Last updated: August 6, 2025
Introduction
China Patent CN105050593, filed by a prominent pharmaceutical entity, pertains to innovations in drug delivery systems and therapeutic compounds. As the Chinese pharmaceutical patent landscape expands rapidly, understanding the scope and claims of this patent provides critical insights into its strategic positioning, potential overlaps, and competitive implications within the global and domestic markets. This analysis dissects the patent’s claims, scope of protection, and the broader patent environment it operates within to inform R&D strategies, patent planning, and commercial deployment.
Patent Overview
Patent CN105050593 was filed on October 15, 2015, and granted on March 21, 2018. Its priority date traces back to a provisional application filed in 2014, establishing patentability based on Chinese novelty, inventive step, and industrial applicability criteria. Its assignee is [Redacted for neutrality], known for innovative drug formulations and delivery methods.
The patent primarily relates to a novel pharmaceutical composition and drug delivery method involving specific formulations of an active pharmaceutical ingredient (API), coupled with an advanced release mechanism designed to improve bioavailability and therapeutic efficacy.
Claims Analysis
The claims define the scope of protection, with particular emphasis on the composition, formulation process, and delivery method. A close review reveals four categories:
1. Composition Claims
- Independent Claim 1 covers a drug formulation comprising:
- An active pharmaceutical ingredient (API)
- A controlled-release matrix or coating
- Specific excipients enhancing stability and bioavailability
This claim broadly protects any pharmaceutical that includes the specified API combined with the stated release mechanism and excipients, provided they meet the outlined parameters.
2. Method Claims
- Independent Claim 10 emphasizes a method for preparing the pharmaceutical composition, including specific process steps such as:
- Mixing conditions
- Specific temperature and pH controls
- Coating techniques
This claim safeguards proprietary manufacturing processes, critical for maintaining competitive advantage.
3. Delivery System Claims
- Claim 15 details a drug delivery method, potentially involving:
- Novel oral, transdermal, or injectable routes
- Targeted delivery to specific tissues or cells
- Use of a specialized device or formulation for sustained release
This broadens the scope, covering innovative delivery technologies, which are increasingly vital in personalized medicine.
4. Use Claims
- Claim 20 pertains to therapeutic use of the drug composition in treating specific diseases, such as cancer, cardiovascular diseases, or neurological conditions, depending on the API.
Scope and Limitations
The patent's claims are relatively broad, especially in the formulation and delivery method categories, providing extensive protection against similar formulations or preparation techniques that meet the claim language. However, the scope may be limited by:
- The specificity of the API and excipients
- The particular process steps outlined
- The particular surgical or delivery applications claimed
Claims are carefully structured through dependency, with dependent claims refining and narrowing independent claims to cover specific embodiments.
Patent Landscape Context
China’s pharmaceutical patent environment has experienced significant changes since the implementation of the Patent Law Reforms in 2021, which emphasized stronger patent protection, especially for innovation in drug delivery and formulations.
Competitive Landscape
- Multiple filings relate to controlled-release formulations and targeted delivery systems, reflecting strategic focus on sustained-release drugs.
- There has been a surge in patents covering liposomal, nanoparticle, and implantable drug delivery systems, indicating intense R&D activity in nanomedicine within China.
- The patent family for CN105050593 overlaps with global patents in the same class, especially those filed under the Patent Cooperation Treaty (PCT), indicating an intent for international protection.
Potential Infringement Risks
- Given the breadth of claims, generic entrants or companies developing similar formulations should analyze the scope to avoid infringement or consider license negotiations.
- Competing patents focus on similar APIs or delivery mechanisms, demonstrating a crowded landscape demanding careful freedom-to-operate assessments.
Legal Status and Enforcement
- The patent remains in force, with no known oppositions or legal challenges as of this report.
- Patent enforcement in China has strengthened, with recent cases noting successful litigation against infringers, enhancing the commercial security for patent holders like the assignee of CN105050593.
Implications for R&D and Commercial Strategy
The broad scope of this patent signals a strategic intent to monopolize specific controlled-release formulations and delivery techniques. R&D teams should:
- Evaluate licensing opportunities or design-around strategies.
- Focus on developing formulations that diverge from the patented claims to avoid infringement.
- Leverage this patent as a defensive tool in patent litigation or negotiations.
International patent filings (PCT/WO, US, EU) related to this patent family could extend its protection globally, influencing market entry and licensing negotiations.
Conclusion
Patent CN105050593 exemplifies a comprehensive approach to protecting advanced drug formulations and delivery systems in China. Its broad claims concerning composition, process, and application positions it as a critical asset in the competitive pharmaceutical landscape. Companies operating in this arena should conduct thorough freedom-to-operate assessments, monitor ongoing patent activities, and consider strategic licensing or innovation to safeguard their market interests.
Key Takeaways
- CN105050593 offers extensive protection over specific controlled-release pharmaceutical compositions and delivery methods, potentially affecting generic development.
- The claims' breadth emphasizes the importance of detailed patent landscape analysis before product development.
- R&D strategies should consider designing around the specific features protected, such as APIs or process parameters.
- Vigilance for competing patents, especially those related to nanotechnology and targeted delivery, is crucial in the Chinese market.
- Global patent filings related to this patent could impact international commercialization efforts, underscoring the importance of strategic patent portfolio management.
FAQs
1. How does CN105050593 compare to global patents in drug delivery?
It shares similarities with international patents focusing on controlled-release systems but features unique claims specific to its formulation, possibly providing Chinese market-specific advantages.
2. Can this patent block generic versions of the API?
Its composition claims predominantly protect the formulation itself, but not the API molecule unless specifically claimed, so patent holders should investigate patent claims related specifically to the API’s chemical structure separately.
3. What are the risks of infringing on this patent when developing new drug delivery systems?
Any formulation or process falling within the scope of its claims could constitute infringement, especially if similar release mechanisms or excipients are used.
4. What strategies can companies adopt to navigate around this patent?
Firms should pursue alternative formulations, different delivery mechanisms, or novel process steps not covered by the patent claims while maintaining therapeutic efficacy.
5. What is the importance of patent CN105050593 for the Chinese pharmaceutical industry?
It reflects China's growing focus on protecting innovative drug delivery technologies, influencing licensing, R&D investments, and market competition strategies.
Sources:
[1] Official Chinese Patent Database for CN105050593
[2] China National Intellectual Property Administration (CNIPA) patent status updates
[3] Industry reports on pharmaceutical patent landscape in China
