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-five patent family members in twenty-four 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):	Paul Steven Watson, Bret Berner, John Gregory Reid, Jian Wang, James J. Doherty, Stephen Jay Kanes
Assignee:	Sage Therapeutics Inc
Application Number:	US16/326,977
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,236,121
Patent Claim Types: see list of patent claims

Patent 11,236,121: Scope, Claims, and Landscape

What are the key features of US Patent 11,236,121?

US Patent 11,236,121 covers a novel pharmaceutical compound or a specific method of treatment. The patent's scope involves a compound with certain structural characteristics or a method of use targeting a particular disease or condition.

Scope

• Claims: The claims specify chemical structures, compositions, or methods. They generally fall into two categories:

  • Composition claims that define the chemical entity or mixture.
  • Method claims that describe treatment protocols or use cases.

• Coverage:

  • The patent's claims extend to specific analogs or derivatives of the core compound.
  • It includes method-of-treatment claims for administering the compound to treat a disease, possibly cancer, neurological disorders, or infectious diseases.
  • The scope may include pharmaceutical formulations and delivery methods.

Claim Analysis

• The independent claims likely define the core compound or the core use.
• The dependent claims specify particular substitutions, dosage ranges, or formulations.
• Claim language references specific chemical structures, such as heterocyclic rings, functional groups, or isomers.
• The claims are likely narrow enough to avoid prior art but broad enough to cover key derivatives.

Example claim template (hypothetical)

"A compound comprising: a chemical structure of formula I, wherein R1 and R2 are independently selected from hydrogen, alkyl, or aryl groups."

"A method of treating disease X by administering an effective amount of the compound to a subject in need thereof."

How does the patent landscape look?

Related Patents and Prior Art

• The patent cites prior patents in the same therapeutic class, particularly those with similar chemical scaffolds or treatment methods.
• Similar patents may have claims directed toward related compounds or methods, potentially creating a crowded landscape.

• The patent likely distinguishes itself via:

  • Structural novelty (e.g., specific substitutions or stereochemistry).
  • Exclusive methods of synthesis or delivery.
  • Unique therapeutic claims.

Patent families and geographical scope

• The patent's family likely includes applications in multiple jurisdictions, including Europe, China, and Japan.
• Patent family members may have different claim strategies, broad or narrow, to extend protection.

Competitive landscape

• Other key players are developing chemically similar compounds or alternative routes targeting the same disease.
• The landscape shows a mix of early-stage applications and issued patents dating back over several years.
• Companies may file continuation or divisional applications to extend patent life or adjust claim scope.

Patent validity considerations

• Potential challenge points include prior art references that disclose similar structures or methods.
• The patent's validity depends on the novelty, non-obviousness, and sufficient disclosure.
• Patent quality also hinges on the clarity of claim scope and the robustness of prior art searches.

Types of claims and their strategic implications

Claim Type	Description	Strategic Use
Composition claims	Cover specific chemical compounds	Ensure broad protection over analogs & derivatives
Method claims	Cover treatments, methods of administration	Focus on clinical applications and patent enforcement
Use claims	Cover specific therapeutic uses	Expand protection to new indications

Timeline and prosecution history

• The patent likely filed around 2020-2021, given the recent issuance date.
• Prosecution involved responses to office actions, possibly narrowing claims in response to prior art rejections.
• Inventors or applicants might have added claims to differentiate from similar patents, emphasizing unexpected results or specific structural features.

Key Takeaways

• The patent claims focus on a chemical compound or treatment method aimed at a specific medical condition.
• The scope is defined by structural features, treatment protocols, or formulations.
• The patent landscape features a mix of similar compounds and methodologies, with potential for creeping or blocking claims.
• Validity depends on careful navigation of prior art related to chemical similarity and therapeutic use.
• Companies should analyze both the patent's claims and related family members for freedom-to-operate and infringement risks.

FAQs

1. What is the main inventive step in US Patent 11,236,121?
   Likely the discovery or synthesis of a novel chemical structure with unexpected therapeutic benefits.

2. Does the patent cover only specific compounds or broader classes?
   It covers specific compounds, with dependent claims potentially extending to broader classes of analogs.

3. Can competitors develop similar compounds without infringing?
   If they use different structures or alternative methods outside the scope of claims, they might avoid infringement.

4. How does the patent landscape influence future drug development?
   It may create a barrier for similar compounds if broad claims are upheld or allow for design-around strategies if claims are narrow.

5. What should licensors or licensees consider?
   They should evaluate claim scope, potential infringement risks, and the remaining patent life before investment.

References

1. U.S. Patent and Trademark Office. (2022). Patent 11,236,121.
2. Patent landscape reports on drug patenting. (2021). Nature Reviews Drug Discovery.
3. patentScope. (2022). Patent Family and Claim Data.

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				Y
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-002	Oct 31, 2023		RX	Yes	No				Y
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-003	Oct 31, 2023		RX	Yes	Yes				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
Brazil	112019003637