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Last Updated: December 22, 2024

Details for Patent: 10,105,444


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Which drugs does patent 10,105,444 protect, and when does it expire?

Patent 10,105,444 protects JUBLIA and is included in one NDA.

Summary for Patent: 10,105,444
Title:Compositions and methods for treating diseases of the nail
Abstract: Methods and compositions for treating disorders of the nail and nail bed. Such compositions contain a vehicle in which all components of the composition are dissolved, suspended, dispersed, or emulsified, a non-volatile solvent, a wetting agent, and a pharmaceutically active ingredient that is soluble in the non-volatile solvent and/or a mixture of the vehicle and the non-volatile solvent, which composition has a surface tension of 40 dynes/cm or less and has continuing spreadability, and which composition is effective in treating a disorder of the nail or nail bed.
Inventor(s): Winckle; Gareth (Petaluma, CA), Fieldson; Gregory T. (Morgantown, WV)
Assignee: Dow Pharmaceutical Sciences, Inc. (Petaluma, CA)
Application Number:15/826,109
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,105,444
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Compound; Delivery;
Patent landscape, scope, and claims:

Analyzing the Scope and Claims of United States Patent 10,105,444

Introduction

United States Patent 10,105,444, titled "Compositions and methods for treating diseases of the nail," is a significant patent in the field of dermatology and pharmaceuticals. This patent outlines innovative compositions and methods aimed at treating various nail and nail bed disorders. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

The patent, filed under the application number US15/826,109, was granted on October 23, 2018. It is classified under the category of pharmaceutical compositions and methods for treating nail diseases, which includes conditions such as onychomycosis, nail psoriasis, and other nail bed disorders[1].

Scope of the Patent

The scope of the patent encompasses several key aspects:

Compositions

The patent describes specific compositions designed to treat nail and nail bed diseases. These compositions typically include a vehicle in which all components of the formulation are dissolved or suspended. The vehicle can be a solvent, a mixture of solvents, or other carriers that facilitate the delivery of the active ingredients to the nail and surrounding tissue[1].

Active Ingredients

The active ingredients in these compositions can vary but often include antifungal agents, anti-inflammatory agents, and other therapeutic compounds tailored to address specific nail conditions. The patent highlights the importance of selecting ingredients that are effective yet safe for topical application[1].

Methods of Treatment

The methods outlined in the patent involve applying the compositions to the affected nail and nail bed. The application can be in various forms such as creams, ointments, gels, or solutions, and the frequency of application can be adjusted based on the severity of the condition and the patient's response to treatment[1].

Claims of the Patent

The claims of the patent are crucial as they define the legal boundaries of the invention. Here are some key claims:

Independent Claims

  • Claim 1 typically defines the broadest scope of the invention, such as a composition comprising a vehicle and at least one active ingredient for treating nail diseases.
  • Claim 2 might specify the type of vehicle used, such as an aqueous or non-aqueous solvent.
  • Claim 3 could detail the specific active ingredients and their concentrations[1].

Dependent Claims

  • These claims build upon the independent claims and provide additional details or limitations. For example, Claim 4 might specify the method of application, such as topical administration, while Claim 5 could describe the frequency of application[1].

Patent Landscape

Understanding the patent landscape is essential for navigating the intellectual property rights associated with this invention.

Prior Art

The patent landscape includes prior art that has influenced the development of this invention. Prior art in this field would include existing treatments for nail diseases, such as oral antifungals and topical creams. The patent must demonstrate how it improves upon or differs from existing treatments[1].

Competing Patents

Other patents in the same field could pose potential competition. For instance, patents covering similar compositions or methods for treating nail diseases would need to be analyzed to ensure that the claims of US 10,105,444 do not infringe on existing patents. Tools like the USPTO's Patent Public Search and Global Dossier can be used to identify and analyze these competing patents[4].

International Patent Landscape

Given the global nature of pharmaceutical research, it is important to consider the international patent landscape. Databases such as the European Patent Office's esp@cenet, the Japan Patent Office, and WIPO's PATENTSCOPE can provide insights into similar patents filed in other countries[4].

Claim Coverage and Scope Concepts

To fully understand the value and coverage of the patent claims, a Claim Coverage Matrix and scope concepts can be utilized. This involves categorizing the patents by claims and overarching scope concepts, which helps in identifying gaps or opportunities in the patent coverage. Tools like ClaimScape® software can generate interactive claim charts to facilitate this analysis[3].

Practical Applications and Future Directions

The practical applications of this patent are significant, as it provides new and potentially more effective treatments for common nail diseases. For companies holding this patent, it is crucial to track the claims and scope concepts to identify areas where the current coverage may be lacking and to explore future design opportunities.

Legal and Regulatory Considerations

The validity of the patent is presumed under 35 USC 282, which means that each claim of the patent is presumed valid independently. However, this presumption can be challenged through various defenses, such as prior art or obviousness[5].

Key Takeaways

  • Compositions and Methods: The patent covers specific compositions and methods for treating nail and nail bed diseases.
  • Claims: The claims define the legal scope of the invention, including independent and dependent claims.
  • Patent Landscape: Understanding prior art, competing patents, and the international patent landscape is crucial.
  • Practical Applications: The patent has significant practical applications in treating nail diseases and offers opportunities for future development.
  • Legal Considerations: The patent's validity is presumed, but it can be challenged through various legal defenses.

FAQs

Q: What is the primary focus of United States Patent 10,105,444? A: The primary focus is on compositions and methods for treating diseases of the nail and nail bed.

Q: What types of compositions are described in the patent? A: The compositions typically include a vehicle and at least one active ingredient, such as antifungal or anti-inflammatory agents.

Q: How can the patent landscape be analyzed for this invention? A: Tools like the USPTO's Patent Public Search, Global Dossier, and international patent databases can be used to analyze the patent landscape.

Q: What is the significance of scope concepts in patent analytics? A: Scope concepts help in categorizing patents by claims and identifying gaps or opportunities in the patent coverage.

Q: What legal presumption applies to the validity of this patent? A: The patent is presumed valid under 35 USC 282, with each claim presumed valid independently.

Sources

  1. US10105444B2 - Compositions and methods for treating diseases of the nail - Google Patents
  2. U.S. Patent Small Claims Court - ACUS
  3. Patent Analytics | Intellectual Property Law - SLWIP
  4. Search for patents - USPTO
  5. 35 USC 282: Presumption of validity; defenses - US Code

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Drugs Protected by US Patent 10,105,444

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Bausch JUBLIA efinaconazole SOLUTION;TOPICAL 203567-001 Jun 6, 2014 AB RX Yes Yes 10,105,444 ⤷  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

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