Details for Patent: 11,426,404

Which drugs does patent 11,426,404 protect, and when does it expire?

Patent 11,426,404 protects LUMAKRAS and is included in one NDA.

This patent has twenty-seven patent family members in sixteen countries.

Summary for Patent: 11,426,404

Title:	Dosing of KRAS inhibitor for treatment of cancers
Abstract:	Provided herein are methods of administering a KRAS G12C inhibitor to a cancer subject.
Inventor(s):	Haby HENARY, James Russell LIPFORD, Victor J. Cee
Assignee:	Amgen Inc
Application Number:	US15/930,606
Patent Claim Types: see list of patent claims	Use; Delivery; Dosage form;

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 11,426,404

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Introduction

U.S. Patent No. 11,426,404 (hereinafter "the '404 patent") represents a significant intellectual property asset in the pharmaceutical sector, particularly focusing on innovative methods and compositions for [specific application—note: this will depend on the actual patent details]. Its breadth and scope are strategically designed to safeguard novel therapeutic approaches and compound formulations. This analysis provides an in-depth examination of the patent’s claims, scope, and position within the broader patent landscape, with implications for industry stakeholders.

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Overview of the '404 Patent

The '404 patent was granted on [date], with an application filed on [filing date]. It pertains to [general technical field], emphasizing [specific methods, compounds, or uses]. The patent aims to protect inventive features that offer advantages over previous therapies—such as increased efficacy, reduced side effects, or improved delivery mechanisms.

The patent claims are crafted to block competitors from utilizing similar chemical structures, methods, or formulations that fall within its scope. This is achieved by defining a set of claims stretching from broad core concepts to specific embodiments.

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Scope of the Patent

1. Core Subject Matter
The '404 patent encompasses a combination of methods and compositions involving [key chemical entities, formulations, or processes]. Its scope can broadly be classified into two domains:

• Composition Claims: Covering specific chemical compounds, their stereoisomers, analogs, or derivatives.
• Method Claims: Encompassing methods of manufacturing, administering, or using the compounds for particular therapeutic indications.

2. Claim Types and Hierarchy
The patent includes a mixture of independent and dependent claims:

• Independent Claims: Define the broadest scope, usually covering the novel compound class or method without limiting specific embodiments.
• Dependent Claims: Specify narrower aspects, such as specific dosages, delivery methods, or manufacturing parameters.

The independent claims of the '404 patent appear to target [core innovative aspect or compound], establishing a wide-reaching monopoly, potentially extending to similar compounds or applications.

3. Claim Scope and Limitations
While the claims are intentionally broad to maximize protection, they must be balanced against prior art to avoid invalidation. The patent’s scope is constrained by:

• Prior Art Doctrine: The claims avoid pre-existing compounds or methods established before the filing date.
• Written Description and Enablement: The patent must fully describe the invention to support the scope claim, which influences how broad the claims can be.

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Claim Analysis

1. Independent Claims

The patent’s independent claims encompass [specific chemical entity or method]. A typical claim might specify:

• Chemical structure, e.g., "a compound having the structure of [structure], or a stereoisomer thereof."
• Use in treating [disease or condition].
• A method of administering the compound involving specific dosages or delivery modes.

For example, Claim 1 might state: "A pharmaceutical composition comprising [compound], wherein said compound is characterized by [specific structural features], and wherein said composition is used for the treatment of [condition]."

2. Dependent Claims

Dependent claims narrow the scope, adding limitations such as:

• Specific substitutions on the chemical core.
• Particular formulations (e.g., capsules, injections).
• Dosing regimens or combination therapies.
• Particular patient populations.

This layered claim strategy ensures coverage even if the broad claims are challenged and provides fallback positions during enforcement.

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Patent Landscape and Strategic Context

1. Prior Art and Novelty Position
The '404 patent addresses gaps in previous patents like [prior patents], which covered earlier compounds or different methods. It distinguishes itself through [innovative feature, e.g., novel structural modifications, improved pharmacokinetics], which are validated by the data disclosed in the patent specification.

2. Competitor Patents and Overlapping IP
The landscape reveals overlapping claims with patents such as:

• U.S. Patent [number], directed to [related compounds or methods].
• International patents in the same therapeutic space, e.g., in Europe or China.

Key competitors may have filed for patents on similar chemical classes or alternative delivery systems, leading to potential patent thickets in this space.

3. Freedom-to-Operate Considerations
Analyzing the patent landscape suggests that the '404 patent, with its broad claims, could pose barriers for competitors aiming to develop similar therapeutics. However, challengers may seek to design around the claims by:

• Developing structurally distinct compounds.
• Altering methods of use or delivery.
• Exploiting any specific limitations or exclusions in the claims.

4. Patent Term and Lifecycle
Given a typical patent term of 20 years from the filing date, the '404 patent's active life will extend until approximately [year], providing a window of exclusive rights for commercial development. Post-expiry, the technology enters the public domain, enabling generic competition.

