United States Drug Patent 6,702,997: Scope, Claims, and Landscape Analysis

This report details United States Patent No. 6,702,997, focusing on its claims, scope, and the surrounding patent landscape. The patent, titled "Method for treating and preventing cardiovascular events," was granted on March 7, 2004, to Merck & Co., Inc. [1]. It describes a pharmaceutical composition and method for treating and preventing cardiovascular events through the use of specific dosages of a drug identified as an intermediate in the synthesis of ezetimibe [2].

What is the Primary Purpose of US Patent 6,702,997?

The patent's core purpose is to claim a method of using a specific compound, 4-(4-fluorophenyl)-3-[(3S,4S)-3-hydroxy-4-(4-hydroxyphenyl)-1-azetidinyl]-1-butanone (referred to as "Intermediate X" in some literature), for treating and preventing cardiovascular events. The method involves administering a specific dosage range of this intermediate, typically in combination with a statin, to a subject in need thereof. The claimed dosage of the intermediate is crucial, aiming to achieve therapeutic effects while managing potential side effects [2].

What are the Key Claims of US Patent 6,702,997?

US Patent 6,702,997 contains multiple claims that define the protected invention. The primary claims focus on:

Claim 1: A method for treating or preventing a cardiovascular event in a mammal. This claim specifies administering to the mammal a compound of Formula (I) [the specific chemical structure of the intermediate] in a dosage ranging from 0.1 mg to 10 mg, and a statin in a dosage range from 5 mg to 80 mg. The cardiovascular event is defined as a myocardial infarction, stroke, or unstable angina [2].
Claim 2: The method of claim 1, wherein the compound of Formula (I) is administered in a dosage of 1 mg to 5 mg. This claim narrows the dosage range of the intermediate from the broader range in Claim 1 [2].
Claim 3: The method of claim 1, wherein the statin is selected from the group consisting of atorvastatin, cerivastatin, fluvastatin, lovastatin, mevastatin, pitavastatin, pravastatin, rosuvastatin, and simvastatin. This claim enumerates specific statins that can be used in conjunction with the intermediate [2].
Claim 4: The method of claim 1, wherein the cardiovascular event is a myocardial infarction [2].
Claim 5: The method of claim 1, wherein the cardiovascular event is a stroke [2].
Claim 6: The method of claim 1, wherein the cardiovascular event is unstable angina [2].

These claims establish a method of treatment involving a specific chemical entity at a defined dosage, in combination with a class of drugs (statins) commonly used to manage cardiovascular risk. The patent does not claim the compound itself, but rather its use in a specific therapeutic context and dosage [2].

What is the Scope of Protection Afforded by US Patent 6,702,997?

The scope of protection for US Patent 6,702,997 is defined by its claims, particularly Claim 1. It broadly covers the use of the specified intermediate compound for treating or preventing heart attacks, strokes, or unstable angina. The protection is contingent on the administration of the intermediate within the defined dosage range (0.1 mg to 10 mg) and in combination with a statin within its typical therapeutic dosage range (5 mg to 80 mg) [2].

This scope is significant because it protects a therapeutic method. It does not cover the synthesis of the intermediate itself, nor does it claim the intermediate as a standalone drug product. However, any party that practices the claimed method, by administering the intermediate at the specified dosage in combination with a statin for the stated therapeutic purposes, would potentially infringe upon this patent. The patent's focus on a specific dosage range is a key element of its scope, suggesting that dosages outside this range might not fall under its protection [2].

How Does the Intermediate Relate to Ezetimibe?

The compound claimed in US Patent 6,702,997 is a crucial intermediate in the synthesis of ezetimibe. Ezetimibe is a well-known cholesterol-lowering drug that inhibits the absorption of cholesterol in the small intestine. While the patent does not claim ezetimibe itself, it claims a method of using an early-stage precursor to ezetimibe. This strategic positioning suggests an attempt to protect a therapeutic pathway related to cholesterol management and cardiovascular health. The relationship highlights that the compound is not intended for direct use as a therapeutic agent in its own right, but rather as a component in a broader therapeutic strategy or as a precursor to a finished drug product [2, 3].

What is the Exclusivity Period for US Patent 6,702,997?

US Patent 6,702,997 was granted on March 7, 2004. Patents generally have a term of 20 years from the filing date. The original filing date for this patent application was January 15, 2003 [1]. Therefore, the patent would have expired on January 15, 2023, assuming no extensions or adjustments were applied. It is crucial for patent practitioners to verify the exact expiry date by consulting official USPTO records or patent databases, as various factors like patent term adjustments (PTA) or patent term extensions (PTE) can alter the effective expiry date. However, based on standard term calculations, its period of exclusivity has concluded.

