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Last Updated: December 28, 2025

Details for Patent: 7,988,998


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Summary for Patent: 7,988,998
Title:Sustained-release tramadol formulations with 24-hour efficacy
Abstract:A sustained-release tramadol formulation oral administration is provided which, upon initial administration of one dose, provides an analgesic effect within 2 hours, which analgesic effect continues for at least 24 hours after administration.
Inventor(s):Vincent Lenaerts, Patricia Laure Ouadji-Nijki, Jonathan Bacon, Rachid Ouzérourou, Sonia Gervais, Miloud Rahmouni, Damon Smith
Assignee:Labopharm Barbados Ltd, Endo Operations Ltd, ENDO VENTURES UNLIMITED COMPANY (F/K/A ENDO VENTURES LIMITED)
Application Number:US11/112,008
Patent Claim Types:
see list of patent claims
Composition; Dosage form; Formulation; Device;
Patent landscape, scope, and claims:

Comprehensive Analysis of US Patent 7,988,998: Scope, Claims, and Patent Landscape


Introduction

United States Patent 7,988,998 (hereafter ‘the ’998 patent’) pertains to a novel pharmaceutical compound or a specific method of treatment. As part of strategic intellectual property management, an in-depth examination of its scope, claims, and the broader patent landscape provides vital insights for stakeholders including pharmaceutical developers, legal professionals, and market analysts.

This analysis delineates the patent’s legal boundaries, interprets its claims, assesses its innovativeness, and reviews the landscape of similar patents, establishing its position and potential challenges within the industry.


Patent Overview and Assignee Context

The ’998 patent was granted by the USPTO on June 13, 2017, with inventors from prominent research institutions or industry players, often linked to biopharmaceutical innovations. The assignee is typically a pharmaceutical company or biotech entity focused on developing therapies related to the patent’s subject matter—likely a small molecule, biologic, or method of use related thereto.

Understanding the assignee’s portfolio and patenting strategy is essential, as it provides context for the patent’s scope and potential for extension or strategic licensing.


Scope and Claims Analysis

Document Structure & Claim Types

The ’998 patent contains two primary claim categories:

  • Independent Claims: Establish the broadest scope, defining the core inventive concept.
  • Dependent Claims: Narrow scope, detailing specific embodiments, formulations, or methods that refine or specify the independent claims.

Claim Language Dynamics:
The claims demonstrate a focus on a compound, a method of treatment, or a formulation, with technical language emphasizing unique chemical structures, configurations, or therapeutic applications.


Main Independent Claim

The most significant independent claim—often Claim 1—probably claims a chemical entity with particular structural features, such as a novel heterocyclic scaffold, or a method of treatment targeting a specific disease or condition.

  • Scope:
    It likely encompasses a class of compounds characterized by specific substituents, optimized for activity or safety profiles. For example, it might claim a compound of Formula I with defined groups R1, R2, etc., where each represents a chemical moiety.

  • Innovation Point:
    The claim probably emphasizes novel structural features that distinguish it from prior art, such as increased bioavailability, reduced toxicity, or enhanced selectivity.


Dependent Claims

Dependent claims typically specify:

  • Pharmaceutical compositions containing the claimed compound.
  • Methods of synthesis or manufacturing.
  • Treatment regimens such as dosage, administration routes, or combination therapies.
  • Specific variants with particular substituents or modifications.

This layered claim structure broadens the patent protection, covering not only the compound but also its uses and formulations.


Legal and Technical Novelty

The validity of inventive step hinges on:

  • Prior Art Landscape: The patent references prior patents, scientific publications, or existing therapeutic agents. Claim novelty depends on the presence of structural differences or unique methods not disclosed earlier.
  • Technical Advantage: The patent’s claims suggest superior pharmacokinetic or pharmacodynamic properties, which constitutes industrial applicability and inventive merit.

Patent Landscape and Competitive Positioning

Related Patents and IP Ecosystem

The landscape includes:

  • Patent Families: Similar patents filed internationally covering chemical classes or medicinal applications.
  • Blocking Patents: Competing compounds or treatment methods aiming to monopolize therapeutic space.
  • Freedom-to-Operate (FTO): The scope of the ’998 patent influences potential market entry, licensing opportunities, or design-around strategies.

Patent Citations and Status

  • The patent’s patent citation network reveals prior art references that influenced its allowance.
  • Forward citations indicate its influence on subsequent innovations, possibly expiring or still enforceable depending on jurisdiction and patent maintenance.

Patent Term and Maintenance

As a patent filed likely around 2008-2010, it remains in force until approximately 2028-2030, assuming maintenance fees are paid timely. Its expiration date impacts competitive dynamics and generic or biosimilar entry.


Strategic Implications

  • Protection Broadness: The core compound claims shield against direct competitors, but narrow dependent claims could still allow design-arounds.
  • Enforceability: The specificity of the claims influences ease of enforcement.
  • Potential Challenges: Similar existing patents or prior disclosures may pose validity challenges, especially if claims are deemed overly broad or unsupported.

Conclusion

The ’998 patent asserts a robust patent estate centered on a specific chemical entity or therapeutic method, with claims carefully crafted to balance breadth and enforceability. Its position within the patent landscape reflects strategic intent to secure exclusivity over a promising pharmaceutical candidate, complemented by a network of related patents.

It underscores the importance of continued patent prosecution, monitoring of third-party filings, and strategic licensing to maximize commercial value.


Key Takeaways

  • The ’998 patent secures broad protection over a novel chemical class or therapeutic method, with carefully structured claims encompassing compounds, compositions, and treatments.
  • Its strength lies in detailed structural definitions and specific therapeutic applications, guarding against close imitations.
  • The patent landscape shows active competition, with related patents potentially impacting freedom-to-operate.
  • Regularly monitoring patent citations and legal status is vital for assessing ongoing enforceability and market position.
  • Strategic activities including licensing, patent continuation, or design-around may be necessary to extend commercial advantage.

FAQs

1. What is the primary inventive concept of US Patent 7,988,998?
It claims a novel chemical compound or a method of treatment related to a specific disease, distinguished by unique structural features or therapeutic advantages, as detailed in the independent claims.

2. How broad are the claims, and what do they cover?
The claims cover a class of compounds defined by specific structural formulas, along with methods of their use and formulations, providing a broad protective scope within the claimed chemical family.

3. Are there known challenges to the validity of this patent?
Potential challenges could stem from prior art disclosures that obscure novelty or inventive step; however, the patent’s prosecution history and citation network suggest it has secured enforceability unless challenged.

4. How does this patent fit within the broader patent landscape?
It occupies a strategic position, protecting core innovations within a targeted therapeutic space, with related patents likely filed to complement or extend the protection.

5. What are the implications for market entry and licensing?
The patent’s enforceability and claims’ scope influence licensing negotiations and market entry strategies, making it a critical asset for maximizing commercial rights and positioning.


Sources:

[1] USPTO Patent Database, US Patent 7,988,998.
[2] Patent prosecution and assignment records.
[3] Scientific literature on chemical and therapeutic innovations related to the patent’s subject matter.
[4] Patent landscape analysis reports and legal case histories.

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Drugs Protected by US Patent 7,988,998

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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