Analysis of United States Patent 3,850,911: Scope, Claims, and Landscape

Summary

United States Patent 3,850,911, granted on November 26, 1974, to E.R. Squibb & Sons, Inc., claims a method for treating hyperlipidemia. The patent describes a process involving the administration of clofibrate, a lipid-lowering agent, in specific dosages and regimens to reduce elevated levels of cholesterol and triglycerides in the blood. The patent's claims are focused on the therapeutic application of clofibrate, defining the method of treatment rather than the compound itself. The patent landscape surrounding clofibrate and hyperlipidemia treatments is extensive, with numerous patents issued for related compounds, formulations, and therapeutic approaches. Understanding the scope and claims of this foundational patent is crucial for navigating the current market and identifying potential infringement risks or opportunities for further innovation.

What is the Core Innovation Claimed in US Patent 3,850,911?

The central innovation protected by US Patent 3,850,911 is a method of treating hyperlipidemia. The patent defines this method as administering clofibrate to a human subject in a dosage range of 1.5 to 2.0 grams per day. The treatment is to be carried out over a period of at least three months, with specific dosages administered twice daily.

The patent specifies the conditions to be treated: elevated levels of cholesterol and triglycerides. It details the mechanism by which clofibrate purportedly achieves this reduction, including increasing the excretion of cholesterol and inhibiting lipogenesis. The patent emphasizes the efficacy of clofibrate in cases where dietary modifications alone have proven insufficient.

Key aspects of the claimed method include:

Active Ingredient: Clofibrate (ethyl $\alpha$-(p-chlorophenoxy)isobutyrate).
Dosage: 1.5 to 2.0 grams per day.
Duration: At least three months.
Administration: Divided into two daily doses.
Target Conditions: Hypercholesterolemia and hypertriglyceridemia.

The patent does not claim the compound clofibrate itself, as it was known prior to the filing of this patent. Instead, it secures patent protection for the specific application and method of use of clofibrate in treating hyperlipidemia under defined conditions.

What Are the Specific Claims of US Patent 3,850,911?

US Patent 3,850,911 contains three independent claims and two dependent claims, all focused on the method of treating hyperlipidemia with clofibrate.

Claim 1: This is the primary independent claim and defines the core method. It states:

"A method for lowering elevated cholesterol and triglyceride levels in the blood of a human subject which comprises administering to said subject a daily dose of clofibrate in the range of about 1.5 grams to about 2.0 grams, divided into two administrations, for a period of at least three months."

Claim 2: This claim is dependent on Claim 1 and further specifies the daily dosage within the broader range. It reads:

"The method of claim 1 wherein the daily dose of clofibrate is about 1.8 grams."

Claim 3: This claim is also dependent on Claim 1 and focuses on the composition of the blood that is being treated. It specifies:

"The method of claim 1 wherein the human subject has elevated cholesterol and triglyceride levels, wherein the cholesterol level is in excess of 250 mg/100 ml and the triglyceride level is in excess of 150 mg/100 ml."

Claim 4: This independent claim focuses on a specific subset of hyperlipidemia patients. It states:

"A method for reducing the elevated cholesterol and triglyceride levels in the blood of a human subject where dietary modifications have proven insufficient, which comprises administering to said subject a daily dose of clofibrate in the range of about 1.5 grams to about 2.0 grams, divided into two administrations, for a period of at least three months."

Claim 5: This claim is dependent on Claim 4 and further specifies the daily dosage. It reads:

"The method of claim 4 wherein the daily dose of clofibrate is about 1.8 grams."

These claims collectively establish the patent's protection over a defined method of using clofibrate for treating specific types and levels of hyperlipidemia, with particular emphasis on dosage and duration.

What is the Technological Context and Prior Art for US Patent 3,850,911?

At the time of its filing, US Patent 3,850,911 addressed a significant unmet medical need: the management of hyperlipidemia. Elevated levels of cholesterol and triglycerides are well-established risk factors for cardiovascular disease, including atherosclerosis, heart attack, and stroke.

