United States Patent 4,895,726: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 4,895,726, issued on January 19, 1989, is a significant patent in the pharmaceutical industry, particularly in the treatment of hyperlipidemia and hypercholesterolemia. This patent, held by Fournier Industrie et Santé, pertains to a novel therapeutic composition and method involving fenofibrate, a lipid and cholesterol lowering agent. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent describes a therapeutic composition presented in the form of gelatin capsules, designed for the oral treatment of hyperlipidemia and hypercholesterolemia. The composition contains a co-micronized mixture of particles of fenofibrate and a solid surfactant, with a mean particle size of less than 15 µm[4].
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific aspects of the invention that are protected.
Claims Overview
The patent includes two independent claims:
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Claim 1: This claim defines a therapeutic composition in the form of gelatin capsules, useful for the oral treatment of hyperlipidemia and hypercholesterolemia. The composition contains a co-micronized mixture of particles of fenofibrate and a solid surfactant, with the mean particle size of the mixture being less than 15 µm[4].
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Claim 10: This claim describes a method for improving the bioavailability of fenofibrate in vivo. The method involves co-micronization of a fenofibrate/solid surfactant mixture until the particle size of the powder obtained is less than 15 µm[4].
Claim Construction
The construction of these claims is crucial for understanding the scope of protection. The term "co-micronization" is explicitly defined in the patent specification as "micronization of an intimate mixture of fenofibrate and a solid surfactant," excluding any other excipients. This definition was upheld in court, emphasizing that the patentee had chosen to be their own lexicographer[4].
Key Aspects of the Claims
Co-Micronization
The co-micronization process is a critical aspect of the patent. It involves micronizing an intimate mixture of fenofibrate and a solid surfactant, which significantly improves the bioavailability and dissolution rate of fenofibrate compared to other methods[4].
Particle Size
The mean particle size of the co-micronized mixture must be less than 15 µm. This specific requirement is a key element of the claims and distinguishes the invention from prior art[4].
Exclusion of Other Excipients
The claims explicitly exclude any ingredients other than fenofibrate and a solid surfactant in the co-micronized mixture. This exclusion is based on the patent specification and has been upheld in court[4].
Patent Landscape
Related Patents
Other patents related to fenofibrate, such as U.S. Patent Nos. 6,277,405, 6,589,552, and 6,652,881, also deal with therapeutic compositions and methods for improving the bioavailability of fenofibrate. These patents often involve different formulations and dissolution profiles, but they share the common goal of enhancing the efficacy of fenofibrate[1].
Litigation and Enforcement
The patent has been involved in several legal disputes, notably in cases such as Abbott Laboratories v. Novopharm Ltd. and Abbott Laboratories v. Cipher Pharmaceuticals Ltd. These cases highlight the importance of precise claim construction and the enforcement of patent rights in the pharmaceutical industry[1][5].
Impact on the Pharmaceutical Industry
Bioavailability Enhancement
The co-micronization method described in the patent significantly enhances the bioavailability of fenofibrate, making it a valuable innovation in the treatment of hyperlipidemia and hypercholesterolemia. This improvement is crucial for the efficacy of the drug and has contributed to its widespread use[4].
Competitive Landscape
The patent has influenced the competitive landscape in the pharmaceutical industry, particularly in the development of lipid and cholesterol lowering agents. Companies must carefully navigate the patent landscape to avoid infringement while developing new formulations and methods[3].
Patent Analytics and Claim Coverage
To manage and analyze the complex patent landscape surrounding fenofibrate, companies often use patent analytics tools. These tools help in tracking patents by claims and scope concepts, identifying gaps or opportunities, and ensuring that all claims are actively protecting the intellectual property. Claim charts and coverage matrices are essential for this purpose, enabling technical experts to review and determine the applicability of scope concepts to target products or methods[3].
Conclusion
The United States Patent 4,895,726 is a pivotal patent in the pharmaceutical industry, particularly in the treatment of hyperlipidemia and hypercholesterolemia. Its claims, centered around the co-micronization of fenofibrate and a solid surfactant, define a specific and valuable innovation. Understanding the scope and construction of these claims is essential for both patent holders and competitors in the industry.
Key Takeaways
- Co-Micronization Process: The patent's core innovation involves the co-micronization of fenofibrate and a solid surfactant to improve bioavailability.
- Particle Size Requirement: The mean particle size of the co-micronized mixture must be less than 15 µm.
- Exclusion of Other Excipients: Only fenofibrate and a solid surfactant are allowed in the co-micronized mixture.
- Patent Landscape: The patent is part of a broader landscape involving related patents and legal disputes.
- Industry Impact: The patent has significantly enhanced the efficacy of fenofibrate treatments and influenced the competitive landscape.
FAQs
What is the main innovation described in U.S. Patent 4,895,726?
The main innovation is the co-micronization of fenofibrate and a solid surfactant to improve the bioavailability and dissolution rate of fenofibrate.
What is the significance of the particle size in the patent claims?
The mean particle size of the co-micronized mixture must be less than 15 µm, which is a critical element distinguishing the invention from prior art.
Why is claim construction important in this patent?
Claim construction is crucial because it defines the scope of protection, particularly the exclusion of other excipients and the specific definition of co-micronization.
How has this patent impacted the pharmaceutical industry?
The patent has enhanced the efficacy of fenofibrate treatments and influenced the development of lipid and cholesterol lowering agents, shaping the competitive landscape in the industry.
What tools are used to manage and analyze the patent landscape related to this patent?
Patent analytics tools, including claim charts and coverage matrices, are used to track patents, identify gaps or opportunities, and ensure that all claims are actively protecting the intellectual property.
Sources
- Abbott Laboratories v. Cipher Pharmaceuticals LTD - Casetext
- United States Patent (19) 4,895,726 - googleapis.com
- Patent Analytics | Intellectual Property Law - SLWIP
- Abbott Labs. v. Novopharm, 02-1387 - University of Houston Law Center
- Abbott Laboratories v. Novopharm LTD, 323 F.3d 1324 - Casetext