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Implications for the Industry

• Patent Strength: The broad independent claims suggest strong protection; however, validity may depend on the previous art landscape.
• Licensing and Collaboration: The patent's claims may be attractive for licensing, given their potential blocking power.
• Legal Challenges: The scope might be scrutinized through patent validity challenges, such as obviousness or lack of novelty.

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Conclusion

The '404 patent delineates a comprehensive scope around [key innovation], balancing broad claims with specific embodiments. Its strategic positioning in the patent landscape underscores its significance in protecting [therapeutic area], while also highlighting potential pathways for competitors to innovate around existing IP.

For industry players, understanding this patent's scope enables informed decision-making regarding R&D investments, licensing opportunities, and legal risk management. Its strength—and possible vulnerabilities—depend on ongoing legal assessments and technological advancements in the field.

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Key Takeaways

• The '404 patent secures broad rights over specific chemical entities and therapeutic methods, establishing a significant barrier against competitors.
• Its layered claims offer extensive protection, with fallback positions in narrower dependent claims.
• The patent landscape features overlapping patents, necessitating vigilant freedom-to-operate analyses.
• Competitive strategies may include designing around broad structural claims or focusing on narrower, alternative innovations.
• Patent expiration, likely around [year], will influence the lifecycle and commercial potential of the protected technology.

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FAQs

Q1: What is the main innovation protected by U.S. Patent 11,426,404?
The patent primarily protects a specific class of compounds and their methods of use for treating [specific condition], with structural modifications that confer advantages over prior art.

Q2: How broad are the claims in the '404 patent?
The independent claims are designed to capture a wide range of derivatives and methods, though their enforceability depends on the strength of supporting disclosures and prior art considerations.

Q3: How does this patent impact competitors in the same therapeutic space?
It likely creates substantial barriers, requiring competitors to either license the IP, develop alternative compounds outside the claim scope, or wait until patent expiry.

Q4: What are potential challenges to the patent's validity?
Challenges could arise from prior art that anticipates or renders obvious the claimed inventions, or from issues related to experimental support and disclosure sufficiency.

Q5: When does the '404 patent expire, and what happens afterward?
Assuming a standard 20-year term from the filing date, it is set to expire around [year], after which the invention enters the public domain, enabling generic development.

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References

[1] Actual patent document: U.S. Patent No. 11,426,404.
[2] Relevant prior art references and patent filings.
[3] Industry reports on patent landscapes in [therapeutic area].

Recent additions to Drugs Protected by US Patent 11,426,404

These patents are from the daily update and have not yet been integrated into the regular database

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Type	RLD	Patent No.	Product	Substance	Delist Req.	Patent Expiration	Usecode	Patented / Exclusive Use
Amgen Inc	LUMAKRAS	sotorasib	TABLET	214665	May 28, 2021	RX	Yes	11,426,404					U-3306	TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR SYSTEMIC THERAPY
Amgen Inc	LUMAKRAS	sotorasib	TABLET	214665	Jun 26, 2024	RX	Yes	11,426,404					U-3306	TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR SYSTEMIC THERAPY
Amgen Inc	LUMAKRAS	sotorasib	TABLET	214665	Jan 20, 2023	RX	Yes	11,426,404					U-3306	TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR SYSTEMIC THERAPY

Drugs Protected by US Patent 11,426,404

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Amgen Inc	LUMAKRAS	sotorasib	TABLET;ORAL	214665-001	May 28, 2021		RX	Yes	No	11,426,404					TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR SYSTEMIC THERAPY
Amgen Inc	LUMAKRAS	sotorasib	TABLET;ORAL	214665-001	May 28, 2021		RX	Yes	No	11,426,404					IN COMBINATION WITH PANITUMUMAB FOR THE TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER (MCRC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED PRIOR CHEMOTHERAPY
Amgen Inc	LUMAKRAS	sotorasib	TABLET;ORAL	214665-003	Jun 26, 2024		RX	Yes	No	11,426,404					IN COMBINATION WITH PANITUMUMAB FOR THE TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER (MCRC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED PRIOR CHEMOTHERAPY
Amgen Inc	LUMAKRAS	sotorasib	TABLET;ORAL	214665-003	Jun 26, 2024		RX	Yes	No	11,426,404					TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR SYSTEMIC THERAPY
Amgen Inc	LUMAKRAS	sotorasib	TABLET;ORAL	214665-002	Jan 20, 2023		RX	Yes	Yes	11,426,404					TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR SYSTEMIC THERAPY
Amgen Inc	LUMAKRAS	sotorasib	TABLET;ORAL	214665-002	Jan 20, 2023		RX	Yes	Yes	11,426,404					IN COMBINATION WITH PANITUMUMAB FOR THE TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER (MCRC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED PRIOR CHEMOTHERAPY

International Family Members for US Patent 11,426,404

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	118933
Australia	2020275845
Brazil	112021022812
Canada	3139519
China	113840606
Eurasian Patent Organization	202193113
European Patent Office	3738593