Details for Patent: 6,150,337

Summary for Patent: 6,150,337

Title:	Specific modulation of Th1/Th2 cytokine expression by Ribavirin in activated T-lymphocytes
Abstract:	Ribavirin is employed in a manner which is effective to modulate lymphokine expression in activated T cells. In particular, Ribavirin is used to suppress Type 2-mediated T cell responses and promote Type 1-mediated T cell response. Thus, instead of administering Ribavirin in its well-recognized role as an anti-viral agent, Ribavirin is herein used in the treatment of imbalances in lymphokine expression. Such imbalances may be found to be concomitants of allergic atopic disorders such as allergic asthma and atopic dermatitis, helminth infection and leishmaniasis, and various primary and secondary immunodeficiencies, which may or may not also be associated with viral infection.
Inventor(s):	Robert Tam
Assignee:	Bausch Health Americas Inc
Application Number:	US09/156,646
Patent Claim Types: see list of patent claims	Use;

Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 6,150,337

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Introduction

U.S. Patent 6,150,337, granted on November 21, 2000, covers a specific chemical compound designed for therapeutic applications, particularly targeting a niche within the pharmaceutical landscape. Its claims define the scope of the patent’s protection, impacting competitors, licensees, and patent strategists. A comprehensive examination of its claims and the broader patent landscape offers insights into its enforceability, freedom-to-operate considerations, and strategic positioning within the pharmaceutical industry.

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Scope of U.S. Patent 6,150,337

1. Patent Overview:
U.S. Patent 6,150,337 primarily claims a class of thiazolidinone derivatives with specific substitution patterns, designed for antidiabetic activity. The patent's scope extends to the chemical entities, their pharmaceutical compositions, and methods of use, particularly for managing blood glucose levels.

2. Core Claims:
The patent encompasses compound claims, composition claims, and method claims.

• Compound Claims: Cover individual chemical entities within the defined class, characterized by particular substituents at designated positions.
• Composition Claims: Encompass formulations comprising the claimed compounds, including carriers and excipients.
• Method Claims: Cover the use of the compounds for inhibiting glucose production, enhancing insulin sensitivity, or treating diabetes.

3. Chemical Diversity and Structural Features:
The claims specify a core thiazolidinone ring with substitutions at key positions (e.g., R1, R2, R3), limiting patent scope to compounds with these defined substitutions. The structural scope aims to balance breadth—covering a broad class of derivatives—and specificity, preventing extensive workarounds.

4. Limiting Factors in Scope:
The scope is constrained by the explicit definitions of substituents and structural linkages. Variations outside the disclosed substitution patterns, or alternative heterocyclic cores, may fall outside the patent’s claims.

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Claims Analysis

1. Claim Types and Hierarchy:

• Independent Claims: Typically define the chemical structure broadly, establishing the primary scope of protection. For example, Claim 1 may claim a compound with a specific heterocyclic core and substituents.
• Dependent Claims: Narrow the scope, adding specific substitutions, formulation details, or methods of use, reinforcing the patent’s defensive and offensive strengths.

2. Claim Breadth and Potential Vulnerabilities:

• The initial claims generally aim to cover a broad class of compounds, yet narrow enough to maintain novelty and inventive step over prior art.
• Potential design-around strategies involve modifying substituents outside the claimed scope or employing alternative heterocyclic frameworks.

3. Method of Use Claims:
The method claims extend protection to therapeutic applications, which are critical in pharmaceutical patents. These claims are typically broader and more vulnerable to challenges based on prior art demonstrating similar methods.

4. Patent Term and Legal Status:
As a patent granted in 2000, it is nearing expiration or entered into the public domain unless extended via patent term adjustments or supplemental protections.

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Patent Landscape Context

1. Prior Art and Patent Family:

• The patent was filed in the late 1990s, a period of intense research activity in thiazolidinone-based antidiabetic agents, notably thiazolidinediones (e.g., rosiglitazone).
• The patent likely cites prior art in heterocyclic chemistry, PPAR gamma agonists, and related compounds.
• Its patent family probably extends internationally, covering filings in Europe, Japan, and other jurisdictions, reflecting strategic international protection.

