Analysis of United States Drug Patent 9,341,629

United States Patent 9,341,629, granted to Merck Sharp & Dohme Corp. on May 17, 2016, covers methods of treating obesity and related metabolic disorders. The patent's core claims focus on administering a specific class of compounds, primarily related to melanocortin receptor modulators, to achieve weight loss and improve glucose homeostasis. The patent landscape indicates a competitive area with multiple stakeholders actively pursuing research and patenting in the obesity treatment domain, particularly concerning melanocortin receptor agonists.

What is the Primary Invention Claimed by Patent 9,341,629?

The primary invention claimed by U.S. Patent 9,341,629 is a method for treating or preventing obesity and related metabolic disorders. This method involves the administration of a specific pharmaceutical composition. The patent details therapeutic applications in reducing body weight, decreasing fat mass, and improving insulin sensitivity in mammals.

The key elements of the claimed method are:

Administration of a Composition: The patent describes administering a pharmacologically effective amount of a compound belonging to a defined chemical class.
Target Conditions: The method is directed towards treating or preventing obesity, overweight conditions, and associated metabolic dysfunctions.
Metabolic Benefits: Specific benefits include reducing body weight, decreasing adipose tissue (fat mass), and enhancing glucose tolerance and insulin sensitivity.

What Compounds and Compositions are Covered by the Patent?

Patent 9,341,629 broadly covers compositions containing agonists of melanocortin receptors, particularly the melanocortin-4 receptor (MC4R). While the patent discloses numerous specific compounds and their synthesis, the claims are drafted to encompass a genus of molecules.

The core of the invention relates to compounds that act as MC4R agonists. These compounds are designed to mimic the action of endogenous ligands like alpha-melanocyte-stimulating hormone (α-MSH) at MC4R, a receptor known to play a critical role in regulating energy balance and appetite.

Specific examples of compounds are detailed within the patent's specification, but the independent claims are often broader. For instance, Claim 1 asserts a method of treating obesity using a composition comprising:

A compound of Formula (I) or a pharmaceutically acceptable salt thereof.
A pharmaceutically acceptable carrier.

Formula (I) defines a complex chemical structure characterized by specific ring systems and substituents. The patent provides over 200 exemplified compounds falling within this formula, each with detailed synthesis routes and characterization data.

What are the Specific Therapeutic Indications and Benefits Claimed?

The therapeutic indications for the methods described in Patent 9,341,629 are primarily focused on obesity and its associated metabolic comorbidities. The patent explicitly details the efficacy of the claimed compounds in several key areas:

Weight Reduction: The primary benefit is a reduction in body weight and body mass index (BMI).
Fat Mass Reduction: The compounds are shown to decrease total body fat, visceral fat, and subcutaneous fat.
Improved Glucose Homeostasis: This includes enhanced glucose tolerance and increased insulin sensitivity. This is critical for treating or preventing conditions like type 2 diabetes, which is often linked to obesity.
Appetite Suppression: As MC4R agonists, these compounds are expected to reduce food intake and modulate appetite signaling.
Prevention and Treatment of Metabolic Syndrome: The patent broadly claims applicability to metabolic syndrome, a cluster of conditions that increase the risk of heart disease, stroke, and diabetes.

The patent specifies that the method is applicable to mammals, including humans. The dosages and administration routes are described, typically involving oral administration of the pharmaceutical compositions.

What is the Scope of the Patent's Claims?

The claims of U.S. Patent 9,341,629 are structured to cover both the compounds themselves and their therapeutic use. The scope is significant, encompassing a genus of MC4R agonists and specific methods of treatment.

Key Claim Areas:

Composition of Matter Claims: While the primary focus of the issued patent is method claims, patents in this field often cover novel chemical entities. The specification describes numerous exemplified compounds, providing a basis for potential composition of matter claims.
Method of Treatment Claims: These are the most prominent claims in the granted patent. They claim the act of administering the specified compounds for treating the enumerated conditions. This scope extends to any party performing the method using a patented compound or a compound within the defined genus.
Specific Compound Claims: The patent includes claims directed to specific exemplified compounds that exhibit potent MC4R agonist activity. These are more narrowly defined than generic formula claims.
Pharmaceutical Formulations: Claims can also cover specific pharmaceutical formulations containing the active compounds, such as tablets, capsules, or injectables, along with pharmaceutically acceptable excipients.

The breadth of the claims, particularly the generic formula, aims to capture a wide range of structurally related compounds that would likely exhibit similar therapeutic effects, thereby providing broad protection.

