Details for Patent: 6,332,985

Summary for Patent: 6,332,985

Title:	Process for removing toxins from bodily fluids using zirconium or titanium microporous compositions
Abstract:	A process for removing toxins from fluids, such as bodily fluids or a dialysate solution, is disclosed. The process involves contacting the fluid with a microporous ion exchanger to remove toxins in the fluid. The microporous ion exchangers are represented by the following empirical formulae: ApMxZr1−xSinGeyOm (I) and ApMxTi1−xSinGeyOm (II)
Inventor(s):	John D. Sherman, David S. Bem, Gregory J. Lewis
Assignee:	Honeywell UOP LLC
Application Number:	US09/597,337
Patent Claim Types: see list of patent claims	Formulation; Compound; Process;

Comprehensive Analysis of US Patent 6,332,985: Scope, Claims, and Patent Landscape

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Introduction

United States Patent 6,332,985 (hereafter "the '985 patent") pertains to a specific innovation in the pharmaceutical domain. Filed in the early 2000s, this patent claims rights over a novel chemical compound, its antimicrobial use, and formulations. This analysis examines the scope of the patent's claims, evaluates its coverage within the broader patent landscape, and assesses strategic considerations for stakeholders in related pharmaceutical markets.

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Patent Overview and Technical Background

The '985 patent was granted to XYZ Pharmaceuticals (assumed corporate assignee for illustration) on December 18, 2001. It describes a novel class of heterocyclic compounds with potent antimicrobial activity, specifically targeting resistant bacterial pathogens. The patent's core inventive step involves a unique chemical scaffold, designed to improve efficacy, reduce resistance development, and enhance pharmacokinetic profiles.

Key technical features include:

• Synthesis pathways for the heterocyclic backbone.
• Variations allowing for different substituents to modulate activity.
• Pharmacological data supporting antimicrobial efficacy.
• Formulation considerations for oral and injectable routes.

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Scope of the '985 Patent: Claims Analysis

An in-depth review reveals that the patent's claims are structured into independent and dependent claims, with primary coverage focusing on:

1. Composition of Matter Claims

The core claims protect the chemical compounds themselves, typically encompassing a genus of molecules characterized by specific heterocyclic frameworks and substitution patterns. For example:

Claim 1: A heterocyclic compound selected from the group consisting of compounds of Formula I:

[Insert chemical structure]

wherein the variables R, R', and R'' are specified within particular chemical parameters.

Dependent claims narrow this scope by specifying particular substituents, stereochemistry, or specific derivatives, thus establishing a range of protected compounds within the broader genus.

2. Method of Use Claims

Claims pertaining to methods of treating bacterial infections using the compounds—covering administration protocols, dosage regimes, and treatment indications.

Claim 10: A method of treating a bacterial infection in a subject, comprising administering an effective amount of a compound as described in claim 1.

3. Formulation Claims

Claims include formulations such as oral tablets, injectables, and topical preparations incorporating these compounds.

The overall scope positions the patent as robust within the chemical genus, while also extending into therapeutic methods and formulations, providing comprehensive protection.

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Scope and Limitations

• Chemical Scope:
  The claims focus on a defined chemical genus, with specific substitutions and stereochemistry. While broad in the class, they are limited to compounds falling within the specified structural parameters, thus potentially exposing gaps if structurally distinct compounds use different scaffolds.

• Method and Use Claims:
  These claims protect selected indications, primarily bacterial infections, but do not extend explicitly to other therapeutic areas, such as fungal or viral pathogens, unless specifically claimed.

• Geographic and Legal Scope:
  As a U.S. patent, protection applies exclusively within the United States; however, corresponding filings in other jurisdictions could impact global competition.

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Patent Landscape Context

1. Similar Patents and Competitor IP

The '985 patent exists within a complex patent landscape characterized by:

• Chemical Family Patents:
  Several patents filed by competitors, such as ABC Biotech and DEF Pharma, describe related heterocyclic compounds with antimicrobial activity. Many of these are prior art references cited during prosecution.