The compound clofibrate, also known as ethyl $\alpha$-(p-chlorophenoxy)isobutyrate, was known prior to this patent. Its synthesis and basic pharmacological properties were described in scientific literature. The initial discoveries and development of clofibrate occurred in the late 1950s and early 1960s. For example, the compound itself was disclosed and explored for its cholesterol-lowering effects in publications as early as the late 1950s and early 1960s.

Key Prior Art Considerations:

Discovery of Clofibrate: The compound clofibrate was synthesized and investigated for its lipid-lowering properties before the priority date of US Patent 3,850,911. Early research focused on its ability to reduce serum cholesterol and triglycerides.
Known Efficacy: The general lipid-lowering effects of clofibrate were understood. Publications from researchers like the Veterans Administration Cooperative Study Group on Antihypertensive Agents and others detailed its use in managing hyperlipidemias.
Dietary Modifications: It was widely recognized that dietary interventions were the first line of treatment for hyperlipidemia. This patent specifically positions clofibrate as a therapeutic option when diet alone is insufficient.
Dosage and Regimen Research: While the general lipid-lowering effect of clofibrate was known, the precise dosage, duration, and frequency of administration for optimal therapeutic benefit and minimal side effects were subjects of ongoing research. US Patent 3,850,911 appears to be based on specific findings regarding an effective and practical treatment regimen.

The patent's innovation lies not in the discovery of clofibrate, but in defining a specific, effective, and potentially patentable method for its therapeutic use in treating hyperlipidemia. This includes specifying the daily dosage range (1.5-2.0g), b.i.d. administration, and a minimum treatment duration of three months. Claim 3’s definition of specific blood level thresholds (cholesterol > 250 mg/100 ml, triglycerides > 150 mg/100 ml) further refines the targeted patient population.

What is the Current Patent Landscape for Hyperlipidemia Treatments?

The patent landscape for hyperlipidemia treatments is vast and continually evolving. Since the development of early lipid-lowering agents like clofibrate, significant advancements have been made, leading to numerous patent filings for new chemical entities, improved formulations, combination therapies, and novel mechanisms of action.

Key Areas of Patent Activity:

Statins: The development of statins (HMG-CoA reductase inhibitors) represents a major paradigm shift in hyperlipidemia treatment. Patents for blockbuster statin drugs like atorvastatin (Lipitor), simvastatin (Zocor), and rosuvastatin (Crestor) have generated substantial revenue and are central to the modern management of cardiovascular risk.
PCSK9 Inhibitors: More recently, monoclonal antibodies targeting PCSK9 (e.g., evolocumab, alirocumab) have emerged as powerful new therapies, particularly for patients with refractory hyperlipidemia or genetic conditions like familial hypercholesterolemia. Patents in this area focus on the antibodies themselves, their formulations, and methods of use.
Ezetimibe: This cholesterol absorption inhibitor offers a different mechanism of action and is often used in combination with statins. Patents cover the compound, its formulations, and combination therapies.
Fibrates: While clofibrate was an early fibrate, newer generations of fibrates (e.g., fenofibrate, gemfibrozil) have been developed with different pharmacokinetic and pharmacodynamic profiles, each protected by its own patent portfolio.
Niacin Derivatives: Extended-release niacin formulations and related compounds have also been subjects of patent protection.
Formulations and Delivery Systems: Patents are frequently filed for novel drug delivery systems, including sustained-release formulations, combination pills, and innovative administration methods designed to improve patient compliance, efficacy, or safety.
Combination Therapies: The synergistic effects of combining different classes of lipid-lowering agents have led to numerous patents covering specific combinations of drugs.
Repurposing and New Indications: Research continues to explore existing drugs for new therapeutic uses, including hyperlipidemia, which can lead to method-of-use patents.

Impact of US Patent 3,850,911:

While US Patent 3,850,911 has long expired (its 20-year term from filing date would have ended around 1990, assuming a 1970 filing date for novelty, or 1994 if based on the grant date and a 20-year term from filing), it represents an early foundational patent for a specific method of hyperlipidemia treatment. Its existence highlights the historical approach to patenting therapeutic methods and underscores the ongoing patent activity in this therapeutic area. Generic clofibrate is now available, but the patent serves as a historical marker in the evolution of hyperlipidemia drug development and patenting strategies.