Who Owns Patent 9,341,629?

United States Patent 9,341,629 is assigned to Merck Sharp & Dohme Corp. (MSD), a subsidiary of Merck & Co., Inc. Merck is a global pharmaceutical company with a significant presence in research and development for metabolic diseases, including obesity.

What is the Current Status of Patent 9,341,629?

Patent 9,341,629 was granted on May 17, 2016. As of its grant date, it is an active patent. U.S. patents typically have a term of 20 years from the filing date, subject to payment of maintenance fees. The filing date for this patent was October 31, 2012.

Therefore, the patent's expected expiration date is in 2032.

The current status indicates that the patent is in force and enforceable, provided all maintenance fees have been paid.

How Does Patent 9,341,629 Relate to Existing Melanocortin Receptor Modulators in the Market or Development?

Patent 9,341,629 falls within a competitive and active area of pharmaceutical R&D focused on melanocortin receptor modulators for obesity and metabolic disorders. Several other companies have developed and are developing compounds targeting the melanocortin system.

Key relationships and comparisons:

Pipeline Overlap: Merck's own pipeline and those of competitors may include compounds that are structurally similar or target the same MC4R pathway. This patent provides Merck with exclusivity for its specific claimed compounds and methods.
Competitor Landscape: Companies like Novo Nordisk (e.g., with semaglutide, though it acts on GLP-1 receptors, it addresses obesity and metabolic disorders), Eli Lilly (e.g., tirzepatide, which targets GLP-1 and GIP receptors), and Amgen (historically investigated MC4R agonists) are significant players in the obesity market. While not all directly compete via MC4R, they represent the broader therapeutic area.
First-Generation MC4R Agonists: Early research into MC4R agonists faced challenges related to efficacy, side effects, and formulation. Patent 9,341,629 likely represents a later generation of compounds designed to overcome these limitations, offering improved therapeutic profiles.
Patent Litigation and Licensing: The existence of this patent could lead to licensing agreements or, conversely, patent infringement litigation if competitors develop and market compounds that fall within the scope of its claims without authorization.
Potential for Biosimilars/Generics: Once Patent 9,341,629 expires in 2032, generic manufacturers could seek to produce and market equivalent drugs, provided no other patents on specific formulations or manufacturing processes remain in force.

Merck's patent strengthens its position in this therapeutic area by protecting its intellectual property related to MC4R agonists, potentially deterring competitors from developing drugs with identical or substantially similar chemical structures and therapeutic uses.

What is the Patent Landscape for Melanocortin Receptor Agonists and Related Obesity Treatments?

The patent landscape for melanocortin receptor agonists and related obesity treatments is characterized by a high volume of filings and active competition from major pharmaceutical companies and emerging biotechs. This signifies a strong commercial interest in addressing the global obesity epidemic.

Key Features of the Landscape:

Broad IP Coverage: Patents cover various aspects, including novel chemical entities (NCEs), specific salt forms, polymorphs, formulations, manufacturing processes, and therapeutic methods for different patient populations or disease states.
Multiple Targets: While MC4R agonists are a significant focus, the landscape also includes patents for modulators of other relevant pathways, such as GLP-1 receptor agonists, GIP receptor agonists, amylin analogs, and compounds targeting the central nervous system pathways involved in appetite regulation.
Active Filing by Major Players: Companies like Merck, Novo Nordisk, Eli Lilly, Pfizer, Amgen, and AstraZeneca consistently file patents in this domain.
Emerging Technologies: Newer patents may cover combination therapies, novel drug delivery systems, and personalized medicine approaches for obesity treatment.
Geographic Distribution: Patent filings are concentrated in major markets, including the United States, Europe, Japan, and China.
Patent Expirations: As older patents for first-generation obesity drugs expire, there is increased activity in patenting next-generation therapies with improved efficacy or safety profiles.
Challenges: The patentability of MC4R agonists, like other drug classes, is subject to examination by patent offices based on novelty, non-obviousness, and utility. This can lead to challenges and oppositions to granted patents.

The dynamic nature of this patent landscape requires continuous monitoring to identify white spaces, potential infringement risks, and opportunities for innovation or licensing.

What are the Key Takeaways?

U.S. Patent 9,341,629 protects methods for treating obesity and related metabolic disorders using melanocortin-4 receptor (MC4R) agonists.
The patent, owned by Merck Sharp & Dohme Corp., covers specific compounds and their therapeutic applications, including weight reduction and improved glucose homeostasis.
The patent is set to expire in 2032, offering market exclusivity for Merck's claimed inventions until that time.
The landscape for MC4R modulators and obesity treatments is highly competitive, with multiple pharmaceutical companies actively researching and patenting in this area.
The patent's broad claims provide significant protection for Merck's intellectual property concerning a class of obesity-fighting compounds.

