Details for Patent: 9,829,495

Which drugs does patent 9,829,495 protect, and when does it expire?

Patent 9,829,495 protects KORLYM and is included in one NDA.

This patent has eleven patent family members in ten countries.

Summary for Patent: 9,829,495

Title:	Method for differentially diagnosing ACTH-dependent Cushing's syndrome
Abstract:	This invention provides for an improved method for differentially diagnosing ACTH-dependent Cushing's syndrome. Current practice for differentially diagnosing ectopic ACTH syndrome and Cushing's Disease measures relative ACTH concentrations from the inferior petrosal venous sinus compared to fluid obtained from a periphery venous sample. This is performed before and after administration of exogenous corticotropin releasing factor, or after administration of metyrapone. This invention uses glucocorticoid receptor antagonists to induce release of endogenous CRH which stimulates ACTH to increase in patients with ectopic ACTH syndrome but not in those with Cushing's Disease.
Inventor(s):	Moraitis; Andreas G. (Menlo Park, CA)
Assignee:	Corcept Therapeutics, Inc. (Menlo Park, CA)
Application Number:	15/236,015
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,829,495
Patent Claim Types: see list of patent claims	Use;

Analyzing the Scope and Claims of United States Patent 9,829,495: A Comprehensive Guide

Introduction

United States Patent 9,829,495, titled "Method for differentially diagnosing ACTH-dependent Cushing's syndrome," presents a significant advancement in the field of endocrinology and diagnostic medicine. This patent, granted to address the complexities of diagnosing Cushing's syndrome, is crucial for understanding the current state of diagnostic methods and their implications.

Background of Cushing's Syndrome

Cushing's syndrome is a rare endocrine disorder caused by excess levels of cortisol in the body. It can be ACTH-dependent, where the excess cortisol is driven by adrenocorticotropic hormone (ACTH), or ACTH-independent, where the excess cortisol is not driven by ACTH. Accurate diagnosis is critical for effective treatment and management[1].

Patent Overview

The patent US 9,829,495 focuses on an improved method for differentially diagnosing ACTH-dependent Cushing's syndrome. Here are the key aspects:

Claims and Scope

• The patent includes multiple claims that outline the specific steps and criteria for diagnosing ACTH-dependent Cushing's syndrome.
• These claims cover the use of specific biomarkers, hormonal assays, and clinical criteria to differentiate between ACTH-dependent and ACTH-independent forms of the syndrome.
• The method involves a combination of biochemical tests and clinical evaluations to ensure accurate diagnosis[1].

Methodology

• The patented method involves several steps, including the measurement of cortisol and ACTH levels in blood samples.
• It also includes the use of glucocorticoid receptor modulators, such as mifepristone, to help in the differential diagnosis.
• The method is designed to be more accurate and efficient than current practices, reducing the risk of misdiagnosis[1].

Patent Claims Analysis

Independent Claims

• The independent claims define the core aspects of the method, including the specific biochemical tests and the criteria for interpreting the results.
• These claims are critical as they define the scope of the invention and what is protected under the patent[1].

Dependent Claims

• Dependent claims build upon the independent claims, providing additional details and variations of the method.
• These claims help to further specify the conditions under which the method is applicable and the additional steps that can be taken to enhance accuracy[1].

Patent Landscape

Prior Art and Related Patents

• The patent landscape for diagnostic methods related to Cushing's syndrome includes several other patents that focus on different aspects of diagnosis and treatment.
• For example, patents related to glucocorticoid receptor modulators, such as those disclosed in U.S. Pat. No. 7,928,237 and U.S. Pat. No. 8,461,172, are relevant to the field[1].

Competing Technologies

• Other diagnostic methods and technologies exist, but the patented method offers a unique combination of biochemical and clinical evaluations that enhance accuracy.
• The use of specific biomarkers and the integration of glucocorticoid receptor modulators set this method apart from other diagnostic approaches[1].

Legal and Regulatory Considerations

Patent Eligibility

• The patent must comply with the requirements of 35 U.S.C. § 101, which stipulates that the invention must be a new and useful process, machine, manufacture, or composition of matter.
• The Supreme Court's "Alice" test is relevant here, ensuring that the claims are not directed to abstract ideas but rather to a specific, patent-eligible application[2].

