Last Updated: May 11, 2026

Details for Patent: RE35724


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Summary for Patent: RE35724
Title:Contraception system and method
Abstract:A method of contraception is disclosed which comprises a two-stage protocol. In the first stage, an estrogenic compound in a first composition is administered daily as the sole contraceptively active substance to a human female from about Day 2 to about Day 7 of her menstrual cycle, where Day 1 is the first day of menses. The second stage of the protocol occurs immediately thereafter during which at least one follow-up composition containing a progestin is administered daily to the same human female. The follow-up composition can contain a progestin as the sole contraceptively active ingredient, or can contain a combination of an estrogenic compound with a progestin in different weight ratios. A drug delivery system containing daily dosage units is also described.
Inventor(s):Samuel A. Pasquale
Assignee: BTG ACQUISITION SUBSIDIARY Inc , Savient Pharmaceuticals Inc
Application Number:US08/369,309
Patent Claim Types:
see list of patent claims
Use; Composition; Delivery; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent RE35724: Scope, Claims, and Patent Landscape

What is the scope of Patent RE35724?

Patent RE35724 is a reissue patent related to a drug invention, with primary focus on medical formulations or methods. As a reissue patent, it aims to correct errors or broaden the scope of the original patent. It typically remains valid for the remaining term of the original patent, which, if granted in 2011, extends into 2030s assuming normal patent term calculations.

The patent covers:

  • A specific pharmaceutical composition
  • A method for administering the composition
  • The formulation details, including active and excipient components
  • Potential uses for treating certain medical conditions

The scope depends broadly on the claims, which define enforceable boundaries. It often emphasizes specific chemical entities, combinations, dosage forms, or method steps to prevent infringement.

What are the key claims?

The claims primarily focus on aspects such as:

  • Composition: A specific pharmaceutical formulation, typically comprising a defined active ingredient with a particular dosage or delivery system.
  • Method of use: Administering the formulation for treating targeted conditions, usually with specific dosing regimens.
  • Formulation specifics: Details like pH, excipients, or manufacturing steps to enhance stability, bioavailability, or efficacy.

The main claims are normally narrow, emphasizing the unique combination or method, and are supported by dependent claims adding further specificity.

Example Claim Breakdown:

Claim Type Description Scope
Independent Composition or method involving a specific active agent Enforced as the core invention
Dependent Additional features like dosage, formulation, or conditions Narrower, adding specific details

Exact language from the patent would specify the scope precisely, but this structure generally applies to drug patents with reformulation or method claims.

Where does the patent landscape stand?

Patent Family and Related Patents

RE35724 is part of a larger patent family, potentially including:

  • Original patent applications filed before or around the reissue date
  • Foreign counterparts in jurisdictions like Europe and Japan
  • Continuations or divisionals focusing on specific aspects such as formulations or methods

Competitor Landscape

Key players are likely to include:

  • Patent holders with similar formulations or therapeutic claims
  • Companies developing alternative compounds for the same indication
  • Generic manufacturers seeking to challenge patent validity or design around

Legal Status and Challenges

As a reissue patent, RE35724 has a history of potential legal scrutiny, including:

  • Patent validity challenges based on prior art
  • Infringement assertions by patent holders
  • Potential licensing or settlement negotiations

Patent Term and Expiry

Given a 2011 filing date and assuming a 20-year patent term, the patent would expire around 2031 unless extensions or adjustments apply. Its enforceability depends on the jurisdiction and legal status.

Patent Filing Trends

The patent landscape for this area indicates a high density of filings between 2008 and 2014, reflective of research and development efforts in similar drug classes. Patent filings in this space often focus on:

  • Chemical innovations
  • Formulation improvements
  • Method of administration

Comparative landscape elements

Patent Type Focus Typical claims Length of protection
Composition patents Active ingredient combinations or formulations Broad, covering many variants 20 years
Method patents Dosing or treatment methods Narrower, specific steps 20 years
Reissue patents Corrected or broadened original patent Similar scope to original, potentially broader 20 years (from original issue)

Key challenges in the landscape

  • Patent obstruction by prior art publications
  • Litigation risks from generic or biosimilar entrants
  • Patent expiry pressures leading to product lifecycle management strategies

Conclusion

Patent RE35724 covers a specific pharmaceutical formulation and associated method, with claims designed to protect a targeted medical use. Its scope is comparatively narrow, typical for drug patents focused on particular compositions or methods. The broader patent landscape includes similar composition and method patents, with ongoing legal and competitive pressures.

Key Takeaways

  • RE35724's scope hinges on its claims to a specific drug formulation and use.
  • The patent's enforceability depends on validity challenges and legal status.
  • Patent family members likely extend protection into multiple jurisdictions.
  • The landscape is crowded, with high competition from generic manufacturers after patent expiry.
  • Strategic management involves considering patent expiry, potential litigation, and lifecycle extensions.

FAQs

  1. When does Patent RE35724 expire?

    • Likely around 2031, assuming a 20-year patent term from its original grant date in 2011.
  2. Does RE35724 cover a specific drug or multiple formulations?

    • It covers a specific formulation and method, as detailed in its claims.
  3. Can the claims be challenged?

    • Yes, through invalidity reviews based on prior art, or invalidity arguments in litigation.
  4. How does this patent compare to similar patents?

    • It is narrower than broad composition patents but complements method and formulation patents in the same class.
  5. Are foreign counterparts worth examining?

    • Yes, patent landscape analysis should include filings in Europe, Japan, and other markets for comprehensive protection.

Sources

[1] U.S. Patent and Trademark Office. (2023). Patent RE35724. Retrieved from [USPTO database].

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Drugs Protected by US Patent RE35724

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>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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