You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: January 3, 2025

Details for Patent: 9,925,264


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 9,925,264 protect, and when does it expire?

Patent 9,925,264 protects ZTLIDO and is included in one NDA.

This patent has fourteen patent family members in eight countries.

Summary for Patent: 9,925,264
Title:Non-aqueous patch
Abstract: Non-aqueous patches comprising lidocaine, which is not dissolved and is present in a crystalline state, have poor permeability to the skin. Therefore, non-aqueous patches have a high concentration of lidocaine. It is pointed out that lidocaine has an adverse effect on the heart. Prolonged use of a high concentration of lidocaine causes side effects, such as shock, rubor, and irritating sensation. External preparations comprising more than 5 mass % of lidocaine are designated as powerful drugs, and cannot be used as household (nonprescription) medicine. Provided is a non-aqueous patch that is effective to relieve muscle pain, the non-aqueous patch comprising lidocaine and/or its reactant, and a dissolving agent composed of an organic acid and a polyalcohol, which are contained in a base.
Inventor(s): Mori; Tatsuya (Saga, JP), Saida; Naoyuki (Saga, JP)
Assignee: Itochu Chemical Frontier Corporation (Tokyo, JP) Oishi Koseido Co., Ltd. (Saga, JP)
Application Number:15/065,075
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,925,264
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 9,925,264

Introduction

United States Patent 9,925,264, hereafter referred to as the '264 patent, is a significant intellectual property asset in the pharmaceutical sector, particularly related to non-aqueous patches containing lidocaine. This article delves into the scope and claims of this patent, as well as the broader patent landscape in which it resides.

Patent Overview

The '264 patent, titled "Non-aqueous Patch," describes a specific formulation of a lidocaine-containing patch that is not dissolved and is present in a crystalline state. This design addresses the issue of poor permeability to the skin associated with traditional non-aqueous patches[2].

Claims Analysis

Independent Claims

The '264 patent includes several independent claims that define the scope of the invention. These claims typically outline the essential features of the non-aqueous patch, such as the composition of the patch, the crystalline state of lidocaine, and the specific permeability characteristics.

Dependent Claims

Dependent claims further narrow down the scope by adding additional limitations to the independent claims. These could include specific concentrations of lidocaine, the type of polymers used in the patch, and other detailed specifications.

Breadth of Claims

The breadth of the claims is a critical aspect, as it determines the extent of protection afforded by the patent. Broader claims can encompass a wider range of variations, but they may also face challenges regarding enablement and undue experimentation. For instance, in a recent court case, an expert witness argued that broad claims might require undue experimentation to practice, which could impact their validity[1].

Patent Scope Metrics

Independent Claim Length and Count

Research suggests that patent scope can be measured using metrics such as independent claim length and independent claim count. These metrics can provide insights into the breadth and clarity of the patent claims. Patents with narrower claims at publication tend to have a higher probability of grant and a shorter examination process compared to those with broader claims[3].

Patent Landscape Analysis

Definition and Importance

Patent landscape analysis, also known as patent mapping, is a comprehensive process that analyzes and organizes vast amounts of patent data to provide valuable insights into a technological domain. This analysis helps in identifying competitors, understanding market trends, and assessing the commercial potential of existing patents[5].

Competitor Identification

For the '264 patent, a patent landscape analysis would help identify other key players in the field of transdermal drug delivery systems. This includes companies like Scilex Pharmaceuticals Inc., which developed ZTLIDO®, a product that the '264 patent's generic version aims to compete with[1].

Legal Status and Expiry Dates

Understanding the legal status (alive, pending, lapsed, revoked, or expired) and expected expiry dates of related patents is crucial for strategic planning. For example, knowing when the '264 patent is set to expire can help competitors plan their entry into the market or negotiate licensing agreements[5].

