Detailed Analysis of the Scope and Claims of United States Patent 8,043,628
Introduction
The United States Patent 8,043,628, titled "Ocular Implant Made by a Double Extrusion Process," is a significant patent in the field of ophthalmology, particularly concerning the development and manufacture of ocular implants. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
This patent, assigned to Allergan, Inc., describes a method for creating biodegradable ocular implants using a double extrusion process. The implants are designed to deliver active agents into the ocular region without a high burst release, which is crucial for maintaining therapeutic efficacy over an extended period.
Scope of the Patent
The scope of the patent encompasses the following key aspects:
Biodegradable Implants
The patent focuses on biodegradable implants made from a mixture of hydrophilic and hydrophobic ends of poly(lactic-co-glycolic acid) (PLGA). This material selection ensures the implants degrade over time, eliminating the need for surgical removal[1].
Double Extrusion Process
The double extrusion process is a novel method for manufacturing these implants. This process involves extruding two different materials simultaneously to create a uniform and consistent implant structure. This method helps in achieving a controlled release of the active agents[1].
Ocular Region
The implants are specifically designed for implantation in the ocular region, addressing various medical conditions of the eye. The controlled release mechanism ensures that the therapeutic agents are delivered effectively and safely[1].
Claims of the Patent
The patent includes several claims that define the invention's scope:
Composition of the Implant
Claims specify the composition of the implant, including the use of PLGA and the ratio of hydrophilic to hydrophobic ends. This ensures the implant's biodegradability and controlled release properties[1].
Manufacturing Process
Claims detail the double extrusion process, including the steps and conditions necessary to produce the implants. This process is critical for achieving the desired physical and chemical properties of the implants[1].
Delivery Mechanism
Claims describe the mechanism by which the active agents are delivered into the ocular region. This includes the absence of a high burst release, ensuring sustained therapeutic efficacy[1].
Patent Landscape Analysis
Saturation of the Patent Space
The patent space for ocular implants is relatively saturated, with numerous patents and patent applications filed over the years. This saturation indicates a highly competitive and innovative field, where new entrants must navigate existing intellectual property to avoid infringement and find novel solutions[3].
Competitors and Existing Patents
Several companies, including Allergan, Inc., have a significant presence in this patent space. The expiration of patents like US8,043,628 (which expired in November 2023) opens up opportunities for new entrants but also highlights the need for continuous innovation to maintain a competitive edge[4].
Strategic Insights
A comprehensive patent landscape analysis reveals that companies in this space are continually developing new technologies and improving existing ones. For instance, the focus on biodegradable materials and controlled release mechanisms is a trend that is likely to continue. This analysis helps in making strategic decisions about research and development, patent prosecution, and market entry[3].
Impact of Patent Expiration
The expiration of the US8,043,628 patent, along with other related patents, has significant implications:
Generic and Biosimilar Entries
The expiration allows for the potential entry of generic or biosimilar versions of the ocular implants, which could reduce costs and increase accessibility for patients[4].
Innovation and Competition
The expiration also encourages further innovation as companies seek to develop new and improved ocular implant technologies to fill the gap left by expired patents[3].
Key Takeaways
- Biodegradable Implants: The patent focuses on biodegradable ocular implants made from PLGA, ensuring controlled release of therapeutic agents.
- Double Extrusion Process: The novel manufacturing process is crucial for the uniform and consistent production of these implants.
- Ocular Region: The implants are designed for the ocular region, addressing various eye conditions.
- Patent Landscape: The patent space is saturated, with ongoing innovation and competition.
- Expiration Implications: The expiration of this and related patents opens up opportunities for generic entries and further innovation.
Frequently Asked Questions (FAQs)
Q1: What is the main focus of the US8,043,628 patent?
A1: The main focus is on biodegradable ocular implants made using a double extrusion process.
Q2: What material is used in the implants described in the patent?
A2: The implants are made from a mixture of hydrophilic and hydrophobic ends of poly(lactic-co-glycolic acid) (PLGA).
Q3: What is the significance of the double extrusion process?
A3: The double extrusion process ensures the uniform and consistent production of implants with controlled release properties.
Q4: What are the implications of the patent's expiration?
A4: The expiration allows for the entry of generic or biosimilar versions and encourages further innovation in ocular implant technologies.
Q5: How does the patent landscape analysis help in this field?
A5: It provides strategic insights into the saturation level of the patent space, guiding decisions on research, development, and patent prosecution.
Sources Cited
- United States Patent and Trademark Office, "Ocular Implant Made by a Double Extrusion Process," US Patent 10,702,539 B2, July 7, 2020.
- United States Patent and Trademark Office, "Patent and Trademark Office Notices," Official Gazette, Week 07, 2012.
- AcclaimIP, "Patent Landscape Analysis - Uncovering Strategic Insights," Patent Landscape Analysis.
- Pharsight, "Ozurdex Patent Expiration," Drug Patent Expiration Dates.
