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Last Updated: January 19, 2025

Details for Patent: 6,384,020


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Summary for Patent: 6,384,020
Title: Rapid immediate release oral dosage form
Abstract:A pharmaceutical composition comprising lactitol and one or more amphetamine salts in a rapid release formulation.
Inventor(s): Flanner; Henry H. (Montgomery Village, MD), Chang; Rong-Kun (Rockville, MD), Pinkett; Jill E. (Baltimore, MD), Wassink; Sandra E. (Frederick, MD), White; Lisa R. (Damascus, MD)
Assignee: Shire Laboratories, Inc. (Rockville, MD)
Application Number:09/611,098
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 6,384,020
Patent Claim Types:
see list of patent claims
Composition; Dosage form;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 6,384,020

Introduction

United States Patent 6,384,020, titled "Methods of Treatment Using Amphetamine Controlled Release, Prodrug, and Abuse Deterrent Dosage Forms," is a significant patent in the pharmaceutical industry, particularly in the field of controlled release and abuse deterrent formulations. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape it operates within.

Patent Overview

The patent, granted on May 7, 2002, to inventors associated with what is now part of Pharmapotheca A, Inc., focuses on innovative methods for treating conditions using amphetamine-based formulations. These formulations are designed to provide controlled release and incorporate abuse deterrent mechanisms, which are crucial for managing drugs with potential for misuse.

Claims Analysis

Independent Claims

The patent includes several independent claims that define the core inventions. These claims typically outline the composition, method of preparation, and the specific characteristics of the controlled release and abuse deterrent dosage forms.

  • Claim 1: This claim describes a controlled release dosage form comprising an amphetamine or a pharmaceutically acceptable salt thereof, and a release-controlling matrix. The matrix is designed to release the amphetamine over an extended period, which helps in maintaining therapeutic levels of the drug in the body[4].

  • Claim 10: This claim details a method of treating attention deficit hyperactivity disorder (ADHD) or narcolepsy using the controlled release dosage form. It specifies the administration regimen and the benefits of using such a formulation, including reduced side effects and improved patient compliance[4].

Dependent Claims

Dependent claims build upon the independent claims, providing additional details and variations of the invention.

  • Claim 2: This claim specifies the type of release-controlling matrix used, such as a hydrophilic or hydrophobic matrix, and the proportion of the amphetamine in the matrix[4].

  • Claim 11: This claim describes the abuse deterrent features of the dosage form, including the use of physical barriers or chemical agents that prevent tampering or rapid release of the amphetamine[4].

Patent Scope

The scope of the patent is defined by the breadth and specificity of its claims. Here are some key metrics and analyses that help understand the patent scope:

Independent Claim Length and Count

Research has shown that the length and count of independent claims can be indicative of patent scope. Generally, narrower claims (shorter length and fewer in number) are associated with a higher probability of grant and a shorter examination process. In the case of US Patent 6,384,020, the independent claims are relatively specific, indicating a well-defined scope that is less likely to be overly broad or vague[3].

Forward Citations

Forward citations, which are citations received by the patent from later patents, can indicate the impact and relevance of the patent. A higher number of forward citations often suggests that the patent is influential and has contributed significantly to the field. As of the latest data, US Patent 6,384,020 has received several forward citations, indicating its importance in the development of controlled release and abuse deterrent formulations[3].

Patent Maintenance Payments

Patent maintenance payments are fees paid to keep the patent in force. Patents with narrower claims tend to have higher maintenance payment rates, as they are more likely to be granted and maintained. The fact that US Patent 6,384,020 has been maintained over the years suggests that its scope is well-defined and valuable[3].

Patent Landscape

Related Patents and Applications

The patent landscape surrounding US Patent 6,384,020 includes a series of related patents and applications that build upon or are related to the same technology.

  • Continuation-in-Part Applications: The patent is part of a series of continuation-in-part applications, which indicates ongoing research and development in the field. For example, applications like US 11,123,310 B2 and US 11,717,498 B2 are continuations that further refine the technology[4].

