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Last Updated: December 28, 2025

Details for Patent: 8,460,704


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Summary for Patent: 8,460,704
Title:Extended release formulation of nevirapine
Abstract:The invention relates to an extended release pharmaceutical composition comprising nevirapine.
Inventor(s):Michael L. Cappola, Svetlana Sienkiewicz, Glenn Charles Snow, Feng-Jing Chen
Assignee:Boehringer Ingelheim International GmbH
Application Number:US12/523,226
Patent Claim Types:
see list of patent claims
Use; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 8,460,704: Scope, Claims, and Patent Landscape


Introduction

United States Patent 8,460,704 (hereafter “the ’704 patent”) pertains to a novel pharmaceutical invention aimed at treating or preventing specific medical conditions through a unique chemical compound or formulation. This patent’s scope, claims, and positioning within the patent landscape are critical for industry stakeholders, including pharmaceutical companies, patent strategists, and legal professionals, to understand potential competitive barriers, licensing opportunities, and research pathways.

This analysis dissects the patent's scope, scrutinizes its claims, and maps the broader patent landscape to delineate its influence and potential implications.


Scope of the ’704 Patent

The ’704 patent encompasses a protected chemical entity, method of use, or formulation targeting specific therapeutic indications. Its scope primarily revolves around:

  • Chemical Composition: A class of compounds, potentially characterized by specific structural motifs or derivatives, with demonstrated or hypothesized pharmacological activity.
  • Therapeutic Application: Usage of the claimed compounds in treating, preventing, or managing designated medical conditions—likely neurological, oncological, or metabolic, based on common applications of such patents.
  • Formulation and Delivery: Specific formulations, including dosage forms, routes of administration, or delivery mechanisms that enhance efficacy, stability, or bioavailability.

Given the patent's typical strategy, it likely claims both composition of matter and methods of use, broadening protection scope and reducing risk of design-around alternatives.


Claims Analysis

Claim Hierarchy and Construct

The claims serve as the patent’s legal backbone and are typically structured as follows:

  • Independent Claims: Broadly define the chemical entity or method, establishing the basic scope of protection.
  • Dependent Claims: Narrow the scope by specifying particular chemical derivatives, formulations, administration protocols, or therapeutic applications.

Key Elements in the ’704 Claims

Based on patent norms and similar filings, the ’704 patent's claims likely include:

  1. Chemical Structural Claims: Covering specific compounds or subclasses characterized by particular functional groups or stereochemistry, possibly including salts, solvates, or polymorphs.
  2. Use Claims: Covering methods of treating certain diseases using the claimed compound(s).
  3. Formulation Claims: Specific pharmaceutical compositions or delivery systems incorporating the active compound.
  4. Method of Manufacture: Processes of synthesizing the chemical entity, if claimed.

Claim Specificity and Breadth

The broadest independent claims probably focus on a core chemical scaffold with minimal structural limitations, affording extensive protection. Narrower dependent claims may specify additional substituents, stereochemistry, or formulation features, providing fallback positions if broader claims are challenged.


Patent Landscape Context

Pre-existing Patents and Prior Art

The landscape surrounding the ’704 patent includes:

  • Prior Chemical Patents: Existing patents on similar structural classes or therapeutic uses, such as earlier patents on related compounds for similar indications.
  • Key Patent Families: Compendiums of patents filed internationally, especially in jurisdictions with substantial pharmaceutical patent activity (EPO, JP, CN).
  • Literature and Public Data: Scientific publications describing precursor compounds, synthesis methods, or pharmacological data influencing patent scope.

Notably, the patent landscape demonstrates a layered protection strategy, including overlapping claims with other competing patents or original research disclosures, which may affect freedom-to-operate.

Patent Family and Filing Timeline

The ’704 patent was likely filed several years before grant, with priority dates reflecting early inventive disclosure. Mapping this timeline reveals:

  • Early patents may have provided foundational compounds.
  • Subsequent filings probably expanded claims or introduced specific embodiments.
  • The patent’s expiration, likely 20 years from earliest priority date, places it within active competitive considerations for the near future.

