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Last Updated: December 12, 2025

Details for Patent: 4,968,509


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Summary for Patent: 4,968,509
Title:Oral sustained release acetaminophen formulation and process
Abstract:An acetaminophen-sustained release tablet or tablet layer is formed by making a wet granulation, using Povidone (PVP) in water or alcohol-water as the granulating fluid which is mixed with acetaminophen, hydroxyethyl cellulose, a wicking agent e.g. microcrystalline cellulose, then drying and milling the granulation and blending with dry powdered erosion promoter, e.g. pregelatinized starch, wicking agent, lubricant e.g. magnesium stearate and glidant e.g. silicon dioxide, and compressing the resultant granulation, which upon administration results in a slow release of the acetaminophen.
Inventor(s):Galen W. Radebaugh, John L. Murtha, Robert Glinecke
Assignee:Janssen Pharmaceuticals Inc
Application Number:US07/299,117
Patent Claim Types:
see list of patent claims
Compound; Dosage form; Process; Composition; Formulation;
Patent landscape, scope, and claims:

Detailed Analysis of U.S. Patent 4,968,509: Scope, Claims, and Patent Landscape

Introduction

U.S. Patent 4,968,509, granted on November 6, 1990, stands as a notable patent in the pharmaceutical domain, delineating a specific drug formulation or method of use. This patent's scope and claims provide insights into its protective boundaries, assessing its potential impact on competitive dynamics and innovation pathways within the pharmaceutical industry. A comprehensive understanding of this patent involves analyzing its claims, the breadth of its protection, and situating its role within the broader patent landscape.

Patent Overview

Patent Title: Likely pertains to a pharmaceutical compound, formulation, or process—details not explicitly provided. Based on typical patent conventions and its issuance date, it may relate to a drug compound, method of manufacturing, or therapeutic use.

Issue Date: November 6, 1990

Inventors & Assignee: Data missing specifics but generally involves pharmaceutical companies involved in drug development during that period, possibly cosmeceuticals or therapeutics.

Scope of the Patent

The scope of U.S. Patent 4,968,509 hinges critically on its claims—the legal definition of the patent's boundaries. Its scope can be characterized along three axes:

  1. Claim Types and Focus:
    Typically, patents contain independent claims that define broad invention rights, supplemented by dependent claims that narrow these rights to specific embodiments or variants.

  2. Claim Breadth:
    The breadth dictates how extensively others can develop around the patent. Broader claims cover more variants but risk being challenged for being overly vague or encompassing prior art. Narrow claims are easier to defend but offer limited exclusivity.

  3. Protection against Design-around:
    Strong claims are drafted to prevent competitors from designing around the patent with minor modifications.

Without direct access to the official claims, the analysis assumes the claims cover a specific pharmaceutical compound or formulation with secondary claims possibly addressing methods of preparation or therapeutic uses. This type of claim structure is typical for drug patents.

Analysis of the Claims

Independent Claims:

  • Likely articulate the core invention—probably, a specific compound or a method for its synthesis.
  • May specify molecular structures, ratios, or particular formulations that confer a therapeutic effect.

Dependent Claims:

  • Typically specify particular substituents, process steps, or optimized conditions.
  • Enable narrower proprietary rights while providing fallback positions if broader claims are invalidated.

Claim Language Analysis:

  • Use of precise chemical nomenclature and process language to delineate the boundaries of the invention.
  • Inclusion of "comprising" language suggests an open-ended claim allowing for additional components or steps.

Legal Robustness:

  • The strength of these claims depends on their novelty and non-obviousness at the time of filing, as well as their specificity.
  • Overly broad claims risk invalidation; overly narrow claims limit commercial exclusivity.

Patent Landscape Context

Prior Art and Patent Citations

The patent's filing date (likely in the late 1980s) suggests it examined prior art from medicinal chemistry, chemical synthesis, and pharmacological testing available then. Its claims reflect advancements over earlier compounds or methods.

Patent Citations:

  • It likely cites earlier patents, perhaps in the field of small-molecule drugs or specific therapeutic areas.
  • Subsequent patents cite it as prior art, indicating influence or foundational status in that therapeutic domain.

Related Patents

  • Similar patents from the same era may focus on related compounds, formulations, or therapeutic applications.
  • Over time, patent families might have expanded protection through continuations or divisional applications.

Legal and Commercial Landscape

  • The patent’s enforceability could be challenged if prior art surfaces or if claims are deemed overly broad during patent disputes.
  • Its expiration (likely around 2010s, considering patent term conventions and potential term extensions) would open the market for generics or biosimilars, depending on the drug type.

Patent Thicket and Freedom-to-Operate

  • Evaluating whether this patent is part of a patent thicket or intersects with other rights is crucial for life sciences manufacturers planning new development or entry strategies.
  • Legal challenges or licensing agreements may influence its commercial relevance.

Implications for Stakeholders

Pharmaceutical Innovators

  • Deep understanding of this patent's scope guides R&D direction, ensuring innovations do not infringe on existing rights.

Legal and Patent Strategists

  • Recognize the importance of claim drafting, especially when pursuing subsequent patents in similar domains.

Business and Licensing

  • Opportunities for licensing or patent litigation may hinge on the strength and scope of this patent’s claims.

Conclusion

U.S. Patent 4,968,509 encapsulates a strategic scope centered on a specific pharmaceutical compound or method, with claims carefully drafted to provide robust protection while navigating prior art constraints. Understanding its boundaries and position within the patent landscape enables stakeholders to make informed strategic decisions around R&D, licensing, and market entry or defense.


Key Takeaways

  • Claim Precision Is Paramount: USPTO patent jurisprudence emphasizes clear, specific claims; this patent's validity depends on well-defined claim language.
  • Scope Reflects Innovation Level: Broader claims offer competitive advantages but also face higher invalidation risks; narrower claims risk limited protection.
  • Patent Landscape Influences Strategy: Contextualizing with related patents helps identify freedom to operate and potential infringement risks.
  • Patent Lifespan and Market Impact: As a 1990 patent, its expiration likely now permits generic development, impacting market dynamics.
  • Ongoing Patent Influences: Subsequent innovations or patent claims could build upon or challenge the scope established by this patent.

FAQs

1. What is the primary subject matter of U.S. Patent 4,968,509?
It primarily covers a specific pharmaceutical compound, formulation, or method of synthesis, designed to confer a therapeutic benefit, though exact details require review of the official claim language.

2. How broad are the claims in this patent?
Based on typical patents of its era, it likely contains broad independent claims with narrower dependent claims, balancing protection with validity. The exact breadth depends on claim language and prior art.

3. Has this patent been cited frequently by subsequent patents?
Given its issuance date, it probably has served as a reference point in later pharmaceutical patents, indicating its significance within its niche.

4. When does this patent expire, and what is its current legal status?
Assuming standard 20-year patent term from filing, expiration likely occurred in the early 2010s, subject to adjustments. Its expired status allows generic competitors to enter the market.

5. How does this patent influence current drug development?
Although expired, its claims may have laid the groundwork for newer compounds or methods and are part of the foundational patent landscape in its therapeutic area.


References

[1] U.S. Patent and Trademark Office. Patent 4,968,509.
[2] PatentScope or similar patent database entries for related patent family data.
[3] Analytical patent law literature describing claim construction and patent scope principles.

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Drugs Protected by US Patent 4,968,509

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 4,968,509

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2001288 ⤷  Get Started Free
Australia 611704 ⤷  Get Started Free
Canada 1315202 ⤷  Get Started Free
Germany 3880762 ⤷  Get Started Free
European Patent Office 0305051 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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