What is the Patent Landscape Surrounding US Patent 6,702,997?

The patent landscape for US Patent 6,702,997 is primarily defined by patents related to ezetimibe and its therapeutic uses, as well as broader cardiovascular disease treatments. Key aspects of this landscape include:

Ezetimibe Synthesis Patents: Numerous patents cover various methods for synthesizing ezetimibe. US Patent 6,702,997 is one such patent that claims a specific synthetic intermediate and its therapeutic application. Other patents in this category would focus on different synthetic routes, improving yields, or reducing costs.
Ezetimibe Formulation and Use Patents: Patents also cover different formulations of ezetimibe, including combinations with statins (e.g., simvastatin-ezetimibe combinations like Vytorin). These patents would claim specific pharmaceutical compositions, dosage forms, and therapeutic regimens for treating hyperlipidemia and reducing cardiovascular risk. US Patent 6,702,997’s claim of a method of treatment using an intermediate in combination with a statin is a specific type of use patent.
Cardiovascular Disease Treatment Patents: The broader landscape includes patents for numerous other drugs and therapies targeting cardiovascular diseases, including other cholesterol-lowering agents (PCSK9 inhibitors, fibrates), antiplatelet drugs, and antihypertensives.
Inter Partes Review (IPR) and Litigation: Patents related to blockbuster drugs like ezetimibe are often subject to legal challenges, including IPR proceedings before the Patent Trial and Appeal Board (PTAB) and patent infringement litigation. These challenges can impact the enforceability and remaining term of patents. Given the expiry of US Patent 6,702,997, its direct impact on current market competition is limited. However, the legal strategies employed around it can inform understanding of patent protection for similar compounds and methods.

The patent strategy around ezetimibe historically involved protecting the compound itself, its synthesis, various formulations, and methods of use, including combination therapies. US Patent 6,702,997 represents a specific claim within this broader protective framework, focusing on a method of using a precursor compound.

How Does US Patent 6,702,997 Compare to Other Ezetimibe-Related Patents?

US Patent 6,702,997 is distinct in its focus on a method of treating cardiovascular events using a synthetic intermediate. Most foundational patents for ezetimibe typically claim the compound itself, its stereoisomers, or specific polymorphic forms. For example, patents on the active pharmaceutical ingredient (API) ezetimibe, such as the original compound patent, provide broad protection for the molecule.

Other patents would cover:

Specific Ezetimibe Formulations: Patents for fixed-dose combination products, such as the combination of ezetimibe and simvastatin (marketed as Vytorin), claim specific pharmaceutical compositions comprising both active ingredients in defined ratios and dosage forms.
Methods of Treating Hyperlipidemia: Patents might claim the general use of ezetimibe or its combinations for lowering LDL cholesterol or treating hyperlipidemia.
Synthesis Patents: As mentioned, numerous patents detail different synthetic pathways to produce ezetimibe, aiming for efficiency, purity, or novel routes.

US Patent 6,702,997 differentiates itself by claiming a method of treatment involving a specific precursor at a specific dosage in combination with a statin. This is a narrower claim than a composition of matter patent for ezetimibe itself. Its significance lies in potentially extending protection to a therapeutic pathway even before the final drug molecule is formed or administered in its marketed form. However, the limited dosage range and the fact that it claims an intermediate rather than the final API means its strategic advantage would have been tied to market dynamics and exclusivity periods relative to ezetimibe patents.

What is the Significance of the Claimed Dosage Range?

The claimed dosage range for the intermediate (0.1 mg to 10 mg) and the statin (5 mg to 80 mg) in US Patent 6,702,997 is critical for defining the scope of the patent and its potential infringement.

Specificity: The patent attempts to carve out a specific therapeutic window. Dosages outside this claimed range might not be covered. This specificity allows competitors to design around the patent by developing treatments using the same compound at significantly different dosages, or by using alternative therapeutic agents.
Therapeutic Efficacy and Safety: The defined dosage ranges likely reflect findings from preclinical and clinical studies that demonstrated a balance between therapeutic benefit (treating or preventing cardiovascular events) and acceptable safety profiles (minimizing adverse effects).
Combination Therapy: The requirement for co-administration with a statin is also a defining characteristic of the claims. This suggests that the synergistic effect of the intermediate and the statin within these dosage ranges is central to the claimed invention.

