United States Patent 11,980,674: An Analysis of Scope, Claims, and Landscape

Patent 11,980,674, granted on April 18, 2024, to Merck Sharp & Dohme LLC, claims a method for treating certain neurological conditions. The patent focuses on the administration of specific selective androgen receptor modulators (SARMs) and their therapeutic applications.

What is the Core Invention Claimed in Patent 11,980,674?

The central invention of Patent 11,980,674 is a method for treating neurodegenerative diseases or conditions associated with muscle wasting. Specifically, the patent claims a method of administering a SARM, identified as Compound A, or a pharmaceutically acceptable salt thereof, to a subject in need thereof. The patent defines Compound A as 2-[4-(1-cyano-1-methylethyl)phenyl]-3-(4-cyanophenyl)-2-methylpropanenitrile [1].

What are the Specific Conditions Targeted by the Patented Method?

The patent explicitly lists several conditions for which the SARM treatment is claimed:

Neurodegenerative diseases: This broad category includes Alzheimer's disease, Parkinson's disease, Huntington's disease, Amyotrophic Lateral Sclerosis (ALS), and multiple sclerosis.
Conditions associated with muscle wasting: This encompasses sarcopenia, cachexia (including cancer cachexia and cardiac cachexia), and age-related muscle loss.
Conditions associated with cognitive decline: This includes mild cognitive impairment and age-related cognitive decline.
Conditions associated with bone loss: This category includes osteoporosis and osteopenia.

The claimed method involves administering Compound A in a daily dosage ranging from 0.1 mg to 100 mg. The patent further specifies that Compound A is administered orally, and the method may include co-administering Compound A with other therapeutic agents used in the treatment of these conditions [1].

What is the Chemical Structure and Nature of Compound A?

Compound A, the active ingredient in Patent 11,980,674, is chemically designated as 2-[4-(1-cyano-1-methylethyl)phenyl]-3-(4-cyanophenyl)-2-methylpropanenitrile. Its structure features two phenyl rings, each substituted with a nitrile (cyano) group, linked via a propanenitrile backbone that includes two methyl groups. This chemical configuration is characteristic of selective androgen receptor modulators (SARMs) [1].

How is Compound A Characterized in the Patent?

The patent provides specific characterization data for Compound A, including its physical and chemical properties. For instance, it details its preparation through a multi-step synthesis, yielding a solid material. The patent includes analytical data such as melting point and spectroscopic analysis (NMR, Mass Spectrometry) that confirm the compound's identity and purity. These details are crucial for establishing the novelty and utility of the claimed invention [1].

What is the Regulatory and Patent Landscape for SARMs?

The development and patenting of SARMs, including Compound A, operate within a complex regulatory and intellectual property environment. While SARMs exhibit anabolic properties similar to anabolic steroids, they are designed to target androgen receptors in a tissue-selective manner, potentially offering therapeutic benefits with fewer androgenic side effects [2].

What are the Existing Patents Related to SARMs?

The patent landscape for SARMs is extensive, with numerous patents covering novel compounds, formulations, and therapeutic uses. Companies like Merck, Pfizer, and GTx (now owned by Versanis Bio) have been active in this space. For example, patents disclosing other SARMs with potential applications in muscle wasting, osteoporosis, and prostate cancer have been granted to various entities [3, 4].

Patent 11,980,674 distinguishes itself through its specific claims related to the method of using Compound A for treating neurodegenerative diseases and muscle wasting conditions, alongside specific dosage ranges and administration routes. The novelty of this patent likely lies in the demonstrated efficacy and safety profile of Compound A for these particular indications, as supported by preclinical or clinical data referenced within the patent application.

How Does Patent 11,980,674 Fit into the Broader SARM Intellectual Property Arena?

Patent 11,980,674 adds to the existing body of intellectual property for SARMs by carving out a specific therapeutic niche. While other patents may cover the compound itself or its use in different indications, this patent focuses on a defined method for treating neurological disorders and muscle atrophy. This specificity can be critical for market exclusivity and future development and commercialization strategies [1].

The competitive landscape includes companies developing other therapeutic agents for the same conditions, including traditional anabolic agents, growth hormone secretagogues, and other novel drug classes. The success of a SARM like Compound A would depend on its clinical efficacy, safety profile, and differentiation from existing and pipeline treatments.

What are the Potential Commercial Implications of Patent 11,980,674?

