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Last Updated: January 6, 2025

Details for Patent: 10,632,066


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Which drugs does patent 10,632,066 protect, and when does it expire?

Patent 10,632,066 protects ANNOVERA and is included in one NDA.

Summary for Patent: 10,632,066
Title:Method of providing birth control
Abstract: The present disclosure describes a vaginal system comprising segesterone acetate and ethinyl estradiol configured for thirteen 28-day product-use cycles that is compatible with male condoms comprising natural rubber latex, polyisoprene, or polyurethane and a method of providing birth control using the vaginal system wherein a secondary contraception is employed when the vaginal system is removed or expelled from the vagina for specified amounts of time during any of the product-use cycles.
Inventor(s): Creasy, II; George William (Glen Gardner, NJ), Merkatz; Ruth Beverly (Rye, NY)
Assignee: The Population Council, Inc. (New York, NY)
Application Number:16/265,222
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

United States Patent 10,632,066: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 10,632,066, titled "Method of providing birth control," is a significant patent in the field of reproductive health, particularly concerning vaginal contraceptive systems. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

Issuance and Inventors

Patent 10,632,066 was issued on April 28, 2020, to inventors George William Creasy II and Ruth Beverly Merkatz, with The Population Council, Inc. as the assignee[2].

Patent Expiration Dates

The patent is set to expire on February 1, 2039, which is approximately 20 years from the date of filing, a standard duration for most patents[2].

Scope of the Patent

Invention Description

The patent describes a vaginal system comprising segesterone acetate and ethinyl estradiol, designed for thirteen 28-day product-use cycles. This system is compatible with male condoms made of natural rubber latex, polyisoprene, or polyurethane. The method involves using the vaginal system as a primary form of contraception and employing secondary contraception when the system is removed or expelled from the vagina for specified periods during the product-use cycles[2].

Key Components

  • Active Ingredients: Segesterone acetate and ethinyl estradiol.
  • Compatibility: With various types of male condoms.
  • Usage Cycle: Thirteen 28-day cycles.
  • Secondary Contraception: Required during specific times when the vaginal system is not in place.

Claims of the Patent

Independent and Dependent Claims

The patent includes both independent and dependent claims that define the scope of the invention. Independent claims outline the core aspects of the invention, while dependent claims build upon these and provide additional details.

  • Independent Claims: These typically describe the overall method of providing birth control using the vaginal system and its compatibility with male condoms.
  • Dependent Claims: These may include specific details about the composition of the vaginal system, the duration of use, and the conditions under which secondary contraception is required[2].

Patent Landscape

Related Patents

Several related patents have been issued to The Population Council, Inc., all of which pertain to similar methods of providing birth control using vaginal systems. These include:

  • Patent 10,765,628: Issued on September 8, 2020.
  • Patent 10,940,157: Issued on a later date.
  • Patent 11,529,308: Issued on a later date.
  • Patent 11,850,251: Issued on a later date. All these patents have similar expiration dates, indicating a coordinated strategy in protecting the intellectual property related to these contraceptive systems[2].

Global Patent Family

The Global Dossier service provided by the USPTO allows users to view the patent family for a specific application, including related applications filed at participating IP Offices. This service can help in understanding the global reach and protection of this invention[1].

Search and Analysis Tools

USPTO Resources

To conduct a thorough analysis of this patent, several USPTO resources can be utilized:

  • Patent Public Search: A modern web-based tool that replaces legacy search tools and provides enhanced access to prior art.
  • Global Dossier: Allows access to file histories of related applications from participating IP Offices.
  • Patent and Trademark Resource Centers (PTRCs): Local resources that offer training in patent search techniques[1].

Historical Patents

For a broader understanding, historical patents related to contraceptive methods can be searched through resources like the New York Public Library's guide to historical U.S. patents. This includes accessing annual reports from the Commissioner of Patents and other historical indexes[4].

