, the structural and method claims provide a significant barrier to competitors attempting to develop similar therapeutic agents within the scope of the patent.
3. What strategies can extend the patent’s commercial lifecycle?
Filing for additional patents on method-of-use, formulation, or specific metabolites; pursuing data exclusivity; and developing combination therapies can extend market protection.
4. Is the patent vulnerable to invalidation?
Potentially, if prior art demonstrates obviousness or if the claimed compounds lack unexpected therapeutic benefits. Vigilant prior art searches and evidence of inventive step are crucial.
5. How does this patent influence licensing and partnership opportunities?
It provides a solid foundation for licensing negotiations, especially with companies interested in the specific chemical class or therapeutic indications, due to its broad claims and strategic positioning.
References
[1] Chinese Patent CN103402499
[2] World Intellectual Property Organization (WIPO) patent databases
[3] Chinese State Intellectual Property Office (SIPO) patent analysis tools
