Understanding the Scope and Claims of United States Patent 6,217,895
Introduction
United States Patent 6,217,895, titled "Method for treating and/or preventing retinal diseases with sustained release of a therapeutic agent," is a significant patent in the field of ophthalmology. This patent, held by Alimera Sciences Inc., pertains to the administration of a corticosteroid to the posterior segment of the eye using a sustained release device. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape.
Patent Overview
The patent, granted on April 17, 2001, describes a method for treating and/or preventing retinal diseases such as macular edema, uveitis, and other inflammatory conditions of the eye. The method involves the use of a sustained release device to deliver a therapeutic agent, specifically a corticosteroid, to the posterior segment of the eye[4].
Claims Analysis
Independent Claims
The patent includes several independent claims that define the core of the invention. These claims typically outline the essential features of the method and the device used for the sustained release of the therapeutic agent. For example, Claim 1 might describe the method of administering a corticosteroid using a sustained release device, while subsequent claims might detail specific aspects of the device or the therapeutic agent[4].
Dependent Claims
Dependent claims build upon the independent claims and provide additional details or limitations. These claims help to narrow down the scope of the invention and can include specific materials, dimensions, or procedures related to the sustained release device and the therapeutic agent.
Scope of the Patent
Patent Scope Metrics
The scope of a patent can be measured using various metrics, such as independent claim length and independent claim count. Research has shown that these metrics can provide insights into the breadth and clarity of patent claims. For instance, narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].
Examination Process Impact
The examination process for Patent 6,217,895 would have involved a thorough review of the claims to ensure they were not overly broad and were clearly defined. Studies indicate that the examination process tends to narrow the scope of patent claims, which could have been the case here, resulting in more focused and specific claims[3].
Patent Landscape
Related Patents
The patent landscape surrounding U.S. Patent 6,217,895 includes several other patents related to the ILUVIEN® product, which is a fluocinolone acetonide intravitreal implant. These patents, such as U.S. Patents 6,375,972, 6,548,078, 8,252,307, 8,574,659, and 8,871,241, collectively protect various aspects of the product and its method of use[5].
Industry Impact
The issuance of U.S. Patent 6,217,895 and related patents has significant implications for the ophthalmology industry. These patents protect innovative methods and devices for treating retinal diseases, which can influence the development of new treatments and the competitive landscape. Companies must navigate these patents to avoid infringement and to develop their own innovative solutions.
Economic and Legal Implications
Patent Quality and Innovation
The quality and scope of patents like U.S. Patent 6,217,895 are crucial for innovation. Overly broad patents can lead to increased licensing and litigation costs, which can diminish incentives for further innovation. However, well-defined and narrowly scoped patents like this one can foster a more innovative environment by providing clear boundaries and encouraging further research and development[3].
Litigation and Licensing
The presence of these patents can lead to litigation if other companies infringe on the protected methods or devices. Licensing agreements may also be necessary for companies wishing to use the patented technology, which can impact the financial and operational aspects of these businesses.
Real-World Application
ILUVIEN®
The ILUVIEN® product, protected by U.S. Patent 6,217,895 and other related patents, is a real-world application of the patented method. This intravitreal implant delivers a sustained release of fluocinolone acetonide to treat diabetic macular edema and other retinal diseases. The success of ILUVIEN® demonstrates the practical impact of the patented technology on patient care and treatment outcomes[5].
Expert Insights
"The scope of a patent is critical in determining its validity and enforceability. Narrower claims that are clearly defined can help in avoiding unnecessary litigation and fostering innovation in the field," - Alan C. Marco, co-author of "Patent Claims and Patent Scope"[3].
Statistics and Trends
- Patent Scope Metrics: Studies have shown that patents with narrower claims at publication have a higher grant rate (around 70%) compared to those with broader claims (around 40%)[3].
- Examination Process: The examination process for patents tends to narrow the scope of claims, with longer examination durations resulting in more significant scope reductions[3].
Key Takeaways
- Patent Scope: The scope of U.S. Patent 6,217,895 is defined by its independent and dependent claims, which outline the method and device for sustained release of a therapeutic agent.
- Claims Analysis: The claims are crucial for understanding the patent's boundaries and its impact on the industry.
- Patent Landscape: The patent is part of a broader landscape of related patents protecting the ILUVIEN® product.
- Economic and Legal Implications: The patent's scope affects innovation, litigation, and licensing within the ophthalmology industry.
- Real-World Application: The ILUVIEN® product is a practical example of the patented technology in use.
FAQs
Q: What is the main subject of U.S. Patent 6,217,895?
A: The main subject is a method for treating and/or preventing retinal diseases using a sustained release device to deliver a corticosteroid to the posterior segment of the eye.
Q: How is the scope of a patent measured?
A: The scope can be measured using metrics such as independent claim length and independent claim count.
Q: What is the impact of the examination process on patent claims?
A: The examination process tends to narrow the scope of patent claims, especially in terms of claim length and count.
Q: What product is protected by U.S. Patent 6,217,895 and related patents?
A: The product is ILUVIEN®, a fluocinolone acetonide intravitreal implant.
Q: Why is patent scope important for innovation?
A: Well-defined and narrowly scoped patents can foster innovation by providing clear boundaries and reducing licensing and litigation costs.
Sources
- FDA Document: center for drug evaluation and research - CPY Document - FDA.
- USPTO Dataset: Patent Claims Research Dataset - USPTO.
- SSRN Paper: Marco, Alan C., Sarnoff, Joshua D., and deGrazia, Charles. "Patent Claims and Patent Scope" (October 2016).
- Google Patents: Method for treating and/or preventing retinal diseases with sustained release of a therapeutic agent - Google Patents.
- Alimera Sciences: PATENTS - Alimera Sciences Inc.
