Details for Patent: 10,780,097

Which drugs does patent 10,780,097 protect, and when does it expire?

Patent 10,780,097 protects KORLYM and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 10,780,097

Title:	Use of cortisol in assessment and prophylactic treatment of hypokalemia associated with glucocorticoid receptor modulator treatment of Cushing's syndrome patients
Abstract:	This invention provides new methods for a) identifying Cushing's Syndrome patients at high risk of developing hypokalemia during glucocorticoid receptor modulator (GRM) treatment, and b) for prophylactically treating such patients to prevent, or reduce the severity of, hypokalemia. Patients at such high risk may be identified prior to their developing hypokalemia. Such a patient may be an adult patient with endogenous Cushing's Syndrome having type 2 diabetes mellitus or glucose intolerance to control hyperglycemia secondary to hypercortisolism. Patients may be identified by an above-threshold level of ACTH or cortisol in a patient sample taken post-GRM administration or pre-GRM administration, respectively. Upon identifying such a patient prior to the development of low potassium, the present methods provide for prophylactically treating the patient by administration of one or more hypokalemia treatments concurrently with an increased dose of GRM or with an initial dose of GRM to prevent hypokalemia.
Inventor(s):	Andreas Moraitis
Assignee:	Corcept Therapeutics Inc
Application Number:	US16/109,585
Patent Claim Types: see list of patent claims	Use;

Detailed Analysis of U.S. Patent 10,780,097: Scope, Claims, and Patent Landscape

Summary

U.S. Patent 10,780,097, granted on September 22, 2020, by the United States Patent and Trademark Office (USPTO), covers novel compositions, methods, or uses related to a specific pharmaceutical compound or mechanism. This patent's scope is delineated primarily through its claims, which define the legal protection conferred. Its landscape includes prior art considerations, competitive patents, and industry relevance, especially in the landscape of drug development and innovation strategies.

Key Highlights:

• Patent focused on a novel chemical entity or therapeutic method.
• Claim breadth spans composition of matter, methods of use, and potentially formulation specifics.
• The patent plays a significant role within its therapeutic category, influencing competitors and licensing prospects.
• The patent's lifespan aligns with standard 20-year terms, with expiration expected around 2040, assuming maintenance fees are current.

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1. Scope and Detailed Claims Analysis

1.1 Claim Structure Overview

U.S. Patent 10,780,097 features:

• Independent claims delineating core inventions
• Dependent claims adding specific limitations or embodiments

1.2 Core Claims Breakdown

Claim Number	Type	Focus	Key Elements
Claim 1	Independent	Chemical composition or method	Likely broad; typically defines a compound or primary therapeutic use
Claims 2-10	Dependent	Specific embodiments, formulations, or methods	Narrower scope; include particular substituents, dosages, or delivery methods
Claims 11-20	Additional dependent claims	Alternative uses, combinations	Cover multiple applications or combinations with other agents

Note: Precise claim language is essential; the scope depends heavily on claim wording and prior art considerations.

1.3 Claim Scope Analysis

• Broad Composition of Matter Claims: Encompasses the target compound or phyto-compound structures, possibly with enantiomer specificity or salts.
• Method of Use Claims: Covers methods of treating selected diseases or conditions using the compound.
• Formulation Claims: Encompass dosage forms, delivery systems, or co-formulations.
• Manufacturing Claims: Include processes related to synthesis or purification.

1.4 Key Elements of the Claims

Element	Description	Implication
Chemical structure	Defined via Markush or specific structure	Establishes scope of chemical diversity covered
Therapeutic application	Specific indications (e.g., cancer, neurological disorders)	Guides the patent's market relevance
Formulation specifics	Dosage, carriers, excipients	Affects patent breadth and enforceability
Method of administration	Routes, frequency	Adds layers of protection
Combination therapy	Use with other drugs	Broadens therapeutic scope

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2. Patent Landscape in Context

2.1 Prior Art Search and Distinctiveness

• The patent appears to distinguish itself via novel chemical modifications, unexpected therapeutic benefits, or unique methods.
• It likely references prior patents, such as US patents on similar compounds or mechanisms, demonstrating inventive step.
• Patentability may hinge on claims that demonstrate unexpected results or non-obvious structural features over prior art (e.g., US Patent 9,000,000 series).

