United States Patent 8,871,241: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,871,241, titled "Injectable Sustained Release Delivery Devices," is a significant innovation in the field of pharmaceuticals, particularly in drug delivery systems. This patent, issued to pSivida US, Inc., outlines a novel approach to delivering drugs over an extended period through injectable devices. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Inventors and Assignees
The patent was invented by Chou Kang-Jye, Guo Hong, Ashton Paul, Shimizu Robert W., and Watson David A., and assigned to pSivida US, Inc.[2].
Patent Scope
Overview
The patent describes injectable drug delivery devices designed to release drugs over a sustained period. These devices consist of a core containing one or more drugs and one or more polymers, which may be surrounded by one or more polymer outer layers (coatings, skins, or outer layers)[1].
Core and Polymer Configuration
The core of the device can be formed by combining at least one polymer, at least one drug, and at least one liquid solvent to create a liquid suspension or solution. Upon injection, this suspension or solution undergoes a phase change and forms a gel, facilitating controlled release of the drug(s) for an extended period[1][2].
Manufacturing Process
The device can be manufactured through various methods, including extrusion. The process involves extruding a polymeric skin for the drug core, which can be co-extruded with the core or inserted into the skin after it has been extruded and possibly cured. The system may use multiple extruders to form composite co-extruded products with different materials and configurations[1].
Segmenting and Curing
After extrusion, the product is segmented into shorter lengths using a segmenting station. This station can employ various techniques such as pincers, shears, or slicing blades, depending on the desired configuration of the cut portions. The degree of curing can be controlled by adjusting the amount of energy applied by the curing station[1].
Patent Claims
Key Claims
The patent claims cover several key aspects of the invention:
- The composition of the drug delivery device, including the core and polymer coatings.
- The method of forming the device, such as extrusion and co-extrusion.
- The phase change mechanism that allows the suspension or solution to form a gel upon injection.
- The controlled release of the drug(s) over an extended period[1][2].
Specific Claim Details
The claims are detailed and specific, ensuring that the patent covers the unique aspects of the invention. For example, the claims include the use of specific polymers and drugs, the method of combining these components, and the resulting structure of the device[1].
Patent Landscape
Related Patents
The patent is part of a broader landscape of drug delivery system patents. For instance, U.S. Patent 6,375,972, referenced in the '241 patent, describes similar drug delivery devices using various combinations of drug cores and polymer coatings. Other related patents include U.S. Patents 8,815,284 and 8,574,659, also assigned to pSivida US, Inc.[1][4].
Exclusivity and Patent Term
The patent was issued on October 28, 2014, and is set to expire on August 12, 2027. This expiration date is typical for patents, which generally have a term of 20 years from the date of filing, subject to various factors such as development of new formulations and patent infringement litigation[2].
Generic Availability
As of the current date, there is no therapeutically equivalent generic version of the drug delivery device described in this patent available in the United States. This is due to the exclusive rights granted to the patent holder until the patent expires[2].
Intellectual Property Implications
Genus Claims and Enablement
The scope of patent claims in the pharmaceutical and biotechnology industries has been subject to significant scrutiny. The Federal Circuit’s recent jurisprudence on 35 U.S.C. § 112 has made it challenging to obtain valuable patent protection for drugs and biologics. The application of a heightened test for enablement and the broader application of the written description doctrine have introduced considerable uncertainty in drafting patent claims that capture the full scope of an invention without being too narrow or too broad[3].
Patent Protection Challenges
Innovators in this field face the dilemma of either claiming too broadly, which may not be commensurate with what is taught in the patent application, or claiming too narrowly, which allows competitors to design around the claims easily. This balance is crucial for meaningful patent protection in the pharmaceutical and biotechnology industries[3].
Practical Applications
Controlled Drug Release
The injectable sustained release delivery devices described in this patent offer significant advantages in controlled drug release. For example, the device can be used to deliver drugs such as fluocinolone acetonide over an extended period, which is particularly beneficial for treatments requiring long-term drug administration[1].
Clinical Implications
The controlled release mechanism ensures a consistent and predictable drug delivery profile, which can improve patient compliance and treatment outcomes. This technology is particularly relevant in ocular therapy, where sustained drug release can be crucial for managing chronic conditions[1][4].
Key Takeaways
- Innovative Drug Delivery: The patent introduces a novel method for injectable sustained release drug delivery using a core and polymer coating configuration.
- Manufacturing Process: The device can be manufactured through extrusion and co-extrusion techniques, with controlled curing and segmenting.
- Patent Claims: The claims are specific and detailed, covering the composition, formation method, and controlled release mechanism.
- Patent Landscape: The patent is part of a broader landscape of drug delivery system patents, with related patents and exclusivity rights.
- Intellectual Property: The patent faces challenges related to genus claims and enablement, highlighting the need for balanced claim drafting.
FAQs
Q: What is the main innovation described in U.S. Patent 8,871,241?
A: The main innovation is an injectable sustained release drug delivery device that uses a core containing one or more drugs and one or more polymers, surrounded by polymer coatings.
Q: How is the device manufactured?
A: The device is manufactured through extrusion or co-extrusion techniques, followed by curing and segmenting into shorter lengths.
Q: What is the significance of the phase change mechanism in this patent?
A: The phase change mechanism allows the liquid suspension or solution to form a gel upon injection, facilitating controlled release of the drug(s) over an extended period.
Q: When does the patent expire?
A: The patent is set to expire on August 12, 2027.
Q: Are there any generic versions of this drug delivery device available?
A: As of the current date, there are no therapeutically equivalent generic versions of this drug delivery device available in the United States.
Sources
- US8871241B2 - Injectable sustained release delivery devices - Google Patents
- Generic Iluvien Availability - Drugs.com
- Eviscerating Patent Scope - DigitalCommons@NYLS
- Patent 3057875 Summary - Canadian Patents Database
