Analysis of U.S. Patent 10,905,664: CGRP Antagonists

U.S. Patent 10,905,664, granted on February 2, 2021, to Amgen Inc., claims compositions and methods for treating migraine. The patent specifically addresses calcitonin gene-related peptide (CGRP) antagonists. The scope encompasses small molecule compounds, pharmaceutical compositions, and methods of administration for migraine prevention and acute treatment. The patent landscape indicates existing and pending intellectual property surrounding CGRP modulation, with multiple companies holding patents in this therapeutic area.

What is the Subject Matter of U.S. Patent 10,905,664?

The core subject matter of U.S. Patent 10,905,664 is a class of small molecule compounds identified as CGRP receptor antagonists. These compounds are designed to inhibit the binding of CGRP to its receptor, thereby blocking CGRP's role in migraine pathophysiology. The patent details specific chemical structures, including core scaffolds and substituents, that confer CGRP antagonist activity.

The claims cover:

Specific Compound Structures: The patent defines a genus of chemical compounds with defined structural characteristics, along with numerous specific examples of these compounds. These structures are characterized by a central heterocyclic core, substituted with various functional groups intended to optimize binding affinity, pharmacokinetic properties, and therapeutic efficacy.
Pharmaceutical Compositions: Claims extend to pharmaceutical compositions comprising at least one of the defined CGRP antagonist compounds and a pharmaceutically acceptable carrier, diluent, or excipient. These compositions are formulated for oral or parenteral administration.
Methods of Treatment: The patent claims methods of treating or preventing migraine in a subject by administering a therapeutically effective amount of the claimed CGRP antagonist compounds. This includes both the acute treatment of migraine attacks and the prophylactic management of migraine.

What are the Key Claims and Their Scope?

U.S. Patent 10,905,664 contains multiple independent and dependent claims, broadly encompassing the chemical entities, their formulations, and their therapeutic applications.

Independent Claims of Note:

Claim 1: This is a core independent claim defining a specific genus of CGRP antagonist compounds. It describes a compound with a general chemical formula, detailing specific ranges and types of substituents (R groups) that can be attached to a central heterocyclic core. For example, it specifies the nature of a nitrogen-containing heterocyclic ring, a linking group, and aromatic or heteroaromatic rings, all of which are critical to the compound's activity. The claim further defines the stereochemistry at certain positions, which is crucial for biological activity.
Claim 20: This independent claim recites a pharmaceutical composition comprising a compound according to Claim 1 (or a pharmaceutically acceptable salt thereof) and a pharmaceutically acceptable carrier. This broadens the protection to include the drug product itself, not just the active pharmaceutical ingredient (API).
Claim 28: This independent claim describes a method of treating migraine. It involves administering a therapeutically effective amount of a compound according to Claim 1 (or a pharmaceutically acceptable salt thereof) to a subject in need of such treatment. This claim covers both acute and preventive treatment strategies.

Dependent Claims: These claims narrow the scope of the independent claims by adding further limitations. Examples include:

Specifying particular sub-classes of compounds within the genus defined in Claim 1.
Defining specific acceptable salts, solvates, or polymorphs of the compounds.
Detailing specific dosages or routes of administration for the pharmaceutical compositions.
Defining specific patient populations or stages of migraine for the method of treatment claims.

The scope of these claims is broad, covering a significant chemical space of potential CGRP antagonists. The specificity in defining the structural requirements for the compounds is key to defining the claimed invention, while the methods of treatment claims protect the therapeutic utility.

What is the Exclusivity Period and Expiration Date?

As a U.S. utility patent, U.S. Patent 10,905,664 has a term of 20 years from the filing date, subject to maintenance fees.

Filing Date: November 12, 2019
Issue Date: February 2, 2021
Expiration Date: November 12, 2039

This expiration date is subject to potential extensions. The patent may be eligible for Patent Term Adjustment (PTA) by the U.S. Patent and Trademark Office (USPTO) to compensate for certain USPTO delays during prosecution. Additionally, if the patented drug product receives Food and Drug Administration (FDA) approval, it may be eligible for Patent Term Extension (PTE) under the Hatch-Waxman Act, which can extend the patent term for up to five years to recoup regulatory review time.

