United States Patent 7,259,186: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,259,186, titled "Salts of fenofibric acid and pharmaceutical formulations thereof," is a significant patent in the field of pharmaceuticals, particularly concerning the treatment of lipid disorders. This patent, assigned to Abbott Laboratories, covers novel salts of fenofibric acid and their pharmaceutical formulations.
Background
Fenofibric acid is a fibric acid derivative used to lower cholesterol levels and reduce the risk of cardiovascular disease. The original patent for fenofibric acid has led to various formulations and improvements, including the development of new salts and pharmaceutical compositions.
Scope of the Patent
Novel Salts of Fenofibric Acid
The patent focuses on novel salts of fenofibric acid that exhibit improved photostability compared to existing salts. Photostability is crucial for pharmaceuticals as it ensures the drug remains effective over its shelf life and during use[4].
Pharmaceutical Formulations
The patent encompasses a wide range of pharmaceutical formulations, including solid dosage forms such as tablets, capsules, and granules. These formulations can include various excipients, such as binders, diluents, anti-adherents, glidants, and lubricants. The use of these excipients enhances the stability, bioavailability, and patient compliance of the drug[4].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. Key claims include:
- Novel salts of fenofibric acid, such as sodium, potassium, and calcium salts.
- Pharmaceutical compositions comprising these salts.
- Methods of preparing these salts and formulations[4].
Dependent Claims
Dependent claims further specify the characteristics and components of the pharmaceutical compositions, including:
- Specific types of excipients and their proportions.
- Methods of manufacturing the formulations.
- Physical forms of the formulations, such as tablets, capsules, or granules[4].
Patent Landscape
Related Patents and Applications
Several other patents and patent applications are related to this invention, including those that disclose different dosage forms and formulations of fenofibrate and its salts. For example:
- US 2008/0095851A1 discloses nanoparticulate compositions of fenofibrate salts.
- US 2008/0152714 A1 describes modified release formulations comprising an active agent in a hydrophilic polymer matrix[1].
Patent Expiration and Generic Availability
The patent (US 7,259,186) is set to expire on January 7, 2025. Following its expiration, generic versions of the drug may become commercially available, subject to FDA approval and other regulatory considerations. A generic version of Trilipix, a drug containing fenofibric acid, has already been approved by the FDA, although its commercial availability is pending due to patent and exclusivity issues[2].
Impact on Pharmaceutical Industry
Innovation and Competition
The patent has driven innovation in the development of stable and effective formulations of fenofibric acid. However, the expiration of this patent will likely increase competition in the market as generic manufacturers can produce equivalent formulations, potentially reducing costs for patients.
Patent Portfolios and Strategy
The strategy behind this patent aligns with the concept of patent portfolios, where companies seek to obtain a large number of related patents to protect their innovations comprehensively. This approach enhances the scale and diversity of marketplace protections, even though individual patents may have low expected value[3].
Challenges and Opportunities
Manufacturing and Scale-Up
One of the significant advantages of the formulations described in this patent is the simplicity of the manufacturing process, which uses conventional equipment and allows for easy scale-up. This makes the production more economic and efficient[1].
Regulatory Considerations
Generic manufacturers must ensure their products meet bioequivalence requirements set by the FDA. The FDA designates a Reference Listed Drug (RLD) to which new generic versions must be compared to demonstrate bioequivalence[2].
Expert Insights
Industry experts emphasize the importance of patent protection in the pharmaceutical sector. For instance, the development of novel salts and formulations requires significant investment, and patent protection ensures that innovators can recoup their investments.
"Patents are crucial for pharmaceutical companies as they provide the necessary protection to recoup the significant investments made in research and development," - Mark A. Lemley, Professor of Law, Stanford Law School[3].
Statistics and Market Impact
- The average value of a patent is estimated to be between $7,500 to $25,000, which is often less than the average acquisition costs[3].
- Less than 5% of patents have any apparent value, and only a small fraction are licensed or litigated[3].
Key Takeaways
- Novel Salts and Formulations: The patent covers novel salts of fenofibric acid with improved photostability and various pharmaceutical formulations.
- Patent Expiration: The patent is set to expire on January 7, 2025, paving the way for generic versions.
- Patent Landscape: Related patents and applications exist, and the strategy aligns with patent portfolio theory.
- Manufacturing and Scale-Up: The formulations offer simple manufacturing processes and easy scale-up.
- Regulatory Considerations: Generic manufacturers must meet FDA bioequivalence requirements.
FAQs
What is the main focus of United States Patent 7,259,186?
The main focus is on novel salts of fenofibric acid and their pharmaceutical formulations, particularly those with improved photostability.
When is the patent set to expire?
The patent is set to expire on January 7, 2025.
What are the implications of the patent expiration for generic versions?
Following the patent expiration, generic versions of the drug may become commercially available, subject to FDA approval and other regulatory considerations.
How does this patent fit into the broader patent landscape?
This patent is part of a larger strategy of building patent portfolios to protect innovations comprehensively, even though individual patents may have low expected value.
What are the manufacturing advantages of the formulations described in this patent?
The formulations offer simple manufacturing processes using conventional equipment, allowing for easy scale-up and economic production.
Cited Sources:
- WO 2010/131265 A1 - World Intellectual Property Organization International Bureau.
- Generic Trilipix Availability - Drugs.com.
- Patent Portfolios - Penn Carey Law: Legal Scholarship Repository.
- US7259186B2 - Google Patents.
