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Last Updated: April 30, 2025

Details for Patent: 10,682,338


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Which drugs does patent 10,682,338 protect, and when does it expire?

Patent 10,682,338 protects SOLOSEC and is included in one NDA.

This patent has sixteen patent family members in five countries.

Summary for Patent: 10,682,338
Title:Secnidazole for use in the treatment of bacterial vaginosis
Abstract: Method of treating bacterial vaginosis in a subject in need thereof involving administering to the subject a therapeutically effective amount of secnidazole in a microgranule formulation, wherein the microgranule formulation comprises a plurality of microgranules having a volume-weighted particle size distribution within a microgranule population, wherein the volume-weighted particle size distribution as measured from a representative sample of the microgranule population comprises (a) 10% of the microgranule population having a volume-weighted particle size about no less than 470 micrometers; (b) 50% of the microgranule population having a volume-weighted particle size between about no less than 640 micrometers and about no more than 810 micrometers; (c) 90% of the microgranule population having a volume-weighted particle size about no more than 1170 micrometers; or (d) a combination thereof, which can include some or all of (a) through (c) above.
Inventor(s): Pentikis; Helen S. (Timonium, MD), Palling; David (Glen Ridge, NJ), Braun; Carol J. (Ellicott City, MD), Holl; Richard (Somerset, NJ)
Assignee: Lupin Inc. (Baltimore, MD)
Application Number:16/049,032
Patent Claim Types:
see list of patent claims
Use; Formulation; Delivery;
Patent landscape, scope, and claims:

Analyzing the Scope and Claims of United States Patent 10,682,338

Introduction

Understanding the scope and claims of a patent is crucial for inventors, researchers, and businesses to navigate the intellectual property landscape. This article will provide a detailed analysis of the scope and claims of United States Patent 10,682,338, focusing on its context, claims, and the broader patent landscape.

Overview of the Patent

United States Patent 10,682,338 titled "Secnidazole for use in the treatment of bacterial vaginosis" is a patent that describes a method for treating bacterial vaginosis using the antibiotic secnidazole.

Patent Claims

Independent Claims

The patent includes several independent claims that define the scope of the invention. Here are some key points:

  • Claim 1: This claim typically sets the broadest scope of the invention, often describing the main method or product. For example, Claim 1 of US 10,682,338 might state: "A method of treating bacterial vaginosis in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of secnidazole"[5].

  • Dependent Claims: These claims build upon the independent claims, adding specific details or limitations. For instance, dependent claims might specify the dosage, administration route, or duration of treatment.

Claim Construction

Claim construction is the process of interpreting the meaning of the claims. This is critical for determining the scope of protection and potential infringement. The claims are analyzed in light of the specification, prosecution history, and any relevant prior art[1].

Patent Specification

Detailed Description

The specification provides a detailed description of the invention, including the background, summary, and detailed description of the preferred embodiments. For US 10,682,338, the specification would include:

  • Background: An overview of bacterial vaginosis, its current treatments, and the limitations of existing therapies.
  • Summary: A brief summary of the invention, highlighting the use of secnidazole as a treatment.
  • Detailed Description: A detailed explanation of how secnidazole is used, including dosage, administration methods, and expected outcomes[5].

Prior Art and Patent Landscape

Searchable Databases

To understand the patent landscape, one must conduct thorough searches using various databases:

  • USPTO Patent Public Search: This tool provides access to prior art and allows users to search existing patents and published patent applications[1].
  • Global Dossier: This service offers access to file histories of related applications from participating IP Offices, helping to identify prior art and office actions[1].
  • International Patent Offices: Databases such as the European Patent Office's Espacenet, Japan Patent Office, and World Intellectual Property Organization's PATENTSCOPE can be used to search for international prior art[1].

Relevant Prior Art

Identifying relevant prior art is essential to understand the novelty and non-obviousness of the invention. For US 10,682,338, prior art would include existing treatments for bacterial vaginosis and any previous uses of secnidazole.

Patent Scope and Claims Analysis

Scope of Protection

The scope of protection is defined by the claims and is interpreted in light of the specification and prior art. For US 10,682,338, the scope would include the specific method of treating bacterial vaginosis using secnidazole, as well as any dependent claims that add additional limitations.

Claim Scope vs. Specification

The claims must be supported by the specification, meaning that the specification must provide sufficient disclosure to enable one skilled in the art to practice the invention. Any claims that are not supported by the specification may be deemed invalid.

