Detailed Analysis of the Scope and Claims of United States Patent 10,159,682
Introduction
United States Patent 10,159,682, assigned to Cassiopea S.p.A., is a significant patent in the pharmaceutical industry, particularly for the treatment of acne vulgaris. Here, we delve into the scope, claims, and patent landscape of this patent.
Patent Overview
Title and Abstract
The patent is titled "Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives." It describes a new enzymatic process for producing 17 alpha-monoesters of cortexolone and its derivatives, starting from the corresponding 17 alpha,21-diesters through an enzymatic alcoholysis reaction. The patent also covers new crystalline forms of cortexolone-17 alpha-propionate and 9,11-dehydro-cortexolone 17 alpha-butanoate[2].
Inventors and Assignee
The inventors of this patent are Mauro Ajani and Luigi Moro, and the assignee is Cassiopea S.p.A., an Italian pharmaceutical company[2].
Patent Claims
Types of Claims
The patent includes various types of claims, such as use claims, composition claims, and dosage form claims. Specifically, the patent claims cover:
- The enzymatic process for obtaining the specified compounds.
- The new crystalline forms of the compounds.
- The method of using these compounds, particularly for treating acne vulgaris[2].
Specific Claims
At least claims 1-3, 7-9, 13-16, 19, and 20 of the '682 patent read on a method of using the approved product, WINLEVI®. These claims are crucial as they define the scope of protection for the patented process and product[1].
Approved Product and Regulatory Approval
WINLEVI®
The patent protects WINLEVI®, a topical cream containing clascoterone, which is used for the treatment of acne vulgaris. WINLEVI® was approved by the FDA on August 26, 2020, under the New Drug Application (NDA) number 213433-001[2].
Patent Term Extension
Eligibility and Calculation
The patent is eligible for a term extension under 35 U.S.C. § 156 due to the regulatory review period for WINLEVI®. The applicant, Cassiopea S.p.A., has requested a patent term extension of 489 days. This period was calculated based on the regulatory review period, which began on March 1, 2012, and ended on August 26, 2020, totaling 3102 days. The extension would result in a new expiration date of December 16, 2029[1].
Patent Family and International Coverage
Global Presence
The patent has a significant global presence with seventy-two patent family members in twenty-four countries. This includes patents in countries such as Argentina, Australia, and others, ensuring broad international protection for the invention[2].
Foreign Priority and PCT Information
Priority Dates
The patent claims priority to Italian Patent Application No. MI2007A1616, filed on August 3, 2007, and International Patent Application No. PCT/EP2008/059702, filed on July 24, 2008[1][2].
Patent Landscape
Related Patents
The '682 patent is part of a larger family of patents related to the same technology. Other related U.S. patents include U.S. Patent Nos. 8,143,240, 8,785,427, 8,865,690, 9,211,295, 9,433,628, and 9,486,458. These patents also cover various aspects of the production and use of cortexolone derivatives[1].
Scope of Protection
Enzymatic Process
The patent's scope includes the enzymatic alcoholysis reaction process, which is a novel method for obtaining the specified compounds. This process is a key innovation protected by the patent[2].
Crystalline Forms
The patent also covers new crystalline forms of cortexolone-17 alpha-propionate and 9,11-dehydro-cortexolone 17 alpha-butanoate, which are important for the stability and efficacy of the final product[2].
Impact on Innovation
Patent Quality and Scope
The debate over patent quality often involves the breadth and clarity of patent claims. Metrics such as independent claim length and independent claim count can be used to measure patent scope. In the case of U.S. Patent 10,159,682, the detailed claims and the specific enzymatic process described contribute to a clear and defined scope of protection, which can incentivize further innovation in the field[3].
Conclusion
United States Patent 10,159,682 is a critical patent in the pharmaceutical sector, particularly for the treatment of acne vulgaris. It protects a novel enzymatic process and new crystalline forms of cortexolone derivatives, ensuring Cassiopea S.p.A.'s exclusive rights over WINLEVI® until December 16, 2029, following the patent term extension.
Key Takeaways
- Patent Title and Abstract: Covers the enzymatic process for obtaining 17 alpha-monoesters of cortexolone and its derivatives.
- Inventors and Assignee: Mauro Ajani and Luigi Moro, assigned to Cassiopea S.p.A.
- Claims: Include use, composition, and dosage form claims, particularly for treating acne vulgaris.
- Approved Product: WINLEVI®, a topical cream containing clascoterone, approved by the FDA on August 26, 2020.
- Patent Term Extension: Eligible for a 489-day extension, resulting in a new expiration date of December 16, 2029.
- Global Coverage: Seventy-two patent family members in twenty-four countries.
- Scope of Protection: Includes the enzymatic alcoholysis reaction process and new crystalline forms of cortexolone derivatives.
FAQs
Q: What is the main subject of U.S. Patent 10,159,682?
A: The patent covers a new enzymatic process for obtaining 17 alpha-monoesters of cortexolone and its derivatives, as well as new crystalline forms of these compounds.
Q: Who are the inventors of this patent?
A: The inventors are Mauro Ajani and Luigi Moro.
Q: What is the approved product protected by this patent?
A: The approved product is WINLEVI®, a topical cream containing clascoterone, used for treating acne vulgaris.
Q: When was WINLEVI® approved by the FDA?
A: WINLEVI® was approved by the FDA on August 26, 2020.
Q: How long is the patent term extension requested for this patent?
A: The patent term extension requested is 489 days, resulting in a new expiration date of December 16, 2029.
Sources
- Application for Extension of Patent Term Under 35 U.S.C. § 156 - Regulations.gov
- Pharmaceutical drugs covered by patent 10,159,682 - DrugPatentWatch
- Patent Claims and Patent Scope - Hoover Institution
- Application for Extension of Patent Term Under 35 U.S.C. § 156 - Regulations.gov
- Application for patent term extension (PTE) of U.S. Patent No. 10,159,682 - Regulations.gov