Market Developments

Patent landscape reports also reveal market developments such as mergers and acquisitions, in/out-licensing activities, and litigation trends. These insights can help companies navigate the complex landscape and capitalize on opportunities while minimizing risks[5].

Case Study: Scilex Pharmaceuticals Inc. vs. Aveva Drug Delivery Systems, Inc.

A recent court case involving Scilex Pharmaceuticals Inc. and Aveva Drug Delivery Systems, Inc. highlights the importance of patent scope and landscape analysis. Aveva's attempt to market a generic version of ZTLIDO® led to a patent infringement lawsuit, where the breadth of the asserted patents, including the '264 patent, was a central issue. The court's decision to allow the expert witness's opinions on the broadness of the claims underscores the complexity and importance of these issues in patent litigation[1].

Impact on Innovation and Competition

The scope and claims of the '264 patent, along with the broader patent landscape, significantly influence innovation and competition in the pharmaceutical industry. Overly broad patents can increase licensing and litigation costs, potentially diminishing incentives for innovation. Conversely, well-defined and narrowly scoped patents can foster a more competitive and innovative environment[3].

Conclusion

Understanding the scope and claims of the '264 patent, as well as the broader patent landscape, is essential for navigating the complex world of pharmaceutical intellectual property. Here are the key takeaways:

  • Claims Analysis: The '264 patent's claims define the invention's scope, with independent and dependent claims outlining essential features.
  • Patent Scope Metrics: Metrics like independent claim length and count can help assess the breadth and clarity of patent claims.
  • Patent Landscape Analysis: This analysis is crucial for identifying competitors, understanding market trends, and assessing commercial potential.
  • Legal and Market Insights: Knowing the legal status and expiry dates of patents, as well as market developments, is vital for strategic planning.
  • Impact on Innovation: The scope and claims of patents can significantly influence innovation and competition in the industry.

FAQs

  1. What is the main subject of United States Patent 9,925,264? The main subject of the '264 patent is a non-aqueous patch containing lidocaine in a crystalline state, designed to improve skin permeability.

  2. How can the breadth of patent claims be measured? The breadth of patent claims can be measured using metrics such as independent claim length and independent claim count.

  3. What is the purpose of patent landscape analysis? Patent landscape analysis helps in understanding the technological domain, identifying competitors, and assessing market trends and commercial potential.

  4. Why is the legal status of patents important? Knowing the legal status (alive, pending, lapsed, revoked, or expired) and expected expiry dates of patents is crucial for strategic planning and decision-making.

  5. How do broad patent claims impact innovation? Overly broad patent claims can increase licensing and litigation costs, potentially diminishing incentives for innovation.

Sources

  1. Expert Witness Profiler - Court refuses to exclude Pharmaceutical Expert Witness’ Opinions Regarding Breadth of Asserted Claims
  2. Unified Patents Portal - US-9925264-B2 - Non-aqueous Patch
  3. SSRN - Patent Claims and Patent Scope
  4. USPTO - Search for patents
  5. Sagacious Research - Navigating Technological Domains with Patent Landscape Analysis

More… ↓

⤷  Subscribe


Drugs Protected by US Patent 9,925,264

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Patented / Exclusive UseSubmissiondate
Scilex Pharms ZTLIDO lidocaine PATCH;TOPICAL 207962-001 Feb 28, 2018 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y METHOD FOR RELIEVING THE PAIN ASSOCIATED WITH POST-HERPETIC NEURALGIA ⤷  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
Showing 1 to 1 of 1 entries

International Family Members for US Patent 9,925,264

CountryPatent NumberEstimated ExpirationSupplementary Protection CertificateSPC CountrySPC Expiration
Brazil 112013028802 ⤷  Subscribe
Brazil 122021017591 ⤷  Subscribe
Canada 2835595 ⤷  Subscribe
>Country>Patent Number>Estimated Expiration>Supplementary Protection Certificate>SPC Country>SPC Expiration
Showing 1 to 3 of 3 entries

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.