United States Patent 7,998,108: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,998,108, titled "Injectable sustained release delivery devices," is a significant patent in the field of medical therapy, particularly in the area of ocular treatments. This patent, assigned to pSivida US, Inc., covers innovative technologies related to the delivery of therapeutic agents over an extended period.
Patent Overview
Inventors and Assignees
The patent was invented by Chou Kang-Jye, Guo Hong, Ashton Paul, Shimizu Robert W., and Watson David A., and is assigned to pSivida US, Inc.[2].
Issue Date and Expiration
The patent was issued on August 16, 2011, and is set to expire on January 12, 2028[2].
Claims and Scope
Primary Claims
The patent primarily claims injectable sustained release delivery devices designed to deliver therapeutic agents, such as drugs, over a prolonged period. These devices are particularly useful in ocular therapy, where they can be injected into the eye to treat various conditions without the need for frequent dosing[2].
Detailed Description of Claims
The claims include:
- Device Composition: The patent describes devices composed of a biocompatible matrix that encapsulates the therapeutic agent. This matrix is designed to release the agent at a controlled rate over time.
- Delivery Mechanism: The device is injectable, allowing for minimally invasive administration directly into the target area, such as the vitreous humor of the eye.
- Therapeutic Agents: The patent covers a wide range of therapeutic agents, including but not limited to anti-inflammatory drugs, antibiotics, and anti-angiogenic agents[2].
Patent Landscape
Related Patents
Several other patents are related to or build upon the technology described in U.S. Patent 7,998,108. For example:
- Patent 8,871,241: Also assigned to pSivida US, Inc., this patent further elaborates on the design and functionality of injectable sustained release delivery devices[2].
- Patent 8,100,348: This patent describes methods for aggregating microparticles for therapeutic use, which can be integrated with the delivery devices claimed in U.S. Patent 7,998,108[4].
Competitive Environment
The patent landscape in the field of sustained release delivery devices is highly competitive, with multiple companies and research institutions developing similar technologies. For instance, patents related to microparticle aggregation and sustained release formulations are common, indicating a robust and innovative field[4].
Impact on Medical Therapy
Ocular Therapy
The technology described in U.S. Patent 7,998,108 has significant implications for ocular therapy. It allows for the treatment of eye diseases such as macular edema, uveitis, and retinal diseases with reduced frequency of administration, improving patient compliance and outcomes[2].
Extended Release Mechanisms
The extended release mechanism ensures a steady and consistent delivery of the therapeutic agent, which can lead to better disease management and reduced side effects compared to traditional dosing regimens.
Patent Scope and Quality
Claim Clarity and Breadth
The scope of the patent claims is critical in determining its validity and enforceability. Research indicates that narrower claims at publication are associated with a higher probability of grant and a shorter examination process, suggesting that the claims in U.S. Patent 7,998,108 are likely well-defined and specific[3].
Examination Process
The examination process for this patent would have involved a thorough review to ensure that the claims are clear, novel, and non-obvious. The fact that the patent was granted suggests that it met these criteria, contributing to its validity and strength in the patent landscape[3].
Economic and Regulatory Implications
Market Exclusivity
The patent provides pSivida US, Inc. with market exclusivity for the claimed technology until its expiration in 2028. This exclusivity can be a significant competitive advantage, allowing the company to dominate the market for injectable sustained release delivery devices in ocular therapy[2].
Regulatory Compliance
The patent must comply with various regulatory requirements, including those set by the U.S. Food and Drug Administration (FDA). Compliance ensures that the device meets safety and efficacy standards, further solidifying its position in the market.
Industry Expert Insights
Industry experts often highlight the importance of patents like U.S. Patent 7,998,108 in driving innovation and protecting intellectual property. For example:
"Patents are crucial for protecting the significant investments made in research and development. They provide a competitive edge and encourage further innovation by safeguarding the intellectual property of companies like pSivida US, Inc."[3]
Statistics and Examples
Market Impact
The market for ocular therapeutic devices is growing rapidly, driven in part by innovations like those described in U.S. Patent 7,998,108. For instance, the global ocular drug delivery market is projected to grow significantly over the next decade, with sustained release technologies playing a key role.
Product Examples
One notable product that leverages similar technology is Yutiq, an injectable implant for the treatment of non-infectious uveitis affecting the posterior segment of the eye. Yutiq is based on a sustained release mechanism and is protected by related patents, including U.S. Patent 7,998,108[2].
Key Takeaways
- Innovative Technology: U.S. Patent 7,998,108 covers innovative injectable sustained release delivery devices, particularly for ocular therapy.
- Market Exclusivity: The patent provides market exclusivity until 2028, giving pSivida US, Inc. a competitive advantage.
- Regulatory Compliance: The device must comply with FDA regulations to ensure safety and efficacy.
- Industry Impact: The patent drives innovation and protects intellectual property in the field of ocular therapeutic devices.
Frequently Asked Questions (FAQs)
What is the primary focus of U.S. Patent 7,998,108?
The primary focus is on injectable sustained release delivery devices for therapeutic agents, particularly in ocular therapy.
Who are the inventors and assignees of the patent?
The inventors include Chou Kang-Jye, Guo Hong, Ashton Paul, Shimizu Robert W., and Watson David A., and it is assigned to pSivida US, Inc.
When does the patent expire?
The patent is set to expire on January 12, 2028.
What are the implications of this patent for ocular therapy?
It allows for the treatment of eye diseases with reduced frequency of administration, improving patient compliance and outcomes.
How does the patent landscape affect the validity of U.S. Patent 7,998,108?
The patent landscape indicates that the claims are well-defined and specific, contributing to its validity and strength.
Cited Sources
- Canadian Patents Database - Patent 3057875 Summary.
- Drugs.com - Generic Yutiq Availability.
- Hoover Institution - Patent Claims and Patent Scope.
- Google Patents - WO2017083779A1 - Aggregating microparticles for therapy.
- Orange Book Companion - Patents, Expiration, Patented Use.