Economic and Market Impact

Market Dominance

A patent like US 10,682,338 can provide significant market dominance if it covers a novel and non-obvious method of treatment. This can lead to exclusive rights to market secnidazole for bacterial vaginosis, potentially impacting the competitive landscape.

Licensing and Collaboration

Patents can also facilitate licensing agreements and collaborations. For example, the patent holder could license the use of secnidazole for bacterial vaginosis to other pharmaceutical companies, generating revenue and expanding market reach.

Legal and Regulatory Considerations

Patent Enforcement

To maintain market dominance, the patent holder must enforce the patent against potential infringers. This involves monitoring for infringement and taking legal action when necessary.

Regulatory Approvals

In addition to patent protection, any new treatment must also receive regulatory approvals from bodies like the FDA. The patent holder must ensure compliance with all relevant regulations to bring the treatment to market.

Tools and Resources for Patent Search

USPTO Resources

  • Patent Public Search: A powerful tool for searching prior art and existing patents[1].
  • Patent and Trademark Resource Centers (PTRCs): Local resources that offer training in patent search techniques[1].
  • Patent Examination Data System (PEDS): Allows users to search, view, and download bibliographic data for patent applications[1].

International Resources

  • European Patent Office (EPO): Provides access to European patent databases through Espacenet[1].
  • World Intellectual Property Organization (WIPO): Offers the PATENTSCOPE search service for international patent applications[1].

Historical Context of Patents

Early Patents

Understanding the historical context of patents can provide insights into the evolution of intellectual property. For example, early U.S. patents from 1790 to 1836, known as "X" patents, were not numbered but can be found through specific indexes and microfilm records[4].

Conclusion

Analyzing the scope and claims of a patent like US 10,682,338 involves a thorough understanding of the patent specification, prior art, and the broader patent landscape. This analysis is crucial for inventors, researchers, and businesses to navigate the complex world of intellectual property and to leverage patents for market dominance.

Key Takeaways

  • Patent Claims: Define the scope of the invention and must be supported by the specification.
  • Prior Art: Essential for determining novelty and non-obviousness.
  • Patent Landscape: Includes international databases and prior art searches.
  • Market Impact: Patents can provide market dominance and facilitate licensing agreements.
  • Legal and Regulatory Considerations: Include patent enforcement and regulatory approvals.
  • Tools and Resources: Utilize USPTO and international resources for comprehensive patent searches.

FAQs

Q1: How do I search for existing patents related to my invention? You can use the USPTO's Patent Public Search tool, Global Dossier, and other international patent databases to search for existing patents and prior art[1].

Q2: What is the importance of claim construction in patent analysis? Claim construction is crucial for determining the scope of protection and potential infringement by interpreting the meaning of the claims in light of the specification and prior art[1].

Q3: How can I ensure my patent is novel and non-obvious? Conduct thorough searches using various databases to identify relevant prior art and ensure that your invention is significantly different from existing technologies[1].

Q4: What are the economic benefits of holding a patent? Holding a patent can provide market dominance, facilitate licensing agreements, and generate revenue through exclusive rights to market the invention[3].

Q5: Where can I find historical U.S. patents? Historical U.S. patents can be found through resources like the New York Public Library's SIBL, Hathi Trust, and the USPTO's Public Search Facility[4].

Sources

  1. USPTO - Search for patents: https://www.uspto.gov/patents/search
  2. USA.gov - U.S. Patent and Trademark Office: https://www.usa.gov/agencies/u-s-patent-and-trademark-office
  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. Google Patents - Secnidazole for use in the treatment of bacterial vaginosis: https://patents.google.com/patent/US10682338B2/en

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Drugs Protected by US Patent 10,682,338

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Evofem Inc SOLOSEC secnidazole GRANULE;ORAL 209363-001 Sep 15, 2017 RX Yes Yes 10,682,338 ⤷  Try for Free Y TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER ⤷  Try for Free
Evofem Inc SOLOSEC secnidazole GRANULE;ORAL 209363-001 Sep 15, 2017 RX Yes Yes 10,682,338 ⤷  Try for Free Y TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN ⤷  Try for Free
>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 10,682,338

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2015311674 ⤷  Try for Free
Australia 2018203882 ⤷  Try for Free
Australia 2018217262 ⤷  Try for Free
Canada 2959414 ⤷  Try for Free
Canada 3046521 ⤷  Try for Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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