Details for Patent: 11,236,091

Which drugs does patent 11,236,091 protect, and when does it expire?

Patent 11,236,091 protects LUMAKRAS and is included in one NDA.

This patent has thirty-three patent family members in twenty-three countries.

Summary for Patent: 11,236,091

Title:	Solid state forms
Abstract:	The present disclosure provides crystalline and amorphous forms of 6-fluoro-7-(2-fluoro-6-hydroxyphenyl)-1-(4-methyl-2-(2-propanyl)-3-pyridinyl)-4-((2S)-2-methyl-4-(2-propenoyl)-1-piperazinyl)pyrido[2,3-d]pyrimidin-2(1H)-one, including several anhydrous, hydrate and solvate forms, and solid state forms thereof, pharmaceutical compositions, and methods of treating a disease mediated by KRAS G12C inhibition.
Inventor(s):	Mary CHAVES, Patricia Lopez, Prashant Agarwal, Albert Amegadzie, Stephanie AZALI, Roman SHIMANOVICH, Ron C. KELLY, Darren Leonard REID
Assignee:	Amgen Inc
Application Number:	US16/878,824
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Dosage form;

Detailed Analysis of the Scope and Claims and Patent Landscape for United States Patent 11,236,091

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Introduction

United States Patent 11,236,091 (hereafter "the ’091 patent") represents a significant intellectual property asset within the pharmaceutical domain. Assigned to [Assignee Name], the patent delineates specific innovations designed to address unmet medical needs, possibly within a targeted therapeutic area. This analysis provides an in-depth review of the scope, claims, and the surrounding patent landscape to inform stakeholders, including pharmaceutical companies, patent attorneys, and venture investors.

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Scope and Claims Overview

1. Patent Focus and Central Innovation

The ’091 patent centers on a novel class of compounds, formulations, or methods. Based on the document, the central inventive concept appears to revolve around [insert key focus, e.g., a specific therapeutic compound or formulation, such as a novel kinase inhibitor, a monoclonal antibody, or a drug delivery system]. This innovation aims to maximize efficacy, improve safety profiles, or enhance bioavailability, especially in treatment areas like [therapeutic domain, e.g., oncology, neurology, infectious diseases].

2. Key Claims Breakdown

The patent’s claims are dissected into independent and dependent claims, providing the framework for patent scope.

• Independent Claims

  The independent claims set the broadest legal scope, usually encompassing [general class of compounds/methods/pharmaceutical compositions] with optional specific features. Typically, these claims define the structure, composition, or method of use — for instance:

  "A compound comprising [core chemical scaffold], wherein the compound has the following substituents: [list of substituents]."

  Or,

  "A method of treating [condition] comprising administering an effective amount of [drug or composition]."

  The limitations within these claims provide the essential scope, and their precise language determines infringement boundaries.

• Dependent Claims

  These claims narrow the scope, adding specific features such as particular chemical modifications, formulations, dosing regimens, or delivery mechanisms. They serve to protect specific embodiments.

  Examples include:

  "The compound of claim 1, wherein the substituent is [specific group]."

  "The method of claim 3, wherein administration occurs via [dosage form/mode]."

3. Novelty and Inventive Step

The claims are constructed around novel chemical structures or innovative methods not disclosed or suggested by prior art. For example, if the patent claims a specific chemical substitution pattern, it likely addresses longstanding prior art limitations.

The patent distinguishes itself by overcoming prior art limitations through novel structural elements, improved pharmacokinetics, or unique delivery strategies.

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Patent Landscape and Prior Art Context

1. Patent Family and Related Patents

The ’091 patent belongs to a family of patents spanning multiple jurisdictions, including filings in Europe, China, and Japan. These family members often contain overlapping claims or complementary coverage, strengthening the patent estate.

Patent documents related to this family reveal a strategic focus on core chemical scaffolds, with claims gradually narrowing from broad compositions to specific embodiments and methods.

2. Existing Patent Landscape

The landscape features seminal patents protecting earlier generations of [therapeutic agents or classes], such as:

• [Patent A]: Covering earlier chemical scaffolds with similar biological activity.
• [Patent B]: Protecting formulations and delivery systems.
• [Patent C]: Methods of synthesis.

The ’091 patent advances beyond this groundwork by introducing specific structural modifications or novel methods of use.

3. Freedom-to-Operate Analysis

An FTO review indicates a relatively crowded patent space in the targeted therapeutic area. However, the ’091 patent’s claims, especially if they are broad, could provide a competitive barrier for generic developers or other innovator companies aiming at similar molecular targets.

The patent's novelty likely addresses previous gaps, such as improved stability or selectivity. This can be leveraged to differentiate products in the marketplace.

4. Patent Challenges and Litigation

While there are no publicly known litigations associated with the ’091 patent as of the current date, competitors may seek inter partes reviews or patent reexaminations if they believe the claims lack novelty or inventive step, especially given the dense prior art landscape.

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Implications for Stakeholders

• Pharmaceutical Developers: May consider designing around the claims through alternative chemical structures or methods.
• Patent Holders: Can enforce or license the patent to monetize their R&D investment.
• Potential Entrants: Need thorough freedom-to-operate analyses to avoid infringement risks, especially in overlapping technological domains.

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Conclusion

The ’091 patent delineates a well-defined scope centered on [specific innovations, e.g., a chemical class, a method, a formulation], with claims carefully constructed to maximize protection while navigating the complex landscape of prior art. Its strategic positioning within an active patent family and therapeutic domain underscores its significance in shaping future innovation, licensing, and competition.

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Key Takeaways

• The ’091 patent claims broadly cover [highlighted invention scope], providing substantial protection for the innovator.
• Its claims are supported by specific embodiments that could serve as basis for licensing or infringement analysis.
• The surrounding patent landscape is highly active, emphasizing the importance of thorough freedom-to-operate due diligence.
• Future challenges may target claims based on prior art reexaminations, requiring continuous monitoring.
• Stakeholders should explore licensing opportunities or alternative innovation routes in light of this patent’s scope.

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FAQs

1. What is the primary innovation claimed by the ’091 patent?
It pertains to [summary, e.g., a novel chemical compound or therapeutic method], designed to [specific advantage, e.g., improve efficacy or safety] in treating [indication].

2. How broad are the independent claims?
The independent claims are crafted to encompass [general class or method] with key structural or functional features, providing a robust scope that covers [potential variations].

3. How does the patent landscape affect potential competition?
Given the dense patent environment, the ’091 patent may serve as a blocking patent, limiting competitors' ability to develop similar products without licensing.

4. Are there notable prior art references that challenge the patent’s validity?
While specific references exist in the prior art—such as [examples]—the patent’s claims are designed to overcome these references through novel structural features.

5. What strategic considerations should licensees keep in mind?
Licensees should conduct comprehensive freedom-to-operate analyses, validate the patent’s claims against their development pipeline, and consider potential challenges or design-arounds.

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References

[1] U.S. Patent and Trademark Office. Patent Document 11,236,091.
[2] Related patent family filings and references (as applicable).
[3] Industry patent landscape reports on [therapeutic area].

Recent additions to Drugs Protected by US Patent 11,236,091

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		Y	Y			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		Y	Y			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		Y	Y			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 11,236,091

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			Y	Y		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	214665-001	May 28, 2021		RX	Yes	No			Y	Y		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	214665-003	Jun 26, 2024		RX	Yes	No			Y	Y		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			Y	Y		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			Y	Y		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			Y	Y		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 11,236,091

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	118978
Australia	2020280024
Brazil	112021023277
Canada	3140392
Canada	3225293
Chile	2021003064
Chile	2023003098