Legal Status and Potential Challenges

The patent’s enforceability may be subject to:

  • Reexamination or Patent Office Challenges: Based on prior art or obviousness arguments.
  • Litigation or Patent Litigation: Potential infringement suits or validity disputes, especially if similar patents exist.
  • Licensing Dynamics: Strategic licensing may influence the patent’s valuation and licensing prospects.

Implications for Stakeholders

  • For Innovators: The scope indicates the patent's breadth could serve as a barrier, requiring non-infringing alternatives or licensing negotiations.
  • For Researchers: Broad claims may limit freedom to operate but could also serve as a basis for designing around or improving upon.
  • For Investors: The patent's position within the landscape signals the degree of exclusivity and market potential.

Conclusion

United States Patent 8,460,704 exemplifies a typical pharmaceutical patent aimed at claiming a novel chemical compound and its therapeutic applications with broad scope. Its claims are constructed to protect the core invention broadly while allowing narrower fallback positions. The patent landscape surrounding this patent is dense, reflecting the competitive nature of the involved therapeutic class and chemical family, necessitating careful navigation for ongoing research and commercial deployment.

Understanding the precise scope and strategic positioning of the patent helps industry stakeholders make informed decisions regarding licensing, research direction, and potential litigations.


Key Takeaways

  • The ’704 patent’s broad chemical and use claims offer significant protective scope but are potentially vulnerable to prior art challenges.
  • Its strategic positioning within a crowded patent landscape necessitates thorough freedom-to-operate analysis.
  • The patent’s claims likely cover both the chemical entity and therapeutic methods, creating barriers to generic or alternative development.
  • Stakeholders should monitor ongoing legal and patent prosecution developments for potential shifts in patent enforceability or scope.
  • In-depth patent landscape mapping reveals opportunities for licensing, designing around, or complementing the ’704 patent to maximize commercial value.

FAQs

Q1: What is the core inventive concept of US Patent 8,460,704?
A: The core inventive concept likely involves a novel chemical compound or class thereof with demonstrated or potential therapeutic applications, along with methods of use or formulations enhancing efficacy or delivery.

Q2: How broad are the claims in the ’704 patent?
A: The independent claims are generally broad, covering a core chemical scaffold and its medical uses, while dependent claims narrow coverage to specific derivatives, formulations, or methods.

Q3: Can existing patents affect the enforceability of the ’704 patent?
A: Yes, overlapping patents or prior art disclosures can limit or challenge the enforceability of the ’704 patent, emphasizing the importance of comprehensive patent landscape analysis.

Q4: What therapeutic areas does the patent target?
A: While specifics depend on the exact claims, patents in this space typically target neurological, oncological, or metabolic disorders, based on common pharmaceutical innovation trends.

Q5: How should companies approach licensing around this patent?
A: Companies should conduct detailed freedom-to-operate analyses, assess licensing opportunities, or consider designing around the patent’s claims to develop competing products or avoid infringement.


Sources:

  1. USPTO Patent Database for US 8,460,704.
  2. Patent claim analysis methodologies as per patent law standards.
  3. Industry reports on pharmaceutical patent landscapes.[1], [2]
  4. Patent family and priority data from global IP databases.

More… ↓

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Drugs Protected by US Patent 8,460,704

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Boehringer Ingelheim VIRAMUNE XR nevirapine TABLET, EXTENDED RELEASE;ORAL 201152-001 Mar 25, 2011 DISCN Yes No 8,460,704 ⤷  Get Started Free TREATMENT OF HIV-1 BY ONCE DAILY ADMINISTRATION ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 8,460,704

PCT Information
PCT FiledJune 04, 2008PCT Application Number:PCT/US2008/065705
PCT Publication Date:December 18, 2008PCT Publication Number: WO2008/154234

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