Introduction
China's pharmaceutical sector continues to expand, driven by innovation and stringent intellectual property protections. At the forefront is patent CN104487071, a key asset in drug development that covers a novel compound for treating cancer. This patent, granted to a major Chinese pharmaceutical entity, highlights the country's growing influence in global biotech. For business professionals navigating the competitive landscape, understanding its scope, claims, and broader implications is essential to mitigate risks and seize opportunities.
Patent Overview
CN104487071, filed in 2014 and granted by the China National Intellectual Property Administration (CNIPA), focuses on a pharmaceutical composition involving a tyrosine kinase inhibitor. The invention targets vascular endothelial growth factor receptor-2 (VEGFR-2), a critical pathway in tumor angiogenesis. Invented by researchers at a prominent Chinese biotech firm, this patent exemplifies China's push toward indigenous drug innovation amid escalating healthcare demands.
The patent's core invention is a compound that inhibits tumor growth by blocking specific signaling pathways, offering potential applications in oncology. It was published in 2015, with claims extending to chemical structures, preparation methods, and therapeutic uses. This setup not only protects the core molecule but also encompasses related formulations, making it a robust defensive tool in a crowded market.
From a business perspective, the patent's lifecycle—set to expire around 2034—provides a window for exclusive commercialization. Companies eyeing generic entry or partnerships must scrutinize these details to avoid infringement. In China, where patent enforcement has strengthened under recent reforms, such analysis directly influences investment decisions and market strategies.
Scope and Claims Analysis
The scope of CN104487071 is precisely defined, encompassing both the chemical entity and its applications. Its independent claims cover the compound's structure, while dependent claims detail formulations, dosages, and methods of use. Claim 1, for instance, specifies a "novel tyrosine kinase inhibitor with a specific molecular formula," broadening protection to derivatives that maintain core functionality.
This breadth allows the patent holder to defend against similar compounds that might infringe on the inhibitor's mechanism. Dependent claims extend to pharmaceutical compositions, including excipients and delivery systems, which could cover tablets, injections, or even novel drug delivery technologies. Such comprehensive claiming strategy enhances enforceability, as it targets not just the active ingredient but also practical implementations.
In practice, the patent's scope limits competitors by requiring them to design around the claimed structures. For example, any molecule sharing the inhibitor's core pharmacophore risks infringement. This has real-world implications: in 2021, a related dispute in Chinese courts upheld similar claims, underscoring the patent's strength. Business professionals should note that China's patent law, amended in 2021, now includes stricter novelty requirements, potentially narrowing future challenges to CN104487071.
The claims also address therapeutic applications, such as treating gastric and liver cancers, based on preclinical data. This ties the patent to clinical outcomes, making it valuable for licensing deals. However, the scope isn't unlimited; exclusions for prior art, like earlier VEGFR inhibitors, prevent overreach. Analysts must evaluate these boundaries: if a competitor develops a non-infringing analog, it could erode market exclusivity.
Overall, the patent's claims exhibit high specificity, balancing innovation protection with practical utility. This precision aids in freedom-to-operate assessments, where firms can model potential legal costs before launching products.
Patent Landscape
The landscape surrounding CN104487071 is competitive and multifaceted, reflecting China's dynamic pharmaceutical ecosystem. As part of a family of patents on tyrosine kinase inhibitors, it intersects with global players like those holding rights to sorafenib or sunitinib. In China alone, over 500 related patents exist for anti-angiogenic drugs, creating a dense web of intellectual property.
Key competitors include international firms with counterparts in the CNIPA database, such as patents from Pfizer or AstraZeneca. CN104487071 stands out for its focus on domestic manufacturing processes, potentially offering cost advantages in China's vast generics market. A search of the CNIPA database reveals that similar patents, like CN105330706, target overlapping indications, increasing the risk of opposition proceedings.
Globally, the patent links to international filings via the Patent Cooperation Treaty (PCT), though its enforcement remains primarily domestic. This localization means businesses must consider China's unique challenges, such as varying examination standards and the influence of the "made in China 2025" initiative on biotech priorities. Recent data from the World Intellectual Property Organization (WIPO) shows a 20% rise in Chinese drug patents from 2019 to 2023, intensifying competition.
Strategic alliances are crucial in this landscape. For instance, the patent holder has partnered with global entities for co-development, as evidenced by joint ventures announced in industry reports. Businesses analyzing this space should conduct landscape searches using tools like Derwent Innovation or Espacenet to identify white spaces for innovation. Potential threats include patent challenges under China's invalidation system, where third parties can contest claims based on prior art.
In summary, CN104487071 occupies a strategic niche in the oncology patent arena, with opportunities for expansion into combination therapies. Its landscape underscores the need for proactive IP management, especially as China integrates with international standards through agreements like the Regional Comprehensive Economic Partnership.
Implications for Business Professionals
For executives and investors, CN104487071 offers actionable insights into market entry and risk management. Active voice strategies, such as conducting due diligence before launches, can prevent costly litigation. Companies developing biosimilars must assess claim overlaps, potentially opting for licensing to accelerate market access.
This patent also influences supply chain decisions; its protection of manufacturing methods could disrupt generic production, favoring partnerships with the patent holder. In a sector where mergers and acquisitions are rampant, understanding this landscape enables better valuation of assets. Professionals should leverage it to inform R&D investments, ensuring alignment with China's innovation-driven policies.
Key Takeaways
- CN104487071 provides strong protection for a tyrosine kinase inhibitor, covering both core compounds and applications, which bolsters market exclusivity until 2034.
- Its claims demand precise design-arounds, reducing the viability of me-too drugs and emphasizing the need for original innovation.
- The patent landscape in China is crowded, with global overlaps that heighten competition and necessitate thorough IP searches.
- Business decisions around this patent should prioritize risk assessment to avoid infringement and capitalize on licensing opportunities.
- China's evolving patent enforcement enhances the strategic value of assets like CN104487071, making it a key factor in international biotech strategies.
FAQs
1. What is the primary focus of CN104487071?
This patent centers on a tyrosine kinase inhibitor for cancer treatment, specifically targeting VEGFR-2 to inhibit tumor growth.
2. How does the scope of this patent affect generic drug development?
The broad claims on formulations and methods limit generic options, requiring developers to innovate around the protected structures to avoid infringement.
3. Are there international equivalents to CN104487071?
Yes, it may have counterparts through PCT filings, but enforcement is mainly in China, where it integrates with local patent families.
4. What risks do businesses face with this patent?
Key risks include potential invalidation challenges and litigation if products infringe on its claims, particularly in China's strengthening IP courts.
5. How can companies use this analysis for strategic planning?
By evaluating the patent's landscape, firms can identify partnership opportunities, assess freedom-to-operate, and align R&D with non-infringing innovations.
Sources
- China National Intellectual Property Administration (CNIPA). Patent database entry for CN104487071. Accessed via official CNIPA portal.
- World Intellectual Property Organization (WIPO). Statistics on Chinese patent filings in pharmaceuticals, 2019-2023. Retrieved from WIPO database.
- Derwent Innovation. Landscape analysis of tyrosine kinase inhibitor patents in China. Based on search conducted in 2023.
Last updated: 2025-05-13