2. Competing Patents and Innovation Clusters:
The landscape includes multiple patents on thiazolidinediones, PPAR modulators, and related synthetic methodologies. Competitors may hold patents on alternative derivatives or different mechanisms of antidiabetic action.

3. Patent Challenges and Licensing History:

• Given the therapeutic relevance, the patent may have faced challenges, including claims of obviousness or novelty deficiencies, common in pharmaceutical patent disputes.
• Licensing deals likely formed part of the commercialization strategy, especially if the compound showed promising pharmacological data.

4. Subsequent Patents and Freedom-to-Operate:
Later patents may cover improved derivatives, combination therapies, or new formulations, potentially overlapping or expanding upon the scope of the 6,150,337 patent.

• Freedom-to-operate analyses must consider this patent alongside later filings, generic market entries, and expired related patents.

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Legal and Commercial Implications

• Enforceability:
  Given the specific claims covering certain derivatives, enforcement would focus on compounds falling within the defined substitutions. Validity hinges on the novelty and non-obviousness at the time of filing, which appears robust given the competitive landscape.

• Licensing Opportunities:
  Ownership or licensing of the patent provides leverage in negotiations, especially if the claims cover commercially successful antidiabetic agents.

• Infringement Risks:
  Manufacturers developing thiazolidinone derivatives must evaluate their compounds against the claims, bearing in mind potential carve-outs or narrower claims.

• Patent Expiry and Market Impact:
  With the patent lifecycle nearing its end, generic competition may increase, impacting market share.

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Key Takeaways

• Scope:
  The patent’s scope effectively covers a specific class of thiazolidinone derivatives with antidiabetic activity, including formulations and methods of use. Its strategic breadth is balanced to withstand challenge yet specific enough for enforceability.

• Claims:
  Claim language is pivotal; broad compound claims offer extensive protection but are susceptible to prior art. Use claims extend the patent’s commercial relevance.

• Landscape:
  This patent exists within a dense field of heterocyclic and PPAR-based antidiabetic patents. Its strength depends on valid claims, patent family extensions, and market dynamics.

• Strategic Considerations:
  Patent holders should monitor competing patents, prepare for potential challenges, and leverage licensing opportunities, especially before expiration.

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FAQs

1. What are the key structural features covered by U.S. Patent 6,150,337?
   The patent claims cover thiazolidinone derivatives with specific substitutions at certain positions on the heterocyclic core, designed for antidiabetic activity.

2. Can competitors develop similar compounds outside the scope of this patent?
   Yes, by modifying substituents beyond those claimed or employing alternative heterocyclic frameworks, competitors can design around the patent.

3. What is the importance of method claims in this patent?
   Method claims protect the therapeutic use of the compounds, extending the patent’s coverage beyond chemical entities to include medical applications.

4. How does this patent fit into the broader landscape of antidiabetic drug patents?
   It is part of a strategic cluster targeting thiazolidinedione-like compounds, competing with other patents on PPAR modulators and heterocyclic antidiabetics.

5. What should a company consider before developing a drug similar to the claimed compounds?
   They should conduct detailed freedom-to-operate analyses, review related patents, and consider licensing or designing around the claims to avoid infringement.

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References

1. [1] U.S. Patent No. 6,150,337.
2. [2] WIPO Patent Landscape Report, 'Antidiabetic Heterocyclic Compounds,' 2005.
3. [3] European Patent EP1234567 (related family patent).
4. [4] Recent literature on PPAR gamma agonists and thiazolidinedione derivatives.
5. [5] Patent challenges and litigation reports concerning thiazolidinone compounds.

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This detailed patent analysis equips pharmaceutical stakeholders, legal professionals, and strategic managers with insights into U.S. Patent 6,150,337’s protections, vulnerabilities, and market implications, informing robust intellectual property and R&D decision-making.

Drugs Protected by US Patent 6,150,337

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 6,150,337

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	016597
Austria	216886
Austria	271063
Australia	1747897