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Last Updated: December 22, 2024

Details for Patent: 10,052,386


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Summary for Patent: 10,052,386
Title:Progesterone formulations
Abstract: Various pharmaceutical formulations are disclosed herein. For example, a pharmaceutical formulation is disclosed comprising ultra-micronized progesterone.
Inventor(s): Bernick; Brian A. (Boca Raton, FL), Amadio; Julia M. (Boca Raton, FL), Persicaner; Peter H. R. (Boca Raton, FL), Cacace; Janice Louise (Miami, FL), Thorsteinsson; Thorsteinn (West Palm Beach, FL), Sancilio; Frederick D. (Palm Beach Gardens, FL)
Assignee: TherapeuticsMD, Inc. (Boca Raton, FL)
Application Number:14/125,547
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,052,386
Patent Claim Types:
see list of patent claims
Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Analyzing the Scope and Claims of United States Patent 10,052,386

Introduction

When analyzing a patent, understanding its scope and claims is crucial for determining its validity, enforceability, and potential impact on the market. This article will delve into the details of United States Patent 10,052,386, focusing on its scope, claims, and the broader patent landscape.

Patent Overview

United States Patent 10,052,386 is associated with TherapeuticsMD, Inc., and it protects one of their products, BIJUVA®. Here is a brief overview of the patent:

  • Patent Title: The title of the patent is not explicitly provided in the sources, but it is related to the formulation and delivery of estradiol, a key component of BIJUVA®, a vaginal insert for the treatment of moderate to severe dyspareunia (painful intercourse) in postmenopausal women.
  • Patent Number: 10,052,386
  • Assignee: TherapeuticsMD, Inc.
  • Issue Date: This information is not provided in the sources, but it can be found through the USPTO database.

Patent Scope

The scope of a patent is defined by its claims, which outline the specific inventions or innovations that are protected.

Claim Analysis

To understand the scope, one must analyze the claims of the patent. Here are some key points to consider:

  • Independent Claims: These are the broadest claims in the patent and define the core invention. For example, Claim 1 might describe the composition of the vaginal insert, including the active ingredient estradiol and other components.
  • Dependent Claims: These claims are narrower and build upon the independent claims. They might specify particular concentrations of estradiol, the formulation process, or specific delivery mechanisms[3].

Metrics for Measuring Scope

Research has shown that metrics such as independent claim length and independent claim count can be useful in measuring patent scope. Patents with narrower claims at publication tend to have a higher probability of grant and a shorter examination process[3].

Claims of Patent 10,052,386

While the exact claims of Patent 10,052,386 are not detailed in the provided sources, here is how one might approach analyzing them:

  • Claim Language: Review the language used in each claim to understand the breadth and specificity of the invention. Look for keywords and phrases that define the invention.
  • Claim Structure: Identify independent and dependent claims. Independent claims are typically broader, while dependent claims are more specific.
  • Claim Examples: For instance, a claim might read: "A vaginal insert comprising estradiol and a carrier, wherein the estradiol is present in a concentration of about 10 mg."

Patent Landscape

Understanding the patent landscape involves looking at related patents, competitors, and the broader intellectual property environment.

Related Patents

  • Family Members: Use tools like the Global Dossier to identify related applications filed at participating IP Offices. This can help in understanding the broader patent family and any international protections[1].
  • Citation Data: The Common Citation Document (CCD) application can provide a single point of access to citation data from multiple offices, helping to identify prior art and related inventions[1].

Competitors

  • Market Analysis: Identify competitors in the same therapeutic area. For TherapeuticsMD, competitors might include other pharmaceutical companies with products for treating menopausal symptoms.
  • Patent Portfolios: Analyze the patent portfolios of competitors to understand their intellectual property strategies and potential areas of overlap or differentiation.

International Protection

  • International Patent Offices: Search databases such as the European Patent Office's esp@cenet, the Japan Patent Office, and WIPO's PATENTSCOPE to see if similar patents have been filed or granted internationally[1][4].

Search Tools and Resources

Several tools and resources are available for conducting a thorough patent search:

  • Patent Public Search: This tool provides enhanced access to prior art and is a powerful resource for searching U.S. patents[1].
  • Patent and Trademark Resource Centers (PTRCs): These centers offer local search resources and training in patent search techniques[1].
  • Global Dossier: This service allows users to view the file histories of related applications from participating IP Offices[1].

Legal and Regulatory Considerations

Understanding the legal and regulatory environment is crucial for enforcing and maintaining a patent.

  • Virtual Patent Marking: Ensure compliance with virtual patent-marking provisions, such as those under the America Invents Act, to provide notice of patent protection[2].
  • Office Actions: Use tools like the Global Dossier to identify office actions and understand the examination history of the patent[1].

Key Takeaways

  • Patent Scope: Defined by the claims, which must be carefully analyzed to understand the breadth and specificity of the invention.
  • Claim Analysis: Independent and dependent claims must be reviewed to understand the core invention and its variations.
  • Patent Landscape: Understanding related patents, competitors, and international protections is essential for strategic decision-making.
  • Search Tools: Utilize resources like Patent Public Search, Global Dossier, and PTRCs to conduct thorough patent searches.
  • Legal Considerations: Ensure compliance with legal and regulatory requirements to maintain and enforce the patent.

FAQs

  1. What is the purpose of analyzing the claims of a patent?

    • Analyzing the claims helps in understanding the specific inventions or innovations that are protected, defining the scope of the patent.
  2. How can one measure the scope of a patent?

    • Metrics such as independent claim length and independent claim count can be used to measure patent scope, as they correlate with patent maintenance payments, forward citations, and other indicators of patent quality[3].
  3. What is the Global Dossier service?

    • The Global Dossier service provides access to the file histories of related applications from participating IP Offices, allowing users to view the patent family and related data[1].
  4. Why is it important to search international patent databases?

    • Searching international patent databases helps in identifying similar patents filed or granted in other countries, ensuring global protection and avoiding potential infringement issues[1][4].
  5. What is the role of the Patent Public Search tool?

    • The Patent Public Search tool provides enhanced access to prior art, improving the overall patent searching process with its modern interfaces and flexible capabilities[1].

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Drugs Protected by US Patent 10,052,386

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 BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-002 Dec 28, 2021 RX Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  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

Foreign Priority and PCT Information for Patent: 10,052,386

PCT Information
PCT FiledJune 18, 2013PCT Application Number:PCT/US2013/046442
PCT Publication Date:December 27, 2013PCT Publication Number: WO2013/192248

International Family Members for US Patent 10,052,386

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2782584 ⤷  Subscribe 301153 Netherlands ⤷  Subscribe
European Patent Office 2782584 ⤷  Subscribe 2021C/558 Belgium ⤷  Subscribe
European Patent Office 2782584 ⤷  Subscribe 122021000080 Germany ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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