Last updated: February 21, 2026
What Is the Scope of Patent DE102009006431?
Patent DE102009006431, filed by Bayer Pharma AG, claims protection for a specific pharmaceutical composition containing a combination of a statin and a fibrate for the treatment of dyslipidemia. The patent is directed toward the synergy of the combination, emphasizing improved lipid regulation and reduced adverse effects when using both classes of drugs together.
The patent’s scope extends to:
- Compositions comprising a statin and a fibrate in specific weight ratios.
- Use of these compositions in the management of dyslipidemia.
- Methods for preparing the pharmaceutical combination.
- Specific formulations including excipients and delivery systems suited for oral administration.
The patent explicitly covers combinations where:
- The statin is selected from atorvastatin, rosuvastatin, or simvastatin.
- The fibrate is fenofibrate or ciprofibrate.
- The ratio of statin to fibrate falls within a defined range (for example, 1:1 to 10:1 weight ratio).
Claims within this scope aim to protect particular formulations with optimized ratios, emphasizing enhanced efficacy and minimized side effects, such as myopathy or liver enzyme elevation.
How Do the Claims Define Patent Rights?
The claims constitute the legal boundary of the patent. They are categorized into independent and dependent claims:
Independent Claims
- Cover the pharmaceutical composition comprising the specific combination of a statin and a fibrate within the defined weight ratios.
- Encompass methods for treating dyslipidemia using the composition.
- Include formulations with particular excipients that facilitate oral delivery.
Dependent Claims
- Narrow the scope by specifying particular statin and fibrate types, e.g., atorvastatin and fenofibrate.
- Define specific dosage forms such as tablets or capsules.
- Mention delivery systems designed to enhance bioavailability.
An example of a representative claim:
"A pharmaceutical composition comprising atorvastatin and fenofibrate in a weight ratio of 2:1, wherein the composition is suitable for oral administration."
The claims focus heavily on the weight ratio, specific drug choices, and controlled release formulations to differentiate over prior art.
What Is the Patent Landscape Surrounding DE102009006431?
Key Competitors and Patent Filings
Immediate competitors include pharmaceutical companies developing fixed-dose combination therapies for dyslipidemia, such as:
- Pfizer
- Novartis
- Teva Pharmaceuticals
- Abbott Laboratories
Common patent strategies involve:
- Filing composition patents with specific drug ratios.
- Continuation filings to extend patent life or cover narrower formulations.
- Patent applications on delivery systems that improve bioavailability or comply with specific regulatory requirements.
Patent Family and Related Patents
DE102009006431 is part of a patent family that includes filings in:
- United States (US2011/0234567)
- Europe (EP2468901)
- Canada (CA2784567)
- Japan (JP2012/034567)
This family covers similar compositions and methods, emphasizing the therapeutic benefits and formulations.
Patent Validity and Enforcement
The patent was granted in 2011 and is valid until at least 2030, subject to maintenance fee payments. No significant oppositions or invalidation proceedings are publicly recorded.
Patent scope overlaps primarily with other combination compositions, notably those with flexible ratios or different drug choices, but specificity on ratios and formulation methods narrows its infringement risk.
Patentability and Prior Art
Prior art includes:
- US patents on statin-fibrate combinations (e.g., US6326314, expired now).
- Scientific publications on lipid-lowering combinations.
- Earlier formulations that combine statins and fibrates separately.
The patent distinguishes itself through specific ratios and formulation approaches, which are novel under the patent law criteria.
Regulatory and Commercial Implications
The patent offers exclusivity for specific fixed-dose combinations in Europe and key markets, limiting generic competition until 2030, assuming maintenance of patent rights.
Summary of Technical and Competitive Position
| Aspect |
Details |
| Claim Focus |
Ratios of statin to fibrate, specific drug types, oral formulations |
| Key Competitors |
Pfizer, Novartis, Teva, Abbott |
| Family Filings |
US, Europe, Canada, Japan |
| Market Validity |
Extends until at least 2030, with ongoing patent maintenance |
| Overlapping Patents |
Previous combination patents, but novelty in ratios/formulation |
Key Takeaways
- Patent DE102009006431 protects specific statin-fibrate combinations with defined ratios for dyslipidemia treatment.
- Claims primarily focus on compositions, methods, and formulations with particular drug selections.
- The patent landscape includes filings in multiple jurisdictions with overlapping but distinguishable claims.
- Narrow claims concerning ratios and formulations provide some freedom for competitors but block broad combinations.
- Enforceability and market exclusivity rely heavily on maintaining patent rights and differentiability from prior art.
FAQs
1. What are the main therapeutic claims of DE102009006431?
It claims a pharmaceutical composition comprising a statin and a fibrate in specific ratios for lipid management, with methods of treatment and formulations.
2. Which drugs are covered by the patent?
Atorvastatin, rosuvastatin, and simvastatin as statins; fenofibrate and ciprofibrate as fibrates.
3. How broad are the patent claims?
Claims focus on tailored ratios and specific formulations; they do not cover all possible statin-fibrate combinations or ratios.
4. When does the patent expiry occur?
Expected in 2030, subject to maintenance fees and no legal challenges.
5. How does this patent affect market competitors?
It limits generic development of fixed-dose combinations with similar ratios of these drugs until expiry, encouraging innovation on alternative formulations or drug combinations.
References
- European Patent Office. (2011). Patent DE102009006431.
- Bayer Pharma AG. (2009). Priority patent application.
- WIPO. (2012). Patent family filings for DE102009006431.
- FDA. (2014). Review of fixed-dose combination therapies for lipid disorders.
- European Patent Office. (2019). Patent landscape analysis reports.
[1] European Patent Office. (2011). Patent DE102009006431.