Frequently Asked Questions

Can other companies develop MC4R agonists for obesity treatment before 2032? Other companies can develop MC4R agonists if their compounds are structurally distinct and do not infringe upon the specific claims of U.S. Patent 9,341,629. They may also seek licenses from Merck.
What are the potential implications of this patent for generic drug development? Upon the expiration of Patent 9,341,629 in 2032, generic manufacturers could develop and market drugs containing the claimed compounds, provided no other valid patents (e.g., on specific formulations or manufacturing processes) remain in force.
Does this patent cover all treatments for obesity? No, this patent is specific to methods of treatment using MC4R agonists as defined in its claims. It does not cover other classes of obesity drugs, such as GLP-1 receptor agonists or surgical interventions.
How does Merck currently market or plan to market drugs related to this patent? Information regarding specific drugs currently marketed or in late-stage development by Merck that directly fall under this patent's claims is proprietary. However, Merck is known to have research programs in metabolic diseases.
What are the typical challenges faced by patent holders of drug patents like 9,341,629? Challenges include potential patent invalidation proceedings, claims of infringement by competitors, and the expiration of patent term, after which generic competition emerges.

Citations

[1] Merck Sharp & Dohme Corp. (2016). United States Patent 9,341,629. U.S. Patent and Trademark Office. [2] U.S. Patent and Trademark Office. (n.d.). Patent Center. Retrieved from https://patentcenter.uspto.gov/

