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Last Updated: December 27, 2024

Details for Patent: 6,375,986


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Summary for Patent: 6,375,986
Title: Solid dose nanoparticulate compositions comprising a synergistic combination of a polymeric surface stabilizer and dioctyl sodium sulfosuccinate
Abstract:Disclosed are solid dose nanoparticulate compositions comprising a poorly soluble active agent, at least one polymeric surface stabilizer, and dioctyl sodium sulfosuccinate (DOSS). The solid dose compositions exhibit superior redispersibility of the nanoparticulate composition upon administration to a mammal, such as a human or animal. The invention also describes methods of making and using such compositions.
Inventor(s): Ryde; Niels P. (Malvern, PA), Ruddy; Stephen B. (Schwenksville, PA)
Assignee: Elan Pharma International Ltd. (Clare, IE)
Application Number:09/666,539
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 6,375,986
Patent Claim Types:
see list of patent claims
Composition; Formulation; Use;
Patent landscape, scope, and claims:

United States Patent 6,375,986: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 6,375,986, titled "Solid dose nanoparticulate compositions comprising a synergistic combination of a polymeric surface stabilizer and dioctyl sodium sulfosuccinate," is a significant patent in the field of pharmaceuticals and nanotechnology. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

Publication and Status

The patent was published on April 23, 2002, and has since expired. The publication number is US6375986B1, and it was filed under the application number US09/666,539[4].

Inventors and Assignees

The patent was granted to inventors associated with Elan Pharma International Ltd., a company known for its innovations in drug delivery systems.

Technical Field

The patent pertains to the field of nanotechnology, specifically focusing on solid dose nanoparticulate compositions. These compositions are designed to enhance the redispersion of nanoparticulates upon administration, which is crucial for improving the bioavailability of active pharmaceutical ingredients[4].

Scope of the Patent

Background

The invention addresses a need in the art for solid dose nanoparticulate compositions that exhibit superior redispersion properties. This is important because poor redispersion can lead to reduced efficacy and variability in drug delivery.

Summary of the Invention

The patent describes solid dose nanoparticulate compositions that include a synergistic combination of a polymeric surface stabilizer and dioctyl sodium sulfosuccinate. This combination enhances the stability and redispersion characteristics of the nanoparticulates, ensuring consistent and effective drug delivery[4].

Claims of the Patent

Independent Claims

The patent includes several independent claims that define the scope of the invention. These claims typically describe the composition, the components involved, and their specific roles. For example, Claim 1 might describe the composition as comprising a nanoparticulate active agent, a polymeric surface stabilizer, and dioctyl sodium sulfosuccinate, where the combination enhances redispersion[4].

Dependent Claims

Dependent claims further specify the details of the composition, such as the types of polymeric surface stabilizers, the concentration of dioctyl sodium sulfosuccinate, and the particle size of the nanoparticulates. These claims narrow down the scope to specific embodiments of the invention.

Patent Landscape

Prior Art

The patent cites several prior art references that highlight the existing state of the art in nanoparticulate compositions. These references often discuss the challenges associated with nanoparticulate stability and redispersion, which the current invention aims to overcome[4].

Classification

The patent is classified under various categories, including Y10S977/00 for nanotechnology, Y10S977/70 for nanostructure, and Y10S977/773 for nanoparticles. These classifications indicate the patent's relevance to broader technological fields[4].

International Context

Similar patents and applications can be found in other jurisdictions, such as the European Patent Office (EPO) and the World Intellectual Property Organization (WIPO). These international patents often cover similar technological areas and can be accessed through databases like esp@cenet and PATENTSCOPE[1].

Litigation and Validity

Legal Challenges

The patent has been involved in legal disputes, particularly regarding its validity. For instance, in the case of ELAN PHARMA INTERNATIONAL LTD. v. LUUPIN LIMITED, the validity of the claims of the '986 patent was challenged under various provisions of patent law[5].

Office Actions and Examinations

The patent's file history, accessible through the USPTO's Global Dossier or Patent Examination Data System (PEDS), provides insights into the examination process and any office actions that were addressed during the patent's prosecution[1].

Impact and Significance

Technological Impact

The invention has contributed significantly to the field of pharmaceutical nanotechnology by providing a solution to the long-standing issue of poor redispersion in solid dose nanoparticulate compositions. This has potential implications for improving drug efficacy and patient outcomes.

Commercial Impact

The patent has likely influenced the development of various drug products that utilize nanoparticulate technology. Companies involved in pharmaceutical research and development have likely referenced this patent in their own research and product development.

Search and Analysis Tools

USPTO Resources

To conduct a thorough analysis of this patent, one can use the USPTO's Patent Public Search tool, which provides enhanced access to prior art and related patent documents. The Global Dossier service is also useful for viewing the file histories and patent families related to this invention[1].

International Databases

Databases such as esp@cenet from the EPO and PATENTSCOPE from WIPO offer comprehensive search capabilities for international patent applications and grants, which can help in understanding the broader patent landscape[1].

Key Takeaways

  • Patent Scope: The patent covers solid dose nanoparticulate compositions with enhanced redispersion properties.
  • Claims: Independent and dependent claims define the composition and its components.
  • Patent Landscape: The patent is part of a broader landscape in nanotechnology and pharmaceuticals.
  • Litigation: The patent has been involved in legal challenges regarding its validity.
  • Impact: The invention has significant technological and commercial implications.

FAQs

Q: What is the main innovation of the United States Patent 6,375,986?

A: The main innovation is the use of a synergistic combination of a polymeric surface stabilizer and dioctyl sodium sulfosuccinate to enhance the redispersion of nanoparticulates in solid dose compositions.

Q: How can I access the file history of this patent?

A: You can access the file history through the USPTO's Global Dossier service or the Patent Examination Data System (PEDS)[1].

Q: What are some of the legal challenges faced by this patent?

A: The patent has faced challenges regarding its validity, as seen in cases like ELAN PHARMA INTERNATIONAL LTD. v. LUUPIN LIMITED[5].

Q: How does this patent contribute to the field of nanotechnology?

A: It provides a solution to the issue of poor redispersion in solid dose nanoparticulate compositions, which is crucial for improving drug efficacy.

Q: Where can I find similar international patents?

A: Similar patents can be found through databases like esp@cenet from the EPO and PATENTSCOPE from WIPO[1].

Sources

  1. USPTO - Search for patents: https://www.uspto.gov/patents/search
  2. Casetext - Ex Parte Carty et al: https://casetext.com/admin-law/ex-parte-carty-et-al?sort=relevance
  3. USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
  4. Google Patents - US6375986B1: https://patents.google.com/patent/US6375986B1/en
  5. CaseMine - ELAN PHARMA INTERNATIONAL LTD. v. LUUPIN LIMITED: https://www.casemine.com/judgement/us/5914646aadd7b049342787a4/amp

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Drugs Protected by US Patent 6,375,986

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>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 6,375,986

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 040110 ⤷  Subscribe
Argentina 072134 ⤷  Subscribe
Argentina 072135 ⤷  Subscribe
Argentina 111501 ⤷  Subscribe
Austria 293959 ⤷  Subscribe
Austria 333265 ⤷  Subscribe
Austria 343376 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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