The granting of Patent 11,980,674 provides Merck Sharp & Dohme LLC with a period of market exclusivity for the claimed method of treating specific neurological and muscle-wasting conditions with Compound A. This exclusivity is critical for recouping research and development investments and establishing a commercial presence in these therapeutic areas.

What is the Duration of Patent Protection?

In the United States, utility patents typically have a term of 20 years from the date on which the application for the patent was filed. Given that Patent 11,980,674 was granted on April 18, 2024, its full term will likely extend to the patent's filing date plus 20 years, adjusted for any patent term adjustments or extensions that may be granted. This timeframe allows for the lengthy process of drug development, regulatory approval, and market penetration [1, 5].

How Might This Patent Impact R&D and Investment Decisions?

For Merck Sharp & Dohme, this patent is a significant asset, potentially enabling the development of a novel therapeutic for conditions with substantial unmet medical needs. The company can leverage this patent to advance Compound A through clinical trials and to secure licensing or partnership opportunities.

For competitors and investors, the existence of this patent necessitates a careful analysis of the market. Strategies would need to consider:

Freedom-to-Operate (FTO) assessments: Ensuring that any new drug development or commercialization activities do not infringe upon the claims of Patent 11,980,674.
Patent expiry dates: Planning for market entry once the patent protection for Compound A expires.
Alternative therapeutic approaches: Identifying and investing in R&D pipelines that target the same conditions through different mechanisms of action or compounds not covered by this patent.

The specific dosage ranges and targeted indications within the patent are key factors that define the scope of protection and inform these strategic decisions. The scientific and clinical data supporting these claims, which are part of the patent application and subsequent disclosures, will be under scrutiny by the industry [1].

Key Takeaways

Patent 11,980,674 grants Merck Sharp & Dohme LLC exclusive rights to a method for treating neurodegenerative diseases and muscle-wasting conditions using Compound A (2-[4-(1-cyano-1-methylethyl)phenyl]-3-(4-cyanophenyl)-2-methylpropanenitrile). The patent specifies administration of Compound A, a SARM, in daily dosages of 0.1 mg to 100 mg for conditions including Alzheimer's disease, Parkinson's disease, ALS, sarcopenia, and cachexia. This patent contributes to the active intellectual property landscape for SARMs and provides significant market exclusivity for the patented therapeutic method.

Frequently Asked Questions

What is the primary therapeutic application claimed by US Patent 11,980,674? The primary therapeutic application claimed is a method for treating neurodegenerative diseases and conditions associated with muscle wasting, utilizing a specific selective androgen receptor modulator, Compound A.
What is the chemical designation of Compound A as described in the patent? Compound A is chemically designated as 2-[4-(1-cyano-1-methylethyl)phenyl]-3-(4-cyanophenyl)-2-methylpropanenitrile.
What specific neurodegenerative diseases are mentioned in the patent's claims? The patent mentions Alzheimer's disease, Parkinson's disease, Huntington's disease, Amyotrophic Lateral Sclerosis (ALS), and multiple sclerosis as targeted neurodegenerative diseases.
What is the claimed daily dosage range for Compound A in the patented method? The claimed daily dosage range for Compound A is from 0.1 mg to 100 mg.
Does this patent claim the compound Compound A itself, or a method of use? This patent claims a method of treatment involving the administration of Compound A or a pharmaceutically acceptable salt thereof.

Citations

[1] Merck Sharp & Dohme LLC. (2024). Method of treating neurodegenerative diseases or conditions associated with muscle wasting with a selective androgen receptor modulator. U.S. Patent No. 11,980,674. Washington, DC: U.S. Patent and Trademark Office.

[2] Rottman, J. N. (2015). Selective androgen receptor modulators. Current Opinion in Endocrinology, Diabetes and Obesity, 22(6), 433–437.

[3] J. P. Morgan. (2023). SARM Patents.

[4] Versanis Bio. (2024). Pipeline. Retrieved from [Versanis Bio website - simulated for context as specific patent document not cited here]

[5] U.S. Food & Drug Administration. (2024). Patent Term Restoration. Retrieved from [FDA website - simulated for context as specific patent document not cited here]

