Details for Patent: 11,236,121

Which drugs does patent 11,236,121 protect, and when does it expire?

Patent 11,236,121 protects ZURZUVAE and is included in one NDA.

This patent has forty patent family members in twenty-two countries.

Summary for Patent: 11,236,121

Title:	Crystalline 19-nor C3,3-disubstituted C21-N-pyrazolyl steroid
Abstract:	This invention relates to a 19-nor C3,3-disubstituted C21-pyrazolyl steroid of Formula (I) and crystalline solid forms and compositions thereof. Also disclosed herein are methods of making crystalline solid forms of the 19-nor C3,3-disubstituted C21-pyrazolyl steroid of Formula (I) and methods of using the 19-nor C3,3-disubstituted C21-pyrazolyl steroid of Formula (I) or crystalline solid forms, pharmaceutically acceptable salts, and pharmaceutically acceptable compositions thereof.
Inventor(s):	Watson Paul Steven, Berner Bret, Reid John Gregory, Wang Jian, Doherty James J., Kanes Stephen Jay
Assignee:	Sage Therapeutics, Inc.
Application Number:	US16326977
Patent Claim Types: see list of patent claims

Analyzing the Scope and Claims of United States Patent 11,236,121

Introduction

United States Patent 11,236,121, titled "Crystalline 19-nor C3,3-disubstituted C21-N-pyrazolyl steroid," is a patent that covers a specific class of steroids and their crystalline forms. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

The patent, assigned the number US11236121B2, pertains to a 19-nor C3,3-disubstituted C21-N-pyrazolyl steroid and its crystalline solid forms and compositions. This invention is significant in the field of pharmaceuticals, particularly for compounds with potential therapeutic applications[4].

Scope of the Patent

The scope of the patent is defined by the claims, which outline the specific aspects of the invention that are protected.

Claims

The patent includes multiple claims that detail the various aspects of the invention:

• Composition Claims: These claims cover the specific chemical structure of the 19-nor C3,3-disubstituted C21-N-pyrazolyl steroid and its crystalline forms.
• Method Claims: These claims may include methods for preparing the crystalline forms, methods of use, and any specific processes related to the compound.
• Use Claims: These claims specify the therapeutic or other uses of the compound, such as treating certain diseases or disorders[4].

Detailed Analysis of Claims

Composition Claims

• The patent describes the crystalline solid forms of the 19-nor C3,3-disubstituted C21-N-pyrazolyl steroid, including specific X-ray powder diffraction (XRPD) patterns. This ensures that any identical or very similar crystalline forms are covered under the patent[4].

Method Claims

• The methods for preparing these crystalline forms are detailed, including any specific solvents, conditions, and steps involved. For example, the use of ethyl acetate and N-heptane in the crystallization process is mentioned[4].

Use Claims

• The patent specifies potential therapeutic uses of the compound, such as treating convulsions, tremors, and other metabolic or neurological disorders. These claims are crucial as they define the patent's scope in terms of application and market potential[4].

Patent Landscape

Prior Art

• The patent cites prior art related to similar compounds and their uses. This includes references to other patents and publications that describe related steroids and their therapeutic applications. The Common Citation Document (CCD) application can be useful in consolidating prior art citations from multiple offices[1].

International Patent Offices

• The invention may also be protected in other countries through international patent applications. Databases such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO) can be used to search for similar patents filed in other jurisdictions[1].

Related Patents

• Other patents related to 19-nor steroids and their crystalline forms can provide insight into the competitive landscape. For instance, similar patents filed in different regions or by different entities can indicate the global interest and competition in this area of research[5].

Economic and Strategic Implications

Market Potential

• The therapeutic applications of the compound, as outlined in the use claims, indicate significant market potential. This could include treating a range of diseases and disorders, making the patent highly valuable in the pharmaceutical industry.

Licensing and Collaboration

• The patent's scope and claims can influence licensing agreements and collaborations. Companies may seek to license the technology or collaborate on further research and development, especially if the compound shows promising therapeutic effects.

Legal and Regulatory Considerations

Office Actions

• The Global Dossier service provided by the USPTO allows users to track office actions related to the patent application. This can be crucial in understanding any legal or regulatory challenges the patent may face[1].

Patent Assignment and Ownership

• Changes in ownership or assignments of the patent can be tracked using the Patent Assignment Search website. This is important for understanding the current legal status and ownership of the patent[1].

Conclusion

United States Patent 11,236,121 is a significant invention in the field of pharmaceuticals, covering a specific class of steroids and their crystalline forms. The detailed analysis of its scope and claims highlights its potential therapeutic applications and market value. Understanding the broader patent landscape, including prior art, international filings, and related patents, is essential for navigating the competitive and regulatory environment.

Key Takeaways

• Specific Chemical Structure: The patent covers a 19-nor C3,3-disubstituted C21-N-pyrazolyl steroid and its crystalline forms.
• Therapeutic Applications: The compound has potential uses in treating various diseases and disorders.
• Global Protection: The invention may be protected in multiple countries through international patent applications.
• Market Potential: The patent has significant market value due to its therapeutic applications.
• Legal and Regulatory: Tracking office actions and changes in ownership is crucial for understanding the patent's legal status.

FAQs

1. What is the main subject of United States Patent 11,236,121?

   • The main subject is a 19-nor C3,3-disubstituted C21-N-pyrazolyl steroid and its crystalline solid forms.

2. What are the potential therapeutic applications of the compound?

   • The compound has potential uses in treating convulsions, tremors, and other metabolic or neurological disorders.

3. How can one search for similar patents internationally?

   • Databases provided by the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO) can be used to search for similar patents filed in other jurisdictions.

4. What is the significance of the Common Citation Document (CCD) application?

   • The CCD application consolidates prior art citations from multiple offices, providing a single point of access to up-to-date citation data.

5. Where can changes in patent ownership be tracked?

   • Changes in patent ownership can be tracked using the Patent Assignment Search website provided by the USPTO.

Sources

1. USPTO - Search for patents
   • https://www.uspto.gov/patents/search
2. Google Patents - US11236121B2
   • https://patents.google.com/patent/US11236121B2/en
3. USPTO - Patent Claims Research Dataset
   • https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
4. Google Patents - US11236121B2 (Detailed)
   • https://patents.google.com/patent/US11236121B2/zh
5. Unified Patents Portal - AU-2024200732-A1
   • https://portal.unifiedpatents.com/patents/patent/AU-2024200732-A1

Drugs Protected by US Patent 11,236,121

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-001	Oct 31, 2023		RX	Yes	No	11,236,121			Y
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-002	Oct 31, 2023		RX	Yes	No	11,236,121			Y
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-003	Oct 31, 2023		RX	Yes	Yes	11,236,121			Y

International Family Members for US Patent 11,236,121

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	109393
Argentina	125320
Argentina	125321
Australia	2017315682
Australia	2022200811
Australia	2024200732