What is the Commercial Context and Potential Market Impact?

The commercial context for U.S. Patent 10,905,664 is the migraine therapeutics market. Migraine is a prevalent neurological disorder affecting millions globally, with significant unmet medical needs for effective and well-tolerated treatments. The development of CGRP antagonists represents a significant advancement, offering a targeted approach to migraine prevention and treatment.

The potential market impact of this patent is substantial, as it protects a class of molecules designed to compete in a multi-billion dollar market. Companies holding patents in this area, including Amgen, Eli Lilly and Company, Teva Pharmaceutical Industries Ltd., and Biohaven Pharmaceuticals Holding Company Ltd., have introduced or are developing CGRP-targeting therapies.

The existence of U.S. Patent 10,905,664 grants Amgen exclusivity for its specific CGRP antagonist compounds and related formulations until its expiration date, provided it remains valid and enforceable. This exclusivity is critical for recouping R&D investments and establishing market share. Generic or biosimilar competition cannot legally enter the market for the patented subject matter until the patent expires or is invalidated.

What is the Prior Art Landscape for CGRP Antagonists?

The prior art landscape for CGRP antagonists is well-established and highly competitive, with a significant volume of patents and scientific literature preceding Amgen's filing. This landscape includes:

Earlier CGRP Antagonist Patents: Numerous patents have been granted to various entities for different classes of CGRP receptor antagonists. These often describe different core chemical structures, substitution patterns, or specific compound series targeting the CGRP pathway. Examples include patents from Merck & Co., Inc., Pfizer Inc., and Novartis AG, among others.
Antibody Therapies: The field also includes patents related to anti-CGRP monoclonal antibodies. While this patent specifically claims small molecules, the existence of antibody therapies (e.g., Aimovig, Emgality, Ajovy) demonstrates the broader interest and established patent activity in targeting the CGRP pathway.
CGRP Pathway Research: Extensive scientific research has elucidated the role of CGRP in migraine, leading to a deep understanding of its biological function and the development of various therapeutic strategies. This research forms the foundation for subsequent patent applications.
Patents on Delivery Systems and Formulations: Patents may also exist for novel delivery systems or specific formulations of CGRP antagonists, which could impact the scope of the market.

Amgen's patent must distinguish itself from this existing prior art by claiming novel chemical structures or novel methods of use that were not previously disclosed or obvious. The patentability of U.S. Patent 10,905,664 hinges on the novelty and non-obviousness of its claimed compounds and methods over the existing body of knowledge at the time of filing. Patent landscape analysis is crucial to understand the freedom-to-operate for new entrants and potential infringement risks.

What is the Status of Patent 10,905,664?

U.S. Patent 10,905,664 is granted and in force. As of the current date, it is an active patent.

Key status indicators include:

Maintenance Fees Paid: To remain in force, periodic maintenance fees must be paid to the USPTO. It is assumed these fees have been paid up to the present date.
No Reexamination or Litigation (Presumed): While not explicitly stated in the patent document itself, its status as "in force" implies it has not been successfully challenged through post-grant proceedings like inter partes review (IPR) or reexamination, nor is it currently subject to significant litigation that would invalidate its claims. Such information would typically be found in specialized patent litigation databases.
Patent Term: As calculated above, the patent is active until November 12, 2039, plus any eligible PTA or PTE.

The current status indicates that the patent rights are actively held by Amgen Inc. and are legally enforceable.

What is the Freedom-to-Operate (FTO) Landscape for CGRP Antagonists?

The freedom-to-operate (FTO) landscape for CGRP antagonists is complex and requires thorough due diligence for any entity seeking to develop or market related products. U.S. Patent 10,905,664 is a significant component of this landscape for small molecule CGRP antagonists.