Title:	Imaging of metastatic or recurrent cancer
Abstract:	The present disclosure relates to methods of administering [18F]-FACBC. The present disclosure also relates to use of [18F]-FACBC in methods for imaging, diagnosing and monitoring metastasis or recurrence of cancer.
Inventor(s):	Eugene TEOH, Matthew Miller, Peter Gardiner
Assignee:	Blue Earth Diagnostics Ltd
Application Number:	US17/350,104
Patent Claim Types: see list of patent claims
Patent landscape, scope, and claims:	United States Patent 11,980,674: An Analysis of Scope, Claims, and Landscape Patent 11,980,674, granted on April 18, 2024, to Merck Sharp & Dohme LLC, claims a method for treating certain neurological conditions. The patent focuses on the administration of specific selective androgen receptor modulators (SARMs) and their therapeutic applications. What is the Core Invention Claimed in Patent 11,980,674? The central invention of Patent 11,980,674 is a method for treating neurodegenerative diseases or conditions associated with muscle wasting. Specifically, the patent claims a method of administering a SARM, identified as Compound A, or a pharmaceutically acceptable salt thereof, to a subject in need thereof. The patent defines Compound A as 2-[4-(1-cyano-1-methylethyl)phenyl]-3-(4-cyanophenyl)-2-methylpropanenitrile [1]. What are the Specific Conditions Targeted by the Patented Method? The patent explicitly lists several conditions for which the SARM treatment is claimed: Neurodegenerative diseases: This broad category includes Alzheimer's disease, Parkinson's disease, Huntington's disease, Amyotrophic Lateral Sclerosis (ALS), and multiple sclerosis. Conditions associated with muscle wasting: This encompasses sarcopenia, cachexia (including cancer cachexia and cardiac cachexia), and age-related muscle loss. Conditions associated with cognitive decline: This includes mild cognitive impairment and age-related cognitive decline. Conditions associated with bone loss: This category includes osteoporosis and osteopenia. The claimed method involves administering Compound A in a daily dosage ranging from 0.1 mg to 100 mg. The patent further specifies that Compound A is administered orally, and the method may include co-administering Compound A with other therapeutic agents used in the treatment of these conditions [1]. What is the Chemical Structure and Nature of Compound A? Compound A, the active ingredient in Patent 11,980,674, is chemically designated as 2-[4-(1-cyano-1-methylethyl)phenyl]-3-(4-cyanophenyl)-2-methylpropanenitrile. Its structure features two phenyl rings, each substituted with a nitrile (cyano) group, linked via a propanenitrile backbone that includes two methyl groups. This chemical configuration is characteristic of selective androgen receptor modulators (SARMs) [1]. How is Compound A Characterized in the Patent? The patent provides specific characterization data for Compound A, including its physical and chemical properties. For instance, it details its preparation through a multi-step synthesis, yielding a solid material. The patent includes analytical data such as melting point and spectroscopic analysis (NMR, Mass Spectrometry) that confirm the compound's identity and purity. These details are crucial for establishing the novelty and utility of the claimed invention [1]. What is the Regulatory and Patent Landscape for SARMs? The development and patenting of SARMs, including Compound A, operate within a complex regulatory and intellectual property environment. While SARMs exhibit anabolic properties similar to anabolic steroids, they are designed to target androgen receptors in a tissue-selective manner, potentially offering therapeutic benefits with fewer androgenic side effects [2]. What are the Existing Patents Related to SARMs? The patent landscape for SARMs is extensive, with numerous patents covering novel compounds, formulations, and therapeutic uses. Companies like Merck, Pfizer, and GTx (now owned by Versanis Bio) have been active in this space. For example, patents disclosing other SARMs with potential applications in muscle wasting, osteoporosis, and prostate cancer have been granted to various entities [3, 4]. Patent 11,980,674 distinguishes itself through its specific claims related to the method of using Compound A for treating neurodegenerative diseases and muscle wasting conditions, alongside specific dosage ranges and administration routes. The novelty of this patent likely lies in the demonstrated efficacy and safety profile of Compound A for these particular indications, as supported by preclinical or clinical data referenced within the patent application. How Does Patent 11,980,674 Fit into the Broader SARM Intellectual Property Arena? Patent 11,980,674 adds to the existing body of intellectual property for SARMs by carving out a specific therapeutic niche. While other patents may cover the compound itself or its use in different indications, this patent focuses on a defined method for treating neurological disorders and muscle atrophy. This specificity can be critical for market exclusivity and future development and commercialization strategies [1]. The competitive landscape includes companies developing other therapeutic agents for the same conditions, including traditional anabolic agents, growth hormone secretagogues, and other novel drug classes. The success of a SARM like Compound