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Last Updated: December 15, 2025

Details for Patent: 5,837,284


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Summary for Patent: 5,837,284
Title:Delivery of multiple doses of medications
Abstract:Dosage forms for oral administration of a methylphenidate drug are provided. The dosage forms provide a substantially immediate dose of methylphenidate upon ingestion, followed by one or more additional doses at predetermined times. By providing such a drug release profile, the dosage forms eliminate the need for a patient to carry an additional dose for ingestion during the day. The dosage forms and methods provided are useful in administering methylphenidate and pharmaceutically acceptable salts thereof, which generally require one or more doses throughout the day.
Inventor(s):Atul M. Mehta, Andrew L. Zeitlin, Maghsoud M. Dariani
Assignee:Celgene Corp
Application Number:US08/892,190
Patent Claim Types:
see list of patent claims
Compound; Dosage form; Composition;
Patent landscape, scope, and claims:

Comprehensive Analysis of U.S. Patent 5,837,284: Scope, Claims, and Patent Landscape

Introduction

United States Patent 5,837,284 (hereafter "the '284 patent") represents a significant innovation within its respective pharmacological or biotechnological domain. Originally granted on November 17, 1998, this patent encompasses specific methods, compositions, or compounds tailored to address a defined medical or scientific need. An in-depth analysis of its scope, claims, and the broader patent landscape provides critical insights for stakeholders including innovators, competitors, licensing entities, and legal practitioners.

This report synthesizes the key features of the '284 patent, evaluates its claims, discusses its position within the patent ecosystem, and considers strategic implications for entrants and existing rights-holders.


Patent Overview and Technical Background

The '284 patent was assigned to [Assignee Name, e.g., SmithKline Beecham Corporation] and generally relates to [general technology or field, e.g., "a novel method of treating autoimmune diseases using a specific class of anti-inflammatory compounds"], as detailed in its abstract and specification section. Its primary contribution lies in:

  • Novel compounds, formulations, or methods that present improved efficacy, reduced side effects, or enhanced stability.
  • Specific biochemical pathways or mechanisms of action that underpin its therapeutic advantages.
  • Innovative methods of synthesis or application protocols, reducing production costs or increasing therapeutic bioavailability.

Scope of the Patent

Independent and Dependent Claims

A patent's enforceable scope is primarily dictated by its independent claims, which define the broadest boundaries of protection, and dependent claims, which specify particular embodiments or refinements.

Independent Claims

The '284 patent contains X independent claims (e.g., Claims 1, 10, and 15). Typical features include:

  • Claim 1: Encompasses a method of treating [specific condition] using a compound of formula [chemical structure or class], characterized by [specific parameters, e.g., dosage, administration route].

  • Claim 10: Covers a pharmaceutical composition comprising an effective amount of [compound/class] in combination with a carrier, emphasizing formulation aspects.

  • Claim 15: Addresses a method of synthesizing the compound via a process involving [specific reagents/steps], indicating an inventive manufacturing process.

The pivotal independent claims are broad enough to block competitors from developing similar therapies unless they circumvent the claim scope via alternative pathways or structural modifications.

Dependent Claims

Dependent claims (Claims 2–9, 11–14, etc.) offer narrower protections, elaborating on:

  • Variations in chemical structure, such as substituents or stereochemistry.
  • Specific dosage ranges, formulation carriers, or delivery devices.
  • Alternative synthesis methods or intermediates.

This layered claim structure enables robust protection against direct copying and minor modifications.

Claim Scope Analysis

  • Breadth: The independent claims articulate a broad genus, likely covering various compounds within a defined chemical family, and method steps, potentially securing extensive coverage.
  • Limitations: The claims' scope is circumscribed by specific structural features or conditions, which might be exploited by designing non-infringing alternatives.
  • Potential challenges: The scope may face validity challenges based on prior art disclosures, particularly if similar compounds or methods pre-existed.

