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Last Updated: January 8, 2025

Details for Patent: 11,084,788


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Which drugs does patent 11,084,788 protect, and when does it expire?

Patent 11,084,788 protects SOFDRA and is included in one NDA.

This patent has eighty-six patent family members in twenty-two countries.

Summary for Patent: 11,084,788
Title:Formulation for soft anticholinergic analogs
Abstract:Topical formulations comprising soft glycopyrrolates are useful for treating excessive sweating conditions in subjects, such as humans suffering from hyperhidrosis. Preferably, at least one soft anticholinergic agent is provided in an effective amount or concentration in an anhydrous formulation that can inhibit excessive perspiration resulting from a condition such as hyperhidrosis.
Inventor(s):Nicholas S. Bodor, John J. Koleng, David Angulo
Assignee:Bodor Laboratories Inc
Application Number:US17/116,501
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 11,084,788: A Detailed Analysis

Introduction

Patent US-11084788-B2, titled "Formulation for soft anticholinergic analogs," is a significant patent in the pharmaceutical sector, particularly in the area of anticholinergic medications. This article will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

Invention Description

The patent US-11084788-B2 describes formulations for soft anticholinergic analogs, which are designed to treat various conditions such as overactive bladder, chronic obstructive pulmonary disease (COPD), and other disorders where anticholinergic therapy is beneficial. These formulations aim to improve the efficacy, stability, and patient compliance of anticholinergic treatments[5].

Scope of the Patent

Claims

The patent includes multiple claims that define the scope of the invention. These claims typically cover the composition of the formulation, the method of preparation, and the specific uses of the anticholinergic analogs. Here are some key aspects:

  • Composition Claims: These claims specify the active ingredients, excipients, and other components of the formulation. For example, the patent might claim a specific ratio of the anticholinergic analog to other ingredients or the use of particular solvents or stabilizers.
  • Method of Preparation Claims: These claims outline the steps and conditions under which the formulation is prepared. This could include details on mixing, heating, or other processing steps.
  • Use Claims: These claims define the therapeutic uses of the formulation, such as treatment of overactive bladder or COPD[5].

Dependent and Independent Claims

The patent will include both independent and dependent claims. Independent claims stand alone and define the invention broadly, while dependent claims build upon the independent claims and provide more specific details. For instance, an independent claim might state the composition of the formulation, while a dependent claim might specify a particular method of preparing that composition.

Patent Landscape

Prior Art and Novelty

To understand the patent landscape, it is crucial to examine the prior art in the field of anticholinergic formulations. The patent office would have conducted a thorough search to ensure that the claimed invention is novel and non-obvious over existing prior art. This involves analyzing previous patents, scientific literature, and other relevant sources to determine the uniqueness of the invention[4].

Competing Patents

The patent landscape also includes competing patents in the same or related fields. For example, other patents related to anticholinergic formulations or treatments for similar conditions would be relevant. Analyzing these competing patents helps in understanding the market position and potential infringement risks of the patented formulation.

Regulatory and Legal Context

America Invents Act (AIA)

The Leahy-Smith America Invents Act (AIA) of 2011 significantly changed the U.S. patent system, shifting from a first-to-invent to a first-inventor-to-file system. This change affects how priority is determined for patents, including those related to pharmaceutical formulations. Under the AIA, the first person to file a patent application for an invention has priority, even if another inventor can establish an earlier invention date[2].

Patent Litigation Trends

Recent trends in patent litigation, as highlighted by the Government Accountability Office (GAO), show an increase in patent infringement lawsuits, particularly in the software and technology sectors. However, pharmaceutical patents, including those related to formulations, are also subject to litigation. The GAO report suggests that the U.S. Patent and Trademark Office (USPTO) has taken steps to improve patent quality and reduce litigation, which could impact the enforcement and validity of patents like US-11084788-B2[1].

Data and Research Tools

USPTO Datasets

The USPTO provides several datasets and tools that can be used to analyze patents, including the Patent Claims Research Dataset. This dataset contains detailed information on claims from U.S. patents granted between 1976 and 2014 and U.S. patent applications published between 2001 and 2014. Such datasets can help in understanding the scope and claims of patents, as well as trends in patenting within specific industries[3].

Advanced Patent Searching

Advanced patent searching tools, such as those provided by the USPTO and international patent offices, allow for full-text searching of patent grants and applications. These tools, including the Cooperative Patent Classification (CPC) database and the PATENTSCOPE database, are essential for conducting thorough searches of prior art and analyzing the patent landscape[4].

Key Takeaways

  • Patent Claims: The patent US-11084788-B2 includes specific claims related to the composition, preparation, and use of soft anticholinergic analogs.
  • Patent Landscape: Understanding the prior art, competing patents, and regulatory context is crucial for navigating the patent landscape.
  • Regulatory Changes: The AIA's first-inventor-to-file system affects the priority of patents, including those in the pharmaceutical sector.
  • Litigation Trends: Recent trends in patent litigation highlight the importance of patent quality and the potential for litigation in the pharmaceutical industry.
  • Research Tools: Utilizing USPTO datasets and advanced patent searching tools is essential for thorough analysis and strategic decision-making.

FAQs

What is the main focus of the patent US-11084788-B2?

The main focus of the patent US-11084788-B2 is on formulations for soft anticholinergic analogs, designed to treat conditions such as overactive bladder and COPD.

How does the America Invents Act (AIA) impact this patent?

The AIA's shift to a first-inventor-to-file system means that the priority of the patent is determined by the filing date of the patent application, rather than the date of invention.

What tools can be used to analyze the patent landscape for this invention?

Tools such as the USPTO's Patent Claims Research Dataset, the Cooperative Patent Classification (CPC) database, and the PATENTSCOPE database can be used to analyze the patent landscape.

Why is it important to understand prior art in patent analysis?

Understanding prior art is crucial to ensure that the claimed invention is novel and non-obvious over existing prior art, which is a requirement for patentability.

How can recent trends in patent litigation affect the enforcement of this patent?

Recent trends in patent litigation, including the increase in lawsuits and efforts to improve patent quality, can impact the enforcement and validity of the patent. It is important to monitor these trends to ensure the patent remains enforceable.

Sources

  1. GAO Report: Assessing Factors That Affect Patent Infringement Litigation Could Help Improve Patent Quality, GAO-13-465.
  2. SNIPR Technologies Limited v. Rockefeller University: CAFC Opinion, 22-1260.
  3. USPTO Patent Claims Research Dataset: USPTO Economic Working Paper 2016-04.
  4. Advanced Patent Searching: Clemson University Libraries, Research and Course Guides.
  5. Patent US-11084788-B2: PubChem Summary.

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Drugs Protected by US Patent 11,084,788

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Botanix Sb SOFDRA sofpironium bromide GEL, METERED;TOPICAL 217347-001 Jun 18, 2024 RX Yes Yes 11,084,788 ⤷  Subscribe Y TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER ⤷  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 11,084,788

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2015229243 ⤷  Subscribe
Australia 2016297601 ⤷  Subscribe
Australia 2017298469 ⤷  Subscribe
Australia 2019257421 ⤷  Subscribe
Australia 2023202689 ⤷  Subscribe
Australia 2024227714 ⤷  Subscribe
Brazil 112016021011 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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