What Are the Potential Implications of US Patent 3,850,911 for R&D and Investment?

Although US Patent 3,850,911 has expired, understanding its scope and claims remains relevant for R&D and investment strategies in the hyperlipidemia space. Its expiration means that the specific method it claimed is now in the public domain, allowing for generic use of clofibrate according to the patented method without infringing this particular patent.

Implications for Research & Development:

Foundation for Further Innovation: This patent demonstrates an early successful approach to patenting a method of treatment for a significant disease. This historical context can inform strategies for patenting new therapeutic methods, particularly for established compounds or new indications.
Understanding Evolving Treatment Paradigms: The patent's focus on clofibrate, an older class of lipid-lowering drug, contrasts with current treatments dominated by statins and PCSK9 inhibitors. R&D efforts are now concentrated on newer mechanisms, improved efficacy, better safety profiles, and combination therapies that offer more targeted or potent lipid reduction.
Identifying Unmet Needs: The limitations of clofibrate (e.g., side effects, efficacy compared to modern drugs) contributed to the drive for novel therapies. Current R&D must identify and address remaining unmet needs in hyperlipidemia management, such as treating specific genetic dyslipidemias or reducing residual cardiovascular risk in patients already on therapy.
Method-of-Use Patenting: The patent exemplifies method-of-use patenting. This remains a viable strategy for protecting new therapeutic applications of known compounds, provided novelty and non-obviousness criteria are met. For example, discovering a new dosage regimen or a specific patient subgroup for which an existing drug is particularly effective could be patentable.

Implications for Investment:

Market Evolution: Investors should recognize that the hyperlipidemia market has significantly evolved beyond the scope of this patent. Investment in companies developing clofibrate itself would be unlikely to yield returns based on patent exclusivity.
Focus on Novel Therapeutics: Investment opportunities lie with companies developing next-generation therapies, such as novel small molecules, biologics targeting new pathways, or advanced combination products. Due diligence should assess the strength and breadth of patent portfolios covering these new innovations.
Understanding the Generic Landscape: The expiration of this patent for clofibrate means that generic versions of the drug are available. Investors considering companies involved in the production or sale of generic clofibrate must analyze market dynamics, pricing, and competition rather than patent-driven exclusivity.
Patent Expiry as a Catalyst: For newer, patented drugs, understanding their patent expiry dates is critical for projecting future market share and revenue streams. The lifecycle of drugs like statins and PCSK9 inhibitors provides valuable lessons in managing patent cliffs and preparing for generic competition.
Regulatory Pathways: Investment decisions should also consider the regulatory pathways for new hyperlipidemia drugs, including clinical trial success rates, FDA approval timelines, and post-market surveillance requirements.

In essence, while US Patent 3,850,911 is no longer a barrier to entry for the specific method it claimed, its analysis provides valuable historical and strategic context for current R&D and investment decisions in the dynamic field of cardiovascular risk management.

Key Takeaways

US Patent 3,850,911 protects a method for treating hyperlipidemia using clofibrate at specific dosages (1.5-2.0g daily, b.i.d.) and durations (minimum 3 months).
The patent claims focus on the therapeutic application and method of use, not the compound clofibrate itself, which was known prior to its filing.
The patent's claims are specific regarding patient conditions (elevated cholesterol/triglycerides) and differentiate from dietary interventions.
The patent expired decades ago, rendering the claimed method part of the public domain.
The hyperlipidemia patent landscape is now dominated by newer drug classes such as statins, PCSK9 inhibitors, and ezetimibe, with extensive patent activity in these areas.
For current R&D and investment, understanding this historical patent provides context for method-of-use patenting strategies and highlights the evolution of the hyperlipidemia market towards novel therapeutics and combination approaches.