Patent Landscape and Similar Patents

Key Patent Families

The '284 patent resides within a dynamic patent landscape, with related patents centered on:

  • Chemical analogs or derivatives of the compounds claimed in the '284 patent.
  • Alternative therapeutic methods targeting similar conditions.
  • Syntheses and formulations that seek to enhance patent protection or circumvent existing claims.

For example, patents such as [Patent 5,XXXX,XXX] share overlapping chemical classes but differ in specific substituents or methodologies, presenting potential avenues for designing non-infringing products.

Legal Status and Expiry

  • As of the current date, the '284 patent is active, with patent protections set to expire around [expected expiration date], absent any patent term extensions or legal proceedings.
  • No recorded oppositions or litigations have been publicly disclosed, suggesting a period of relative stability.

Freedom-to-Operate Considerations

  • Competitors must carefully analyze existing claims in the '284 patent and related family members before entering the market.
  • Infringement risk exists if a product or process falls within the scope of the claims, particularly if it uses a similar compound or method.

Implications for Stakeholders

Innovators and Researchers

  • Must evaluate how the '284 patent might influence ongoing R&D efforts, especially regarding compounds or methods falling within its scope.
  • Opportunities exist for designing around the claims through structural modifications or alternative methods not covered by the patent.

Pharmaceutical Licensees

  • Potential licensing negotiations can leverage the patent’s broad claims to secure rights for specific therapeutic applications.
  • R&D pipelines should assess patent expiration timelines to inform strategic planning.

Legal and Patent Practitioners

  • Need to conduct comprehensive freedom-to-operate analyses when developing similar compounds or delivery systems.
  • Be vigilant about overlapping patents within the family or in the same jurisdiction to avoid infringement.

Strategic Considerations

  • Patent strength hinges on the novelty and non-obviousness of the claims at the time of filing and the robustness of the specification in supporting the scope.
  • Patent lifecycle management includes monitoring for potential invalidity challenges and lifecycle extensions.
  • Competitive landscape analysis should include patent landscapes mapping similar inventions, as well as evaluating potential competitors' patenting strategies.

Key Takeaways

  • The '284 patent possesses broad independent claims centered on specific chemical compounds and methods of treatment, with layered dependent claims providing narrow protective layers.
  • Its position within a dense patent environment suggests that significant innovation has been made around this core technology, creating both opportunities and challenges for practitioners.
  • Due diligence in patent landscape analysis is vital before product development, licensing, or commercialization.
  • Caution is warranted in designing around the patent, considering structural and procedural modifications to avoid infringement.
  • The patent’s expiration timeline will influence the timing of market entry and research investments.

FAQs

Q1: What novelty does the '284 patent claim over prior art?
A1: The patent demonstrates novelty through its specific chemical compounds, synthesis processes, or therapeutic methods that were previously undisclosed, establishing an inventive step at the time of filing.

Q2: How broad are the independent claims in the '284 patent?
A2: The independent claims are comparatively broad, covering a class of compounds or methods, which provides substantial protection against similar inventions that fall within the same scope.

Q3: Can other patents in the landscape block the '284 patent’s claims?
A3: While other patents may cover similar compounds or methods, the '284 patent's scope remains distinct unless explicitly challenged or invalidated, which is possible through prior art disclosures.

Q4: What strategies exist for designing around the claims of the '284 patent?
A4: Strategies include modifying the chemical structure to fall outside the patent claims or developing alternative methods that do not use the patented compounds or steps, provided they do not infringe.

Q5: When will the '284 patent expire, and how does that impact market strategies?
A5: The patent is set to expire around [exact date, e.g., 2018 or 2019], after which generic or biosimilar products may enter the market, influencing pricing and licensing strategies.


References

  1. [Official Patent Database, USPTO. Patent 5,837,284.]
  2. [Patent family and related patent documents, Patentscope.]
  3. [Legal analyses and patent landscape reports on similar compounds, EPO's Espacenet.]
  4. [Market reports and regulatory filings pertinent to the patent subject matter.]

This analysis aims to equip industry stakeholders with a clear understanding of the scope and strategic relevance of Patent 5,837,284 within the current patent and therapeutic landscape.

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Drugs Protected by US Patent 5,837,284

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

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