United States Patent 4,058,552: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 4,058,552, titled "Fenofibrate and Its Therapeutic Use," is a significant patent in the pharmaceutical industry, particularly in the treatment of lipid and cholesterol-related disorders. This patent, granted to the original inventors, has played a crucial role in the development and marketing of fenofibrate, a fibric acid derivative used to lower triglyceride and cholesterol levels.
Background of Fenofibrate
Fenofibrate is a lipid-lowering agent that belongs to the class of fibric acid derivatives. It is used in the treatment of adults with increased triglyceride levels and is known for its efficacy in reducing LDL (low-density lipoprotein) cholesterol and increasing HDL (high-density lipoprotein) cholesterol[1][4].
Patent Claims
The patent 4,058,552 includes several key claims that define the scope of the invention:
Composition Claims
The patent claims cover the composition of fenofibrate itself, including its chemical structure and various forms in which it can be administered. These claims are crucial as they define the exact compound and its derivatives that are protected under the patent[4].
Method of Use Claims
The patent also includes method of use claims, which describe the therapeutic applications of fenofibrate. These claims specify how fenofibrate is used to treat conditions such as hypercholesterolemia, hypertriglyceridemia, and other lipid disorders[4].
Dosage and Administration Claims
Claims related to the dosage and administration of fenofibrate are also included. These specify the optimal dosages, forms (e.g., capsules, tablets), and the frequency of administration to achieve the desired therapeutic effects[4].
Scope of the Patent
The scope of the patent is defined by the claims and the description provided in the patent document.
Therapeutic Applications
The patent highlights the therapeutic applications of fenofibrate, including its use in reducing triglyceride levels, lowering LDL cholesterol, and increasing HDL cholesterol. This scope is critical as it sets the boundaries for what is considered an infringement of the patent[1][4].
Chemical and Pharmaceutical Aspects
The patent delves into the chemical and pharmaceutical aspects of fenofibrate, including its synthesis, formulation, and stability. This detailed description ensures that any subsequent developments or modifications must adhere to these specifications to avoid infringement[4].
Patent Landscape
The patent landscape surrounding fenofibrate is complex and involves multiple patents and legal disputes.
Related Patents
Several other patents have been filed and granted related to fenofibrate, including those for self-emulsifying formulations, combination therapies, and novel pharmaceutical compositions. For example, U.S. Patent 6,277,405 and U.S. Patent 7,863,331 describe advanced formulations and methods of preparation for fenofibrate[2][5].
Legal Disputes
The patent has been involved in significant legal disputes, particularly regarding infringement claims. For instance, the case of Abbott Laboratories v. Cipher Pharmaceuticals LTD involved allegations that Cipher's fenofibrate product infringed on Abbott's patents. The dispute centered on whether Cipher's product met the dissolution profile claims specified in the patents[1].
Impact on the Pharmaceutical Industry
The patent 4,058,552 has had a substantial impact on the pharmaceutical industry.
Innovation and Development
The patent has driven innovation in the development of lipid-lowering agents. It has prompted further research into more effective formulations and delivery methods, such as self-emulsifying formulations and combination therapies[2][5].
Market Competition
The patent has influenced market competition by setting a standard for fenofibrate products. Companies must ensure that their products do not infringe on the claims of this patent, which has led to a competitive environment where companies strive to develop non-infringing alternatives or improvements[1].
Challenges and Controversies
The patent has faced several challenges and controversies.
Patent Scope and Validity
There have been debates about the scope and validity of the patent, particularly in the context of the doctrine of equivalents. Disputes have arisen over whether certain products infringe on the patent claims, highlighting the complexity of patent law and the need for precise claim language[1].
Licensing and Litigation Costs
The patent has been part of broader discussions on patent quality and the costs associated with licensing and litigation. The breadth and clarity of patent claims can significantly impact innovation and competition in the industry[3].
Key Takeaways
- Therapeutic Use: Fenofibrate is a critical lipid-lowering agent used to treat hypertriglyceridemia and hypercholesterolemia.
- Patent Claims: The patent includes composition, method of use, and dosage claims that define the scope of the invention.
- Patent Landscape: The patent is part of a complex landscape involving multiple related patents and legal disputes.
- Impact on Industry: The patent has driven innovation and influenced market competition in the pharmaceutical industry.
- Challenges: The patent has faced challenges related to scope, validity, and the costs associated with licensing and litigation.
FAQs
What is the primary use of fenofibrate as described in U.S. Patent 4,058,552?
Fenofibrate is primarily used to lower triglyceride levels and reduce LDL cholesterol while increasing HDL cholesterol in adults.
What are the key claims in U.S. Patent 4,058,552?
The key claims include composition claims for fenofibrate, method of use claims for its therapeutic applications, and dosage and administration claims.
How has U.S. Patent 4,058,552 impacted the pharmaceutical industry?
The patent has driven innovation in lipid-lowering agents, influenced market competition, and set standards for fenofibrate products.
What are some of the legal disputes related to U.S. Patent 4,058,552?
Significant legal disputes include the case of Abbott Laboratories v. Cipher Pharmaceuticals LTD, which involved allegations of patent infringement related to the dissolution profile of fenofibrate products.
How does the patent landscape around fenofibrate affect innovation?
The patent landscape encourages innovation by prompting the development of non-infringing alternatives and improvements in formulations and delivery methods.
Sources
- Abbott Laboratories v. Cipher Pharmaceuticals LTD - Casetext
- Patent 2490157 Summary - Canadian Patents Database
- Patent Claims and Patent Scope - SSRN
- Patent 2356607 Summary - Canadian Patents Database
- United States Patent 7,863,331 - Google Patents