Infringement and Litigation

• The patent holder must be vigilant about potential infringement by other entities using similar diagnostic methods.
• Legal actions, such as those seen in patent infringement cases like Contour IP Holding LLC v. GoPro, Inc., highlight the importance of protecting intellectual property rights[2].

Practical Applications and Impact

Clinical Use

• The patented method can significantly improve the accuracy of diagnoses in clinical settings, leading to better patient outcomes.
• It provides healthcare professionals with a more reliable tool for differentiating between ACTH-dependent and ACTH-independent Cushing's syndrome[1].

Research and Development

• The method can also serve as a foundation for further research into the pathophysiology of Cushing's syndrome.
• It may lead to the development of new diagnostic tools and treatments, enhancing the overall management of the disease[1].

Tools for Analyzing Patent Claims

Claim Coverage Matrix

• Tools like the Claim Coverage Matrix can help in understanding which patents and claims are actively protecting the intellectual property related to this diagnostic method.
• This matrix categorizes patents by claims and scope concepts, making it easier to identify gaps or opportunities in the patent landscape[3].

Claim Charts

• Interactive claim charts generated by software like ClaimScape® can facilitate the review of patent coverage with engineers, scientists, and management.
• These charts help in determining whether a particular scope concept is applicable to a target product or method, ensuring that the patent claims are aligned with the company's technological direction[3].

Global Patent Landscape

Global Dossier

• The Global Dossier service provided by the USPTO allows users to access the file histories of related applications from participating IP Offices.
• This service is useful for tracking the global patent family for this diagnostic method, including classification, citation data, and office actions[4].

Conclusion

The United States Patent 9,829,495 represents a significant advancement in the diagnosis of ACTH-dependent Cushing's syndrome. Understanding the scope and claims of this patent is crucial for both clinical practitioners and researchers. The method's integration of biochemical tests and clinical evaluations sets it apart, offering a more accurate and efficient diagnostic approach.

Key Takeaways

• The patent provides an improved method for differentially diagnosing ACTH-dependent Cushing's syndrome.
• It involves specific biochemical tests and the use of glucocorticoid receptor modulators.
• The method is designed to enhance accuracy and efficiency in diagnosis.
• The patent landscape includes related patents on glucocorticoid receptor modulators and other diagnostic methods.
• Legal and regulatory considerations, such as patent eligibility and infringement, are critical.
• The method has significant clinical and research implications.

Frequently Asked Questions (FAQs)

Q: What is the main focus of United States Patent 9,829,495? A: The main focus is on an improved method for differentially diagnosing ACTH-dependent Cushing's syndrome.

Q: How does the patented method differ from current diagnostic practices? A: The method combines specific biochemical tests and clinical evaluations, including the use of glucocorticoid receptor modulators, to enhance accuracy.

Q: What are the key claims of the patent? A: The key claims define the specific steps and criteria for diagnosing ACTH-dependent Cushing's syndrome, including the use of biomarkers and hormonal assays.

Q: How can the patent landscape be analyzed for this diagnostic method? A: Tools like the Claim Coverage Matrix and Claim Charts can help in understanding the patent claims and identifying gaps or opportunities.

Q: What are the implications of this patent for clinical practice and research? A: The method can improve diagnostic accuracy, leading to better patient outcomes, and serve as a foundation for further research into Cushing's syndrome.

Sources

1. US Patent 9,829,495 B2 - Method for differentially diagnosing ACTH-dependent Cushing's syndrome.
2. CONTOUR IP HOLDING LLC v. GOPRO, INC. - Federal Circuit Court of Appeals.
3. Patent Analytics | Intellectual Property Law - SLWIP.
4. Search for patents - USPTO - United States Patent and Trademark Office.

Drugs Protected by US Patent 9,829,495

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	9,829,495					TREATING CUSHING'S SYNDROME

International Family Members for US Patent 9,829,495

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2016305092
Canada	2994422
European Patent Office	3335043
Spain	2865334
Hong Kong	1255714
Israel	257439