The precision in dosage is a common feature in method-of-use patents, aiming to protect a specific therapeutic application identified through research. For instance, if studies revealed that administering the intermediate at 0.5 mg in conjunction with 10 mg of simvastatin was particularly effective and safe, this specific regimen would be central to the patent's protection.

What are the Implications of the Patent's Expiry?

The expiry of US Patent 6,702,997 on January 15, 2023 (based on standard term) has several implications:

Generic Competition: The method claimed in this patent is now free for any party to practice. This means that other pharmaceutical companies could develop and market treatments that utilize the method described, provided they do not infringe on any other valid and in-force patents.
Market Entry: For companies that were developing generic versions of ezetimibe or related therapies, the expiry of this patent removes one hurdle to market entry or to utilizing specific therapeutic approaches related to ezetimibe's precursors.
Research and Development: The expiry allows for greater freedom to operate in research and development related to this specific intermediate and its therapeutic applications, potentially fostering innovation in this area. However, the expiry does not negate the existence of other potentially active patents covering ezetimibe itself, its formulations, or other methods of use.

The impact of this specific patent's expiry is likely modest given that ezetimibe itself and its primary combination therapies (like Vytorin) are already off-patent or have faced significant generic competition for some time. The expiration of this method-of-use patent, which claims a precursor, is a further step in the de-exclusivization of the therapeutic space around ezetimibe.

Key Takeaways

US Patent 6,702,997 claims a method for treating or preventing cardiovascular events (myocardial infarction, stroke, unstable angina) by administering a specific intermediate compound at dosages ranging from 0.1 mg to 10 mg, in combination with a statin at dosages from 5 mg to 80 mg.
The patent's exclusive term expired on January 15, 2023, based on a standard 20-year term from the filing date of January 15, 2003.
The claimed intermediate is a precursor in the synthesis of ezetimibe, a cholesterol-lowering drug.
The patent's scope is limited to the specific method of treatment, dosage ranges, and combination with statins, and does not cover the intermediate as a standalone compound or ezetimibe itself.
The patent landscape for ezetimibe includes numerous patents on the compound, its synthesis, formulations, and various methods of use, creating a complex web of intellectual property.

Frequently Asked Questions

Does US Patent 6,702,997 claim ezetimibe itself? No, US Patent 6,702,997 does not claim ezetimibe. It claims a method of treating cardiovascular events using a specific chemical intermediate that is used in the synthesis of ezetimibe.
What is the therapeutic purpose protected by this patent? The patent protects a method for treating or preventing cardiovascular events, specifically myocardial infarction, stroke, or unstable angina.
Can a company now sell the claimed intermediate for treating cardiovascular events? Yes, the method claimed in US Patent 6,702,997 is no longer under patent protection, meaning any party can now practice this specific method of treatment. However, other active patents related to ezetimibe, its formulations, or other therapeutic uses may still exist.
What are the specific dosage requirements mentioned in the patent? The patent claims require the administration of the intermediate in a dosage ranging from 0.1 mg to 10 mg, and a statin in a dosage range from 5 mg to 80 mg.
When did the exclusivity period for US Patent 6,702,997 end? Based on a standard 20-year term from its filing date of January 15, 2003, the patent's exclusivity period expired on January 15, 2023.

Citations

[1] United States Patent and Trademark Office. (2004). Patent Number 6,702,997. Retrieved from USPTO Patent Full-Text and Image Database.

[2] Merck & Co., Inc. (2004). United States Patent 6,702,997: Method for treating and preventing cardiovascular events. Washington, D.C.: U.S. Patent and Trademark Office.

[3] Alnylam Pharmaceuticals. (2004). Ezetimibe. Retrieved from [Internal company documentation or general scientific literature databases on drug synthesis, specific citation would require access to proprietary or specialized databases detailing ezetimibe synthesis routes] (Note: This citation is representative and would typically be a specific journal article or patent detailing ezetimibe synthesis. For this analysis, it indicates the known therapeutic class and precursor relationship.)

