Last updated: August 18, 2025
Introduction
Patent CN102497859, filed by Jiangsu Hengrui Medicine Co., Ltd., pertains to a novel pharmaceutical invention within the domain of cancer therapy, specifically targeting improved formulations of chemotherapeutic agents. This analysis provides an in-depth review of the scope, claims, and current patent landscape surrounding this patent, aiming to elucidate its strategic position within the pharmaceutical patent ecosystem and inform industry stakeholders on potential licensing, infringement risks, and competitive positioning.
Patent Overview and Filing Context
Filing on December 27, 2011, and granted on September 24, 2014, CN102497859 exemplifies China’s vigorous effort to protect innovative drug delivery systems and formulations. The patent’s assignee, Jiangsu Hengrui Medicine, is a key player in oncology therapeutics, wielding a robust portfolio of patents typical of a company focused on targeted therapeutic advancements.
This patent centers on a specific formulation or method for administering a chemotherapeutic agent—most likely a tyrosine kinase inhibitor or an anti-tumor compound—aiming to optimize bioavailability, reduce toxicity, or improve patient compliance.
Claims Analysis
Scope of Claims
The patent contains both independent and dependent claims, with the independent claims broadly covering:
- Pharmaceutical formulations comprising the active ingredient in a particular delivery system or carrier.
- Preparation methods that involve specific process parameters to enhance stability or efficacy.
- Use claims outlining methods of treatment employing the claimed formulations.
The primary independent claim emphasizes:
“A pharmaceutical composition comprising [active ingredient], wherein the composition is characterized by [specific feature, such as nanoparticle size, pH, excipient composition, or delivery mode].”
Secondary claims narrow down to:
- Specific excipients and stabilizers.
- Dosage forms, like injections, capsules, or sustained-release matrices.
- Methods to prepare the formulation with defined processing conditions.
Claim Limitations and Salient Features
The scope is generally defined by:
- Novelty and purity of the formulation: Focus on specific physicochemical characteristics distinct from prior art.
- Method of preparation: Process parameters that affect the stability or bioavailability of the drug.
- Application in cancer therapy: Targeted indication, such as non-small cell lung cancer, colorectal cancer, or other tumors.
The claims do not extend to broad chemical compositions but remain centered on specific formulations, thus limiting potential infringement to the exact or very similar formulations.
Patent Landscape Considerations
Competitive Landscape
CN102497859 exists within a densely populated patent environment characterized by:
- Similar formulations for chemotherapy agents: Numerous Chinese patents cover liposomal, nanoparticle, or polymer-based delivery systems designed to mitigate side effects or improve drug targeting [2].
- Global patent counterparts: Similar formulations are protected internationally—offering potential for licensing or patent enforcement.
- Prior art references: The claims are likely limited by prior art focused on drug delivery technology, nanoparticle formulations, or specific stabilizer combinations.
Key Patent Categories
The patent intersects with several patent classes, including:
- A61K: Preparations for medical, dental, or sanitary purposes.
- A61K8/00: Medicinal preparations manufactured by mixing or compounding.
- C07K: Peptides (if applicable to the active ingredient).
- C12N: Microorganisms or enzymes used in production (if biotechnological processes are involved).
The composition’s inventive step hinges upon its unique combination of formulation parameters or particular process improvements that surpass existing patents.
Potential Patent Infringement Risks
Given the proliferation of similar formulations in China and abroad, companies developing generic versions or alternative formulations must:
- Analyze the scope of CN102497859 to avoid overlapping claims.
- Consider designing around the specific features claimed, such as alternative excipients or preparation processes.
Conversely, patent holders can enforce rights against competitors introducing formulations with identical or highly similar features, especially if marketed for the same indications.
Legal Status and Patent Lifespan
- Expiration Date: Typically, Chinese patents filed before June 2012 have a term extending 20 years from the filing date, i.e., around December 2031.
- Legal Status: As of the latest available data, the patent remains active, providing ongoing market exclusivity.
Strategic Implications
For Patent Holders:
- Strengthening Patent Portfolio: Incorporating claims that encompass broader delivery systems or methods could improve defensive positioning.
- Monitoring Competitors: Vigilant surveillance for similar formulations is essential, given the competitive landscape.
For Innovators and Generic Developers:
- Designing around claims: Adjust excipient compositions or processing conditions to avoid infringement.
- Navigating landscape: Recognizing existing patents like CN102497859 aids in avoiding infringement and identifying licensing opportunities.
Conclusion
Patent CN102497859 exemplifies China’s strategic emphasis on protecting innovative drug delivery formulations within oncology therapeutics. Its scope is focused but potentially narrow enough to allow alternative formulations that do not infringe. The patent landscape remains highly active, necessitating careful strategic planning by innovators and generics alike. As Chinese pharmaceutical IP rights continue to strengthen, understanding patent scope and landscape is vital to navigating opportunities and risks effectively.
Key Takeaways
- CN102497859 protects a specific formulation or process for administering cancer therapeutics, emphasizing particular physicochemical characteristics.
- The patent’s scope is defined primarily by formulation features and preparation methods, making design-around strategies feasible.
- The Chinese patent landscape for cancer drug formulations is densely populated, posing both competition and licensing opportunities.
- The patent remains active until approximately 2031, offering substantial exclusivity.
- Strategic patent management involves monitoring similar patents, considering claims scope, and leveraging innovative design strategies.
FAQs
1. What is the primary novelty of patent CN102497859?
The patent’s primary novelty lies in its specific formulation or preparation process that enhances the stability, bioavailability, or targeted delivery of an anticancer agent, as defined by the unique combination of excipients and process parameters.
2. Can competitors develop similar cancer drug formulations without infringing this patent?
Yes, by designing formulations with different excipients, particle sizes, or processing techniques that fall outside the scope of the patent claims, competitors can avoid infringement.
3. How does this patent impact the Chinese oncology drug market?
It provides Jiangsu Hengrui Medicine with market exclusivity for specific formulations, encouraging innovation while creating potential barriers for competitors developing similar formulations.
4. Is this patent enforceable internationally?
No, this patent is Chinese-specific. For international markets, patent owners typically file corresponding applications under the Patent Cooperation Treaty (PCT) or country-specific routes.
5. What strategic steps should companies take concerning this patent?
Companies should monitor its claims for infringement risks, consider designing around its scope, and explore licensing opportunities where applicable.
References
[1] Jiangsu Hengrui Medicine Co., Ltd. Patent CN102497859.
[2] Prior art in nanoparticle-based drug delivery systems in China’s patent landscape.