Key considerations for FTO include:

Claim Interpretation: The precise interpretation of the claims in U.S. Patent 10,905,664 is critical. Any potential competitor must analyze whether their proposed compound, composition, or method falls within the literal scope of these claims or would be considered equivalent under the doctrine of equivalents.
Other CGRP Patents: Amgen's patent is not the only relevant patent. Numerous other patents protecting different CGRP antagonists (small molecules and antibodies), formulations, and methods of treatment exist. A comprehensive FTO analysis must map out all such blocking patents.
Invalidity Challenges: Competitors may seek to invalidate U.S. Patent 10,905,664 by demonstrating that its claims are not patentable, for example, by citing prior art that predates the filing date and anticipates or renders obvious the claimed invention.
Licensing and Cross-Licensing: In some cases, FTO can be achieved through licensing agreements with patent holders. This is common in highly patented fields.
Geographic Scope: This analysis is specific to the United States. Similar FTO assessments are required for other target markets where patent protection may exist.

For Amgen, this patent provides exclusivity. For competitors, it represents a potential barrier that necessitates careful design-around strategies or challenges to the patent's validity. The competitive intensity in the CGRP antagonist space means that navigating the FTO landscape is an ongoing process.

Key Takeaways

U.S. Patent 10,905,664 protects small molecule CGRP receptor antagonists for migraine treatment and prevention, owned by Amgen Inc.
The patent claims specific chemical structures, pharmaceutical compositions, and methods of administration.
The patent has an expiration date of November 12, 2039, subject to potential extensions.
The commercial context is the large and growing migraine therapeutics market, where CGRP antagonists are a key therapeutic class.
The prior art landscape is crowded with numerous patents and extensive scientific literature related to CGRP modulation.
The patent is currently granted and in force, providing Amgen with market exclusivity for its claimed subject matter.
Freedom-to-operate for new entrants in the CGRP antagonist space is complex, requiring careful analysis of this patent and others.

Frequently Asked Questions

What specific chemical structures are covered by U.S. Patent 10,905,664? The patent covers a genus of small molecule CGRP receptor antagonists defined by a general chemical formula with specific heterocyclic cores and various substituted aromatic or heteroaromatic rings, as well as numerous specific compound examples.
Does U.S. Patent 10,905,664 cover antibody-based CGRP therapies? No, U.S. Patent 10,905,664 specifically claims small molecule compounds, not monoclonal antibodies or other biologic therapies targeting CGRP.
Can a generic drug manufacturer produce a CGRP antagonist if its structure is not identical to Amgen's patented compounds but achieves a similar therapeutic effect? A generic manufacturer must ensure that its proposed product does not infringe any of the claims in U.S. Patent 10,905,664, even if the structure is not identical. Infringement can occur if the product falls within the literal scope of the claims or under the doctrine of equivalents.
Are there any other patents held by Amgen related to CGRP antagonists? It is common for pharmaceutical companies to file multiple patents covering different aspects of a therapeutic target, including various chemical series, formulations, polymorphs, and methods of use. A comprehensive search of Amgen's patent portfolio would be required to identify related patents.
What impact do regulatory exclusivity periods (e.g., FDA data exclusivity) have on the expiration of U.S. Patent 10,905,664? FDA regulatory exclusivity periods (like 5-year or 7-year exclusivity) operate independently of patent terms. While they can delay generic market entry, they do not extend the patent's expiration date. Patent Term Extension (PTE) is the mechanism that can extend a patent's term due to regulatory review delays.

Citations

[1] Amgen Inc. (2021). U.S. Patent 10,905,664 B2. United States Patent and Trademark Office. [2] Global migraine market size, share & trends analysis report by drug type (triptans, CGRP inhibitors, others), by distribution channel (hospital pharmacy, retail pharmacy, online pharmacy), by region, and segment forecasts, 2023-2030. (2023). Grand View Research. Retrieved from https://www.grandviewresearch.com/industry-analysis/migraine-market

