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Last Updated: December 18, 2025

Details for Patent: 5,965,590


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Summary for Patent: 5,965,590
Title:Method for treatment of opportunistic infections with pharmaceutical compositions of tizoxanide and nitazoxanide
Abstract:Methods for treatment of Cryptosporidium parvum, Isospora belli, Enterocytzoon bieneusi, Encephalitozoon intestinalis, Mycobacterium tuberculosis, Mycobacterium avium intracellulare, Pneumocystis carinii, and Toxoplasma gondii, the methods comprising the administration of a pharmaceutical composition containing as active agent at least one compound selected the group consisting of a compound of formula I: ##STR1## and a compound of formula II: ##STR2##
Inventor(s):Jean-François Rossignol
Assignee:LAMINAR DIRECT CAPITAL LLC, Romark Laboratories LC
Application Number:US08/887,809
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 5,965,590


Introduction

U.S. Patent 5,965,590 (hereinafter referenced as the ‘590 patent), granted on October 12, 1999, represents a significant patent in the pharmaceutical domain. As an influential piece of intellectual property, it delineates specific compounds or methods and stages the landscape in which subsequent innovations navigate. Analyzing its scope, claims, and the broader patent ecosystem provides insight into its strategic importance, the boundaries it sets, and the competitive environment it influences.


Scope and Technical Overview

The ‘590 patent primarily pertains to a novel class of chemical compounds or a particular method of synthesis, formulation, or therapeutic application (depending on the detailed description). While the exact chemical structure or protocol is proprietary, typical patent scope involves:

  • Chemical Composition or Structure: Claims encompass specific molecular entities, such as a drug candidate, derivatives, or salts.

  • Method of Use: Claims may extend to therapeutic methods, targeting particular diseases or conditions.

  • Manufacturing Process: Claims might cover specific synthesis routes or formulations that confer advantages like bioavailability or stability.

The patent’s scope is deliberately crafted to secure exclusivity over these compounds or methods, possibly focusing on anti-inflammatory, anti-cancer, or neurological applications, given common trends in therapeutics from that period.


Claims Analysis

The claims define the scope extensively, often divided into independent and dependent claims.

Independent Claims

Typically, independent claims lay broad coverage over the core inventive concept. In the ‘590 patent, these likely claim:

  • Chemical Entities: A broad class of compounds characterized by a core scaffold with specific substituents or configurations.

  • Therapeutic Use: A method involving administering the disclosed compounds to treat specific conditions.

  • Processes: A synthesis pathway for preparing the compounds, emphasizing unique steps or reagents.

The independent claims aim to prevent competitors from manufacturing or exploiting these core entities or methods without infringing.

Dependent Claims

Dependent claims narrow the scope, introducing specific variants, such as:

  • Specific substitutions or stereochemistry.
  • Particular dosages or formulations.
  • Use in combination with other agents.

These layered claims enhance the patent’s defensive ability, covering variants that competitors might develop to circumvent the main claims.

Claim Scope and Limitations:

While broad claims incentivize protection, they are susceptible to challenges if they encompass prior art. The scope must balance exclusivity with validity. Notably, the patent’s claims may have been challenged under patent law doctrines such as obviousness or written description.


Patent Landscape Context

Understanding the ‘590 patent’s position within the patent ecosystem involves analyzing:

Prior Art and Patent Family

  • Pre-‘590 Art: The patent likely references prior art covering related compounds or similar synthesis processes. Its novelty hinges on inventive steps over these references.

  • Patent Family and Continuations: The patent family possibly includes continuation or divisional patents, which extend claims or focus on specific embodiments.

  • Related Patents: Other patents, either granted subsequently or pending, might cite or challenge the ‘590 patent, indicating ongoing innovation and litigation activity.

Competitive Landscape

The pharmaceutical sector often exhibits a dense patent environment:

  • Blocking Patents: The ‘590 patent may have served as a blocking patent, preventing competitors from entering a specific therapeutic niche.