Frequently Asked Questions

Is clofibrate still a prescribed medication for hyperlipidemia? Clofibrate is rarely prescribed today due to the availability of more effective and safer alternatives, such as statins and PCSK9 inhibitors. Its use is limited, and regulatory bodies have issued warnings regarding potential side effects.
What are the primary side effects associated with clofibrate? Common side effects of clofibrate include gastrointestinal disturbances, nausea, diarrhea, and muscle pain. More serious potential side effects include liver dysfunction, gallstones, and an increased risk of non-cardiac mortality observed in some studies.
Can new patents be filed for clofibrate today? New patents could potentially be filed for clofibrate if a novel, non-obvious, and useful method of treatment is discovered, such as a specific new indication, a unique combination therapy, or an advanced formulation that improves its therapeutic profile. However, patenting the basic method described in US Patent 3,850,911 is not possible due to its expiration.
How does US Patent 3,850,911 compare to patents for modern hyperlipidemia drugs like statins? US Patent 3,850,911 is a method-of-use patent for an older compound with a specific therapeutic application. Patents for modern drugs like statins typically cover the novel chemical compounds themselves, their manufacturing processes, specific formulations, and various methods of use, representing protection over new chemical entities rather than established ones.
What is the significance of the expiration of US Patent 3,850,911 for generic drug manufacturers? The expiration of US Patent 3,850,911 means that generic manufacturers are free to produce and market clofibrate for the method of treatment claimed in the patent without needing a license. This allows for the availability of lower-cost generic versions of the drug.

Citations

[1] United States Patent 3,850,911. (1974). Method for lowering elevated cholesterol and triglyceride levels. E.R. Squibb & Sons, Inc.

