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Last Updated: December 22, 2024

Details for Patent: 11,103,513


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Which drugs does patent 11,103,513 protect, and when does it expire?

Patent 11,103,513 protects BIJUVA and is included in one NDA.

This patent has nine patent family members in nine countries.

Summary for Patent: 11,103,513
Title:Natural combination hormone replacement formulations and therapies
Abstract: Pharmaceutical compositions for co-administering estradiol and progesterone to a human subject in need thereof are provided. In some embodiments, the pharmaceutical composition comprises solubilized estradiol, suspended progesterone, and a solubilizing agent comprising a medium chain (C6-C12) oil.
Inventor(s): Bernick; Brian A. (Boca Raton, FL), Persicaner; Peter H. R. (Boca Raton, FL), Amadio; Julia M. (Boca Raton, FL)
Assignee: TherapeuticsMD (Boca Raton, FL)
Application Number:16/885,088
Patent Claim Types:
see list of patent claims
Use; Dosage form;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 11,103,513

Introduction

When analyzing a patent, it is crucial to delve into its scope, claims, and the broader patent landscape to understand its significance and potential impact. This article will provide a detailed analysis of United States Patent 11,103,513, focusing on its claims, the technological context, and the relevant patent landscape.

Patent Overview

To begin, let's establish the basic details of the patent in question.

Patent Number and Title

  • Patent Number: 11,103,513
  • Title: [Insert title here, as the specific title is not provided in the sources]

Inventors and Assignees

  • Inventors: [Insert inventors' names here]
  • Assignees: [Insert assignees' names here]

Claims Analysis

The claims of a patent are its most critical component, as they define the scope of the invention and what is protected by the patent.

Independent and Dependent Claims

  • Independent Claims: These claims stand alone and define the invention without reference to other claims. They are typically broader and more general.
  • Dependent Claims: These claims refer back to and further limit the independent claims. They are often narrower and more specific.

Claim Structure

  • The structure of the claims includes the preamble, the transition phrase, and the body of the claim. Understanding each part is essential for interpreting the patent's scope.
    • Preamble: Introduces the claim and provides context.
    • Transition Phrase: Connects the preamble to the body of the claim (e.g., "comprising," "consisting of").
    • Body of the Claim: Describes the elements of the invention[4].

Technological Context

Understanding the technological context in which the patent was filed is vital.

Industry and Field

  • Identify the industry and field of technology to which the patent pertains. This could be software, pharmaceuticals, mechanical engineering, etc.
  • For example, if the patent is related to software, it might involve specific algorithms, data structures, or software-related innovations[1].

State of the Art

  • The state of the art at the time of filing is crucial. This includes existing technologies, known solutions, and any gaps that the patented invention addresses.
  • For instance, in the pharmaceutical industry, new drug formulations or delivery methods might be patented to address unmet medical needs[2].

Patent Landscape

The patent landscape includes all relevant patents and patent applications in the same or related fields.

Prior Art

  • Prior art refers to all existing knowledge and inventions in the public domain before the filing date of the patent.
  • Conducting a thorough prior art search is essential to ensure the novelty and non-obviousness of the invention[4].

Competing Patents

  • Identify other patents and patent applications that are similar or related to the invention.
  • Analyze how these patents differ and how they might impact the scope and validity of the patent in question.

Legal and Regulatory Framework

The legal and regulatory environment significantly influences the patent's validity and enforcement.

Patent Laws and Regulations

  • The Leahy-Smith America Invents Act (AIA) of 2011 introduced significant changes to the U.S. patent system, including changes to the litigation process and the definition of prior art[1].
  • Understanding these laws is crucial for navigating patent litigation and ensuring compliance.

Judicial Precedents

  • Recent court decisions can impact the interpretation of patent claims and the validity of patents.
  • For example, the Federal Circuit's decisions on obviousness-type double patenting can affect the validity of related patents[2].

Data and Statistics

Using datasets and statistical analysis can provide deeper insights into the patent landscape.

Patent Claims Research Dataset

  • The USPTO's Patent Claims Research Dataset offers detailed information on claims from U.S. patents and applications, which can be used to analyze trends and patterns in patent scope and claims[3].

Litigation Trends

  • Analyzing trends in patent litigation, such as the increase in software-related patent lawsuits, can help in understanding the broader context and potential risks[1].

Practical Implications

Understanding the practical implications of the patent is essential for stakeholders.

Commercial Impact

  • How does the patent affect the market? Does it create a monopoly, or does it open up new opportunities for innovation?
  • For instance, a patent in the pharmaceutical industry could significantly impact the availability and pricing of drugs[2].

Innovation and R&D

  • How does the patent influence research and development in the field? Does it encourage further innovation or stifle it?
  • Patents can serve as a catalyst for innovation by providing a temporary monopoly that incentivizes investment in R&D[3].

Key Takeaways

  • Claims Analysis: The claims define the scope of the patent and are critical for understanding what is protected.
  • Technological Context: Understanding the industry, state of the art, and prior art is essential for evaluating the patent's novelty and non-obviousness.
  • Patent Landscape: Analyzing competing patents and prior art helps in assessing the patent's validity and potential impact.
  • Legal and Regulatory Framework: Knowledge of patent laws and judicial precedents is vital for navigating patent litigation and compliance.
  • Data and Statistics: Using datasets and statistical analysis can provide valuable insights into trends and patterns in the patent landscape.

FAQs

  1. What is the significance of independent and dependent claims in a patent?

    • Independent claims define the invention broadly, while dependent claims further limit and specify the invention.
  2. How does the Leahy-Smith America Invents Act (AIA) impact patent litigation?

    • The AIA introduced changes such as limiting the number of defendants in a lawsuit and altering the definition of prior art, which can affect the volume and characteristics of patent litigation[1].
  3. What is the role of the USPTO's Patent Claims Research Dataset in patent analysis?

    • The dataset provides detailed information on claims from U.S. patents and applications, helping in the analysis of trends and patterns in patent scope and claims[3].
  4. How do judicial precedents affect patent validity?

    • Judicial precedents, such as those related to obviousness-type double patenting, can influence the interpretation of patent claims and the validity of patents[2].
  5. What is the importance of prior art in patent analysis?

    • Prior art is crucial for ensuring the novelty and non-obviousness of the invention, as it represents all existing knowledge and inventions in the public domain before the filing date of the patent[4].

Sources

  1. GAO Report: Assessing Factors That Affect Patent Infringement Litigation[1].
  2. Federal Circuit Opinion: Allergan USA, Inc. v. MSN Laboratories Private Ltd.[2].
  3. USPTO Dataset: Patent Claims Research Dataset[3].
  4. Clemson LibGuide: Advanced Patent Searching[4].

More… ↓

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Drugs Protected by US Patent 11,103,513

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 210132-001 Oct 28, 2018 RX Yes Yes 11,103,513 ⤷  Subscribe TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS ⤷  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

International Family Members for US Patent 11,103,513

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 100562 ⤷  Subscribe
Australia 2015264003 ⤷  Subscribe
Canada 2947767 ⤷  Subscribe
European Patent Office 3145489 ⤷  Subscribe
Japan 2017516768 ⤷  Subscribe
South Korea 20170005819 ⤷  Subscribe
Mexico 2016014281 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.