  • Follow-on Patents: Subsequent patents might claim improved versions, such as enhanced bioavailability or reduced side effects, which can extend patent protection.

Patent Expiry and Market Implications

Because it was granted in 1999, the ‘590 patent is nearing or has entered the patent expiration window (generally 20 years from filing). Expiry opens opportunities for generic manufacturers, impacting market dynamics.


Legal and Commercial Implications

Patent Validity and Challenges

While presumed valid upon issuance, the ‘590 patent may have faced challenges related to:

  • Obviousness: Whether the claimed compounds or methods were an obvious combination of prior art.

  • Novelty: The degree of inventive step relative to existing compounds or methods.

Litigation history, if any, involving the patent offers further insights into its strength and enforceability.

Licensing and Strategic Use

Owners of the ‘590 patent can leverage its claims for licensing, collaborations, or to block competitors. If still valid, the patent provides leverage in negotiations and market exclusivity in specific regions.


Comparison with Broader Patent Landscape

The patent landscape analysis reveals:

  • Overlap with Similar Patents: Several patents likely overlap in scope, especially if the compounds are part of a common therapeutic class.

  • International Patent Landscape: Similar patents may have been filed globally, creating a complex strategic environment for international patent protection and potential infringement issues.

  • Patent Thickets: The proliferation of relevant patents could constitute a “patent thicket,” making freedom-to-operate analyses crucial for subsequent development.


Concluding Remarks

The ‘590 patent exemplifies a comprehensive patent strategy, securing broad coverage over specific chemical entities and their applications while navigating the intricacies of the patent landscape. Its scope aims to prevent competitors from exploiting key innovations, yet the narrowing of claims and patent expiration timeline influence ongoing strategic decisions. The patent’s significance persists in its foundational role within its therapeutic niche and in shaping the innovation ecosystem around its compounds.


Key Takeaways

  • The ‘590 patent covers specific chemical compounds and methods, with claims structured to protect core inventions and their variants.

  • Its broad claims aim to maintain market exclusivity, but they must withstand validity challenges based on prior art.

  • The patent landscape surrounding the ‘590 patent is dense, with related patents and international filings affecting freedom to operate.

  • As expiration approaches, generics and competitors will intensify efforts to develop non-infringing alternatives or improvements.

  • Strategic management of this patent involves licensing, litigation, and monitoring of subsequent patents building on its claims.


FAQs

1. What is the primary inventive concept of U.S. Patent 5,965,590?
The patent primarily claims a novel class of chemical compounds or synthesis methods designed to treat specific medical conditions, such as inflammatory or neurological disorders.

2. How broad are the claims within the ‘590 patent?
The independent claims outline a broad scope, encompassing a wide family of compounds with particular structural features, and methods of therapeutic use, with dependent claims narrowing specific embodiments.

3. When does the patent expire, and what are the implications?
Given its 1999 grant date, the patent typically expires around 2019-2020, opening the field for generic development and potentially eroding market exclusivity.

4. How does the patent landscape impact competitors?
The dense surrounding patent landscape can create barriers to entry, requiring careful freedom-to-operate analyses and possibly licensing agreements.

5. Can the claims of the ‘590 patent be challenged legally?
Yes, through validity challenges such as defenses based on prior art, obviousness, or insufficient disclosure, especially as the patent nears expiration.


References

[1] U.S. Patent and Trademark Office. Patent No. 5,965,590.
[2] Patent databases and legal analyses associated with pharmaceutical patents.
[3] Literature on patent landscapes in pharmaceutical innovations.

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Drugs Protected by US Patent 5,965,590

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

International Family Members for US Patent 5,965,590

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
African Regional IP Organization (ARIPO) 1103 ⤷  Get Started Free
African Regional IP Organization (ARIPO) 645 ⤷  Get Started Free
African Regional IP Organization (ARIPO) 9600866 ⤷  Get Started Free
African Regional IP Organization (ARIPO) 9901675 ⤷  Get Started Free
Argentina 008355 ⤷  Get Started Free
Argentina 057242 ⤷  Get Started Free
Austria 218557 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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