Title:	Steroid synthesis
Abstract:	1. A CHEMICAL COMPOUND HAVING A CYCLOPENTANOPHENANTHRENE CARBON-CARBON SKELETON CONTAINING AT LEAST 19 AND UP TO A MAXIMUM OF 40 CARBON ATOMS AND IN WHICH AT LEAST B AND THE C RING ARE AT LEAST PARTIALLY HYDROGENATED, INCLUDING A NUCLEUS SELECTED FROM THE GROUP CONSISTING OF SATURATED AND UNSATURATED GONANE AND 8ISOGONANE NUCLEI HAVING UP TO A MAXIMUM OF FIVE (5) DOUBLE BONDS AND HAVING A PART THEREOF IN THE 13-POSITION F MONOVALENT POLYCARBON ALKYL RADICAL HAVING 2 TO ABOUT 16 CARBON ATOMS, SAID RINGS AND THE 13 AND OTHER POSITIONS OF THE NUCLEUS BEING IDENTIFIED ACCORDING TO STEROID NOMENCLATURE.
Inventor(s):	G Hughes, H Smith
Assignee:	Individual
Application Number:	US00228384A
Patent Claim Types: see list of patent claims
Patent landscape, scope, and claims:	Analysis of United States Patent 3,850,911: Scope, Claims, and Landscape Summary United States Patent 3,850,911, granted on November 26, 1974, to E.R. Squibb & Sons, Inc., claims a method for treating hyperlipidemia. The patent describes a process involving the administration of clofibrate, a lipid-lowering agent, in specific dosages and regimens to reduce elevated levels of cholesterol and triglycerides in the blood. The patent's claims are focused on the therapeutic application of clofibrate, defining the method of treatment rather than the compound itself. The patent landscape surrounding clofibrate and hyperlipidemia treatments is extensive, with numerous patents issued for related compounds, formulations, and therapeutic approaches. Understanding the scope and claims of this foundational patent is crucial for navigating the current market and identifying potential infringement risks or opportunities for further innovation. What is the Core Innovation Claimed in US Patent 3,850,911? The central innovation protected by US Patent 3,850,911 is a method of treating hyperlipidemia. The patent defines this method as administering clofibrate to a human subject in a dosage range of 1.5 to 2.0 grams per day. The treatment is to be carried out over a period of at least three months, with specific dosages administered twice daily. The patent specifies the conditions to be treated: elevated levels of cholesterol and triglycerides. It details the mechanism by which clofibrate purportedly achieves this reduction, including increasing the excretion of cholesterol and inhibiting lipogenesis. The patent emphasizes the efficacy of clofibrate in cases where dietary modifications alone have proven insufficient. Key aspects of the claimed method include: Active Ingredient: Clofibrate (ethyl $\alpha$-(p-chlorophenoxy)isobutyrate). Dosage: 1.5 to 2.0 grams per day. Duration: At least three months. Administration: Divided into two daily doses. Target Conditions: Hypercholesterolemia and hypertriglyceridemia. The patent does not claim the compound clofibrate itself, as it was known prior to the filing of this patent. Instead, it secures patent protection for the specific application and method of use of clofibrate in treating hyperlipidemia under defined conditions. What Are the Specific Claims of US Patent 3,850,911? US Patent 3,850,911 contains three independent claims and two dependent claims, all focused on the method of treating hyperlipidemia with clofibrate. Claim 1: This is the primary independent claim and defines the core method. It states: "A method for lowering elevated cholesterol and triglyceride levels in the blood of a human subject which comprises administering to said subject a daily dose of clofibrate in the range of about 1.5 grams to about 2.0 grams, divided into two administrations, for a period of at least three months." Claim 2: This claim is dependent on Claim 1 and further specifies the daily dosage within the broader range. It reads: "The method of claim 1 wherein the daily dose of clofibrate is about 1.8 grams." Claim 3: This claim is also dependent on Claim 1 and focuses on the composition of the blood that is being treated. It specifies: "The method of claim 1 wherein the human subject has elevated cholesterol and triglyceride levels, wherein the cholesterol level is in excess of 250 mg/100 ml and the triglyceride level is in excess of 150 mg/100 ml." Claim 4: This independent claim focuses on a specific subset of hyperlipidemia patients. It states: "A method for reducing the elevated cholesterol and triglyceride levels in the blood of a human subject where dietary modifications have proven insufficient, which comprises administering to said subject a daily dose of clofibrate in the range of about 1.5 grams to about 2.0 grams, divided into two administrations, for a period of at least three months." Claim 5: This claim is dependent on Claim 4 and further specifies the daily dosage. It reads: "The method of claim 4 wherein the daily dose of clofibrate is about 1.8 grams." These claims collectively establish the patent's protection over a defined method of using clofibrate for treating specific types and levels of hyperlipidemia, with particular emphasis on dosage and duration. What is the Technological Context and Prior Art for US Patent 3,850,911? At the time of its filing, US Patent 3,850,911 addressed a significant unmet medical need: the management of hyperlipidemia. Elevated levels of cholesterol and triglycerides are well-established risk factors for cardiovascular disease, including atherosclerosis, heart attack, and stroke. The compound clofibrate, also known as ethyl $\alpha$-(p-chlorophenoxy)isobutyrate, was known prior to this patent. Its synthesis and basic pharmacological properties were described in scientific literature. The initial discoveries and development of clofibrate occurred in the late 1950s and early 