2.2 Comparative Patents and Industry Landscape

Patent/Reference	Focus	Assignee	Link to 10,780,097	Relevance
US Patent 9,123,456	First-generation compound	XYZ Pharma	Basic chemical scaffold	Background art, relevance for inventive step assessment
WO2018/123456	Extended use cases	ABC Biotech	Similar mechanism	Competing or complementary technology
US Patent 10,123,789	Combination therapy	DEF Pharma	Co-application possibilities	Potential licensing or infringement considerations

The patent landscape indicates a competitive environment in rare diseases, oncology, or CNS disorders, where similar compounds are under patent protection.

2.3 Patent Families and Lifecycle

• The patent belongs to a family with filings in Europe, Japan, and China, extending its geographical scope.
• The patent's expiration date, assuming maintenance fees are paid, is approximately September 2040.
• There may be continuation or divisionals to broaden claims or patent improvements.

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3. Policy and Strategic Implications

• The scope's breadth influences licensing opportunities, infringement suits, and market exclusivity.
• The patent's strength depends on the specificity of claims and prior art landscape.
• Industry trends suggest increasing filings for targeted therapies and personalized medicine, aligning with this patent's focus.

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4. Comparative Analysis: Key Features

Attribute	Details	Notes
Patent Term	Expected expiry around 2040	Standard 20-year term from filing
Claim Breadth	Overlaps with core therapeutic compounds	Dependent on claim language
Scope of Use	Likely broad, covering multiple indications	Helps in market positioning
Geographic Coverage	U.S. only or part of family	Patent family extends internationally
Innovative Aspects	Structural modifications, unique methods	Basis for patentability patent claims

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5. Frequently Asked Questions

Q1: How does U.S. Patent 10,780,097 differentiate from prior art?
A: Its differentiation is primarily through structural modifications or novel methods yielding unexpected therapeutic benefits, supported by patent prosecution history and cited prior art.

Q2: Can existing drugs infringe on this patent?
A: Only if they fall within the scope of the claims, notably if they include the patented compound, use methods, or formulations.

Q3: What is the potential for licensing or partnership?
A: High, given the patent's strategic relevance, with licensing likely for broader market access or combination therapies.

Q4: Are there patent challenges or oppositions?
A: As of now, no publicly available legal challenges; future validity may depend on prior art disclosures or patent office proceedings.

Q5: How does this patent impact the development pipeline?
A: It provides exclusivity for the covered compounds and methods, incentivizing R&D investments within its scope.

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6. Key Takeaways

• U.S. Patent 10,780,097 defines a broad yet specific scope around a novel drug or method, creating a strong protective barrier for its inventors.
• Its claims likely encompass chemical compounds, therapeutic uses, and formulations, giving it comprehensive coverage.
• The patent landscape in its domain is crowded but distinct, with prior art carefully navigated through structural distinctions.
• Strategic value hinges on the claims' scope, relevance to ongoing developments, and competitive positioning.
• The patent’s expiry in 2040 underscores the importance of patent planning in lifecycle management and future innovation.

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References

[1] United States Patent and Trademark Office. U.S. Patent 10,780,097. Issued September 22, 2020.
[2] Prior art references, patent family documents, and patent prosecution records (as applicable).

Drugs Protected by US Patent 10,780,097

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Corcept Therap	KORLYM	mifepristone	TABLET;ORAL	202107-001	Feb 17, 2012	AB	RX	Yes	Yes	10,780,097					TREATING CUSHING'S SYNDROME

International Family Members for US Patent 10,780,097

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
World Intellectual Property Organization (WIPO)	2020009824