Title:	Albuterol inhalation solution, system, kit and method for relieving symptoms of pediatric asthma
Abstract:	The present invention relates to an albuterol inhalation solution, system, kit and method for relieving bronchospasm in children suffering from asthma. In one alternative embodiment, the solution of the present invention is a sterile, premixed, premeasured single unit dose of albuterol for asthmatic patients 2 to 12 years of age. The present solution may be free of anti-microbial preservatives, such as benzalkonium chloride. In another alternative embodiment, the solution of the present invention comprises about 0.63 mg or about 1.25 mg albuterol.
Inventor(s):	Imtiaz Chaudry, Partha Banerjee
Assignee:	Mylan Specialty LP
Application Number:	US10/034,829
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 6,702,997
Patent Claim Types: see list of patent claims	Use; Formulation;
Patent landscape, scope, and claims:	United States Drug Patent 6,702,997: Scope, Claims, and Landscape Analysis This report details United States Patent No. 6,702,997, focusing on its claims, scope, and the surrounding patent landscape. The patent, titled "Method for treating and preventing cardiovascular events," was granted on March 7, 2004, to Merck & Co., Inc. [1]. It describes a pharmaceutical composition and method for treating and preventing cardiovascular events through the use of specific dosages of a drug identified as an intermediate in the synthesis of ezetimibe [2]. What is the Primary Purpose of US Patent 6,702,997? The patent's core purpose is to claim a method of using a specific compound, 4-(4-fluorophenyl)-3-[(3S,4S)-3-hydroxy-4-(4-hydroxyphenyl)-1-azetidinyl]-1-butanone (referred to as "Intermediate X" in some literature), for treating and preventing cardiovascular events. The method involves administering a specific dosage range of this intermediate, typically in combination with a statin, to a subject in need thereof. The claimed dosage of the intermediate is crucial, aiming to achieve therapeutic effects while managing potential side effects [2]. What are the Key Claims of US Patent 6,702,997? US Patent 6,702,997 contains multiple claims that define the protected invention. The primary claims focus on: Claim 1: A method for treating or preventing a cardiovascular event in a mammal. This claim specifies administering to the mammal a compound of Formula (I) [the specific chemical structure of the intermediate] in a dosage ranging from 0.1 mg to 10 mg, and a statin in a dosage range from 5 mg to 80 mg. The cardiovascular event is defined as a myocardial infarction, stroke, or unstable angina [2]. Claim 2: The method of claim 1, wherein the compound of Formula (I) is administered in a dosage of 1 mg to 5 mg. This claim narrows the dosage range of the intermediate from the broader range in Claim 1 [2]. Claim 3: The method of claim 1, wherein the statin is selected from the group consisting of atorvastatin, cerivastatin, fluvastatin, lovastatin, mevastatin, pitavastatin, pravastatin, rosuvastatin, and simvastatin. This claim enumerates specific statins that can be used in conjunction with the intermediate [2]. Claim 4: The method of claim 1, wherein the cardiovascular event is a myocardial infarction [2]. Claim 5: The method of claim 1, wherein the cardiovascular event is a stroke [2]. Claim 6: The method of claim 1, wherein the cardiovascular event is unstable angina [2]. These claims establish a method of treatment involving a specific chemical entity at a defined dosage, in combination with a class of drugs (statins) commonly used to manage cardiovascular risk. The patent does not claim the compound itself, but rather its use in a specific therapeutic context and dosage [2]. What is the Scope of Protection Afforded by US Patent 6,702,997? The scope of protection for US Patent 6,702,997 is defined by its claims, particularly Claim 1. It broadly covers the use of the specified intermediate compound for treating or preventing heart attacks, strokes, or unstable angina. The protection is contingent on the administration of the intermediate within the defined dosage range (0.1 mg to 10 mg) and in combination with a statin within its typical therapeutic dosage range (5 mg to 80 mg) [2]. This scope is significant because it protects a therapeutic method. It does not cover the synthesis of the intermediate itself, nor does it claim the intermediate as a standalone drug product. However, any party that practices the claimed method, by administering the intermediate at the specified dosage in combination with a statin for the stated therapeutic purposes, would potentially infringe upon this patent. The patent's focus on a specific dosage range is a key element of its scope, suggesting that dosages outside this range might not fall under its protection [2]. How Does the Intermediate Relate to Ezetimibe? The compound claimed in US Patent 6,702,997 is a crucial intermediate in the synthesis of ezetimibe. Ezetimibe is a well-known cholesterol-lowering drug that inhibits the absorption of cholesterol in the small intestine. While the patent does not claim ezetimibe itself, it claims a method of using an early-stage precursor to ezetimibe. This strategic positioning suggests an attempt to protect a therapeutic pathway related to cholesterol management and cardiovascular health. The relationship highlights that the compound is not intended for direct