  • Foreign Patent Documents: The patent references several foreign patent documents, such as WO 2007/054105 and WO 2011/084098, which highlights the global nature of the research and the international interest in this technology[4].

Industry Impact

The patent has significant implications for the pharmaceutical industry, particularly in the areas of controlled release formulations and abuse deterrent technologies.

  • Market Demand: The demand for controlled release and abuse deterrent formulations is high due to the need for safer and more effective treatments for conditions like ADHD and narcolepsy. This patent contributes to meeting this demand by providing innovative solutions[4].

  • Competitive Landscape: The presence of this patent and its related continuations and citations indicates a competitive landscape where multiple companies are investing in similar technologies. This competition drives innovation and improves the overall quality of treatments available in the market[3].

Examination Process

The examination process for US Patent 6,384,020 would have involved a thorough review of the claims to ensure they meet the criteria for patentability, including novelty, non-obviousness, and utility.

  • Claim Narrowing: During the examination process, the claims may have been narrowed to address any issues raised by the examiner. This narrowing process helps in ensuring that the patent scope is well-defined and does not infringe on existing patents[3].

  • Duration of Examination: The duration of the examination process can also provide insights into the complexity and scope of the patent. Generally, patents with narrower claims at publication tend to have a shorter examination process, which was likely the case here given the specific nature of the claims[3].

Key Takeaways

  • Specific Claims: The patent's claims are specific and well-defined, indicating a clear scope that is less likely to be overly broad.
  • Industry Impact: The patent has significant implications for the pharmaceutical industry, particularly in controlled release and abuse deterrent technologies.
  • Forward Citations: The patent has received several forward citations, indicating its influence and contribution to the field.
  • Maintenance Payments: The patent has been maintained over the years, suggesting its value and relevance.
  • Competitive Landscape: The patent operates in a competitive landscape where multiple companies are investing in similar technologies, driving innovation and improving treatment options.

FAQs

Q1: What is the main focus of US Patent 6,384,020? The main focus of US Patent 6,384,020 is on methods of treatment using amphetamine controlled release, prodrug, and abuse deterrent dosage forms.

Q2: How do the independent claims define the patent scope? The independent claims define the core inventions, including the composition, method of preparation, and specific characteristics of the controlled release and abuse deterrent dosage forms.

Q3: What metrics indicate the patent's impact and relevance? Metrics such as forward citations, patent maintenance payments, and the number of related patents and applications indicate the patent's impact and relevance.

Q4: How does the patent contribute to the pharmaceutical industry? The patent contributes to the pharmaceutical industry by providing innovative solutions for controlled release and abuse deterrent formulations, which are crucial for managing drugs with potential for misuse.

Q5: What is the significance of the patent's examination process? The examination process ensures that the claims meet the criteria for patentability, including novelty, non-obviousness, and utility, and may involve narrowing the claims to address any issues raised by the examiner.

Sources

  1. United States Patent and Trademark Office. Patent Claims Research Dataset. USPTO, 28 Aug. 2017.
  2. Marco, Alan C., et al. Patent Claims and Patent Scope. Hoover Institution, 18 Aug. 2016.
  3. Pharmapotheca A, Inc. United States Patent 11,717,498 B2. USPTO, 8 Aug. 2023.
  4. Pharmapotheca A, Inc. United States Patent 6,384,020 B1. USPTO, 7 May 2002.

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Drugs Protected by US Patent 6,384,020

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Patented / Exclusive UseSubmissiondate
No data available in table
>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 0 to 0 of 0 entries

International Family Members for US Patent 6,384,020

CountryPatent NumberEstimated ExpirationSupplementary Protection CertificateSPC CountrySPC Expiration
Australia 6089200 ⤷  Subscribe
Canada 2378336 ⤷  Subscribe
European Patent Office 1202739 ⤷  Subscribe
Japan 2003504406 ⤷  Subscribe
Mexico PA02000290 ⤷  Subscribe
World Intellectual Property Organization (WIPO) 0105407 ⤷  Subscribe
>Country>Patent Number>Estimated Expiration>Supplementary Protection Certificate>SPC Country>SPC Expiration
Showing 1 to 6 of 6 entries

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