Economic and Legal Implications

Patent Exclusivity

The patent grants exclusive legal rights to The Population Council, Inc., preventing others from making, using, or selling the invention without permission. This exclusivity period is crucial for the commercial success of the product, as it allows the patent holder to recoup investment in research and development[2].

Drug Exclusivity

In addition to patent protection, the FDA may grant exclusivity periods that run simultaneously with the patent. These periods can range from 180 days to seven years, depending on the circumstances of the exclusivity grant[2].

Industry Impact

Market Dominance

Patents like 10,632,066 play a significant role in shaping the market landscape for contraceptive products. By securing exclusive rights, The Population Council, Inc. can dominate the market for this specific type of vaginal contraceptive system, influencing consumer choices and competitor strategies.

Innovation

The protection afforded by this patent encourages further innovation in the field. Competitors may be driven to develop alternative contraceptive methods or improve upon existing technologies, leading to advancements in reproductive health.

Key Takeaways

  • Patent Scope: The patent covers a specific vaginal contraceptive system and its method of use.
  • Claims: Include both independent and dependent claims that define the invention's core aspects.
  • Related Patents: Several related patents protect similar methods and compositions.
  • Global Protection: The Global Dossier service helps in understanding the global patent family.
  • Economic Implications: Exclusive rights granted by the patent and potential FDA exclusivity periods are crucial for commercial success.
  • Industry Impact: The patent influences market dynamics and encourages innovation in reproductive health.

FAQs

What is the main invention described in Patent 10,632,066?

The main invention is a vaginal system comprising segesterone acetate and ethinyl estradiol, designed for thirteen 28-day product-use cycles, and compatible with various types of male condoms.

Who are the inventors of this patent?

The inventors are George William Creasy II and Ruth Beverly Merkatz.

What is the expiration date of this patent?

The patent is set to expire on February 1, 2039.

How does this patent impact the market for contraceptive products?

This patent allows The Population Council, Inc. to dominate the market for this specific type of vaginal contraceptive system, influencing consumer choices and competitor strategies.

What other resources can be used to analyze this patent?

Resources include the USPTO's Patent Public Search, Global Dossier, and Patent and Trademark Resource Centers (PTRCs), as well as historical patent databases.

How does FDA exclusivity affect the commercial success of the patented product?

FDA exclusivity periods, which can run simultaneously with the patent, provide additional protection and exclusive marketing rights, helping the patent holder to recoup investment in research and development.

Sources

  1. USPTO - Search for patents: https://www.uspto.gov/patents/search
  2. Drugs.com - Generic Annovera Availability: https://www.drugs.com/availability/generic-annovera.html
  3. USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
  4. NYPL Libguides - How to Search for an Historical U.S. Patent: https://libguides.nypl.org/patents/historical_patents
  5. USA.gov - U.S. Patent and Trademark Office (USPTO): https://www.usa.gov/agencies/u-s-patent-and-trademark-office

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Drugs Protected by US Patent 10,632,066

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 10,632,066 ⤷  Subscribe METHOD OF CONTRACEPTION BY INSERTING A VAGINAL SYSTEM FOR UP TO 13 21/7-DAY (IN/OUT) CYCLES, WHEREIN EFFICACY REQUIRES THE SYSTEM CANNOT BE OUT OF THE VAGINA FOR MORE THAN 2 CUMULATIVE HOURS IN ANY SUCH CYCLE WITHOUT USING ALTERNATIVE CONTRACEPTION ⤷  Subscribe
Mayne Pharma ANNOVERA ethinyl estradiol; segesterone acetate RING;VAGINAL 209627-001 Aug 10, 2018 RX Yes Yes 10,632,066 ⤷  Subscribe METHOD OF PREVENTING PREGNANCY BY INSERTING A VAGINAL SYSTEM CONTAINING 103 MG OF SEGESTERONE ACETATE AND 17.4 MG ETHINYL ESTRADIOL INTO A VAGINA FOR UP TO THIRTEEN 21/7-DAY (IN/OUT) CYCLES ⤷  Subscribe
>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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