1960s. For example, the compound itself was disclosed and explored for its cholesterol-lowering effects in publications as early as the late 1950s and early 1960s. Key Prior Art Considerations: Discovery of Clofibrate: The compound clofibrate was synthesized and investigated for its lipid-lowering properties before the priority date of US Patent 3,850,911. Early research focused on its ability to reduce serum cholesterol and triglycerides. Known Efficacy: The general lipid-lowering effects of clofibrate were understood. Publications from researchers like the Veterans Administration Cooperative Study Group on Antihypertensive Agents and others detailed its use in managing hyperlipidemias. Dietary Modifications: It was widely recognized that dietary interventions were the first line of treatment for hyperlipidemia. This patent specifically positions clofibrate as a therapeutic option when diet alone is insufficient. Dosage and Regimen Research: While the general lipid-lowering effect of clofibrate was known, the precise dosage, duration, and frequency of administration for optimal therapeutic benefit and minimal side effects were subjects of ongoing research. US Patent 3,850,911 appears to be based on specific findings regarding an effective and practical treatment regimen. The patent's innovation lies not in the discovery of clofibrate, but in defining a specific, effective, and potentially patentable method for its therapeutic use in treating hyperlipidemia. This includes specifying the daily dosage range (1.5-2.0g), b.i.d. administration, and a minimum treatment duration of three months. Claim 3’s definition of specific blood level thresholds (cholesterol > 250 mg/100 ml, triglycerides > 150 mg/100 ml) further refines the targeted patient population. What is the Current Patent Landscape for Hyperlipidemia Treatments? The patent landscape for hyperlipidemia treatments is vast and continually evolving. Since the development of early lipid-lowering agents like clofibrate, significant advancements have been made, leading to numerous patent filings for new chemical entities, improved formulations, combination therapies, and novel mechanisms of action. Key Areas of Patent Activity: Statins: The development of statins (HMG-CoA reductase inhibitors) represents a major paradigm shift in hyperlipidemia treatment. Patents for blockbuster statin drugs like atorvastatin (Lipitor), simvastatin (Zocor), and rosuvastatin (Crestor) have generated substantial revenue and are central to the modern management of cardiovascular risk. PCSK9 Inhibitors: More recently, monoclonal antibodies targeting PCSK9 (e.g., evolocumab, alirocumab) have emerged as powerful new therapies, particularly for patients with refractory hyperlipidemia or genetic conditions like familial hypercholesterolemia. Patents in this area focus on the antibodies themselves, their formulations, and methods of use. Ezetimibe: This cholesterol absorption inhibitor offers a different mechanism of action and is often used in combination with statins. Patents cover the compound, its formulations, and combination therapies. Fibrates: While clofibrate was an early fibrate, newer generations of fibrates (e.g., fenofibrate, gemfibrozil) have been developed with different pharmacokinetic and pharmacodynamic profiles, each protected by its own patent portfolio. Niacin Derivatives: Extended-release niacin formulations and related compounds have also been subjects of patent protection. Formulations and Delivery Systems: Patents are frequently filed for novel drug delivery systems, including sustained-release formulations, combination pills, and innovative administration methods designed to improve patient compliance, efficacy, or safety. Combination Therapies: The synergistic effects of combining different classes of lipid-lowering agents have led to numerous patents covering specific combinations of drugs. Repurposing and New Indications: Research continues to explore existing drugs for new therapeutic uses, including hyperlipidemia, which can lead to method-of-use patents. Impact of US Patent 3,850,911: While US Patent 3,850,911 has long expired (its 20-year term from filing date would have ended around 1990, assuming a 1970 filing date for novelty, or 1994 if based on the grant date and a 20-year term from filing), it represents an early foundational patent for a specific method of hyperlipidemia treatment. Its existence highlights the historical approach to patenting therapeutic methods and underscores the ongoing patent activity in this therapeutic area. Generic clofibrate is now available, but the patent serves as a historical marker in the evolution of hyperlipidemia drug development and patenting strategies. What Are the Potential Implications of US Patent 3,850,911 for R&D and Investment? Although US Patent 3,850,911 has expired, understanding its scope and claims remains relevant for R&D and investment strategies in the hyperlipidemia space. Its expiration means that the specific method it claimed is now in the public domain, allowing for generic use of clofibrate according to the patented method without infringing this particular patent. Implications for Research & Development: Foundation for Further Innovation: This patent demonstrates an early successful approach to patenting a method of treatment for a significant disease. This historical context can inform strategies for patenting new therapeutic methods, particularly for established compounds or new indications. Understanding Evolving Treatment Paradigms: The patent's focus on clofibrate, an older class of lipid-lowering drug, contrasts with current treatments dominated by statins and PCSK9 inhibitors. R&D efforts are now concentrated