United States Patent 11,207,332: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 11,207,332, assigned to Cassiopea S.P.A., is a significant patent in the pharmaceutical sector, particularly related to the drug Winlevi. This patent focuses on a new enzymatic process for obtaining 17α-monoesters of cortexolone and its derivatives, which are crucial for the treatment of various skin and hormonal conditions.
Patent Overview
Issuance and Assignee
The patent was issued on December 28, 2021, to Cassiopea S.P.A., an Italian pharmaceutical company. The inventors listed are Ajani Mauro and Moro Luigi, who have contributed to several related patents in this field[5].
Scope of the Patent
Claims
The patent primarily covers a new enzymatic process for obtaining 17α-monoesters of cortexolone and its 9,11-dehydroderivatives. Here are the key aspects of the claims:
- Enzymatic Process: The patent describes an enzymatic alcoholysis reaction starting from the corresponding 17α,21-diesters. This process is innovative in the field of steroid chemistry and is crucial for the synthesis of active pharmaceutical ingredients[5].
- Crystalline Forms: The patent also includes new crystalline forms of cortexolone-17α-propionate and 9,11-dehydro-cortexolone 17α-butanoate. These crystalline forms are important for the stability and bioavailability of the drug[5].
Patent Claims and Scope
Independent Claims
The independent claims of the patent are critical as they define the scope of the invention. These claims typically include:
- The enzymatic process for obtaining the 17α-monoesters.
- The specific crystalline forms of the compounds.
- The pharmaceutical compositions and formulations that incorporate these compounds[5].
Dependent Claims
Dependent claims further specify the details of the independent claims, such as the specific conditions under which the enzymatic process is carried out, the types of enzymes used, and the various pharmaceutical forms (e.g., gel, ointment, tablet) in which the compounds can be formulated[4].
Patent Landscape
Related Patents
The patent landscape for Winlevi is complex, with multiple patents covering different aspects of the drug. Here are some key related patents:
- US 10,159,682: This patent covers a method of treating pathologies affecting the skin and/or cutaneous appendages, which includes the use of cortexolone 17α-propionate. It is part of a series of patents filed from 2008 onwards[1].
- US 9,433,628: This patent focuses on an enzymatic process for obtaining 17α-monoesters of cortexolone and its derivatives, similar to the process described in US 11,207,332[2].
- US 8,143,240: This patent covers 17α, 21-dihydroxypregnene esters as antiandrogenic agents, which are related compounds used in the treatment of conditions like acne and hirsutism[5].
Expiration Dates and Generic Launch
Patent Expiration
The patent US 11,207,332 is set to expire on November 20, 2028. However, the overall patent protection for Winlevi extends beyond this date due to other related patents:
- July 25, 2030: This is the estimated generic launch date based on the expiration of the latest patents covering Winlevi[2][5].
Regulatory Review Period
The regulatory review period for Winlevi, which includes the testing and approval phases, has been significant. The patent term extension under 35 U.S.C. § 156 has been sought to compensate for the time spent in regulatory review. For example, the regulatory review period for U.S. Patent No. 10,159,682 was calculated to be 3102 days, which influenced the extension of the patent term[1].
Legal Activities and Patent Term Extensions
Recent Activities
There have been several recent legal activities related to the patents covering Winlevi:
- Interim Patent Term Extensions: Granted for several related patents, including US 8865690 and US 9211295, to extend the patent term due to regulatory delays[2].
- Maintenance Fees: Payments of maintenance fees have been made to keep the patents active, such as for US 9433628 and US 9486458[2].
Impact on Innovation and Competition
Patent Scope and Quality
The scope and quality of patents like US 11,207,332 are crucial for innovation. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and shorter examination processes. This can encourage more targeted innovation rather than overly broad claims that might impede progress in the field[3].
Competitive Landscape
The patent landscape for Winlevi is highly competitive, with multiple patents protecting different aspects of the drug. This complexity can delay the entry of generic competitors, allowing the original patent holders to maintain market exclusivity for a longer period[2][5].
Key Takeaways
- Innovative Enzymatic Process: US 11,207,332 covers a novel enzymatic process for synthesizing 17α-monoesters of cortexolone and its derivatives.
- Crystalline Forms: The patent includes new crystalline forms of these compounds, enhancing their stability and bioavailability.
- Complex Patent Landscape: Multiple patents protect different aspects of Winlevi, extending its market exclusivity.
- Regulatory Review Period: The patent term has been extended due to the significant regulatory review period.
- Impact on Innovation: The patent's scope and quality encourage targeted innovation and maintain market exclusivity.
FAQs
What is the main focus of US Patent 11,207,332?
The main focus of US Patent 11,207,332 is a new enzymatic process for obtaining 17α-monoesters of cortexolone and its 9,11-dehydroderivatives, along with new crystalline forms of these compounds.
Who is the assignee of US Patent 11,207,332?
The assignee of US Patent 11,207,332 is Cassiopea S.P.A.
When is the patent set to expire?
The patent US 11,207,332 is set to expire on November 20, 2028.
What is the estimated generic launch date for Winlevi?
The estimated generic launch date for Winlevi is July 25, 2030, based on the expiration of the latest related patents.
How does the regulatory review period affect the patent term?
The regulatory review period can lead to an extension of the patent term under 35 U.S.C. § 156 to compensate for the time spent in regulatory review, as seen in the case of related patents like U.S. Patent No. 10,159,682.
Sources
- Application for Extension of Patent Term Under 35 U.S.C. § 156 - [PDF]
- Winlevi patent expiration - Pharsight
- Patent Claims and Patent Scope - Hoover Institution
- EP2503004A1 - Cortexolone-17alpha-propionate in crystalline form I - Google Patents
- Generic Winlevi Availability - Drugs.com
