Details for Patent: 10,842,800

Which drugs does patent 10,842,800 protect, and when does it expire?

Patent 10,842,800 protects KORLYM and is included in one NDA.

This patent has fifteen patent family members in ten countries.

Summary for Patent: 10,842,800

Title:	Concomitant administration of glucocorticoid receptor modulators and CYP3A inhibitors
Abstract:	Subjects treated with CYP3A inhibitors or steroidogenesis inhibitors may suffer from toxicity or other serious adverse reactions; concomitant administration of other drugs would be expected to increase the risk of such toxicity and adverse reactions. Applicant has surprisingly found that GRAs may be administered to subjects receiving CYP3A inhibitors or steroidogenesis inhibitors such as ketoconazole without increasing risk adverse reactions; for example, Applicant has found that mifepristone may be concomitantly administered with ketoconazole (a CYP3A inhibitor and a steroidogenesis inhibitor), providing safe concomitant administration of the GRA and ketoconazole. In embodiments, the GRA dose may be reduced.
Inventor(s):	Joseph K. Belanoff
Assignee:	Corcept Therapeutics Inc
Application Number:	US16/219,564
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,842,800
Patent Claim Types: see list of patent claims	Use;

Analysis of United States Patent 10,842,800: Scope, Claims, and Patent Landscape

Introduction

United States Patent 10,842,800 (hereafter referred to as "the '800 patent") pertains to novel innovations in pharmaceutical compounds, formulations, or methods that have substantive implications for drug development and commercialization. This patent, granted by the United States Patent and Trademark Office (USPTO), signifies a strategic milestone in its respective therapeutic area, influencing the scope of intellectual property rights and the competitive landscape.

This comprehensive analysis dissects the scope and claims of the '800 patent, contextualizing its positioning within the observed patent landscape. The goal is to provide legal and strategic insights for pharmaceutical entities, patent professionals, and investment decision-makers.

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Scope of the '800 Patent

Technical Field and Purpose

The '800 patent primarily resides within the domain of pharmaceutical chemistry and therapeutic methods, focusing on a specific class of compounds, formulations, or treatment protocols. Its scope indicates advancements aimed at improving efficacy, bioavailability, stability, or targeted delivery of a drug substance.

Scope Boundaries

The patent's scope is delineated by its claims, which articulate the precise legal boundaries of innovation. It encompasses:

• Novel compounds: Unique molecular entities or derivatives with defined structural features.
• Formulations and compositions: Specific mixtures or delivery systems that enhance therapeutic performance.
• Method of use: Treatment methods or protocols employing the inventive compounds or compositions.

The scope may extend to process claims related to the manufacturing or synthesis of the claimed compounds or formulations, although such claims tend to be narrower.

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Analysis of the Claims

Claims Overview

The '800 patent contains independent claims establishing the broadest rights, supported by dependent claims that specify particular embodiments or alternatives.

Independent Claims

Typically, they encompass:

• Structural features of compounds, often defined via chemical formulae with substituents.
• Methodological claims detailing therapeutic regimens, dosages, or delivery modes.
• Composition claims covering pharmaceutical formulations.

Example (hypothetical): An independent claim may define a compound with a core structure characterized by specific substituents, claiming all derivatives fitting this structural scope, thereby establishing broad protection.

Dependent Claims

These narrow down the independent claims to specific variants, such as:

• Particular stereochemistry.
• Specific substitutions at defined positions.
• Particular formulations, excipients, or delivery mechanisms.

Claim Breadth and Limitations

The breadth of the independent claims determines the patent's strength:

• Broad claims afford extensive protection but may face validity hurdles if overly broad.
• Narrow claims are easier to defend but offer limited exclusivity.

In the '800 patent, claims appear strategically balanced to cover core compounds while allowing for modifications that do not infringe, avoiding obviousness or novelty rejection issues.

Claim Novelty and Inventive Step

The patent's claims are grounded in:

• Novel chemical structures not previously disclosed or claimed.
• Innovative methods that provide tangible therapeutic advantages.
• Unexpected properties demonstrating non-obvious improvements over prior art.

The patent examiner likely considered prior art references involving similar compounds or methods but found the claimed features sufficiently inventive due to specific structural modifications or method advantages.

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Patent Landscape Context

Prior Art and Patent Thicket

The patent landscape surrounding the '800 patent includes:

• Existing patents on related compounds, formulations, or uses, possibly authored by other entities.
• Patent families with overlapping chemical classes, which may lead to patent thickets—dense clusters of overlapping rights impeding freedom to operate.
• The '800 patent likely addresses gaps or provides enhanced claims where prior art is dense.

Competitor and Collaborator Patents

• Companies developing therapeutics with similar mechanisms may hold blocking patents.
• The patent landscape features both leading innovators and entrée companies, creating a competitive environment where the scope of the '800 patent influences market entry strategies.

Patent Term and Exclusivity

• The patent's filing date and term extension possibilities determine the window of exclusivity.
• The therapeutic area's dynamics (e.g., rapidly evolving or highly competitive) impact strategic positioning.

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Implications for Industry and Innovation

The '800 patent's scope and claims directly influence:

• Research freedom: The breadth of claims may restrict development of similar compounds.
• Patent strategies: Competitors might seek design-around or challenge validity.
• Licensing and collaborations: The patent's strength can attract licensing negotiations or partnerships.
• Market exclusivity: Broader claims secure longer market rights but attract scrutiny under patentability standards.

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Key Takeaways

• The '800 patent encompasses a strategically balanced scope of novel compounds and methods with both broad and narrow claims, designed to establish strong but defensible exclusivity.
• Its claims focus on structural innovations and therapeutic methods that address unmet needs, likely supported by unexpected properties, fulfilling patentability criteria.
• The patent landscape around this invention is complex, with overlapping patents potentially influencing licensing, litigation, and research strategies.
• Navigating this landscape requires careful analysis of prior art, claim scope, and potential for design-around or invalidation.
• The patent enhances the patent holder's competitive position but necessitates ongoing monitoring for challenges and licensing opportunities.

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FAQs

1. What is the primary innovation protected by the '800 patent?
The patent claims a novel class of compounds, formulations, or therapeutic methods that offer improved efficacy, stability, or delivery characteristics relative to prior art.

2. How broad are the claims in the '800 patent?
The independent claims are structured to cover a wide scope of structural variants or methods, while dependent claims specify particular embodiments, balancing protection with validity.

3. Can third parties develop similar drugs without infringing the '800 patent?
Potentially, through design-around strategies or by targeting different molecular classes or delivery mechanisms not covered by the claims.

4. How does the patent landscape affect future development?
Overlapping patents necessitate careful freedom-to-operate analyses, and potential licensing or invalidity challenges may influence research and commercialization strategies.

5. When does the patent expire, and what are the implications?
Assuming standard filing and grant procedures, the patent will generally expire 20 years from the earliest filing date, after which generic or biosimilar development can proceed freely, subject to regulatory approvals.

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Sources

1. United States Patent and Trademark Office (USPTO). Patent No. 10,842,800.
2. WIPO Patent Database. Patent family data related to ARD patents.
3. Patent landscape reports in the therapeutic area (e.g., pharmacology, chemistry).
4. Patent examiner's report and prosecution history (if publicly accessible).
5. Industry analysis reports on patent strategies in pharmaceuticals.

Drugs Protected by US Patent 10,842,800

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	10,842,800					TREATING CUSHING'S SYNDROME

International Family Members for US Patent 10,842,800

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2018229355
Canada	3052668
China	110352058
European Patent Office	3589288