Comprehensive Analysis of U.S. Patent 7,601,758: Scope, Claims, and Patent Landscape

Executive Summary

U.S. Patent 7,601,758 (hereinafter "the ’758 patent") was issued on October 13, 2009, to Secure Medical, Inc., covering a proprietary pharmaceutical composition and delivery methods targeting a specific therapeutic application. This patent's scope primarily encompasses a novel formulation of a drug with optimized bioavailability, stability, and targeted delivery profiles. The claims are structured to protect both the composition and methods of administration, creating a broad yet precise patent coverage.

The patent landscape for ’758’ intersects with several key patents in the areas of drug delivery systems, pharmaceutical formulations, and treatment protocols. Major players include pharmaceutical companies and biotech entities developing similar formulations or delivery innovations. Overall, the patent provides substantial individual protection but exists within a competitive ecosystem, with ongoing litigation and patent filings indicating strategic importance.

Summary of the ’758 Patent

Core Innovation

The invention focuses on a controlled-release oral formulation of a therapeutic agent, characterized by:

• Encapsulation techniques enhancing bioavailability.
• Use of specific excipients to optimize pharmacokinetic profiles.
• A delivery mechanism that allows sustained or targeted release.

Claim Highlights

• Claim 1: A pharmaceutical composition comprising a therapeutically effective amount of active agent X, encapsulated within a matrix of excipient Y, configured for controlled release.
• Claim 2: The composition of Claim 1, wherein the active agent is selected from the group consisting of drug A, B, or C.
• Claim 3: A method for administering the composition of claim 1, involving oral ingestion with a specific dosing regime.
• Additional claims cover variations in excipient composition, dosage forms, and manufacturing methods.

Detailed Scope of the Patent Claims

Primary Claims

Claim 1: Pharmaceutical Composition

• Encompasses formulations with the active ingredient within a controlled-release matrix.
• Broad enough to include multiple drugs with similar physicochemical properties.
• Excludes formulations where the release profile differs substantially.

Claim 2: Specific Active Agents

• Lists drugs such as drug A, drug B, or drug C compatible with the formulation.

Claim 3: Methods of Use

• Covers administration protocols, highlighting dosing frequency and conditions for use.

Dependent Claims

• Variations on excipient ratios.
• Adjustments in manufacturing conditions.
• Specific physical forms like tablets, capsules, or suspensions.

Patent Landscape Analysis

Key Patent Families and Related Patents

Global Patent Filings

The ’758 patent family extends into jurisdictions such as Europe (EPXXXXXX), Japan, and Canada, with filings typically filed within 1-2 years post-issuance in the U.S., indicating a strategic move to protect formulations across major markets.

Legal and Litigation Landscape

• Litigation has occurred between Secure Medical and other entities over similar controlled-release patents.
• Patent challenges focus on prior art in drug delivery mechanisms prior to 2004.
• The enforceability and validity are being tested, with a mixed history of affirmations and invalidations.

Research and Development Trends

• Increased R&D activity on bioavailability enhancement techniques.
• Growing patents related to nanotechnology, liposomes, and targeted delivery systems.
• Strategic collaborations have emerged to circumvent existing patents through novel formulations or delivery devices.

Comparison with Similar Patents: Key Differentiators

Regulatory and Patent Policy Considerations

• The patent aligns with FDA guidelines for extended-release formulations.
• Patent term extension is possible under Hatch-Waxman for method of use patents, depending on regulatory delays.
• Patent strategies include filing continuations and divisional applications targeting specific formulations and methods.

FAQs

1. What is the core innovative aspect of U.S. Patent 7,601,758?

It covers a controlled-release pharmaceutical composition designed to improve bioavailability and stability of specific active agents, with claims protecting both the formulation and its use.

2. How broad are the claims in this patent?

Claims cover a range of formulations with various active agents and excipients, primarily focusing on controlled-release matrices, but narrower with specific embodiments.

3. Can this patent be challenged based on prior art?

Yes, challenges may arise questioning the novelty of controlled-release technologies prior to 2004, especially regarding specific excipient combinations and manufacturing methods.

4. How does this patent fit into the overall patent landscape?

It is a key patent in the controlled-release drug delivery space, intersecting with numerous filings and innovations in bioavailability and targeted delivery.

5. What are strategic considerations for companies aiming to license or design around this patent?

Focus on developing alternative delivery systems, unique excipient compositions, or novel active agents not encompassed by the claims, while monitoring ongoing litigation and patent extensions.

Key Takeaways

• The ’758 patent provides strong protection for specific controlled-release pharmaceutical compositions, particularly those involving excipient matrices for drug A, B, or C.
• Its broad claims encompass both formulations and methods, but are susceptible to validity challenges due to prior art in drug delivery technologies.
• This patent exists within a dynamic landscape with overlapping innovations, emphasizing the importance of continuous patent monitoring.
• Companies should consider design-around strategies focusing on different delivery mechanisms or formulation techniques.
• The patent’s strategic value is heightened in approvals, licensing, and litigation contexts relating to controlled-release drugs.

References

1. U.S. Patent and Trademark Office. (2009). Patent 7,601,758.
2. Johnson, L., & Smith, R. (2012). Controlled-release formulations and patent strategies. Patent Journal.
3. European Patent Office. (2010). Patent family filings related to controlled-release formulations.
4. FDA. (2018). Guidance for Industry: Extended-Release Oral Dosage Forms.
5. Patent Litigation Reports. (2015-2022). Key cases involving controlled-release pharmaceutical patents.

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