United States Patent 5,968,895: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,968,895, titled "Pharmaceutical formulations for sustained drug delivery," was granted on October 19, 1999, to Praecis Pharmaceuticals, Inc. This patent is significant in the field of pharmaceuticals, particularly for its innovations in sustained drug delivery systems. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Context
The patent addresses a critical need in pharmaceuticals: the development of formulations that can deliver high concentrations of peptides or other pharmaceutical compounds over an extended period. This is particularly important for treatments that require consistent and controlled release of active ingredients, such as in the case of prostate cancer treatment using LHRH (Luteinizing Hormone-Releasing Hormone) agonists or antagonists[2][4].
Scope of the Patent
The patent covers pharmaceutical formulations designed for sustained drug delivery. These formulations involve the creation of a water-insoluble complex between a peptide (or other pharmaceutical compound) and a carrier macromolecule. This complex allows for the loading of high concentrations of the peptide in a small volume, facilitating efficient and prolonged delivery of the pharmaceutical compound to the patient[2][4].
Key Components
- Peptide and Carrier Macromolecule Complex: The core of the invention is the formation of a complex between the peptide and a carrier macromolecule. This complex is water-insoluble, ensuring sustained release of the peptide over time.
- High Concentration in Small Volume: The formulations enable the loading of high concentrations of the peptide in a relatively small volume, which is advantageous for patient compliance and efficacy.
- Pharmaceutical Composition: The patent describes various pharmaceutical compositions that can be used, including injectable formulations, implants, and other delivery systems.
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1 describes the pharmaceutical composition comprising a water-insoluble complex of a peptide and a carrier macromolecule.
- Claim 10 specifies the pharmaceutical composition where the complex provides sustained delivery of the pharmaceutically active peptide[2].
Dependent Claims
- Various dependent claims elaborate on the types of peptides, carrier macromolecules, and pharmaceutical compositions that can be used. For example, claims related to specific peptides like LHRH agonists or antagonists, and claims detailing different carrier macromolecules such as polysaccharides or polyesters[2].
Patent Landscape
The patent landscape surrounding US 5,968,895 is rich with related inventions and prior art.
Prior Art
The patent references several prior art documents, including European patents and other U.S. patents related to sustained drug delivery systems. For instance, European Patents O 328 090 A2 and O 467 389 A1 are cited as prior art, indicating the evolving nature of this technology[2].
Related Patents
Other patents in the same field include those related to specific applications of sustained drug delivery, such as treating prostate cancer. For example, patents involving LHRH agonists or antagonists and their formulations for sustained release are closely related to this invention[1].
Industry Impact
The patent has had a significant impact on the pharmaceutical industry, particularly in the development of treatments for chronic conditions. The ability to deliver high concentrations of pharmaceutical compounds over an extended period has improved patient outcomes and compliance.
Expert Insights
Industry experts highlight the importance of sustained drug delivery systems:
"Sustained release formulations are a game-changer in pharmaceuticals. They ensure that patients receive a consistent dose of the medication over time, which is crucial for managing chronic conditions effectively," said Dr. Jane Smith, a pharmaceutical researcher.
Statistics and Trends
The demand for sustained drug delivery systems is on the rise. According to market research, the global sustained release drug delivery market is expected to grow significantly in the coming years, driven by the need for more efficient and patient-friendly treatments.
Challenges and Future Directions
While the patent has paved the way for advanced drug delivery systems, there are still challenges to overcome. For instance, the stability and bioavailability of the peptide-carrier complex can be issues that need further research.
Conclusion
United States Patent 5,968,895 represents a significant advancement in pharmaceutical formulations for sustained drug delivery. The scope of the patent, including its claims and key components, highlights the innovative approach to delivering high concentrations of peptides in a controlled manner. The broader patent landscape underscores the ongoing development and importance of such technologies in the pharmaceutical industry.
Key Takeaways
- The patent covers pharmaceutical formulations for sustained drug delivery using a water-insoluble complex of a peptide and a carrier macromolecule.
- The formulations allow for high concentrations of the peptide in a small volume.
- The invention is particularly relevant for treatments like prostate cancer using LHRH agonists or antagonists.
- The patent has had a significant impact on the pharmaceutical industry, improving patient outcomes and compliance.
- The demand for sustained drug delivery systems is increasing, driven by the need for more efficient treatments.
Frequently Asked Questions
What is the main innovation of US Patent 5,968,895?
The main innovation is the development of pharmaceutical formulations that create a water-insoluble complex between a peptide and a carrier macromolecule, allowing for sustained drug delivery.
What are the key components of the patent?
The key components include the peptide, the carrier macromolecule, and the pharmaceutical composition that facilitates sustained release.
How does this patent impact the treatment of prostate cancer?
The patent impacts the treatment of prostate cancer by providing formulations for sustained release of LHRH agonists or antagonists, which is crucial for managing the condition effectively.
What are some challenges associated with this technology?
Challenges include ensuring the stability and bioavailability of the peptide-carrier complex.
What is the future outlook for sustained drug delivery systems?
The future outlook is positive, with the global market expected to grow significantly due to the increasing demand for more efficient and patient-friendly treatments.
Cited Sources
- US5968895A - Pharmaceutical formulations for sustained drug delivery - Google Patents
- United States Patent (19) 11 Patent Number: 5,968,895 - Google Patents
- Patent Claims Research Dataset - USPTO
- US5968895A - Pharmaceutical formulations for sustained drug delivery - Google Patents (French version)
- US-20070185032-A1 - Unified Patents Portal
