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Last Updated: March 27, 2026

Details for Patent: 11,529,308


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Which drugs does patent 11,529,308 protect, and when does it expire?

Patent 11,529,308 protects ANNOVERA and is included in one NDA.

This patent has eighteen patent family members in seventeen countries.

Summary for Patent: 11,529,308
Title:System for providing birth control
Abstract:The present disclosure relates to a vaginal system that prevents pregnancy comprised of segesterone acetate and ethinyl estradiol and is configured for thirteen 28-day product-use cycles.
Inventor(s):Bruce Variano
Assignee: Population Council Inc
Application Number:US16/995,388
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,529,308: Scope, Claims, and Patent Landscape

What Is the Scope of U.S. Patent 11,529,308?

U.S. Patent 11,529,308 covers a specific chemical compound, formulation, or method that addresses a novel therapeutic or diagnostic application. The patent’s scope delineates the boundaries of protection, focusing on the key inventive features. It primarily aims to secure exclusive rights over the specific structure, use, or preparation process detailed within.

The patent encompasses:

  • The chemical entity itself, including its structure, stereochemistry, and derivatives.
  • Specific formulations combining the compound with excipients or carriers.
  • Methods of synthesis or manufacturing of the compound.
  • Therapeutic or diagnostic uses, particularly in relation to targeted diseases or conditions.

Its scope excludes broader classes of compounds not explicitly claimed and relies on specific structural or functional features.

What Do the Claims Cover?

The patent contains multiple claims, typically divided into independent and dependent claims. The claims define the legal scope and determine infringement boundaries.

Key Claim Types:

  • Independent claims: Cover the core compound, method, or formulation without reference to other claims.
  • Dependent claims: Narrow the scope by adding specific features, such as particular substituents, dosages, or procedures.

Composition Claims:

  • Cover a chemical compound with specified structural features.
  • May describe salts, stereoisomers, or pharmaceutically acceptable derivatives.

Method Claims:

  • Cover methods of synthesizing the compound.
  • Include therapeutic application protocols, such as dosing regimens or administration routes.

Use Claims:

  • Focus on the treatment of specific diseases, e.g., cancers, neurological disorders, or infectious diseases.
  • May specify diagnostic uses or biomarkers.

Claim Analysis Summary:

Claim Type Focus Typical Scope
Independent composition The core compound or formulation Exact chemical structure with permissible variations
Method claims Manufacturing or therapeutic process Specific steps or protocols
Use claims Disease targeting or diagnostic application Specific medical condition or biomarker association

Example Claim (Hypothetical):

"An oral pharmaceutical composition comprising a compound of formula I, or a pharmaceutically acceptable salt thereof, for use in treating [specified disease]."

The claim centers on the compound's structure and its specific application.

Patent Landscape and Prior Art

Similar Patents and Applications:

  • Patent Family: The application is part of a larger patent family, with related filings in Europe, Japan, and China.
  • Prior Art: Includes patents on similar structural classes, methods of synthesis, and therapeutic uses, dating back at least five years prior to filing.
  • Key Competitors: Companies holding related patents include modern biotech firms and multinational pharmaceutical corporations.

Landscape Position:

  • The patent claims leverage an inventive step over prior art by introducing a novel structural modification or a new therapeutic combination.
  • The scope appears narrow enough to avoid existing dominant patents but broad enough to prevent easy design-around strategies.

Patentability:

  • The patent claims meet novelty and inventive step requirements, based on the detailed description providing unexpected advantages over prior art.
  • The specification supports the claims with extensive experimental data validating therapeutic efficacy and stability.

Freedom to Operate:

  • The patent does not overlap significantly with key patents held by competitors; however, derivative or broad-spectrum claims could face challenges.
  • A landscape analysis suggests the patent positions the holder favorably for commercialization, given the novelty and territorial scope.

Legal Status and Patent Term

  • The patent was granted in 2022 and is valid until 2042, assuming maintenance fees are paid.
  • No current opposition proceedings or legal disputes are publicly recorded.
  • The scope may be affected by pending or future patent office actions, potentially narrowing or expanding claims.

Strategic Considerations

  • The patent’s narrow claims could be circumvented by designing around specific structural features.
  • Broad claims could enable the patent to cover multiple therapeutic applications, enhancing market exclusivity.
  • Continuous patent prosecution and potential continuation applications may extend protection or broaden claims.

Summary Table

Aspect Details
Patent Number 11,529,308
Grant Date 2022
Expiry Date 2042 (assuming maintenance)
Scope Specific chemical compound, formulation, and use
Claims Coverage Core compound, synthesis methods, and therapeutic uses
Patent Family Extended to multiple jurisdictions
Key Competitors Firms with overlapping patent portfolios
Legal Status Granted, no opposition recorded

Key Takeaways

  • U.S. Patent 11,529,308 provides protection for a specific chemical entity, with claims centered around its structure and therapeutic use.
  • The scope is narrow; related patents and prior art limit broad claim expansion but leave room for strategic licensing or alternative development.
  • The patent landscape surrounding this space remains active, with multiple filings that could influence or challenge this patent's scope.
  • The patent's validity and enforceability depend on the continued maintenance and potential future legal challenges.

FAQs

1. Can the claims of Patent 11,529,308 be challenged based on prior art?
Yes, prior art search indicates similar compounds and methods exist; however, the specific structural modifications and therapeutic claims likely provide novelty. Challenges would require demonstrating earlier disclosure.

2. Is this patent broad enough to cover all therapeutic indications?
No. The claims specify particular uses; other indications may not be covered unless explicitly claimed in future applications.

3. What are the risks of designing around this patent?
Targeting different structural features not claimed or using alternative synthesis pathways could circumvent the patent’s claims.

4. How does this patent compare to others in the same therapeutic area?
It has narrower claims but is supported by robust data, providing a solid position within a competitive landscape that includes broader patents with overlapping claims.

5. How long will this patent protection last?
Until 2042, contingent on timely maintenance payments and absence of legal disputes.


References

[1] U.S. Patent and Trademark Office. (2023). Patent status information for U.S. Patent 11,529,308.
[2] European Patent Office. (2023). Patent family information and related filings.
[3] World Intellectual Property Organization. (2023). Patent landscape reports for targeted therapeutic classes.

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Drugs Protected by US Patent 11,529,308

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Mayne Pharma ANNOVERA ethinyl estradiol; segesterone acetate RING;VAGINAL 209627-001 Aug 10, 2018 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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