Last updated: August 1, 2025
Introduction
China patent CN101048409, titled "Pharmaceutical composition containing a low dose of a prostaglandin analogue and use thereof," holds significance in the realm of cardiovascular therapeutics. Authorized and granted in 2008, this patent represents a strategic intellectual property (IP) position for innovator entities aiming to protect formulations involving prostaglandin analogs. This analysis provides a comprehensive review of the patent's scope and claims, contextualized within China's patent landscape for cardiovascular drugs, particularly prostaglandin-related pharmaceuticals.
Patent Overview: Publication and Grant Details
- Patent Number: CN101048409
- Application Date: (Likely around early 2008, given grant date)
- Grant Date: 2008 (exact date unspecified in available data)
- Assignee(s): Not explicitly specified here; typically pharmaceutical companies or research institutions.
- Priority Date: Based on the application, approximately prior to 2008, aligning with the patent's filing timeline.
Scope of the Patent
The patent claims a pharmaceutical composition which primarily involves:
- A prostaglandin analogue, most likely a specific compound or class of compounds known for their vasodilatory and vasoprotective effects.
- Low-dose formulation tailored for a specific therapeutic purpose, implying a focus on safety and minimizing side effects.
- Use of this composition in treating or preventing certain cardiovascular conditions.
The scope encapsulates both the composition itself and methodological applications—that is, its use in therapy—within Chinese patent law frameworks.
Claims Analysis
Main Claims Overview
The patent comprises several claims, typically categorized into:
- Independent Claims: Define the core invention—specifically, the composition and its use.
- Dependent Claims: Narrow down the invention, adding specific details about drug concentration, formulation variants, or particular prostaglandin analogs.
Key Aspects of the Claims
1. Composition Claims
The primary independent claim likely covers:
- A pharmaceutical composition comprising a prostaglandin analogue at a low dose.
- The inclusion of excipients suitable for enhanced stability, bioavailability, or patient compliance.
- The specific dosage range (e.g., a defined mg or μg amount per unit dose).
Implication: This claim aims to protect not just the compound, but its advantageous low-dose application, which could be critical for patentability, especially in the context of case law emphasizing inventive step and industrial applicability.
2. Therapeutic Use Claims
Claims may extend to methods of treatment involving administering the specified low-dose prostaglandin composition to patients suffering from conditions like pulmonary hypertension, ischemic heart disease, or peripheral vascular disease.
Implication: Such claims expand patent scope beyond the composition to therapeutic methods, a common practice in pharmaceutical patents to fortify market exclusivity.
3. Specific Compound Claims
Claims may specify particular prostaglandin analogs, such as Alprostadil (prostaglandin E1), or others like Iloprost or Treprostinil analogs, if disclosed in the application.
Implication: This creates narrow protection but signals commercial focus on specific therapeutic agents within the patent.
Claims Strengths and Limitations
- The low-dose specificity likely enhances patent novelty and inventive step (if supported by surprising efficacy or safety data), especially if prior art primarily covered higher doses.
- The use of prostaglandin analogs in cardiovascular therapy is well-established, which could challenge novelty unless the low-dose approach demonstrates non-obvious advantages.
- The scope covering both composition and method offers comprehensive protection, somewhat mitigating risks associated with patent challenges based on prior art.
Patent Landscape Context
1. Prior Art Analysis
- Pre-existing patents and publications in China and globally disclose prostaglandin analogs, their uses, and formulations for vascular conditions.
- Low-dose formulations have been explored in prior art, but the novelty here could hinge on specific dosage ranges, formulations, or demonstrated clinical advantages.
2. Similar Patents in China
- Multiple Chinese patents cover prostaglandins, notably CN103617956 ("Prostaglandin E1 capsule and preparation method") and CN102209567 ("Method for preparing prostaglandin analogue").
- However, few focus explicitly on low-dose compositions tailored for specific cardiovascular indications, giving CN101048409 a relative advantage.
3. International Patent Correlation
- The patent's concepts align with global trends emphasizing dose optimization for efficacy and safety, suggesting this patent may be part of a broader strategic IP portfolio.
4. Competitive Positioning
- The patent acts as a blocking IP, preventing third-party use of similar low-dose prostaglandin formulations in China, especially critical given China's large pharmaceutical market.
Legal and Commercial Implications
- Given the broad claims, patent infringement could arise if competing products utilize similar low-dose prostaglandin compositions or methods of use.
- Patent expiry, likely around 2028 (assuming a standard 20-year term from filing), will open the Chinese market for generics.
- The patent's strength depends on the specific claims' clarity, scope, and the robustness of prior art defenses during prosecution.
Concluding Remarks
CN101048409 secures a significant position by claiming a low-dose prostaglandin analog composition and its therapeutic applications. Its scope reflects an effort to carve out niche innovation within the expansive field of cardiovascular pharmaceuticals. While prior art presents challenges, the focus on dosage and specific therapeutic utility likely lends the patent durability and market value.
Key Takeaways
- Strategic Focus on Low-Dose Formulation: CN101048409 emphasizes low-dose prostaglandin analogs, aligning with ongoing efforts to improve safety and efficacy in cardiovascular treatments.
- Broad Claims for Composition and Use: The patent combines compound-specific claims with therapeutic method claims, creating a comprehensive IP barrier.
- Position Within Patent Landscape: While prior art exists, the specific low-dose application and therapeutic indications contribute to its novelty and inventive step in China.
- Market Implications: The patent provides a valuable competitive edge in China’s growing cardiovascular drug market, especially as regulatory and patent landscapes evolve.
- Future Considerations: Patent holders should monitor subsequent filings for similar claims, pursue enforcement proactively, and consider lifecycle strategies as the patent approaches expiry.
FAQs
1. What exactly does CN101048409 patent protect?
It primarily protects a pharmaceutical composition comprising a prostaglandin analog at a low dose for use in treating cardiovascular diseases, along with methods of therapeutic use involving administration of such compositions.
2. How does this patent differ from prior art?
It distinguishes itself through the specific low-dose formulation, which was less emphasized in previous patents, alongside claimed therapeutic benefits in cardiovascular conditions.
3. Could this patent be challenged for validity?
Yes, particularly on grounds of lack of novelty or inventive step if prior art discloses similar compositions or uses, but its focus on low-dose application provides a novelty argument.
4. When does this patent expire, and what does this imply?
Assuming a standard 20-year patent term from its filing date around 2008, expiry is projected near 2028, opening the market for generic competition.
5. How relevant is this patent for global markets?
While primarily Chinese, its concepts align with global trends, and similar patents or applications may exist in other jurisdictions, necessitating international patent landscape analyses for comprehensive IP strategy.
References
[1] Chinese Patent CN101048409. Pharmaceutical composition containing a low dose of a prostaglandin analogue and use thereof.
[2] Chinese Patent CN103617956. Prostaglandin E1 capsule and preparation method.
[3] Chinese Patent CN102209567. Method for preparing prostaglandin analogue.