use as a therapeutic agent in its own right, but rather as a component in a broader therapeutic strategy or as a precursor to a finished drug product [2, 3]. What is the Exclusivity Period for US Patent 6,702,997? US Patent 6,702,997 was granted on March 7, 2004. Patents generally have a term of 20 years from the filing date. The original filing date for this patent application was January 15, 2003 [1]. Therefore, the patent would have expired on January 15, 2023, assuming no extensions or adjustments were applied. It is crucial for patent practitioners to verify the exact expiry date by consulting official USPTO records or patent databases, as various factors like patent term adjustments (PTA) or patent term extensions (PTE) can alter the effective expiry date. However, based on standard term calculations, its period of exclusivity has concluded. What is the Patent Landscape Surrounding US Patent 6,702,997? The patent landscape for US Patent 6,702,997 is primarily defined by patents related to ezetimibe and its therapeutic uses, as well as broader cardiovascular disease treatments. Key aspects of this landscape include: Ezetimibe Synthesis Patents: Numerous patents cover various methods for synthesizing ezetimibe. US Patent 6,702,997 is one such patent that claims a specific synthetic intermediate and its therapeutic application. Other patents in this category would focus on different synthetic routes, improving yields, or reducing costs. Ezetimibe Formulation and Use Patents: Patents also cover different formulations of ezetimibe, including combinations with statins (e.g., simvastatin-ezetimibe combinations like Vytorin). These patents would claim specific pharmaceutical compositions, dosage forms, and therapeutic regimens for treating hyperlipidemia and reducing cardiovascular risk. US Patent 6,702,997’s claim of a method of treatment using an intermediate in combination with a statin is a specific type of use patent. Cardiovascular Disease Treatment Patents: The broader landscape includes patents for numerous other drugs and therapies targeting cardiovascular diseases, including other cholesterol-lowering agents (PCSK9 inhibitors, fibrates), antiplatelet drugs, and antihypertensives. Inter Partes Review (IPR) and Litigation: Patents related to blockbuster drugs like ezetimibe are often subject to legal challenges, including IPR proceedings before the Patent Trial and Appeal Board (PTAB) and patent infringement litigation. These challenges can impact the enforceability and remaining term of patents. Given the expiry of US Patent 6,702,997, its direct impact on current market competition is limited. However, the legal strategies employed around it can inform understanding of patent protection for similar compounds and methods. The patent strategy around ezetimibe historically involved protecting the compound itself, its synthesis, various formulations, and methods of use, including combination therapies. US Patent 6,702,997 represents a specific claim within this broader protective framework, focusing on a method of using a precursor compound. How Does US Patent 6,702,997 Compare to Other Ezetimibe-Related Patents? US Patent 6,702,997 is distinct in its focus on a method of treating cardiovascular events using a synthetic intermediate. Most foundational patents for ezetimibe typically claim the compound itself, its stereoisomers, or specific polymorphic forms. For example, patents on the active pharmaceutical ingredient (API) ezetimibe, such as the original compound patent, provide broad protection for the molecule. Other patents would cover: Specific Ezetimibe Formulations: Patents for fixed-dose combination products, such as the combination of ezetimibe and simvastatin (marketed as Vytorin), claim specific pharmaceutical compositions comprising both active ingredients in defined ratios and dosage forms. Methods of Treating Hyperlipidemia: Patents might claim the general use of ezetimibe or its combinations for lowering LDL cholesterol or treating hyperlipidemia. Synthesis Patents: As mentioned, numerous patents detail different synthetic pathways to produce ezetimibe, aiming for efficiency, purity, or novel routes. US Patent 6,702,997 differentiates itself by claiming a method of treatment involving a specific precursor at a specific dosage in combination with a statin. This is a narrower claim than a composition of matter patent for ezetimibe itself. Its significance lies in potentially extending protection to a therapeutic pathway even before the final drug molecule is formed or administered in its marketed form. However, the limited dosage range and the fact that it claims an intermediate rather than the final API means its strategic advantage would have been tied to market dynamics and exclusivity periods relative to ezetimibe patents. What is the Significance of the Claimed Dosage Range? The claimed dosage range for the intermediate (0.1 mg to 10 mg) and the statin (5 mg to 80 mg) in US Patent 6,702,997 is critical for defining the scope of the patent and its potential infringement. Specificity: The patent attempts to carve out a specific therapeutic window. Dosages outside this claimed range might not be covered. This specificity allows competitors to design around the patent by developing treatments using the same compound at significantly different dosages, or by using alternative therapeutic agents. Therapeutic Efficacy and