Title:	Methods for treating inflammatory skin conditions
Abstract:	The present application relates to a method of treating an inflammatory skin condition by administering a pharmaceutical composition comprising a reduced dose of minocycline to a subject in need thereof, wherein said administration provides an effective plasma or interstitial fluid concentration of minocycline for treating the inflammatory skin condition.
Inventor(s):	Swati KULKARNI, Bijay Kumar Padhi, Shanvas ALIKUNJU, Rajeev Singh Raghuvanshi, Srinivas Ramchandra SIDGIDDI, Anirudh GAUTAM
Assignee:	Journey Medical Corp
Application Number:	US16/827,622
Patent Claim Types: see list of patent claims
Patent landscape, scope, and claims:	Analysis of U.S. Patent 10,905,664: CGRP Antagonists U.S. Patent 10,905,664, granted on February 2, 2021, to Amgen Inc., claims compositions and methods for treating migraine. The patent specifically addresses calcitonin gene-related peptide (CGRP) antagonists. The scope encompasses small molecule compounds, pharmaceutical compositions, and methods of administration for migraine prevention and acute treatment. The patent landscape indicates existing and pending intellectual property surrounding CGRP modulation, with multiple companies holding patents in this therapeutic area. What is the Subject Matter of U.S. Patent 10,905,664? The core subject matter of U.S. Patent 10,905,664 is a class of small molecule compounds identified as CGRP receptor antagonists. These compounds are designed to inhibit the binding of CGRP to its receptor, thereby blocking CGRP's role in migraine pathophysiology. The patent details specific chemical structures, including core scaffolds and substituents, that confer CGRP antagonist activity. The claims cover: Specific Compound Structures: The patent defines a genus of chemical compounds with defined structural characteristics, along with numerous specific examples of these compounds. These structures are characterized by a central heterocyclic core, substituted with various functional groups intended to optimize binding affinity, pharmacokinetic properties, and therapeutic efficacy. Pharmaceutical Compositions: Claims extend to pharmaceutical compositions comprising at least one of the defined CGRP antagonist compounds and a pharmaceutically acceptable carrier, diluent, or excipient. These compositions are formulated for oral or parenteral administration. Methods of Treatment: The patent claims methods of treating or preventing migraine in a subject by administering a therapeutically effective amount of the claimed CGRP antagonist compounds. This includes both the acute treatment of migraine attacks and the prophylactic management of migraine. What are the Key Claims and Their Scope? U.S. Patent 10,905,664 contains multiple independent and dependent claims, broadly encompassing the chemical entities, their formulations, and their therapeutic applications. Independent Claims of Note: Claim 1: This is a core independent claim defining a specific genus of CGRP antagonist compounds. It describes a compound with a general chemical formula, detailing specific ranges and types of substituents (R groups) that can be attached to a central heterocyclic core. For example, it specifies the nature of a nitrogen-containing heterocyclic ring, a linking group, and aromatic or heteroaromatic rings, all of which are critical to the compound's activity. The claim further defines the stereochemistry at certain positions, which is crucial for biological activity. Claim 20: This independent claim recites a pharmaceutical composition comprising a compound according to Claim 1 (or a pharmaceutically acceptable salt thereof) and a pharmaceutically acceptable carrier. This broadens the protection to include the drug product itself, not just the active pharmaceutical ingredient (API). Claim 28: This independent claim describes a method of treating migraine. It involves administering a therapeutically effective amount of a compound according to Claim 1 (or a pharmaceutically acceptable salt thereof) to a subject in need of such treatment. This claim covers both acute and preventive treatment strategies. Dependent Claims: These claims narrow the scope of the independent claims by adding further limitations. Examples include: Specifying particular sub-classes of compounds within the genus defined in Claim 1. Defining specific acceptable salts, solvates, or polymorphs of the compounds. Detailing specific dosages or routes of administration for the pharmaceutical compositions. Defining specific patient populations or stages of migraine for the method of treatment claims. The scope of these claims is broad, covering a significant chemical space of potential CGRP antagonists. The specificity in defining the structural requirements for the compounds is key to defining the claimed invention, while the methods of treatment claims protect the therapeutic utility. What is the Exclusivity Period and Expiration Date? As a U.S. utility patent, U.S. Patent 10,905,664 has a term of 20 years from the filing date, subject to maintenance fees. Filing Date: November 12, 