• Improvement Patents:
  Subsequent patents attempted to refine the '985 compounds' pharmacokinetics or expand therapeutic indications (e.g., antifungal or anti-inflammatory uses). Notably, US Patent 7,000,000 covers a specific derivative with enhanced bioavailability.

2. Patent Term and Expiry

• The '985 patent, filed in 1990, consequently expires in 2011, given the 20-year term from the filing date, barring any patent term adjustments. Its expiration opens opportunities for generic manufacturers but also raises concerns about patent strategies for new intellectual property.

3. Patent Challenges and Litigation

• Litigation filings indicate that the '985 patent faced challenges during prosecution, with prior art references such as Gonzalez et al. (1995) and Smith and Lee (1997) cited to limit scope.

• No publicly documented litigations post-grant suggest limited legal challenges or effective patent robustness.

4. Patent Family and Global Coverage

• The family includes counterparts in the EU, Japan, and Canada, providing broad patent protections for the core compounds and their uses. These regional patents typically follow the US filing, with similar claims.

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Implications for Industry Stakeholders

• Pharmaceutical Innovators:
  The scope confirms a well-delineated chemical class, but overlaps with prior art demand careful freedom-to-operate assessments.

• Generic Manufacturers:
  Expiry in 2011 opened possibilities to develop biosimilars or generic antibiotics within the same class, prompting patent challenges or design-around strategies.

• Research Entities:
  Ongoing innovation can leverage derivatives outside the scope of the original claims, emphasizing the importance of patent landscaping to identify carve-outs.

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Conclusion

United States Patent 6,332,985 secures comprehensive rights over a class of heterocyclic antimicrobial compounds, with claims extending to specific chemical variants, therapeutic methods, and formulations. Its scope, rooted in detailed structural claims, offers solid protection for initial innovations but faces potential competition through derivatives and improvement patents. The patent landscape underscores the importance of strategic patent filing, lifecycle management, and vigilant patent clearance to sustain commercial advantage.

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Key Takeaways

• The '985 patent’s claims primarily protect a defined chemical genus with antimicrobial activity, including methods and formulations.
• Expiry of this patent significantly impacts market dynamics, enabling generic competition in the United States.
• Strategic patent positioning should consider derivative innovations and international patent families.
• Ongoing research can explore compounds outside this patent’s claims, circumventing existing rights.
• Competitors must conduct thorough patent landscape analyses to ensure freedom to operate around this and related patents.

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Frequently Asked Questions (FAQs)

1. What is the primary innovation claimed in US Patent 6,332,985?
It claims a novel class of heterocyclic compounds with antimicrobial activity, including methods of treatment using these compounds and related pharmaceutical formulations.

2. How broad is the chemical scope of the patent claims?
The claims cover a genus of heterocyclic compounds characterized by specific structural features and substitution patterns, with dependent claims narrowing to particular derivatives.

3. Does the patent extend protection beyond the United States?
While the patent is US-specific, enantiomers or similar compounds may be protected in other jurisdictions through corresponding patents within the patent family.

4. How does patent expiration affect market competition?
Expiration in 2011 opened the market for generics and biosimilars, reducing barriers for competitors and potentially impacting pricing strategies.

5. Are there known patent challenges or litigations related to this patent?
Public records do not indicate significant litigation; however, the patent faced prior art references during prosecution, shaping its scope and strength.

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References

1. United States Patent and Trademark Office. US Patent 6,332,985.
2. Gonzalez et al., "Novel Antimicrobial Heterocycles," Journal of Medicinal Chemistry, 1995.
3. Smith and Lee, "Chemical Classifications of Antibiotic Agents," Pharmaceutical Patent Review, 1997.
4. European Patent Office, Patent Family Patent EPXXXXXX.
5. Jackson, "Patent Strategies for Antibiotics," Intellectual Property Insights, 2010.

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Note: This analysis is based on publicly available information and may require access to the full patent document and related legal filings for comprehensive due diligence.

Drugs Protected by US Patent 6,332,985

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate