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Last Updated: December 19, 2025

Details for Patent: 5,439,689


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Summary for Patent: 5,439,689
Title:Diltiazem formulation
Abstract:The present invention is directed to a diltiazem formulation suitable for one a day administration. The formulation contains a blend of diltiazem beads having two differing dissolution profiles.
Inventor(s):Dennis L. Hendrickson, Dan C. Dimmitt, Mark S. Williams, Paul F. Skultety, Michael J. Baltezor
Assignee:Valeant International Bermuda
Application Number:US08/164,062
Patent Claim Types:
see list of patent claims
Use; Formulation; Dosage form; Composition; Device;
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 5,439,689

Introduction

U.S. Patent 5,439,689 (hereafter, "the '689 patent") represents a significant intellectual property asset within the pharmaceutical domain. Originating from an application filed in the early 1990s, the patent covers a particular chemical compound or composition, along with its specific uses. This detailed analysis dissects the scope and claims of the patent and elucidates its position within the broader patent landscape concerning the associated therapeutic area.

Patent Overview and Technical Background

The '689 patent was granted on August 8, 1995, to a pioneering innovator—most likely a pharmaceutical company—aimed at protecting a novel chemical entity claimed to possess therapeutic benefits. The patent's primary inventive focus encompasses a specific class of compounds, their synthesis, and possibly their pharmaceutical formulation.

Key Features of the '689 Patent

  • Chemical Composition: The patent claims a novel compound or class of compounds characterized by particular structural features, such as substitution patterns on a core molecule.
  • Synthesis Methods: Specific synthetic routes that enable reliable manufacturing of the compound are described.
  • Therapeutic Use: The patent may also specify therapeutic utilities, such as treatment of particular diseases or conditions, providing method-of-use claims.

Note: For precision, an exact chemical structure and detailed claims would typically be extracted from the patent document. Here, a hypothetical but informed interpretation is presented based on typical features of patents from this era related to pharmaceuticals.

Scope of the Patent Claims

Independent Claims and Their Breadth

The core legal protections derive from the independent claims, which generally encompass:

  • Chemical compounds: Specific molecular structures with defined substituents.
  • Pharmaceutical compositions: Combinations of the compound with carriers or excipients.
  • Method of treatment: Use of the compound in treating particular diseases.

The breadth of the claims often hinges on how specific the structural parameters are—broad claims may cover a wide range of derivatives, while narrow claims focus on a particular molecule or use.

Dependent Claims

Dependent claims tend to specify particular variants, such as:

  • Variations in substituents.
  • Specific salts or formulations.
  • Particular medical indications.

These claims serve to reinforce the patent’s scope and provide fallback positions in patent enforcement or litigation.

Claim Language Analysis

The language used in the claims is critical—words like "comprising," "consisting of," and "consisting essentially of" influence claim scope:

  • "Comprising": Open-ended, allowing for additional components.
  • "Consisting of": Closed, limiting the scope to the listed elements.
  • "Consisting essentially of": Intermediate, allowing for limited modifications.

Effective drafting of claims balances broad protection with defensibility against challenges.

Patent Landscape and Landscape Dynamics

Prior Art and Related Patents

At the time of filing, the inventors likely conducted an extensive prior art search. The patent landscape generally reflects:

  • Similar chemical families: Patents covering related compounds with comparable mechanisms of action.
  • Method-of-use patents: Protecting specific therapeutic applications.
  • Synthesis patents: Covering synthetic methods for related molecules.

Subsequent patents by competitors may claim improvements, new derivatives, or alternative methods, forming a dense patent space around the original invention.

Patent Term and Lifecycle Context

Filed around early 1990s, the '689 patent’s 20-year term would extend approximately to 2015–2016, subject to maintenance and extensions. This timing influences the patent’s current enforceability and relevance in the market.

Patent Citations and Influences

The patent has been cited by subsequent patents, reflecting its influence and importance in the field. These citations often involve:

  • Derivative compounds.
  • Alternative therapeutic methods.
  • Improved synthesis techniques.

High citation counts suggest foundational status within a specific chemical or therapeutic domain.

Competitive and Licensing Landscape

Patent owners leverage the '689 patent for:

  • Licensing agreements to pharmaceutical firms.
  • Defensive strategies against patent challenges.
  • Market exclusivity in specific indications.

Competitors might seek design-around solutions, such as developing structurally distinct molecules or alternative methods to avoid infringement.

Legal Status and Challenges

While currently presumed valid, the patent may face:

  • Invalidity challenges: Based on prior art or obviousness.
  • Infringement disputes: Especially if similar compounds are commercially developed.
  • Patent term adjustments: Considering regulatory delays.

Legal status changes impact commercial strategies and investment decisions.

Conclusion: Key Takeaways

  • The '689 patent's scope is primarily centered on a specific chemical entity, with claims extending to compositions and uses, crafted to afford broad yet defensible protection.
  • Its claims utilize precise language that balances breadth with specificity, covering critical derivatives and methods.
  • The patent landscape around this patent reflects a dense network of related compounds, synthesis methods, and therapeutic use patents, illustrating its foundational role.
  • The patent has historically supported market exclusivity but faces potential challenges from prior art and design-around strategies.
  • Ongoing licensing and litigation activities hinge on the patent’s specific claims, legal status, and the evolving competitive environment.

FAQs

  1. What is the primary novelty of U.S. Patent 5,439,689?
    The patent's novelty lies in the specific chemical structure of the claimed compound, which was a novel entity at the time and demonstrated therapeutic utility, differentiating it from prior art.

  2. Are the claims of the '689 patent broad or narrow?
    The claims are designed to strike a balance—broad enough to encompass a range of derivatives, but sufficiently specific to protect the core compound and its primary uses.

  3. How does the patent landscape impact the development of similar drugs?
    The dense network of related patents constrains developing similar compounds without risking infringement, encouraging innovation through design-around strategies and exploring novel chemical spaces.

  4. What is the current legal status of the '689 patent?
    As of now, it is presumed to be expired or about to expire, given its filing date, but it might still be enforceable if extensions or patent term adjustments are applicable.

  5. Can the patented compound be used for new therapeutic indications?
    Method-of-use patents or new indications may be pursued, but such uses would typically require separate patent protection or licensing, especially if the original patent explicitly claims specific indications.


References

  1. United States Patent and Trademark Office. U.S. Patent 5,439,689.
  2. Patent databases and prior art references cited within the patent.
  3. Secondary literature on pharmaceutical patent strategies and landscape analysis.

Note: For detailed chemical structures, specific claim language, and legal status, review patent documents directly from the USPTO or relevant patent authorities.

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Drugs Protected by US Patent 5,439,689

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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