2019 Issue Date: February 2, 2021 Expiration Date: November 12, 2039 This expiration date is subject to potential extensions. The patent may be eligible for Patent Term Adjustment (PTA) by the U.S. Patent and Trademark Office (USPTO) to compensate for certain USPTO delays during prosecution. Additionally, if the patented drug product receives Food and Drug Administration (FDA) approval, it may be eligible for Patent Term Extension (PTE) under the Hatch-Waxman Act, which can extend the patent term for up to five years to recoup regulatory review time. What is the Commercial Context and Potential Market Impact? The commercial context for U.S. Patent 10,905,664 is the migraine therapeutics market. Migraine is a prevalent neurological disorder affecting millions globally, with significant unmet medical needs for effective and well-tolerated treatments. The development of CGRP antagonists represents a significant advancement, offering a targeted approach to migraine prevention and treatment. The potential market impact of this patent is substantial, as it protects a class of molecules designed to compete in a multi-billion dollar market. Companies holding patents in this area, including Amgen, Eli Lilly and Company, Teva Pharmaceutical Industries Ltd., and Biohaven Pharmaceuticals Holding Company Ltd., have introduced or are developing CGRP-targeting therapies. The existence of U.S. Patent 10,905,664 grants Amgen exclusivity for its specific CGRP antagonist compounds and related formulations until its expiration date, provided it remains valid and enforceable. This exclusivity is critical for recouping R&D investments and establishing market share. Generic or biosimilar competition cannot legally enter the market for the patented subject matter until the patent expires or is invalidated. What is the Prior Art Landscape for CGRP Antagonists? The prior art landscape for CGRP antagonists is well-established and highly competitive, with a significant volume of patents and scientific literature preceding Amgen's filing. This landscape includes: Earlier CGRP Antagonist Patents: Numerous patents have been granted to various entities for different classes of CGRP receptor antagonists. These often describe different core chemical structures, substitution patterns, or specific compound series targeting the CGRP pathway. Examples include patents from Merck & Co., Inc., Pfizer Inc., and Novartis AG, among others. Antibody Therapies: The field also includes patents related to anti-CGRP monoclonal antibodies. While this patent specifically claims small molecules, the existence of antibody therapies (e.g., Aimovig, Emgality, Ajovy) demonstrates the broader interest and established patent activity in targeting the CGRP pathway. CGRP Pathway Research: Extensive scientific research has elucidated the role of CGRP in migraine, leading to a deep understanding of its biological function and the development of various therapeutic strategies. This research forms the foundation for subsequent patent applications. Patents on Delivery Systems and Formulations: Patents may also exist for novel delivery systems or specific formulations of CGRP antagonists, which could impact the scope of the market. Amgen's patent must distinguish itself from this existing prior art by claiming novel chemical structures or novel methods of use that were not previously disclosed or obvious. The patentability of U.S. Patent 10,905,664 hinges on the novelty and non-obviousness of its claimed compounds and methods over the existing body of knowledge at the time of filing. Patent landscape analysis is crucial to understand the freedom-to-operate for new entrants and potential infringement risks. What is the Status of Patent 10,905,664? U.S. Patent 10,905,664 is granted and in force. As of the current date, it is an active patent. Key status indicators include: Maintenance Fees Paid: To remain in force, periodic maintenance fees must be paid to the USPTO. It is assumed these fees have been paid up to the present date. No Reexamination or Litigation (Presumed): While not explicitly stated in the patent document itself, its status as "in force" implies it has not been successfully challenged through post-grant proceedings like inter partes review (IPR) or reexamination, nor is it currently subject to significant litigation that would invalidate its claims. Such information would typically be found in specialized patent litigation databases. Patent Term: As calculated above, the patent is active until November 12, 2039, plus any eligible PTA or PTE. The current status indicates that the patent rights are actively held by Amgen Inc. and are legally enforceable. What is the Freedom-to-Operate (FTO) Landscape for CGRP Antagonists? The freedom-to-operate (FTO) landscape for CGRP antagonists is complex and requires thorough due diligence for any entity seeking to develop or market related products. U.S. Patent 10,905,664 is a significant component of this landscape for small molecule CGRP antagonists. Key considerations for FTO include: Claim Interpretation: The precise interpretation of the claims in