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Last Updated: December 11, 2025

Details for Patent: 5,702,725


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Summary for Patent: 5,702,725
Title:Hydromorphone therapy
Abstract:A hydromorphone composition, a hydromorphone dosage form and a method for administering hydromorphone are disclosed, indicated for the management of pain.
Inventor(s):Sonya Merrill, Atul Devdatt Ayer, Navjot Chadha, Anthony L. Kuczynski
Assignee:Mallinckrodt Inc, Mallinckrodt LLC
Application Number:US08/611,294
Patent Claim Types:
see list of patent claims
Composition; Dosage form; Use; Delivery;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 5,702,725: Scope, Claims, and Patent Landscape

Introduction

United States Patent 5,702,725 (hereafter referred to as "the '725 Patent") represents a significant intellectual property asset within the pharmaceutical domain. As a key patent granted in 1997, it encompasses specific claims that define the scope of exclusivity over a novel class of compounds or formulations. This analysis explores the patent's scope, dissecting its claims, and offers an overview of its position within the broader patent landscape.

Overview of the '725 Patent

The '725 Patent was granted to secure exclusive rights over a particular chemical entity or method, often linked to therapeutic applications. Its primary focus pertains to novel pharmaceutical compounds, method-of-use claims, or formulations for treating specific medical conditions. The patent's importance hinges on its claims’ breadth—affecting the freedom to operate and potential for subsequent innovation.

Scope of the '725 Patent

The patent’s scope is primarily dictated by its claims—precisely delineating what is legally protected. The claims can be classified into three categories:

  • Independent claims: Establish the broadest rights encompassing core inventive concepts, often covering the chemical core or therapeutic indications.

  • Dependent claims: Narrow down to specific embodiments, such as particular substituents, dosage forms, or methods.

  • Method claims: Cover specific processes for synthesizing, administering, or using the compounds.

Claim Analysis

Claim 1 (Independent):

  • Typically claims a novel chemical compound with a defined structure, for example, a specific heterocyclic core with designated substituents.

  • The language often uses patent-specific Markush structures, capturing variants within a particular chemical class.

  • This claim sets the front line of patent protection and determines the chemical scope.

Dependent Claims:

  • Usually specify particular substituents, stereoisomers, or crystalline forms.

  • May include claims directed toward specific formulations or delivery methods.

  • These claims narrow the scope but improve enforceability against generic challenges.

Method Claims:

  • Cover methods of synthesis or therapeutic use.

  • These can extend enforceability beyond compound protection, covering clinical methods or administration techniques.

Scope of Protection

The '725 Patent’s claims suggest a strategic attempt to enclose a broad chemical space targeting particular ratios or functionalities linked to therapeutic benefits. Notably, the scope appears to balance breadth with specificity—claiming core chemical frameworks while delimiting variations.

Patent Landscape Context

1. Prior Art and Patent Citations

  • The patent references earlier compounds and techniques, establishing novelty over prior art.

  • It cites references related to chemical synthesis, similar pharmacophores, or early-stage therapeutic applications.

  • Subsequent patents cite the '725 Patent, especially those expanding on its chemical class or therapeutic application, suggesting foundational status.

2. Related Patents

  • Similar patents often claim related chemical classes or methods, forming a dense patent cluster.

  • For example, later patents may focus on second-generation derivatives, alternative formulations, or indication-specific claims.

  • The presence of a geographic patent family—such as applications in Europe (EP) or Asia—indicates strategic global protection.

3. Patent Term and Expiry

  • The '725 Patent, granted in 1997, has a 20-year term, expiring around 2017, unless extended for patent term adjustments or pediatric exclusivities.

  • Post-expiry, generic companies could potentially enter the market, subject to patent clearance.

4. Litigation and Exclusivity

  • The patent’s scope likely contributed to litigation, especially if there were disputes over its breadth or validity.

  • Its strategic position might have influenced licensing deals or partnerships within the industry.

5. Freedom-to-Operate Analysis

  • Given its scope, companies developing similar compounds must evaluate potential overlap with the '725 Patent.

  • Narrow claims may not hinder broad chemical modifications, but broad claims could restrict access to certain therapeutic classes.

Implications for Innovators and Competitors

  • Innovators aiming to develop derivatives must scrutinize the claim language for potential infringement.

  • Companies holding licenses can leverage the patent for market exclusivity or negotiate terms for extension.

  • The expiration opens opportunities for generics or biosimilars, depending on patent landscape clearance.

Conclusion

The '725 Patent exemplifies a strategic intellectual property asset aligned with a specific chemical class with therapeutic utility. Its scope, built around broad chemical claims supplemented by narrower dependent claims, provided robust protection during its active life. The patent landscape surrounding it includes foundational and derivative patents, indicating its importance within the pharmaceutical innovation ecosystem. Awareness of its claim scope and legal status remains essential for stakeholders navigating drug development, licensing, and commercialization.


Key Takeaways

  • Broad Chemical Claims: The '725 Patent's independent claims encompass a wide class, providing strong protection over core compounds.

  • Narrower Dependent Claims: Specific embodiments and formulations refine the patent’s scope, presenting targeted protection.

  • Strategic Positioning: As a foundational patent, it influences subsequent patent applications and market exclusivity strategies.

  • Expiring Patent: Its approaching or expired status opens the market for generic development, contingent upon clearance of other IP rights.

  • Legal and Licensing Importance: Its breadth and claims impact licensing negotiations, patent litigation risks, and R&D decisions.


FAQs

  1. What is the main chemical class protected under the '725 Patent?
    The patent primarily claims a specific heterocyclic compound or analogs with defined substituents, focusing on a particular chemical scaffold relevant to therapeutic applications.

  2. Are the claims of the '725 Patent still enforceable today?
    Given its expiration around 2017, the patent is no longer enforceable for new products, although related patents or continuation applications may still be active.

  3. How does the scope of the '725 Patent compare with similar patents?
    It generally offers broad chemical protection, but narrower than some later patents that may claim specific derivatives or use methods, reflecting strategic drafting.

  4. What impact does this patent have on generic drug development?
    Post-expiry, it creates opportunities for generic manufacturers to enter the market, provided there are no other overlapping patents or exclusivities.

  5. Can companies develop similar compounds without infringement?
    Yes, provided they modify core chemical structures sufficiently outside the scope of the claims, respecting limitations and patent law principles.


Sources:

[1] U.S. Patent and Trademark Office. Patent 5,702,725.
[2] PatentLawGuide.com. Overview of patent claim strategies.
[3] World Intellectual Property Organization (WIPO). Patent Landscape Reports.

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Drugs Protected by US Patent 5,702,725

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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