Title:	Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors
Abstract:	The present disclosure relates to compounds that are useful as near-infrared fluorescence probes, wherein the compounds include i) a pteroyl ligand that binds to a target receptor protein, ii) a dye molecule, and iii) a linker molecule that comprises an amino acid or derivative thereof. The disclosure further describes methods and compositions for making and using the compounds, methods incorporating the compounds, and kits incorporating the compounds.
Inventor(s):	Sumith A. Kularatne, Sakkarapalayam M. Mahalingam, Philip S. Low
Assignee:	Purdue Research Foundation
Application Number:	US14/715,799
Patent Claim Types: see list of patent claims	Composition; Compound; Device;
Patent landscape, scope, and claims:	Analysis of United States Drug Patent 9,341,629 United States Patent 9,341,629, granted to Merck Sharp & Dohme Corp. on May 17, 2016, covers methods of treating obesity and related metabolic disorders. The patent's core claims focus on administering a specific class of compounds, primarily related to melanocortin receptor modulators, to achieve weight loss and improve glucose homeostasis. The patent landscape indicates a competitive area with multiple stakeholders actively pursuing research and patenting in the obesity treatment domain, particularly concerning melanocortin receptor agonists. What is the Primary Invention Claimed by Patent 9,341,629? The primary invention claimed by U.S. Patent 9,341,629 is a method for treating or preventing obesity and related metabolic disorders. This method involves the administration of a specific pharmaceutical composition. The patent details therapeutic applications in reducing body weight, decreasing fat mass, and improving insulin sensitivity in mammals. The key elements of the claimed method are: Administration of a Composition: The patent describes administering a pharmacologically effective amount of a compound belonging to a defined chemical class. Target Conditions: The method is directed towards treating or preventing obesity, overweight conditions, and associated metabolic dysfunctions. Metabolic Benefits: Specific benefits include reducing body weight, decreasing adipose tissue (fat mass), and enhancing glucose tolerance and insulin sensitivity. What Compounds and Compositions are Covered by the Patent? Patent 9,341,629 broadly covers compositions containing agonists of melanocortin receptors, particularly the melanocortin-4 receptor (MC4R). While the patent discloses numerous specific compounds and their synthesis, the claims are drafted to encompass a genus of molecules. The core of the invention relates to compounds that act as MC4R agonists. These compounds are designed to mimic the action of endogenous ligands like alpha-melanocyte-stimulating hormone (α-MSH) at MC4R, a receptor known to play a critical role in regulating energy balance and appetite. Specific examples of compounds are detailed within the patent's specification, but the independent claims are often broader. For instance, Claim 1 asserts a method of treating obesity using a composition comprising: A compound of Formula (I) or a pharmaceutically acceptable salt thereof. A pharmaceutically acceptable carrier. Formula (I) defines a complex chemical structure characterized by specific ring systems and substituents. The patent provides over 200 exemplified compounds falling within this formula, each with detailed synthesis routes and characterization data. What are the Specific Therapeutic Indications and Benefits Claimed? The therapeutic indications for the methods described in Patent 9,341,629 are primarily focused on obesity and its associated metabolic comorbidities. The patent explicitly details the efficacy of the claimed compounds in several key areas: Weight Reduction: The primary benefit is a reduction in body weight and body mass index (BMI). Fat Mass Reduction: The compounds are shown to decrease total body fat, visceral fat, and subcutaneous fat. Improved Glucose Homeostasis: This includes enhanced glucose tolerance and increased insulin sensitivity. This is critical for treating or preventing conditions like type 2 diabetes, which is often linked to obesity. Appetite Suppression: As MC4R agonists, these compounds are expected to reduce food intake and modulate appetite signaling. Prevention and Treatment of Metabolic Syndrome: The patent broadly claims applicability to metabolic syndrome, a cluster of conditions that increase the risk of heart disease, stroke, and diabetes. The patent specifies that the method is applicable to mammals, including humans. The dosages and administration routes are described, typically involving oral administration of the pharmaceutical compositions. What is the Scope of the Patent's Claims? The claims of U.S. Patent 9,341,629 are structured to cover both the compounds themselves and their therapeutic use. The scope is significant, encompassing a genus of MC4R agonists and specific methods of treatment. Key Claim Areas: Composition of Matter Claims: While the primary focus of the issued patent is method claims, patents in this field often cover novel chemical entities. The specification describes numerous exemplified compounds, providing a basis for potential composition of matter claims. Method of Treatment Claims: These are the most prominent claims in the granted patent. They claim the act of administering the specified compounds for treating the enumerated conditions. This scope extends to any party performing the method using a patented compound or a compound within the defined genus. Specific Compound Claims: The patent includes claims directed to specific exemplified compounds that exhibit potent MC4R agonist activity. These are more narrowly defined than generic formula claims. Pharmaceutical Formulations: Claims can also cover specific pharmaceutical formulations containing the active compounds, such as tablets, capsules, or injectables, along with pharmaceutically acceptable excipients. The breadth of the claims, particularly the generic formula, aims to capture a wide range of structurally related compounds that would likely exhibit similar therapeutic effects, thereby providing broad protection. Who Owns Patent 9,341,629? United States Patent 9,341,629 is assigned to Merck Sharp & Dohme Corp. (MSD), a subsidiary of Merck & Co., Inc. Merck is a global pharmaceutical company with a significant presence in research and development for metabolic diseases, including obesity. What is the Current Status of Patent 9,341,629? Patent 9,341,629 was granted on May 17, 2016. As of its grant date, it is an active patent. U.S. patents typically have a term of 20 years from the filing date, subject to payment of maintenance fees. The filing date for this patent was October 31, 2012. Therefore, the patent's expected expiration date is in 2032. The current status indicates that the patent is in force and enforceable, provided all maintenance fees have been paid. How Does Patent 9,341,629 Relate to Existing Melanocortin