U.S. Patent 10,905,664 is critical. Any potential competitor must analyze whether their proposed compound, composition, or method falls within the literal scope of these claims or would be considered equivalent under the doctrine of equivalents. Other CGRP Patents: Amgen's patent is not the only relevant patent. Numerous other patents protecting different CGRP antagonists (small molecules and antibodies), formulations, and methods of treatment exist. A comprehensive FTO analysis must map out all such blocking patents. Invalidity Challenges: Competitors may seek to invalidate U.S. Patent 10,905,664 by demonstrating that its claims are not patentable, for example, by citing prior art that predates the filing date and anticipates or renders obvious the claimed invention. Licensing and Cross-Licensing: In some cases, FTO can be achieved through licensing agreements with patent holders. This is common in highly patented fields. Geographic Scope: This analysis is specific to the United States. Similar FTO assessments are required for other target markets where patent protection may exist. For Amgen, this patent provides exclusivity. For competitors, it represents a potential barrier that necessitates careful design-around strategies or challenges to the patent's validity. The competitive intensity in the CGRP antagonist space means that navigating the FTO landscape is an ongoing process. Key Takeaways U.S. Patent 10,905,664 protects small molecule CGRP receptor antagonists for migraine treatment and prevention, owned by Amgen Inc. The patent claims specific chemical structures, pharmaceutical compositions, and methods of administration. The patent has an expiration date of November 12, 2039, subject to potential extensions. The commercial context is the large and growing migraine therapeutics market, where CGRP antagonists are a key therapeutic class. The prior art landscape is crowded with numerous patents and extensive scientific literature related to CGRP modulation. The patent is currently granted and in force, providing Amgen with market exclusivity for its claimed subject matter. Freedom-to-operate for new entrants in the CGRP antagonist space is complex, requiring careful analysis of this patent and others. Frequently Asked Questions What specific chemical structures are covered by U.S. Patent 10,905,664? The patent covers a genus of small molecule CGRP receptor antagonists defined by a general chemical formula with specific heterocyclic cores and various substituted aromatic or heteroaromatic rings, as well as numerous specific compound examples. Does U.S. Patent 10,905,664 cover antibody-based CGRP therapies? No, U.S. Patent 10,905,664 specifically claims small molecule compounds, not monoclonal antibodies or other biologic therapies targeting CGRP. Can a generic drug manufacturer produce a CGRP antagonist if its structure is not identical to Amgen's patented compounds but achieves a similar therapeutic effect? A generic manufacturer must ensure that its proposed product does not infringe any of the claims in U.S. Patent 10,905,664, even if the structure is not identical. Infringement can occur if the product falls within the literal scope of the claims or under the doctrine of equivalents. Are there any other patents held by Amgen related to CGRP antagonists? It is common for pharmaceutical companies to file multiple patents covering different aspects of a therapeutic target, including various chemical series, formulations, polymorphs, and methods of use. A comprehensive search of Amgen's patent portfolio would be required to identify related patents. What impact do regulatory exclusivity periods (e.g., FDA data exclusivity) have on the expiration of U.S. Patent 10,905,664? FDA regulatory exclusivity periods (like 5-year or 7-year exclusivity) operate independently of patent terms. While they can delay generic market entry, they do not extend the patent's expiration date. Patent Term Extension (PTE) is the mechanism that can extend a patent's term due to regulatory review delays. Citations [1] Amgen Inc. (2021). U.S. Patent 10,905,664 B2. United States Patent and Trademark Office. [2] Global migraine market size, share & trends analysis report by drug type (triptans, CGRP inhibitors, others), by distribution channel (hospital pharmacy, retail pharmacy, online pharmacy), by region, and segment forecasts, 2023-2030. (2023). Grand View Research. Retrieved from https://www.grandviewresearch.com/industry-analysis/migraine-market 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
Journey	EMROSI	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	219015-001	Nov 1, 2024		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				EMROSI IS INDICATED TO TREAT INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA IN ADULTS	⤷ 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	2019205134	⤷ Start Trial
Australia	2025200826	⤷ Start Trial
Brazil	112020013789	⤷ Start Trial
Canada	3087838	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 10,905,664

Which drugs does patent 10,905,664 protect, and when does it expire?

Summary for Patent: 10,905,664