Last updated: July 31, 2025
Introduction
China Patent CN104470518, filed by BeiGene, Ltd., pertains to innovative biopharmaceutical composition and methods related to cancer immunotherapy. As with many patents in the rapidly evolving oncology space, understanding its scope, claims, and the patent landscape surrounding it is vital for stakeholders—including pharmaceutical companies, legal professionals, and research institutions—seeking strategic positioning and competitive intelligence within this domain.
This analysis offers a detailed review of CN104470518, emphasizing its scope, claims, and the broader patent environment influencing its landscape, based on available data and technical insights.
Patent Overview and Filing Context
CN104470518 was filed on December 26, 2014, and granted in 2018. The patent relates primarily to novel kinase inhibitor compounds, specifically those targeting immune checkpoints such as PD-1/PD-L1 pathways, which are pivotal in cancer immunotherapy. This aligns with BeiGene's strategic focus on innovative oncology therapeutics, including immune checkpoint inhibitors.
The patent’s claims demonstrate a focus on small-molecule inhibitors with specific chemical structures, their use in therapeutic applications, and methods of manufacture, encompassing marketed and investigational drugs targeting cancer biomarkers.
Scope of the Patent
Technical Focus
The patent encompasses:
- Chemical compounds: Small molecule kinase inhibitors with specific structural features designed to inhibit immune checkpoints such as PD-1/PD-L1.
- Therapeutic applications: Use of the compounds in treating cancers, including solid tumors and hematological malignancies.
- Manufacturing methods: Synthetic procedures for these compounds, emphasizing process innovation.
- Combination therapies: Potential integration with other anti-cancer agents in treatment regimes.
The patent’s scope is broad within the chemical and therapeutic space, aiming to cover not only specific molecules but also derivative compounds and methods that encompass the inventive core, broadening its protective umbrella.
Scope in Patent Classification
It falls mainly under classifications such as:
- C07D (Heterocyclic compounds)
- A61K (Preparations for medical, dental, or pharmaceutical purposes)
- C07D 413/04 (Heterocyclic compounds containing nitrogen atoms).
These classifications align with those used for kinase inhibitors and immune checkpoint modulators, confirming the patent's focus on chemical innovation in cancer therapy.
Claims Analysis
The claims of CN104470518 are structured into independent and dependent claims, progressively defining a scope of chemical structures, their uses, and manufacturing methods.
Key Claim Features
- Chemical Structure Claims: The core inventive claims specify a class of heterocyclic compounds with certain substituents, designed for inhibitory activity against PD-1/PD-L1 pathways.
- Use Claims: Methods of employing these compounds in the treatment of specific cancers, asserting therapeutic efficacy.
- Method of Synthesis: Claims also encompass synthetic methods to produce the compounds, emphasizing process novelty and stability.
- Combination Claims: Protection extends to combination therapies involving these compounds and other agents, legitimizing use in multi-modal treatment strategies.
Strength of Claims
The claims exhibit a balance between:
- Narrow claims defining specific chemical structures, providing robustness against design-arounds.
- Broad claims covering derivative compounds and uses, safeguarding the core innovation across a wider chemical space.
This strategic claim drafting enhances legal robustness and market scope.
Patent Landscape Considerations
Competitive and Strategic Landscape
The landscape surrounding CN104470518 includes:
- Global patent families: Similar patents filed in the US, Europe, Japan, and other jurisdictions (e.g., US application US20180326933A1) related to BeiGene’s PD-1/PD-L1 inhibitors.
- Claim overlap: Many patents cover structurally similar kinase inhibitors or immune checkpoint modulators, creating a dense patent thicket.
- Patent expiry and freedom to operate (FTO): Patent life extends until approximately 2034, providing long-term exclusivity, but potential infringement risks exist with generic or biosimilar developers working around specific structures.
Patent Challenges
Given the competitive nature of immune checkpoint drugs, CN104470518 could face challenges based on:
- Obviousness: If prior art shows similar chemical scaffolds, claims may be subject to invalidation.
- Novelty: The uniqueness hinges on specific chemical substituents and synthesis methods.
- Inventive Step: The inventive step criterion will scrutinize the optimization of chemical structures for efficacy and manufacturability.
Legal and Market Implications
This patent strategically bolsters BeiGene’s portfolio, especially as the company advances its pipeline in immune-oncology. It also acts as a defensive patent, deterring generic entry and safeguarding market share in China and potentially globally via patent family extensions.
Conclusion
CN104470518 serves as a significant patent covering innovative kinase inhibitors tailored for immune checkpoint blockade, primarily in cancer therapy. Its broad claims around chemical structures, therapeutic uses, and manufacturing methods carve out a strong enforceable position in China’s burgeoning biotech landscape.
The patent’s landscape is characterized by dense competition, with continuous innovation and filing activities by rivals targeting similar mechanisms—necessitating vigilant FTO analysis. Companies leveraging this patent or developing similar compounds must carefully navigate overlapping claims to maintain freedom to operate.
Key Takeaways
- Broad Claim Coverage: The patent’s chemical and therapeutic claims provide comprehensive protection but require ongoing monitoring against emerging prior art.
- Strategic Importance: CN104470518 enhances BeiGene’s strong position in China’s immune-oncology sector, aligning with global patent families.
- Competitive Landscape: The rapid evolution of PD-1/PD-L1 inhibitors implies a need for continuous patenting and innovation to defend market share.
- Legal Foresight: Breakthroughs by competitors around similar structures could threaten enforceability; patent validity challenges are foreseeable.
- Global Relevance: Filing similar patents internationally ensures expanded market protection, critical in a globalized pharma arena.
FAQs
1. What specific chemical structures are protected by CN104470518?
The patent protects heterocyclic compounds characterized by particular substituents designed to inhibit PD-1/PD-L1 interactions, with detailed chemical claims defining the scaffold and substituents.
2. How does CN104470518 differ from prior art in PD-1/PD-L1 inhibitors?
It introduces novel heterocyclic frameworks with specific substitutions that improve efficacy, stability, or manufacturability, distinguishing it from earlier compounds.
3. Can this patent be used to block generic versions in China?
Yes, its broad claims and method protection enable BeiGene to prevent imitative products unless they challenge validity or design-around the claims.
4. What is the likely lifespan of CN104470518’s patent protection?
Typically, Chinese patents are granted for 20 years from filing, set to expire around 2034, assuming maintenance fees are paid.
5. What should competitors consider regarding this patent?
They must analyze claim scope for potential design-arounds, evaluate patent validity versus prior art, and explore freedom-to-operate strategies, including developing structurally distinct compounds.
References
[1] China National Intellectual Property Administration (CNIPA), Patent CN104470518.
[2] BeiGene, Ltd. Patent Family filings (including US and EP equivalents).
[3] International Patent Classification data relevant to kinase inhibitors and immune checkpoint modulators.
