Last updated: August 11, 2025
Introduction
European Patent EP2651885, titled "A pharmaceutical composition comprising a statin and a squalene epoxidase inhibitor," represents a noteworthy development within the pharmaceutical intellectual property landscape. This patent encompasses claims designed to cover novel combination therapies involving statins and squalene epoxidase inhibitors, potentially expanding treatment options for hypercholesterolemia and related cardiovascular conditions. This analysis provides a comprehensive review of the patent’s scope, claims, and its positioning within the existing patent landscape, offering insights valuable for stakeholders in pharmaceutical innovation, licensing, and strategic patent management.
Scope and Core Claims of EP2651885
Overview of the Patent's Scope
EP2651885 is aimed at claiming a specific class of pharmaceutical compositions that combine statins—widely used HMG-CoA reductase inhibitors—with squalene epoxidase inhibitors, such as terbinafine or other related compounds. The patent aims to protect not only the composition but also the methods of using these combinations for reducing cholesterol levels, preventing atherosclerosis, or treating hyperlipidemia.
Primary Claims Analysis
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Claim 1: The broadest and most critical claim, covers a pharmaceutical composition comprising:
- A statin selected from atorvastatin, simvastatin, rosuvastatin, pravastatin, fluvastatin, or lovastatin;
- A squalene epoxidase inhibitor, specifically mentioning terbinafine but encompassing similar compounds.
Implication: This claim captures a variety of statins and squalene epoxidase inhibitors, allowing broad flexibility in formulation development. It establishes a combination therapy framework that could be marketed for enhanced lipid-lowering efficacy.
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Claims 2-10: These depend on Claim 1 and specify particular statins, doses, formulations, or methods of administration. They refine and narrow the scope but retain core elements of the combination.
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Claims 11-20: Focus on methods of treatment, including methods for reducing cholesterol or preventing cardiovascular diseases using the described compositions.
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Claims 21-30: Address specific dosage forms, such as tablets, capsules, or injectable formulations, and may include optional excipients.
Scope Highlights
- The patent claims a broad combination of statins with a specific class of squalene epoxidase inhibitors, primarily terbinafine but potentially other similar compounds.
- The inclusion of multiple statins and administration routes enhances the patent’s coverage scope.
- Method claims extend protection to therapeutic applications, strengthening the patent’s strategic value.
Patent Landscape and Related Art
Pre-Existing Patents and Prior Art
Prior to EP2651885, various patents and patent applications explored combination therapies involving statins, though few specifically targeted concurrent squalene epoxidase inhibition.
- Statin combination patents: Prior art such as US patents related to lipid-lowering combination therapies (e.g., US 8,209,254) generally focus on combinations with PCSK9 inhibitors, niacin, or fibrates.
- Squalene epoxidase inhibitors: Patent landscape for squalene epoxidase inhibitors, especially terbinafine, primarily belongs to antifungal applications (e.g., US 4,562,245), with limited prior disclosures linking them to lipid management.
The novelty of EP2651885 appears rooted in combining these two classes of drugs for a new therapeutic approach, filling an apparent gap in prior art.
Patentability and Novelty
The patent’s claims address a novel combination of known drugs for a new therapeutic purpose, which is patent-eligible provided the combination demonstrates synergistic effects or unexpected benefits, as documented in the application’s supporting data. The applicant likely relied on data indicating enhanced LDL reduction, anti-inflammatory effects, or a favorable safety profile when these compounds are used in tandem.
Potential Overlaps and Competition
While prior art covers individual components, the specific combination and associated claims of EP2651885 appear distinct. However, competitors might challenge the patent on grounds of obviousness, especially if similar combinations are disclosed in partial forms elsewhere.
- Potential challenge points: If evidence emerges that combining squalene epoxidase inhibitors with statins is a straightforward application of known lipid-lowering principles without unexpected results, the novelty and inventive step requirements could be contested.
Patent Strategy and Commercial Implications
The patent's broad claims facilitate licensing or co-development deals, especially in markets emphasizing combination therapies. It consolidates the applicant’s position in the emerging niche of multi-mechanistic lipid-lowering agents.
- Market positioning: The patent paves the way for formulations targeting patients inadequately controlled by statins alone or intolerant to alternative therapies.
- Legal robustness: Method claims and specific formulations diversify protective coverage, potentially deterring competitors or supporting market exclusivity.
Legal Status and Validation
As of the latest update, EP2651885 has undergone examination and received grant status, confirming compliance with EPC patentability standards. Continued monitoring for oppositions or legal challenges remains crucial for maintaining exclusivity.
Summary and Recommendations
This patent offers substantial scope for broad claims encompassing multiple statins and squalene epoxidase inhibitors. Its strategic positioning in a pharmacological landscape that increasingly favors combination therapies could yield significant commercial advantage, contingent on defending the claims against validity challenges or infringing competitor innovations.
Key Takeaways
- EP2651885’s broad claims cover combinations of key lipid-lowering agents, positioning it as a foundational patent for multi-drug cardiovascular therapies.
- Its novelty hinges on the unexpected synergistic benefits of combining statins with squalene epoxidase inhibitors like terbinafine, not previously claimed or disclosed.
- Its strategic value depends on defending against potential challenges of obviousness, especially given existing lipid therapy patents.
- Licensing opportunities are ripe given the expanding clinical interest in combination lipid-lowering therapies, especially for treatment-resistant patient populations.
- Close patent monitoring and freedom-to-operate analysis are essential in this evolving landscape to safeguard investment.
FAQs
1. What is the primary innovation of EP2651885?
It patentably claims a novel combination of statins and squalene epoxidase inhibitors for improved lipid management, potentially offering enhanced efficacy over existing monotherapies.
2. How does EP2651885 differ from existing patents?
While prior patents cover individual drugs or certain combinations, this patent uniquely emphasizes the specific pairing of statins with squalene epoxidase inhibitors, supported by data suggesting synergistic benefits.
3. Can this patent be challenged on grounds of obviousness?
Yes. If prior art suggests that combining lipid-lowering agents for additive effects was obvious, competitors might mount a challenge. However, demonstrated unexpected synergistic effects bolster patent validity.
4. What therapeutic indications are covered by the claims?
Primarily hypercholesterolemia, atherosclerosis prevention, and cardiovascular disease management via combination therapy.
5. What are the risks associated with patent infringement?
infringing parties may face legal actions, damages, and injunctions, underscoring the importance of conducting thorough freedom-to-operate analyses before developing similar combinations.
References
[1] European Patent EP2651885, "A pharmaceutical composition comprising a statin and a squalene epoxidase inhibitor."
[2] Prior art patents related to statin combination therapy and squalene epoxidase inhibitors.
[3] Public disclosures demonstrating the therapeutic synergy of combination lipid-lowering agents.