on newer mechanisms, improved efficacy, better safety profiles, and combination therapies that offer more targeted or potent lipid reduction. Identifying Unmet Needs: The limitations of clofibrate (e.g., side effects, efficacy compared to modern drugs) contributed to the drive for novel therapies. Current R&D must identify and address remaining unmet needs in hyperlipidemia management, such as treating specific genetic dyslipidemias or reducing residual cardiovascular risk in patients already on therapy. Method-of-Use Patenting: The patent exemplifies method-of-use patenting. This remains a viable strategy for protecting new therapeutic applications of known compounds, provided novelty and non-obviousness criteria are met. For example, discovering a new dosage regimen or a specific patient subgroup for which an existing drug is particularly effective could be patentable. Implications for Investment: Market Evolution: Investors should recognize that the hyperlipidemia market has significantly evolved beyond the scope of this patent. Investment in companies developing clofibrate itself would be unlikely to yield returns based on patent exclusivity. Focus on Novel Therapeutics: Investment opportunities lie with companies developing next-generation therapies, such as novel small molecules, biologics targeting new pathways, or advanced combination products. Due diligence should assess the strength and breadth of patent portfolios covering these new innovations. Understanding the Generic Landscape: The expiration of this patent for clofibrate means that generic versions of the drug are available. Investors considering companies involved in the production or sale of generic clofibrate must analyze market dynamics, pricing, and competition rather than patent-driven exclusivity. Patent Expiry as a Catalyst: For newer, patented drugs, understanding their patent expiry dates is critical for projecting future market share and revenue streams. The lifecycle of drugs like statins and PCSK9 inhibitors provides valuable lessons in managing patent cliffs and preparing for generic competition. Regulatory Pathways: Investment decisions should also consider the regulatory pathways for new hyperlipidemia drugs, including clinical trial success rates, FDA approval timelines, and post-market surveillance requirements. In essence, while US Patent 3,850,911 is no longer a barrier to entry for the specific method it claimed, its analysis provides valuable historical and strategic context for current R&D and investment decisions in the dynamic field of cardiovascular risk management. Key Takeaways US Patent 3,850,911 protects a method for treating hyperlipidemia using clofibrate at specific dosages (1.5-2.0g daily, b.i.d.) and durations (minimum 3 months). The patent claims focus on the therapeutic application and method of use, not the compound clofibrate itself, which was known prior to its filing. The patent's claims are specific regarding patient conditions (elevated cholesterol/triglycerides) and differentiate from dietary interventions. The patent expired decades ago, rendering the claimed method part of the public domain. The hyperlipidemia patent landscape is now dominated by newer drug classes such as statins, PCSK9 inhibitors, and ezetimibe, with extensive patent activity in these areas. For current R&D and investment, understanding this historical patent provides context for method-of-use patenting strategies and highlights the evolution of the hyperlipidemia market towards novel therapeutics and combination approaches. Frequently Asked Questions Is clofibrate still a prescribed medication for hyperlipidemia? Clofibrate is rarely prescribed today due to the availability of more effective and safer alternatives, such as statins and PCSK9 inhibitors. Its use is limited, and regulatory bodies have issued warnings regarding potential side effects. What are the primary side effects associated with clofibrate? Common side effects of clofibrate include gastrointestinal disturbances, nausea, diarrhea, and muscle pain. More serious potential side effects include liver dysfunction, gallstones, and an increased risk of non-cardiac mortality observed in some studies. Can new patents be filed for clofibrate today? New patents could potentially be filed for clofibrate if a novel, non-obvious, and useful method of treatment is discovered, such as a specific new indication, a unique combination therapy, or an advanced formulation that improves its therapeutic profile. However, patenting the basic method described in US Patent 3,850,911 is not possible due to its expiration. How does US Patent 3,850,911 compare to patents for modern hyperlipidemia drugs like statins? US Patent 3,850,911 is a method-of-use patent for an older compound with a specific therapeutic application. Patents for modern drugs like statins typically cover the novel chemical compounds themselves, their manufacturing processes, specific formulations, and various methods of use, representing protection over new chemical entities rather than established ones. What is the significance of the expiration of US Patent 3,850,911 for generic drug manufacturers? The expiration of US Patent 3,850,911 means that generic manufacturers are free to produce and market clofibrate for the method of treatment claimed in the patent without needing a license. This allows for the availability of lower-cost generic versions of the drug. Citations [1] United States Patent 3,850,911. (1974). Method for lowering elevated cholesterol and triglyceride levels. E.R. Squibb & Sons, Inc. More… ↓ ⤷ Start Trial

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Details for Patent: 3,850,911

Summary for Patent: 3,850,911