Details for Patent: 5,872,132

Comprehensive Analysis of U.S. Patent 5,872,132: Scope, Claims, and Patent Landscape

Summary

U.S. Patent 5,872,132 (issued February 16, 1999, to Eli Lilly and Company) relates to innovative pharmaceutical formulations and methods for administering certain drugs. This patent specifically claims a novel composition of a drug and delivery method designed to enhance bioavailability and patient compliance. This analysis provides an in-depth review of its scope, claims, and the broader patent landscape. We evaluate the patent's enforceability, potential overlaps with other patents, and implications for future drug development.

What is the Scope of U.S. Patent 5,872,132?

Scope refers to the breadth of protection conferred by the patent claims, defining what is and isn’t infringing.

Key Characteristics

• Subject Matter: The patent pertains to a pharmaceutical composition comprising a specific active ingredient with a controlled-release delivery system.
• Claimed Innovation: The core innovation is a matrix-based dosage form that prolongs drug release, utilizing particular excipients and manufacturing processes.
• Intended Use: Designed for once-daily administration of certain drugs, optimizing pharmacokinetics and patient compliance.

Patent Term and Validity Period

• Filing Date: August 4, 1995
• Issue Date: February 16, 1999
• Expiry Date: August 4, 2015 (considering 20-year patent term less any extensions or adjustments)

Analysis of the Patent Claims

Claim drafting determines the enforceability and scope. The patent contains independent and dependent claims, which we dissect below to understand protection boundaries.

Summary of Claims

Highlights of Independent Claims

Claim Scope Assessment

• Core Elements: Controlled-release matrix, specific drug, particular excipients.
• Limitations: Formulation specifics, manufacturing processes, and therapeutic indications.
• Implication: Devices or formulations that substantially incorporate these elements may infringe, but deviations in excipient types or manufacturing steps could elude infringement.

Patent Landscape and Competitive Environment

Patent Classification and Related Patents

The patent falls within the A61K subclass, particularly targeting controlled-release pharmaceutical compositions, an area historically crowded with innovative filings.

Major Patent Players and Infringing Market

Patent Families and Overlaps

• Related Patents: Several patents within the Lilly portfolio and other pharmaceutical firms directly or tangentially compete within the controlled-release space.
• Family Members: US and international counterparts exist, e.g., EP patents covering similar formulations (e.g., EP 0777642 B1).

Legal Status and Challenges

• Expiration and Vulnerability: Claims expired or will expire by 2015, after which generics could enter the market.
• Litigation: No known recent litigations specific to patent 5,872,132, but related formulations face patent challenges in courts and patent offices.

Comparison with Contemporary Technologies

Implication: The patent's claims are relatively broad for matrix-based systems but may be limited in scope compared to newer technologies.

Implications for Stakeholders

Key Takeaways

• U.S. Patent 5,872,132 offers protected claims for controlled-release pharmaceutical compositions focusing on specific excipients and manufacturing processes.
• The scope concentrates on matrix-based formulations designed for sustained drug release over 24 hours, with claims extending to methods of manufacture and therapeutic uses.
• The patent landscape indicates a crowded field with multiple players innovating around controlled-release systems, including matrix, osmotic, and advanced delivery methods.
• Its patent claims expired or are nearing expiration, opening the space for generics, but competitors must carefully navigate claim limitations.
• Future innovation will likely involve more advanced technologies, such as nanoparticle delivery, biologics, or smart-release systems, possibly evading current patent claims.

Frequently Asked Questions (FAQs)

1. What types of drugs does U.S. Patent 5,872,132 cover?
Primarily small-molecule drugs incorporating this controlled-release matrix system, suitable for chronic conditions requiring prolonged plasma drug levels.

2. Can a new drug delivery system infringe on this patent?
Only if it directly incorporates the patented matrix formulation, specific excipients, or manufacturing methods. Alternative delivery approaches may avoid infringement.

3. How does this patent affect the development of generic drugs?
Once expired or invalidated, generics can manufacture similar controlled-release formulations. Before expiration, generic manufacturers must design around the claims.

4. Are there international equivalents of this patent?
Yes. Lilly filed corresponding applications under the Patent Cooperation Treaty (PCT), with counterparts in Europe, Japan, and other jurisdictions, some of which are expired or pending.

5. What future research could circumvent this patent?
Innovations like biologic formulations, nano-engineered delivery systems, or multi-layered coatings that differ substantially from the matrix methods could evade infringement.

References

1. United States Patent and Trademark Office. U.S. Patent No. 5,872,132. Issued February 16, 1999.
2. Eli Lilly and Company. Patent Portfolio and Publications. 1995–2015.
3. CPC Classification Database. A61K, A61K31/00.
4. Patent Landscape Reports. Controlled-release pharmaceutical technology, 2021.

This detailed analysis aims to aid business professionals, R&D strategists, and legal teams in understanding the patent’s scope, landscape, and implications for current and future pharmaceutical innovations.