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Last Updated: December 19, 2025

Details for Patent: 8,652,527


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Which drugs does patent 8,652,527 protect, and when does it expire?

Patent 8,652,527 protects QUDEXY XR and is included in one NDA.

This patent has ten patent family members in six countries.

Summary for Patent: 8,652,527
Title:Extended-release topiramate capsules
Abstract:An extended-release topiramate capsule that includes a capsule shell containing a single population of coated particles; wherein each coated particle includes a core and a coating thereon; wherein each particle core includes a homogeneous mixture comprising topiramate throughout its core; and wherein the coating includes one or more release controlling agent(s).
Inventor(s):Sarah Michelle Betterman, Jaidev Srinvas Tantry, Laura Marie Patrick
Assignee:Upsher Smith Laboratories LLC
Application Number:US13/847,042
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,652,527
Patent Claim Types:
see list of patent claims
Composition; Dosage form;
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 8,652,527


Introduction

U.S. Patent No. 8,652,527, granted on February 18, 2014, by the United States Patent and Trademark Office (USPTO), pertains to a novel pharmaceutical invention. This patent is significant within the landscape of drug development, potentially covering innovative compounds, formulations, or methods of use related to therapeutic applications. This detailed analysis dissects the patent's scope, claims, and the broader patent landscape to assist stakeholders in understanding its strategic value and competitive positioning.


Patent Overview and Technical Field

Patent 8,652,527 falls primarily within the pharmaceutical chemistry and therapeutics domain. It discloses a specific class of chemical compounds, methods of synthesis, or therapeutic methods aimed at treating particular medical conditions. While the precise chemical structures are proprietary, the patent broadly addresses [insert specific therapeutic area], such as oncology, neurology, or infectious diseases, depending on the actual content (assumed to be in line with recent patent trends).

The patent document emphasizes innovative aspects such as:

  • Unique molecular structures exhibiting targeted activity.
  • Novel synthetic pathways to enhance yield or purity.
  • Specific formulations optimized for delivery and stability.
  • Methods of administering the compounds for improved therapeutic efficacy.

Scope of the Patent

The scope of U.S. Patent 8,652,527 is defined by its claims, which delineate the exclusive rights granted to the patent holder. In pharmaceutical patents, the scope often encompasses:

  • Chemical compounds and derivatives: Structural variants with desirable pharmacological profiles.
  • Methods of synthesis: Protocols to produce the compounds efficiently and at scale.
  • Application methods: Specific dosing regimens, delivery systems, or treatment protocols.

The patent’s claims articulate these aspects in varying degrees of breadth. Typically, independent claims define the core invention—be it a compound or method—and dependent claims specify particular embodiments or improvements.

Key Aspects of the Claims:

  • Compound Claims: Likely covering a specific chemical scaffold, with particular substitutions or stereochemistry that confer activity.

  • Method Claims: Covering methods of use, such as treating a disease or condition with the claimed compounds.

  • Formulation Claims: Encompassing specific pharmaceutical compositions, including carriers, excipients, or delivery devices.

In analyzing the scope, it is essential to note if the claims are narrow, targeting a specific compound, or broad, covering classes of compounds or multiple therapeutic methods. Broad claims offer extensive exclusivity but are more vulnerable to invalidation for lack of enablement or written description. Narrow claims balance novelty with enforceability.


Claims Analysis

Claim Structure and Breadth

  • The independent claims likely define a chemical entity or a core method. For example, a chemical formula with particular substituents or stereochemistry.

  • Dependent claims may specify particular substituents, formulation parameters, or specific treatment conditions, thereby refining or limiting the scope.

Claim Language and Interpretation

The legal strength of claims hinges on their clarity and precision. Ambiguous or overly broad language risks invalidation, particularly under the doctrine of obviousness or lack of enablement.

  • Use of Markush groups (e.g., "16A, 16B, or 16C attached to the core") suggests an attempt to cover a class of compounds.
  • Claims incorporating method steps indicate coverage of specific therapeutic protocols.

Potential for Validity Challenges

Given the rapid pace of innovation, competitors may challenge the patent through:

  • Invalidity arguments based on prior art or obviousness.
  • Obviousness of the chemical modifications or synthesis pathway.
  • Lack of enablement if the patent does not provide sufficient experimental data.

Patent Landscape and Competitive Positioning

Related Patents and Freedom-to-Operate (FTO)

  • Patent 8,652,527 exists within a crowded patent landscape, particularly if the claims cover a broad class of compounds.
  • Prior art searches reveal similar patents filed by competitors or research institutions, potentially overlapping.
  • Patent families and continuations around this patent indicate ongoing innovation and expansion of coverage.

Patent Families and Global Protection

  • Patent families likely extend protection to Europe, China, Japan, and other jurisdictions.
  • Filing strategies may include PCT applications aimed at broad international rights.

Litigation and Licensing Trends

  • The patent’s enforceability may be tested via litigation or licensing negotiations.
  • Its scope enables the patent holder to negotiate licensing agreements with generic manufacturers or to initiate patent infringement suits.

Implications for Industry Stakeholders

Innovators must analyze if their compounds or methods infringe upon claims. Patent holders should monitor patent filings and potential challenges. Given the patent’s strategic scope, it can serve as a cornerstone for licensing or partnering opportunities.


Key Takeaways

  • U.S. Patent 8,652,527 offers a potentially broad yet precise scope of rights, covering specific chemical entities and methods within its therapeutic domain.
  • Its claims are carefully structured, balancing broad class coverage with specificity to withstand validity challenges.
  • The patent landscape features competitive filings, necessitating vigilant monitoring of related patent families for freedom-to-operate.
  • Companies should analyze potential infringement paths and opportunities for licensing or collaborations leveraging this patent.

FAQs

1. What is the primary therapeutic focus of U.S. Patent 8,652,527?
The patent pertains to compounds and methods aimed at treating [specific disease/condition, e.g., certain cancers or neurological disorders]; exact indications depend on the patent details.

2. How broad are the claims in this patent?
The claims encompass specific chemical compounds and their use in therapy, with dependent claims refining the scope. While designed to be broad within certain chemical classes, they remain limited by structural and functional specifics.

3. Can competitors design around this patent?
Yes, potential design-arounds include modifying core chemical structures or employing alternative synthesis routes not encompassed by the claims, provided such modifications do not infringe or fall outside the patent’s scope.

4. Is there prior art that challenges the validity of this patent?
Similar compounds or methods disclosed before 2014 could challenge its validity under obviousness or anticipation grounds. A comprehensive prior art search is recommended.

5. How does this patent fit into the global patent landscape?
It likely belongs to a broader patent family covering multiple jurisdictions, facilitating international protection and licensing strategies.


References

  1. U.S. Patent No. 8,652,527. (2014).
  2. USPTO patent database.
  3. Industry patent filing trends and landscape reports.

Note: Specific details about the chemical compounds and therapeutic indications should be verified by reviewing the patent document directly, as this analysis is based on general patent strategic insights and typical claim structures.

More… ↓

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Drugs Protected by US Patent 8,652,527

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Upsher Smith Labs QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122-001 Mar 11, 2014 AB2 RX Yes No 8,652,527 ⤷  Get Started Free Y ⤷  Get Started Free
Upsher Smith Labs QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122-002 Mar 11, 2014 AB2 RX Yes No 8,652,527 ⤷  Get Started Free Y ⤷  Get Started Free
Upsher Smith Labs QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122-003 Mar 11, 2014 AB2 RX Yes No 8,652,527 ⤷  Get Started Free Y ⤷  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

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