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Last Updated: December 22, 2024

Details for Patent: 10,828,293


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Which drugs does patent 10,828,293 protect, and when does it expire?

Patent 10,828,293 protects JUBLIA and is included in one NDA.

This patent has twelve patent family members in six countries.

Summary for Patent: 10,828,293
Title:Anti-infective methods, compositions, and devices
Abstract: The present invention provides methods for treating onychomycosis. In certain embodiments, the methods comprise comprising applying a pharmaceutically acceptable formulation containing 10% efinaconazole once a day for a treatment period of at least 36 weeks to the treatment area of an onychomycosis patient (a) without debriding the nail or nail-associated tissue initially or during the treatment period and/or (b) without removing the formulation from the treatment area during the treatment period. In certain embodiments, the formulation also comprises, water, cyclomethicone, diisopropyl adipate, alcohol, C12-15 alkyl lactate, butylated hydroxytoluene, citric acid anhydrous, and disodium edetate.
Inventor(s): Pillai; Radhakrishnan (Santa Rosa, CA), Dow; Gordon (Greenbrae, CA)
Assignee: DOW PHARMACEUTICAL SCIENCES, INC. (Petaluma, CA)
Application Number:16/353,849
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 10,828,293: A Comprehensive Analysis

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 10,828,293, focusing on its claims, the patenting process, and the relevant legal and procedural contexts.

Patent Overview

Patent Number and Title

United States Patent 10,828,293 is a specific patent granted by the U.S. Patent and Trademark Office (USPTO). To begin, it is essential to identify the title, inventors, and the assignee of the patent, as these details provide context about the invention and its ownership.

Claims Analysis

Independent and Dependent Claims

Patent claims are the heart of any patent, defining the scope of the invention. Independent claims stand alone and define the broadest scope of the invention, while dependent claims build upon the independent claims and narrow down the scope[2].

  • Independent Claims: These claims should be examined to understand the core aspects of the invention. For example, if the patent is related to a technological innovation, the independent claims might describe the fundamental components and their interactions.
  • Dependent Claims: These claims add specificity to the independent claims, often detailing particular embodiments or variations of the invention.

Claim Construction

The construction of claims is critical for determining the patent's scope. This involves interpreting the language of the claims to understand what is covered and what is not. The USPTO and courts use various guidelines and tests, such as the Alice/Mayo test, to ensure that the claims are not directed to ineligible subject matter like abstract ideas or laws of nature[4].

Patenting Process

Provisional vs. Non-Provisional Applications

The journey to obtaining a patent like 10,828,293 typically begins with a provisional patent application. This allows the applicant to file a non-provisional application within one year, which then enters the national phase of patent prosecution[2].

  • Provisional Application: This initial step provides a temporary protection and allows the applicant to file a non-provisional application within a year.
  • Non-Provisional Application: This is the formal application that undergoes examination by the USPTO.

Examination and Prosecution

During the examination phase, a patent examiner reviews the application to determine if the invention is novel, non-obvious, and enabled. The applicant may need to respond to office actions, amend claims, and argue for the patentability of the invention[2].

Patent Landscape

Family Members and Continuations

Patents often have family members, including continuations, continuations-in-part, and divisional applications. Understanding these relationships is crucial for assessing the overall patent landscape.

  • Continuations: These are applications that claim priority from an earlier application and can extend the life of the original patent.
  • Continuations-in-Part: These applications include new matter not present in the original application but still claim priority from it[1].

Patent Term Adjustment (PTA) and Terminal Disclaimers

Patents can be subject to Patent Term Adjustment (PTA) due to USPTO delays during prosecution. Additionally, terminal disclaimers may be filed to overcome obviousness-type double patenting (ODP) issues[1].

Obviousness-Type Double Patenting (ODP)

ODP Analysis

ODP is a critical issue that can arise when multiple patents from the same family are involved. The analysis involves determining whether the claims of one patent are obvious variants of another patent. This was a key issue in the case of In re Cellect LLC, where the Federal Circuit addressed ODP in the context of patents with different expiration dates due to PTA[1].

Legal and Procedural Contexts

America Invents Act (AIA) and PTAB

The 2011 Leahy-Smith America Invents Act (AIA) significantly altered U.S. patent law, introducing the Patent Trial and Appeal Board (PTAB) and new administrative challenges to patent validity. PTAB can hear inter partes reviews and post-grant reviews, which can impact the validity of patents like 10,828,293[4].

International Considerations

For patents with global implications, international patent applications under the Patent Cooperation Treaty (PCT) may be filed. This preserves the right to file national stage applications in multiple countries within 30 months of the earliest priority date[2].

Economic and Commercial Implications

Costs and Commercialization

The process of obtaining and maintaining a patent is costly. The total cost for a U.S. patent can range from $30,000 to much higher, depending on the complexity and international filings. Commercial partners often play a crucial role in covering these costs, especially for high-value inventions[2].

Case Studies and Examples

Real-World Applications

To illustrate the practical implications, consider real-world examples where patents similar to 10,828,293 have been involved in litigation or licensing agreements. For instance, the In re Cellect LLC case highlights the complexities of ODP and its impact on patent validity[1].

Key Takeaways

  • Claims Analysis: Understanding the independent and dependent claims is crucial for defining the scope of the patent.
  • Patenting Process: The journey from provisional to non-provisional applications and the examination phase is critical.
  • Patent Landscape: Family members, continuations, and PTA can significantly affect the patent's validity and lifespan.
  • Legal Contexts: AIA, PTAB, and international considerations are vital for navigating the patent landscape.
  • Economic Implications: The costs and commercialization strategies are essential for the patent's economic viability.

FAQs

Q: What is the difference between a provisional and non-provisional patent application?

A: A provisional patent application provides temporary protection and allows the applicant to file a non-provisional application within one year. A non-provisional application is the formal application that undergoes examination by the USPTO.

Q: How does the Patent Trial and Appeal Board (PTAB) impact patent validity?

A: PTAB can hear administrative challenges to patent validity, such as inter partes reviews and post-grant reviews, which can result in the invalidation of patent claims.

Q: What is obviousness-type double patenting (ODP), and how does it affect patents?

A: ODP occurs when multiple patents from the same family have claims that are obvious variants of each other. This can lead to the invalidation of claims, as seen in the In re Cellect LLC case.

Q: How do Patent Term Adjustments (PTA) affect the lifespan of a patent?

A: PTA can extend the life of a patent due to delays during prosecution by the USPTO, but it must be considered in the context of ODP and other patent family members.

Q: Why is international patent protection important for some inventions?

A: International patent protection, such as through the PCT, allows applicants to preserve the right to file national stage applications in multiple countries, which is crucial for inventions with global commercial potential.

Sources

  1. In re Cellect, LLC, United States Court of Appeals for the Federal Circuit, 2023.
  2. Intellectual Property Protection, KU Office of Research.
  3. Patent Claims Research Dataset, USPTO.
  4. The Patent Trial and Appeal Board and Inter Partes Review, Congressional Research Service.

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Drugs Protected by US Patent 10,828,293

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 ⤷  Subscribe ⤷  Subscribe ANTIMYCOTIC USES, SPECIFICALLY TREATMENT OF ONYCHOMYCOSIS; TOPICAL TREATMENT OF THE TOENAIL(S) DUE TO TRICHOPHYTON RUBRUM AND TRICHOPHYTON MENTAGROPHYTES ⤷  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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