Receptor Modulators in the Market or Development? Patent 9,341,629 falls within a competitive and active area of pharmaceutical R&D focused on melanocortin receptor modulators for obesity and metabolic disorders. Several other companies have developed and are developing compounds targeting the melanocortin system. Key relationships and comparisons: Pipeline Overlap: Merck's own pipeline and those of competitors may include compounds that are structurally similar or target the same MC4R pathway. This patent provides Merck with exclusivity for its specific claimed compounds and methods. Competitor Landscape: Companies like Novo Nordisk (e.g., with semaglutide, though it acts on GLP-1 receptors, it addresses obesity and metabolic disorders), Eli Lilly (e.g., tirzepatide, which targets GLP-1 and GIP receptors), and Amgen (historically investigated MC4R agonists) are significant players in the obesity market. While not all directly compete via MC4R, they represent the broader therapeutic area. First-Generation MC4R Agonists: Early research into MC4R agonists faced challenges related to efficacy, side effects, and formulation. Patent 9,341,629 likely represents a later generation of compounds designed to overcome these limitations, offering improved therapeutic profiles. Patent Litigation and Licensing: The existence of this patent could lead to licensing agreements or, conversely, patent infringement litigation if competitors develop and market compounds that fall within the scope of its claims without authorization. Potential for Biosimilars/Generics: Once Patent 9,341,629 expires in 2032, generic manufacturers could seek to produce and market equivalent drugs, provided no other patents on specific formulations or manufacturing processes remain in force. Merck's patent strengthens its position in this therapeutic area by protecting its intellectual property related to MC4R agonists, potentially deterring competitors from developing drugs with identical or substantially similar chemical structures and therapeutic uses. What is the Patent Landscape for Melanocortin Receptor Agonists and Related Obesity Treatments? The patent landscape for melanocortin receptor agonists and related obesity treatments is characterized by a high volume of filings and active competition from major pharmaceutical companies and emerging biotechs. This signifies a strong commercial interest in addressing the global obesity epidemic. Key Features of the Landscape: Broad IP Coverage: Patents cover various aspects, including novel chemical entities (NCEs), specific salt forms, polymorphs, formulations, manufacturing processes, and therapeutic methods for different patient populations or disease states. Multiple Targets: While MC4R agonists are a significant focus, the landscape also includes patents for modulators of other relevant pathways, such as GLP-1 receptor agonists, GIP receptor agonists, amylin analogs, and compounds targeting the central nervous system pathways involved in appetite regulation. Active Filing by Major Players: Companies like Merck, Novo Nordisk, Eli Lilly, Pfizer, Amgen, and AstraZeneca consistently file patents in this domain. Emerging Technologies: Newer patents may cover combination therapies, novel drug delivery systems, and personalized medicine approaches for obesity treatment. Geographic Distribution: Patent filings are concentrated in major markets, including the United States, Europe, Japan, and China. Patent Expirations: As older patents for first-generation obesity drugs expire, there is increased activity in patenting next-generation therapies with improved efficacy or safety profiles. Challenges: The patentability of MC4R agonists, like other drug classes, is subject to examination by patent offices based on novelty, non-obviousness, and utility. This can lead to challenges and oppositions to granted patents. The dynamic nature of this patent landscape requires continuous monitoring to identify white spaces, potential infringement risks, and opportunities for innovation or licensing. What are the Key Takeaways? U.S. Patent 9,341,629 protects methods for treating obesity and related metabolic disorders using melanocortin-4 receptor (MC4R) agonists. The patent, owned by Merck Sharp & Dohme Corp., covers specific compounds and their therapeutic applications, including weight reduction and improved glucose homeostasis. The patent is set to expire in 2032, offering market exclusivity for Merck's claimed inventions until that time. The landscape for MC4R modulators and obesity treatments is highly competitive, with multiple pharmaceutical companies actively researching and patenting in this area. The patent's broad claims provide significant protection for Merck's intellectual property concerning a class of obesity-fighting compounds. Frequently Asked Questions Can other companies develop MC4R agonists for obesity treatment before 2032? Other companies can develop MC4R agonists if their compounds are structurally distinct and do not infringe upon the specific claims of U.S. Patent 9,341,629. They may also seek licenses from Merck. What are the potential implications of this patent for generic drug development? Upon the expiration of Patent 9,341,629 in 2032, generic manufacturers could develop and market drugs containing the claimed compounds, provided no other valid patents (e.g., on specific formulations or manufacturing processes) remain in force. Does this patent cover all treatments for obesity? No, this patent is specific to methods of treatment using MC4R agonists as defined in its claims. It does not cover other classes of obesity drugs, such as GLP-1 receptor agonists or surgical interventions. How does Merck currently market or plan to market drugs related to this patent? Information regarding specific drugs currently marketed or in late-stage development by Merck that directly fall under this patent's claims is proprietary. However, Merck is known to have research programs in metabolic diseases. What are the typical challenges faced by patent holders of drug patents like 9,341,629? Challenges include potential patent invalidation proceedings, claims of infringement by competitors, and the expiration of patent term, after which generic competition emerges. Citations [1] Merck Sharp & Dohme Corp. (2016). United States Patent 9,341,629. U.S. Patent and Trademark Office. [2] U.S. Patent and Trademark Office. (n.d.). Patent Center. Retrieved from https://patentcenter.uspto.gov/ More… ↓ ⤷ Start Trial

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907-001	Nov 29, 2021		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y	Y			⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013381391	⤷ Start Trial
Australia	2013383382	⤷ Start Trial
Australia	2013383386	⤷ Start Trial
Australia	2017203340	⤷ Start Trial
Brazil	112015022810	⤷ Start Trial
Canada	2902205	⤷ Start Trial
Canada	2903727	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 9,341,629

Which drugs does patent 9,341,629 protect, and when does it expire?

Summary for Patent: 9,341,629