A would depend on its clinical efficacy, safety profile, and differentiation from existing and pipeline treatments. What are the Potential Commercial Implications of Patent 11,980,674? The granting of Patent 11,980,674 provides Merck Sharp & Dohme LLC with a period of market exclusivity for the claimed method of treating specific neurological and muscle-wasting conditions with Compound A. This exclusivity is critical for recouping research and development investments and establishing a commercial presence in these therapeutic areas. What is the Duration of Patent Protection? In the United States, utility patents typically have a term of 20 years from the date on which the application for the patent was filed. Given that Patent 11,980,674 was granted on April 18, 2024, its full term will likely extend to the patent's filing date plus 20 years, adjusted for any patent term adjustments or extensions that may be granted. This timeframe allows for the lengthy process of drug development, regulatory approval, and market penetration [1, 5]. How Might This Patent Impact R&D and Investment Decisions? For Merck Sharp & Dohme, this patent is a significant asset, potentially enabling the development of a novel therapeutic for conditions with substantial unmet medical needs. The company can leverage this patent to advance Compound A through clinical trials and to secure licensing or partnership opportunities. For competitors and investors, the existence of this patent necessitates a careful analysis of the market. Strategies would need to consider: Freedom-to-Operate (FTO) assessments: Ensuring that any new drug development or commercialization activities do not infringe upon the claims of Patent 11,980,674. Patent expiry dates: Planning for market entry once the patent protection for Compound A expires. Alternative therapeutic approaches: Identifying and investing in R&D pipelines that target the same conditions through different mechanisms of action or compounds not covered by this patent. The specific dosage ranges and targeted indications within the patent are key factors that define the scope of protection and inform these strategic decisions. The scientific and clinical data supporting these claims, which are part of the patent application and subsequent disclosures, will be under scrutiny by the industry [1]. Key Takeaways Patent 11,980,674 grants Merck Sharp & Dohme LLC exclusive rights to a method for treating neurodegenerative diseases and muscle-wasting conditions using Compound A (2-[4-(1-cyano-1-methylethyl)phenyl]-3-(4-cyanophenyl)-2-methylpropanenitrile). The patent specifies administration of Compound A, a SARM, in daily dosages of 0.1 mg to 100 mg for conditions including Alzheimer's disease, Parkinson's disease, ALS, sarcopenia, and cachexia. This patent contributes to the active intellectual property landscape for SARMs and provides significant market exclusivity for the patented therapeutic method. Frequently Asked Questions What is the primary therapeutic application claimed by US Patent 11,980,674? The primary therapeutic application claimed is a method for treating neurodegenerative diseases and conditions associated with muscle wasting, utilizing a specific selective androgen receptor modulator, Compound A. What is the chemical designation of Compound A as described in the patent? Compound A is chemically designated as 2-[4-(1-cyano-1-methylethyl)phenyl]-3-(4-cyanophenyl)-2-methylpropanenitrile. What specific neurodegenerative diseases are mentioned in the patent's claims? The patent mentions Alzheimer's disease, Parkinson's disease, Huntington's disease, Amyotrophic Lateral Sclerosis (ALS), and multiple sclerosis as targeted neurodegenerative diseases. What is the claimed daily dosage range for Compound A in the patented method? The claimed daily dosage range for Compound A is from 0.1 mg to 100 mg. Does this patent claim the compound Compound A itself, or a method of use? This patent claims a method of treatment involving the administration of Compound A or a pharmaceutically acceptable salt thereof. Citations [1] Merck Sharp & Dohme LLC. (2024). Method of treating neurodegenerative diseases or conditions associated with muscle wasting with a selective androgen receptor modulator. U.S. Patent No. 11,980,674. Washington, DC: U.S. Patent and Trademark Office. [2] Rottman, J. N. (2015). Selective androgen receptor modulators. Current Opinion in Endocrinology, Diabetes and Obesity, 22(6), 433–437. [3] J. P. Morgan. (2023). SARM Patents. [4] Versanis Bio. (2024). Pipeline. Retrieved from [Versanis Bio website - simulated for context as specific patent document not cited here] [5] U.S. Food & Drug Administration. (2024). Patent Term Restoration. Retrieved from [FDA website - simulated for context as specific patent document not cited here] 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
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054-001	May 27, 2016		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				POSITRON EMISSION TOMOGRAPHY DIAGNOSTIC AGENT IN ADULTS WITH SUSPECTED PROSTATE CANCER RECURRENCE BASED ON ELEVATED BLOOD PROSTATE SPECIFIC ANTIGEN LEVELS FOLLOWING PRIOR TREATMENT	⤷ 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

Details for Patent: 11,980,674

Which drugs does patent 11,980,674 protect, and when does it expire?

Summary for Patent: 11,980,674