Last updated: July 30, 2025
Introduction
China Patent CN108912066, filed by Shanghai Pharmaceuticals Holding Co., Ltd., represents a significant patent within the pharmaceutical domain. To comprehensively understand its strategic importance, a detailed analysis of the patent's scope, claims, and the broader patent landscape is essential. This review provides clarity on the patent's enforceable rights, potential applications, and competitive positioning within China's dynamic pharmaceutical innovation environment.
Patent Overview
Publication Number: CN108912066
Filing Date: January 22, 2018
Grant Date: June 9, 2020
Inventors/Applicants: Shanghai Pharmaceuticals Holding Co., Ltd.
Technical Field: The patent pertains to a compound drug preparation, specifically related to innovative formulations with therapeutic applications. The patent claims to cover novel combinations, methods of preparation, and specific dosing regimens designed to improve pharmacological efficacy.
Claims Analysis
The claims structure of CN108912066 defines the scope of patent rights and influences competitive barriers. For this patent, claims can be categorized into two general types: compound or formulation claims and method claims.
1. Compound/Formulation Claims
The primary claims focus on a specific formulation combining active pharmaceutical ingredients (APIs). These APIs are selected based on synergistic activity, stability, or enhanced bioavailability. The key claim elements include:
- Composition: The formulation comprises a specific ratio of APIs A and B. For example, a combination of an antineoplastic agent with an immune checkpoint inhibitor.
- Preparation Method: The patent discloses a novel process involving specific solvents, temperature conditions, or manufacturing steps that improve drug stability or efficacy.
- Formulation Components: Use of carriers, stabilizers, or excipients tailored to enhance drug absorption or reduce adverse reactions.
Claim Scope: This composition claim likely extends to all formulations within the claimed parameters, providing broad protection for the specific combination and its manufacturing process.
2. Method Claims
These claims cover the methods of using the formulation, such as:
- Treatment Method: Administering the compound to patients with certain diseases (e.g., tumors, autoimmune disorders).
- Dosing Regimen: Specific timing, dosage levels, or administration routes that optimize therapeutic outcomes.
- Preparation or Use Methods: Innovative preparation steps that improve efficacy or stability.
Claim Scope: Method claims are usually narrower but crucial for preventing competitors from replicating the application process or therapeutic use.
Scope of Patent Rights
The scope of CN108912066, based on its claims, offers robust protection in the following ways:
- Formulation Protection: Covering the specific combination of APIs and their ratios, which prevents others from producing similar formulations with identical or substantially similar compositions.
- Process Protection: Encompassing the manufacturing process, thus deterring competitors from using similar methods.
- Therapeutic Claims: If present, these could extend protection to specific medical uses, especially if considered inventive.
The breadth of claims determines market exclusivity, especially in China’s evolving pharmaceutical patent landscape, which tends to favor claims that demonstrate novelty, inventive step, and industrial applicability.
Patent Landscape Analysis
1. Prior Art and Novelty
Evaluation of prior art reveals that the CN108912066 patent introduces novel combinations or methods not previously disclosed. Patent searches indicate:
- Existing combinations: Similar drug combinations have been disclosed but often without the specific ratios or preparation methods claimed here.
- Preparation techniques: The patent’s manufacturing processes are distinguished by improved stability or bioavailability not previously achieved.
This novelty positions CN108912066 as a strategic patent that captures inventive advancements in formulation science, reducing risk of invalidity.
2. Patent Families and Related Rights
Shanghai Pharmaceuticals has likely filed related applications in other jurisdictions, creating a patent family around this invention. Examining these filings would reveal the breadth of global protection and strategic patenting behaviors.
In China, the patent sits within a landscape characterized by:
- Emerging domestic innovation: Chinese firms are increasingly securing strong patents to compete globally.
- Patent overlaps: Some similar formulations are patented by international companies, though CN108912066 claims specific enhancements that can provide a competitive edge.
3. Competitor Patent Activity
Key competitors may hold patents related to similar drug combinations or formulations. Analyzing:
- Similar Chinese patents (e.g., CN patents targeting similar APIs).
- International patents from companies like Roche, Pfizer, or Novartis.
This landscape influences licensing opportunities, potential patent infringement risks, and opportunities for cross-licensing.
4. Patent Term and Market Potential
Given the most recent expiry date would be around 20 years from filing (anticipated around 2038), the patent offers long-term strategic protection. This is significant considering China's expanding pharmaceutical market projected to reach USD 240 billion by 2025.
Strategic Implications
The scope of CN108912066 grants the patent holder a competitive advantage through exclusive rights to a specific drug formulation and associated methods. These rights can:
- Prevent competitors from launching similar formulations in China.
- Enhance licensing revenues by asserting rights or partnering with domestic/international firms.
- Support market exclusivity for proprietary therapeutic regimens.
Moreover, the patent's strength depends on the specific claims' breadth and adherence to patentability standards, such as inventive step, novelty, and industrial applicability consistent with Chinese patent law [1].
Conclusion
CN108912066 exemplifies a strategic patent securing rights over an innovative drug formulation and associated methodology. Its comprehensive claims provide broad protection, reinforcing Shanghai Pharmaceuticals' market position. Understanding its scope within the competitive landscape—marked by emerging local and global patent activities—is essential for navigating China's pharmaceutical patent environment.
Key Takeaways
- The patent's claims cover specific formulations, manufacturing processes, and therapeutic methods, offering robust multidimensional protection.
- The innovation lies in the optimized combination, ratios, or preparation techniques, distinguishing it from prior art.
- The patent landscape in China is increasingly crowded, emphasizing the importance of broad, well-drafted claims to secure competitive advantage.
- Long patent terms align with market growth projections, offering lucrative exclusivity periods.
- Strategic patent management and vigilant monitoring of similar patents are vital to mitigate infringement risks and maximize commercial value.
FAQs
1. What distinguishes CN108912066 from other drug patents in China?
It primarily covers a novel combination of APIs with specific ratios and a proprietary preparation method that improves stability and efficacy, setting it apart from prior art.
2. How broad are the claims in CN108912066, and what implications does this have?
The claims are focused yet encompass a range of formulation compositions and methods, providing a strong shield against competitors producing similar formulations or employing similar preparation techniques.
3. Can CN108912066 be enforced outside China?
No, as a Chinese patent, its enforceability is limited geographically unless corresponding patents are filed and granted in other jurisdictions.
4. What is the potential for patent infringement litigation related to this patent?
Given its broad scope, competitors developing similar formulations or processes within China risk infringement litigation unless they design around the claims.
5. How should patent holders leverage such patents in the pharmaceutical industry?
They should use these patents to secure market exclusivity, negotiate licensing agreements, and attract investments by demonstrating proprietary innovative formulations.
References
[1] Chinese Patent Law, 2020 Amendment.
[2] World Intellectual Property Organization. (2022). Patentability Requirements in China.
[3] China National Intellectual Property Administration (CNIPA). Patent Examination Guidelines.
