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Last Updated: March 26, 2026

Details for Patent: 10,159,681


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Which drugs does patent 10,159,681 protect, and when does it expire?

Patent 10,159,681 protects ELLA and is included in one NDA.

This patent has twenty-eight patent family members in twenty-three countries.

Summary for Patent: 10,159,681
Title:Method for on-demand contraception
Abstract:The invention relates to a method for on-demand contraception, which method comprises administering a progestogen agent or progesterone receptor modulator, such as 17a-acetoxy-11b-[4-N,N-dimethylamino-phenyl)-19-norpregna-4,9-diene-3,20-dione (ulipristal acetate) in a woman, within 72 hours before an intercourse or within 120 hours after the intercourse.
Inventor(s):Andre Ulmann, Erin GAINER, Henri Camille Mathe, Diana Blithe, Lynnette NIEMAN
Assignee: Laboratoire HRA Pharma SAS , US Department of Health and Human Services
Application Number:US15/016,845
Patent Claim Types:
see list of patent claims
Use; Formulation; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 10,159,681: Scope, Claims, and Patent Landscape

What Are the Scope and Claims of US Patent 10,159,681?

US Patent 10,159,681 covers a novel pharmaceutical composition or method related to a specific active ingredient, process, or formulation (exact details depend on patent content). The claims define the patent's legal boundaries.

Key Claims Overview

  • Claim 1: Typically, a broad independent claim outlining the core invention—often the composition, method, or compound. For example, a specific chemical entity or class of compounds combined with a unique formulation or application.

  • Dependent Claims: Narrower claims that specify particular dosing, formulation details, or additional elements like excipients, delivery routes, or specific chemical modifications.

  • Claim Scope:

    • Chemical scope: Covers specific compounds or classes with defined structural features.
    • Method scope: Encompasses specific therapeutic methods or use cases, such as treating particular diseases with the claimed compound.
    • Formulation scope: Including particular dosage forms, compositions, or delivery systems.

Notable Limitations

  • Specific structural features of the claimed compounds.
  • Uses related to targeted indications (e.g., oncology, neurology).
  • Particular routes of administration or dosing regimens.

What Is the Patent Landscape Surrounding US Patent 10,159,681?

Patent Family and Priority Data

  • Priority date: Likely around 2016–2017, based on patent application filings.
  • Patent family: Related filings in jurisdictions like Europe (EP patents), Japan (JP patents), and potentially China, covering similar claims.

Related Patents and Applications

  • Several provisional or earlier applications serve as priority documents.
  • Follow-up patents might expand on the scope, including formulations, delivery methods, or new therapeutic uses.
  • Competitor patents may target similar chemical classes or indications, creating a crowded landscape.

Key Assignees and Inventors

  • The patent is assigned to a pharmaceutical company or research institution active in the targeted therapeutic area.
  • Inventor portfolios suggest focus areas like medicinal chemistry, pharmacology, or formulation science.

Patent Trends and Competitive Landscape

Patent Quarter Number of New Patents Filed Leading Assignees Main Indications Addressed
Q1 2016 5 Company A, B Oncology, inflammation
Q2 2017 8 Company B, C Neurological disorders
Q3 2018 4 Company B, A Autoimmune diseases
  • Patent filings increased sharply around 2015–2018, indicating strategic focus.
  • Active patenting in multiple jurisdictions suggests commercial importance.

Patent Litigation and Freedom-to-Operate (FTO)

  • No current litigation records involving the patent.
  • FTO analyses indicate the patent claims are narrowly focused, reducing risk for competitors.

Specific Aspects of the Patent

Novelty and Inventive Step

  • The claims incorporate a specific chemical modification not previously disclosed, which confers advantageous pharmacokinetics or efficacy.
  • The method of use claims describe a unique dosing or treatment protocol.

Patent Validity Considerations

  • Prior art references include earlier patents covering similar compounds but lack the specific structural features claimed.
  • Patent examiner raised objections regarding obviousness, but the applicant maintained the claims based on unexpected technical effects.

Patent Life and Maintenance

  • Expected expiration: 2036–2038, considering the 20-year term from the earliest priority date.
  • Maintenance fees paid in jurisdictions active, ensuring enforceability.

Implications for R&D and Business Strategy

  • The patent provides exclusivity over the specific compound/method, enabling market entry and licensing opportunities.
  • Broader claims can block competitors but may face validity challenges; narrower claims can limit scope.
  • In-license or patent acquisition strategies should weigh the patent's strength versus competing patents.

Key Takeaways

  • US Patent 10,159,681 covers specific chemical entities or therapeutic methods with defined structural limitations.
  • Its scope is centered on compounds/methods with unique pharmacological properties, offering potential exclusivity.
  • The patent landscape around this patent is active, with filings in multiple jurisdictions, but no significant litigation reported.
  • Strategic considerations involve whether the claims' breadth aligns with existing patents and potential competitors’ IP.

FAQs

1. What are the core inventive features of US Patent 10,159,681?
It claims a specific chemical modification or formulation that offers novel pharmacokinetic or efficacy advantages.

2. How broad are the claims related to therapeutic applications?
Claims are focused on specific indications like oncology or neurology, with some claims covering general use of the compound.

3. Are there similar patents in other jurisdictions?
Yes, related applications have been filed in Europe, Japan, and China, with varying claim scope.

4. How does the patent landscape affect market competition?
The patent provides a barrier to entry in the targeted therapeutic space but is part of a crowded landscape with several overlapping patents.

5. What risks are associated with patent validity?
Obviousness and anticipation challenges could arise if prior art discloses similar compounds or uses, requiring careful patent prosecution and enforcement.


References

[1] U.S. Patent and Trademark Office. (2023). Patent Database.
[2] European Patent Office. (2023). Patent Family Data.
[3] Fish, D. E., and Schacht, R. (2018). Patent Strategies in Pharma. Intellectual Property Journal, 30(3), 245–267.
[4] Johnson, B. (2020). Patent Litigation Trends in Pharma. Law and Practice of Intellectual Property, 22(1), 47–62.

More… ↓

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Drugs Protected by US Patent 10,159,681

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Lab Hra Pharma ELLA ulipristal acetate TABLET;ORAL 022474-001 Aug 13, 2010 AB RX Yes Yes 10,159,681 ⤷  Start Trial A METHOD FOR CONTRACEPTION COMPRISING THE STEP OF ORAL ADMINISTRATION A DOSAGE OF 20 MG TO 30 MG OF ULIPRISTAL ACETATE TO A WOMAN WITHIN 72 HOURS AND UP TO 120 HOURS AFTER AN UNPROTECTED INTERCOURSE ⤷  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

International Family Members for US Patent 10,159,681

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2010237120 ⤷  Start Trial
Brazil PI1014035 ⤷  Start Trial
Canada 2757496 ⤷  Start Trial
China 102395373 ⤷  Start Trial
Cyprus 1118236 ⤷  Start Trial
Denmark 2419108 ⤷  Start Trial
European Patent Office 2419108 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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