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Last Updated: December 22, 2024

Details for Patent: 9,301,920


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Summary for Patent: 9,301,920
Title:Natural combination hormone replacement formulations and therapies
Abstract: Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.
Inventor(s): Bernick; Brian A. (Boca Raton, FL), Cacace; Janice Louise (Miami, FL), Persicaner; Peter H. R. (Boca Raton, FL), Irani; Neda (Palm Beach Garden, FL), Amadio; Julia M. (Boca Raton, FL)
Assignee: TherapeuticsMD, Inc. (Boca Raton, FL)
Application Number:13/843,428
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,301,920
Patent Claim Types:
see list of patent claims
Use; Formulation; Compound;
Patent landscape, scope, and claims:

Analyzing the Scope and Claims of United States Patent 9,301,920

Introduction

United States Patent 9,301,920, titled "Natural combination hormone replacement formulations and therapies," is a significant patent in the field of pharmaceuticals, particularly focusing on hormone replacement therapies. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Patent Overview

Title and Abstract

The patent, filed under application number 13/843,428, pertains to natural combination hormone replacement formulations and therapies. It specifically involves estrogen and progesterone replacement therapies, which are crucial for treating various hormonal imbalances and conditions[1][5].

Scope of the Patent

Therapeutic Applications

The patent covers formulations and therapies that combine estrogen and progesterone in natural forms. These therapies are designed to address hormonal deficiencies and imbalances, which can occur due to menopause, hormonal disorders, or other medical conditions. The scope includes both the compositions and the methods of administering these therapies.

Composition Details

The patent describes specific formulations that include natural estrogen and progesterone compounds. These formulations are designed to mimic the body's natural hormonal balance, providing a more biologically compatible treatment option compared to synthetic hormones.

Claims of the Patent

Key Claims

The patent includes several claims that define the scope of protection:

  • Composition Claims: These claims specify the exact formulations of estrogen and progesterone, including the ratios and forms in which they are combined.
  • Method Claims: These claims cover the methods of preparing and administering the hormone replacement therapies.
  • Therapeutic Claims: These claims outline the specific therapeutic uses of the formulations, such as treating menopausal symptoms or hormonal deficiencies[1][5].

Patent Claims Analysis

Claim Structure

The claims are structured to provide broad protection while also being specific enough to distinguish the invention from prior art. For example, the composition claims might specify the types of estrogen and progesterone used, their concentrations, and the delivery mechanisms.

Claim Coverage Matrix

To understand the full extent of the patent's protection, a Claim Coverage Matrix can be useful. This matrix categorizes the claims by scope concepts, helping to identify which aspects of the technology are protected and where potential gaps or opportunities exist[3].

Patent Landscape

Related Patents and Litigation

The patent landscape around hormone replacement therapies is complex and involves numerous other patents. For instance, other patents may cover different formulations, delivery methods, or specific therapeutic applications. Litigation in this field is common, as seen in cases involving pharmaceutical companies like Purdue Pharma and Astellas US LLC, which often involve disputes over patent infringement related to various pharmaceutical products[2].

Competing Technologies

Competitors in the hormone replacement therapy market may have their own patents covering similar or alternative formulations. For example, TherapeuticsMD, Inc. has patents related to vaginal inserted estradiol pharmaceutical compositions, which could be seen as competing technologies in the broader hormone replacement therapy space[4].

Impact on the Pharmaceutical Industry

Market Protection

The patent provides significant market protection for the holder by preventing others from manufacturing, using, or selling the specified hormone replacement formulations without permission. This protection is crucial for maintaining market share and preventing generic or biosimilar versions from entering the market prematurely.

Innovation and Research

The patent also encourages innovation by protecting the intellectual property of the inventors, allowing them to recoup their investment in research and development. This can lead to further advancements in hormone replacement therapies as companies continue to innovate within the protected scope.

Challenges and Opportunities

Patent Litigation

Patent litigation is a significant challenge in this field. Companies must be prepared to defend their patents against infringement claims and navigate complex legal landscapes. For example, the case of Purdue Pharma L.P. v. Intellipharmaceutics International Inc. highlights the legal battles that can arise over patent infringement in the pharmaceutical industry[2].

Expiration and Biosimilars

As patents expire, the door opens for biosimilars and generic versions of the drugs. This can significantly impact the market, as seen with biologic drugs where the expiration of patents leads to the entry of biosimilars, potentially reducing market share for the original patent holders[1].

Claim Charts and Patent Analytics

Utilizing Claim Charts

To effectively manage and analyze the patent claims, companies can use tools like Claim Charts generated by software such as ClaimScape®. These charts help in reviewing patent coverage, identifying gaps, and highlighting future design opportunities. This is particularly useful for technical experts, engineers, and management to understand the patent landscape and make informed decisions[3].

Key Takeaways

  • Patent Scope: The patent covers natural combination hormone replacement formulations and therapies involving estrogen and progesterone.
  • Claims Analysis: The claims are structured to provide broad protection for the compositions, methods of preparation, and therapeutic uses.
  • Patent Landscape: The landscape is complex with related patents and litigation, and competitors have their own patents in the hormone replacement therapy space.
  • Market Impact: The patent provides market protection and encourages innovation but also faces challenges such as patent litigation and the eventual expiration leading to biosimilars.

FAQs

What is the main focus of United States Patent 9,301,920?

The main focus of United States Patent 9,301,920 is on natural combination hormone replacement formulations and therapies, specifically involving estrogen and progesterone.

How do the claims of the patent protect the invention?

The claims protect the invention by specifying the exact formulations, methods of preparation, and therapeutic uses of the hormone replacement therapies.

What tools can be used to analyze the patent claims effectively?

Tools such as Claim Charts generated by software like ClaimScape® can be used to analyze the patent claims, identify gaps, and highlight future design opportunities.

How does the patent impact the pharmaceutical industry?

The patent provides market protection, encourages innovation, but also faces challenges such as patent litigation and the eventual expiration leading to biosimilars.

What happens when the patent expires?

When the patent expires, it opens the door for biosimilars and generic versions of the drugs, potentially reducing the market share for the original patent holders.

Sources

  1. Drug Patent Watch: Summary for Patent: 9,301,920.
  2. Patent Docs: Court Report - Patent Docs.
  3. Schwegman: Patent Analytics.
  4. Google Patents: United States Patent Mirkin et al.
  5. Drug Patent Watch: Pharmaceutical drugs covered by patent 9,301,920.

More… ↓

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Drugs Protected by US Patent 9,301,920

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 9,301,920 ⤷  Subscribe Y TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS ⤷  Subscribe
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes 9,301,920 ⤷  Subscribe Y 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 9,301,920

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
European Patent Office 2782584 ⤷  Subscribe LUC00245 Luxembourg ⤷  Subscribe
European Patent Office 2782584 ⤷  Subscribe 132021000000197 Italy ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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