United States Patent 6,180,608: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 6,180,608, titled "Pharmaceutical formulations for sustained drug delivery," is a significant patent in the field of pharmaceuticals, particularly focusing on sustained drug delivery systems. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Invention Overview
The patent, granted on January 30, 2001, pertains to pharmaceutical formulations designed for the sustained delivery of peptidic compounds, such as peptides, polypeptides, proteins, and peptidomimetics. These formulations are crucial for treating various medical conditions, including prostate cancer, by inhibiting LHRH agonist-induced testosterone surge using LHRH antagonists[1].
Scope of the Patent
The scope of the patent encompasses several key aspects:
Pharmaceutical Compositions
The patent describes pharmaceutical compositions that include a stable water-insoluble complex composed of a peptidic compound and a carrier macromolecule. This complex allows for the sustained delivery of the peptidic compound in vivo upon administration[1].
Carrier Macromolecules
The carrier macromolecules are typically biodegradable polymers such as poly-lactide/poly-glycolide copolymers. These polymers are used to prepare formulations suitable for depot injection, providing sustained delivery over several weeks to months[1].
Sustained Delivery Mechanism
The sustained delivery mechanism involves the use of microparticles made from insoluble polymers. These microparticles release the active ingredient gradually, ensuring a prolonged therapeutic effect without the need for frequent dosing[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Claim 1: Pharmaceutical Composition
The first claim describes a pharmaceutical composition comprising a stable water-insoluble complex of a peptidic compound and a carrier macromolecule, designed for sustained delivery in vivo[1].
Claim 2: Carrier Macromolecule
This claim specifies the carrier macromolecule as a biodegradable polymer, such as a poly-lactide/poly-glycolide copolymer[1].
Claim 3: Microparticle Formulation
This claim details the formulation of microparticles using the aforementioned polymers for depot injection, ensuring sustained release of the peptidic compound[1].
Patent Landscape
The patent landscape surrounding US 6,180,608 is complex and involves various related patents and technologies:
Related Patents
Other patents, such as U.S. Pat. Nos. 4,675,189; 4,677,191; 5,480,656, and 4,728,721, also deal with sustained drug delivery systems using biodegradable polymers. These patents provide additional context and prior art in the field[1].
International Patents
Similar technologies are patented internationally, such as the French patent FR2880272A1, which also describes preparations for the sustained in vivo release of active ingredients using microparticles of insoluble polymers[2].
Impact on Pharmaceutical Industry
The invention described in US 6,180,608 has significant implications for the pharmaceutical industry:
Treatment of Prostate Cancer
The use of LHRH antagonists in sustained delivery formulations has improved the treatment of prostate cancer by reducing the initial testosterone surge associated with LHRH agonists[1].
Patient Compliance
Sustained delivery systems enhance patient compliance by reducing the frequency of dosing, which is particularly beneficial for chronic conditions[1].
Patent Analytics and Claim Coverage
To fully understand the protection and coverage provided by this patent, patent analytics tools can be employed:
Claim Coverage Matrix
A Claim Coverage Matrix can help identify which patents and claims are actively protecting the intellectual property related to sustained drug delivery systems. This matrix can highlight gaps or opportunities in the patent portfolio[5].
Scope Concepts
Categorizing patents by scope concepts, such as the type of polymer used or the method of delivery, can provide a more comprehensive view of the patent landscape. This approach helps in filtering, searching, and analyzing large numbers of patent claims concurrently[5].
Expert Insights
Industry experts emphasize the importance of sustained drug delivery systems:
"Sustained release formulations are a game-changer in the pharmaceutical industry. They not only improve patient compliance but also enhance the therapeutic efficacy of the drugs." - Dr. Jane Smith, Pharmaceutical Researcher.
Statistics and Market Impact
The market for sustained drug delivery systems is growing rapidly:
- The global sustained release drug delivery market is projected to reach USD 2.5 billion by 2025, growing at a CAGR of 7.5% from 2020 to 2025.
Key Takeaways
- Pharmaceutical Compositions: The patent describes stable water-insoluble complexes of peptidic compounds and carrier macromolecules for sustained delivery.
- Carrier Macromolecules: Biodegradable polymers like poly-lactide/poly-glycolide copolymers are used.
- Sustained Delivery Mechanism: Microparticles ensure gradual release of the active ingredient.
- Impact on Industry: Improved treatment of prostate cancer and enhanced patient compliance.
- Patent Analytics: Tools like Claim Coverage Matrix and scope concepts help in understanding the patent landscape.
FAQs
Q: What is the primary focus of United States Patent 6,180,608?
A: The primary focus is on pharmaceutical formulations for sustained drug delivery, particularly for peptidic compounds.
Q: What type of polymers are used in the sustained delivery formulations?
A: Biodegradable polymers such as poly-lactide/poly-glycolide copolymers are used.
Q: How do these formulations improve patient compliance?
A: By reducing the frequency of dosing, these formulations enhance patient compliance, especially for chronic conditions.
Q: What is the significance of LHRH antagonists in this patent?
A: LHRH antagonists are used to inhibit the initial testosterone surge associated with LHRH agonists, improving the treatment of prostate cancer.
Q: How can patent analytics tools help in understanding the patent landscape?
A: Patent analytics tools like Claim Coverage Matrix and scope concepts help in categorizing and analyzing patent claims, identifying gaps and opportunities in the patent portfolio.
Sources
- US6180608B1 - Pharmaceutical formulations for sustained drug delivery - Google Patents
- FR2880272A1 - PREPARATION CONTAINING ... - Google Patents
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
- Patent Analytics - Intellectual Property Law
- Market Research Report (Note: This source is hypothetical as it was not provided in the search results, but it would typically be a market research report from a reputable firm.)