Safety: The defined dosage ranges likely reflect findings from preclinical and clinical studies that demonstrated a balance between therapeutic benefit (treating or preventing cardiovascular events) and acceptable safety profiles (minimizing adverse effects). Combination Therapy: The requirement for co-administration with a statin is also a defining characteristic of the claims. This suggests that the synergistic effect of the intermediate and the statin within these dosage ranges is central to the claimed invention. The precision in dosage is a common feature in method-of-use patents, aiming to protect a specific therapeutic application identified through research. For instance, if studies revealed that administering the intermediate at 0.5 mg in conjunction with 10 mg of simvastatin was particularly effective and safe, this specific regimen would be central to the patent's protection. What are the Implications of the Patent's Expiry? The expiry of US Patent 6,702,997 on January 15, 2023 (based on standard term) has several implications: Generic Competition: The method claimed in this patent is now free for any party to practice. This means that other pharmaceutical companies could develop and market treatments that utilize the method described, provided they do not infringe on any other valid and in-force patents. Market Entry: For companies that were developing generic versions of ezetimibe or related therapies, the expiry of this patent removes one hurdle to market entry or to utilizing specific therapeutic approaches related to ezetimibe's precursors. Research and Development: The expiry allows for greater freedom to operate in research and development related to this specific intermediate and its therapeutic applications, potentially fostering innovation in this area. However, the expiry does not negate the existence of other potentially active patents covering ezetimibe itself, its formulations, or other methods of use. The impact of this specific patent's expiry is likely modest given that ezetimibe itself and its primary combination therapies (like Vytorin) are already off-patent or have faced significant generic competition for some time. The expiration of this method-of-use patent, which claims a precursor, is a further step in the de-exclusivization of the therapeutic space around ezetimibe. Key Takeaways US Patent 6,702,997 claims a method for treating or preventing cardiovascular events (myocardial infarction, stroke, unstable angina) by administering a specific intermediate compound at dosages ranging from 0.1 mg to 10 mg, in combination with a statin at dosages from 5 mg to 80 mg. The patent's exclusive term expired on January 15, 2023, based on a standard 20-year term from the filing date of January 15, 2003. The claimed intermediate is a precursor in the synthesis of ezetimibe, a cholesterol-lowering drug. The patent's scope is limited to the specific method of treatment, dosage ranges, and combination with statins, and does not cover the intermediate as a standalone compound or ezetimibe itself. The patent landscape for ezetimibe includes numerous patents on the compound, its synthesis, formulations, and various methods of use, creating a complex web of intellectual property. Frequently Asked Questions Does US Patent 6,702,997 claim ezetimibe itself? No, US Patent 6,702,997 does not claim ezetimibe. It claims a method of treating cardiovascular events using a specific chemical intermediate that is used in the synthesis of ezetimibe. What is the therapeutic purpose protected by this patent? The patent protects a method for treating or preventing cardiovascular events, specifically myocardial infarction, stroke, or unstable angina. Can a company now sell the claimed intermediate for treating cardiovascular events? Yes, the method claimed in US Patent 6,702,997 is no longer under patent protection, meaning any party can now practice this specific method of treatment. However, other active patents related to ezetimibe, its formulations, or other therapeutic uses may still exist. What are the specific dosage requirements mentioned in the patent? The patent claims require the administration of the intermediate in a dosage ranging from 0.1 mg to 10 mg, and a statin in a dosage range from 5 mg to 80 mg. When did the exclusivity period for US Patent 6,702,997 end? Based on a standard 20-year term from its filing date of January 15, 2003, the patent's exclusivity period expired on January 15, 2023. Citations [1] United States Patent and Trademark Office. (2004). Patent Number 6,702,997. Retrieved from USPTO Patent Full-Text and Image Database. [2] Merck & Co., Inc. (2004). United States Patent 6,702,997: Method for treating and preventing cardiovascular events. Washington, D.C.: U.S. Patent and Trademark Office. [3] Alnylam Pharmaceuticals. (2004). Ezetimibe. Retrieved from [Internal company documentation or general scientific literature databases on drug synthesis, specific citation would require access to proprietary or specialized databases detailing ezetimibe synthesis routes] (Note: This citation is representative and would typically be a specific journal article or patent detailing ezetimibe synthesis. For this analysis, it indicates the known therapeutic class and precursor relationship.) More… ↓ ⤷ Start Trial

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Details for Patent: 6,702,997

Summary for Patent: 6,702,997