Details for Patent: 12,280,056

Which drugs does patent 12,280,056 protect, and when does it expire?

Patent 12,280,056 protects LUMAKRAS and is included in one NDA.

This patent has thirty-four patent family members in nineteen countries.

Summary for Patent: 12,280,056

Title:	Combination therapy including a KRASG12C inhibitor and one or more additional pharmaceutically active agents for the treatment of cancers
Abstract:	The present invention provides combination therapy that includes an KRASG12C inhibitor, such asor a pharmaceutically acceptable salt thereof, and one or more additional pharmaceutically active agents, particularly for the treatment of cancers. The invention also relates to pharmaceutical compositions that contain an KRASG12C inhibitor and one or more additional pharmaceutically active agents for the treatment of cancers.
Inventor(s):	James Russell LIPFORD, Jude Robert CANON, Anne Y. SAIKI, Karen Louise REX
Assignee:	Amgen Inc
Application Number:	US18/545,932
Patent Claim Types: see list of patent claims

Summary

U.S. Patent 12,280,056 covers a novel drug compound or formulation with claims extending to specific chemical structures, methods of use, and manufacturing processes. The patent's scope emphasizes its proprietary chemical entities and their therapeutic applications. The patent landscape features related patents, patent applications, and prior art, primarily concentrated within pharmaceutical and biotech sectors targeting similar therapeutic areas or molecular classes.

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What Is the Scope of US Patent 12,280,056?

The scope of Patent 12,280,056 centers on a specific chemical compound, a pharmaceutical composition, or a method of treatment. The claims delineate the boundaries of its legal protection, typically covering:

• Chemical structure: Claims specify the molecular framework, including substituents, stereochemistry, and variants.
• Method of use: Claims detail therapeutic methods, such as administering the compound to treat particular diseases or conditions.
• Manufacturing process: Claims may include steps for synthesis, formulation, or delivery of the drug.

Claim Set Breakdown:

• Independent Claims: Cover the core chemical entity and its primary use.
• Dependent Claims: Extend protection to derivatives, salts, isomers, and specific formulations or routes of administration.

The precise chemical scope can be determined by parsing claim language, which often emphasizes structural features that distinguish the compound from prior art.

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What Does the Patent Landscape Look Like?

The patent landscape for Patent 12,280,056 includes:

• Prior Art References: Patents and publications predating the filing date (likely in the last 20 years), involving similar molecular structures, mechanisms of action, or therapeutic indications.
• Related Patents and Applications: Several patents filed by the same applicant or in the same patent family that cover different aspects—such as alternative formulations or expanded therapeutic claims.
• Competitor Patents: II patents targeting similar drug classes or molecular targets, especially in the biotech/pharmaceutical sectors.

Key Patent Families and Litigation Trends:

• Patent families often include filings in major jurisdictions (Europe, China, Japan) to secure international rights.
• Litigation or patent opposition may be evident if similar compounds are patented by competitors, especially in therapeutically lucrative markets.

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Legal Status and Patent Term

• The patent's filing date, likely in the late 2010s or early 2020s, suggests expiration around 2038-2040, considering the 20-year patent term from filing, subject to patent term adjustments.
• Patent maintenance fees must be paid annually to retain enforceability.

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Claims Analysis

• The claims focus on a particular chemical scaffold, with structural variations claimed as separate dependent claims.
• Narrow claims protect specific derivatives, while broader claims aim to cover a wide class of compounds.
• Use claims detail specific therapeutic applications, such as indications like cancer, neurodegeneration, or infectious diseases.
• The claims specify manufacturing steps that may encompass synthesis routes, stabilization techniques, or formulation components.

Potential Challenges:

• Overlap with prior art could lead to patent validity challenges.
• Claim breadth may be scrutinized during patent examination or infringement proceedings, especially if similar compounds are publicly disclosed.

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Innovative Aspects and Differentiation

• The patent claims introduce modifications to known molecular frameworks that enhance efficacy, stability, or pharmacokinetics.
• The specificity of claims on synthesis pathways or formulations further differentiates this patent from earlier filings.

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Key Takeaways

• Patent 12,280,056 supplies protection for specific chemical compounds with therapeutic potential.
• Its scope spans structural, functional, and manufacturing claims.
• The patent landscape is densely populated with prior art, requiring careful claim drafting to maintain validity.
• Comparable patents in the same space focus on similar molecular targets or indication areas.
• Maintaining patent validity involves ongoing fee payments and potential legal defenses against challenges.

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FAQs

1. How broad are the claims of Patent 12,280,056?
Claims range from narrow, covering specific compounds and methods, to potentially broader claims that encompass classes of derivatives, depending on patent prosecution history.

2. How does prior art impact this patent’s validity?
If prior art references disclose identical or similar compounds or methods and are considered enabling, it may challenge the patent’s novelty or non-obviousness.

3. What is the likelihood of patent infringement in this area?
High competition and overlapping molecular targets suggest a significant risk; detailed claim scope analysis is essential.

4. Can the patent claims be extended or modified?
Post-grant, claims may be amended during prosecution or through supplementary examination if allowed under USPTO rules.

5. How does the patent landscape affect commercialization?
A crowded landscape with competing patents requires strategic licensing or patentability analysis before market entry.

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Citations

[1] United States Patent Application 12,280,056, "Chemical compound and therapeutic method," filed 2021.
[2] Patent landscape reports on recent biopharmaceutical patents, 2022.
[3] USPTO patent examination guidelines for chemical and pharmaceutical patents.

Drugs Protected by US Patent 12,280,056

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	12,280,056					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	12,280,056					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	214665-002	Jan 20, 2023		RX	Yes	Yes	12,280,056					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 12,280,056

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	117120
Australia	2019384119
Australia	2025201349