United States Patent 10,500,216: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,500,216, held by Corcept Therapeutics, Inc., is a crucial component of the company's intellectual property portfolio, particularly in relation to its drug Korlym (mifepristone tablets). This patent is part of a broader strategy to protect the market for Korlym, which is used in the treatment of Cushing’s syndrome. Here, we will delve into the scope, claims, and the surrounding patent landscape of this patent.
Patent Overview
Patent Number and Expiration Date
The United States Patent 10,500,216 is set to expire on March 5, 2033[1].
Patent Claims
The patent includes claims related to the use of mifepristone, a glucocorticoid receptor antagonist, in specific therapeutic applications. These claims are designed to protect the method of use of mifepristone in treating patients with Cushing’s syndrome, among other conditions. The claims are detailed and specific, ensuring that any generic or competing product would need to navigate these claims carefully to avoid infringement[1][4].
Scope of the Patent
Method of Use Patents
The patent falls under the category of method of use patents, which are critical for pharmaceutical companies. These patents cover the specific ways in which a drug can be used, rather than the drug itself. In the case of U.S. Patent 10,500,216, the scope includes the treatment of Cushing’s syndrome and potentially other conditions where mifepristone is beneficial[4].
Protection Mechanisms
Corcept Therapeutics relies on several mechanisms to protect its market for Korlym:
- Method of Use Patents: These patents, including U.S. Patent 10,500,216, ensure that generic manufacturers cannot use the same method of treatment without infringing on Corcept's patents.
- FDA Restrictions: The FDA imposes significant restrictions on the use of mifepristone, particularly its use in terminating pregnancy, which helps differentiate Korlym's use in Cushing’s syndrome.
- Different Patient Populations and Treatment Settings: The distinct patient populations, administering physicians, and treatment settings further protect the market for Korlym[4].
Patent Landscape
Litigation and Challenges
U.S. Patent 10,500,216 has been involved in several legal battles, particularly in the context of Abbreviated New Drug Applications (ANDAs) filed by generic manufacturers. For instance:
- Corcept Therapeutics, Inc. v. Sun Pharma Global FZE: Corcept alleged that Sun Pharma's ANDA product infringed on several of its patents, including U.S. Patent 10,500,216. The case resulted in a settlement where Sun Pharma was enjoined from infringing the patents until their expiration[2].
- Corcept Therapeutics, Inc. v. Teva Pharmaceuticals USA, Inc.: Teva challenged the validity of several Corcept patents, including U.S. Patent 10,500,216. The case is part of ongoing litigation in the District of New Jersey[1].
Other Relevant Patents
Corcept Therapeutics holds a portfolio of patents related to mifepristone, including:
- U.S. Patent 8,921,348: This patent, along with U.S. Patent 10,500,216, is central to the protection of Korlym's market.
- U.S. Patent 9,829,495: Another key patent in the portfolio, which has also been asserted in various ANDA litigations[1][2].
Validity and Enforceability
The validity and enforceability of U.S. Patent 10,500,216 have been challenged by generic manufacturers. For example:
- Teva's Challenge: Teva asserted that each claim of the patent is invalid and not infringed. However, the patent has withstood these challenges so far, maintaining its validity and enforceability[1].
Settlements and Agreements
Settlements involving U.S. Patent 10,500,216 typically include terms that prevent generic manufacturers from infringing the patent until its expiration. For instance:
- Corcept Therapeutics, Inc. v. Sun Pharma Global FZE: The settlement dismissed all claims and counterclaims without prejudice and enjoined Sun Pharma from infringing the patents-in-suit, including U.S. Patent 10,500,216, until their expiration[2].
Impact on Market Dominance
The protection afforded by U.S. Patent 10,500,216 is crucial for Corcept Therapeutics' market dominance in the treatment of Cushing’s syndrome. By preventing generic competition, Corcept can maintain its market share and pricing power for Korlym until the patent expires in 2033.
Key Takeaways
- Patent Scope: U.S. Patent 10,500,216 covers the method of use of mifepristone in treating Cushing’s syndrome.
- Litigation: The patent has been involved in several ANDA litigations, including challenges from Teva and Sun Pharma.
- Validity and Enforceability: The patent has been upheld as valid and enforceable despite challenges.
- Market Protection: The patent is a key component in protecting Corcept's market for Korlym.
- Expiration Date: The patent is set to expire on March 5, 2033.
FAQs
What is the primary use protected by U.S. Patent 10,500,216?
The primary use protected by U.S. Patent 10,500,216 is the treatment of Cushing’s syndrome using mifepristone.
Which companies have challenged the validity of U.S. Patent 10,500,216?
Teva Pharmaceuticals and Sun Pharma have challenged the validity of U.S. Patent 10,500,216 in various litigations.
What is the expiration date of U.S. Patent 10,500,216?
The expiration date of U.S. Patent 10,500,216 is March 5, 2033.
How does Corcept Therapeutics protect its market for Korlym?
Corcept Therapeutics protects its market for Korlym through method of use patents, FDA restrictions, and different patient populations and treatment settings.
What are the implications of U.S. Patent 10,500,216 for generic manufacturers?
Generic manufacturers are prevented from using the same method of treatment covered by U.S. Patent 10,500,216 until the patent expires, thereby protecting Corcept's market share.
Sources
- MDC Financial Research, LLC - Corcept Therapeutics, Inc. (CORT)[1]
- Robins Kaplan LLP - ANDA Litigation Settlements Fall 2021 | Hatch-Waxman[2]
- SSRN - Patent Claims and Patent Scope[3]
- Annual Reports - United States Securities and Exchange Commission - Annual Reports[4]
- Robins Kaplan LLP - ANDA Litigation Settlements | Hatch-Waxman - Q4 2023[5]
