Understanding the Scope and Claims of United States Patent 10,085,958: A Detailed Analysis
Introduction
United States Patent 10,085,958, titled "Bromfenac bioavailability," is a significant patent in the pharmaceutical industry, particularly in the field of ophthalmic medications. This patent, owned by Bausch and Lomb Inc., protects formulations and methods related to bromfenac, a nonsteroidal anti-inflammatory drug (NSAID) used in eye care. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Overview of the Patent
Patent Title and Number
The patent in question is US10085958B2, titled "Bromfenac bioavailability." It was granted to protect specific formulations and methods of administering bromfenac, a key ingredient in ophthalmic solutions like BROMDAY™[4].
Scope of the Patent
Active Ingredient and Formulation
The patent focuses on bromfenac, a potent NSAID used to treat inflammation and pain following cataract surgery. The scope includes the formulation of a topical ophthalmic bromfenac 0.09% solution, which is designed to enhance bioavailability and efficacy in treating ocular conditions[4].
Bioavailability Enhancements
A critical aspect of this patent is the method of enhancing the bioavailability of bromfenac. Bioavailability refers to the extent to which the body can absorb and utilize the drug. The patent describes specific formulations and delivery methods that improve the absorption of bromfenac into the eye, thereby increasing its therapeutic effectiveness[4].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims are crucial as they outline what is protected under the patent. For example, Claim 1 might describe the composition of the bromfenac formulation, while subsequent claims might detail the method of administration or the specific concentrations of bromfenac used[4].
Dependent Claims
Dependent claims build upon the independent claims and provide additional specificity. These claims often describe variations or additional features of the invention that are still within the scope of the independent claims. For instance, a dependent claim might specify the use of a particular excipient or the pH range of the formulation[4].
Metrics for Measuring Patent Scope
Independent Claim Length and Count
Research on patent scope suggests that metrics such as independent claim length and independent claim count can be useful in understanding the breadth of a patent. Shorter independent claims and fewer claims generally indicate a narrower patent scope, which can be associated with a higher probability of grant and shorter examination processes[3].
Patent Landscape and Exclusivities
Patent Expiration and Generic Launch
The patent landscape for bromfenac formulations is complex, with multiple patents protecting different aspects of the drug. The generic launch date for bromfenac formulations is estimated to be around November 11, 2033, based on the expiration of key patents, including US9517220 and US10085958B2[1].
Litigation History
Prolensa, another product containing bromfenac, has been involved in various patent litigations. These litigations can impact the generic launch date if any of the patents are invalidated. For example, patents like US8669290 and US8754131 have been challenged by companies such as Lupin Ltd. and InnoPharma Licensing, Inc.[1].
Economic and Legal Implications
Patent Quality and Innovation
The quality and scope of patents can significantly influence innovation and litigation costs. Broader patents with less clarity can lead to increased licensing and litigation costs, potentially diminishing incentives for innovation. The metrics used to measure patent scope can help in assessing the impact of such patents on the industry[3].
Small Claims Patent Court
There is ongoing discussion about the establishment of a small claims patent court to address the high costs associated with patent litigation. This initiative aims to provide a more accessible and cost-effective way for small entities to resolve patent disputes, which could impact the landscape of pharmaceutical patents like US10085958B2[5].
Industry Expert Insights
Quotes and Perspectives
Industry experts often highlight the importance of patent scope and claims in protecting intellectual property while fostering innovation. For instance, Alan Marco, former Chief Economist for the USPTO, has emphasized the need for well-defined measurements of patent scope to ensure that patents do not overly broaden or diminish innovation incentives[3].
Illustrative Statistics
Patent Maintenance and Litigation Costs
Statistics show that narrower claims at publication are associated with a higher probability of grant and a shorter examination process. For example, a study by the USPTO found that patents with fewer independent claims had a higher grant rate and lower litigation costs[3].
Examples and Case Studies
BROMDAY™ and Prolensa
BROMDAY™, a commercially available topical ophthalmic bromfenac 0.09% solution, is a prime example of a product protected under this patent. Prolensa, another bromfenac-based product, has been subject to various litigations, highlighting the complexities and challenges in the patent landscape for ophthalmic NSAIDs[1][4].
Key Takeaways
- Patent Scope and Claims: The patent US10085958B2 protects specific formulations and methods of administering bromfenac, with a focus on enhancing bioavailability.
- Metrics for Patent Scope: Independent claim length and count are useful metrics for understanding the breadth of a patent.
- Patent Expiration and Litigation: The generic launch date is estimated to be around November 11, 2033, and ongoing litigations could impact this timeline.
- Economic and Legal Implications: The quality and scope of patents significantly influence innovation and litigation costs.
- Industry Insights: Experts emphasize the importance of well-defined patent scope measurements to foster innovation.
FAQs
Q: What is the primary focus of United States Patent 10,085,958?
A: The primary focus is on the formulation and methods of enhancing the bioavailability of bromfenac, an ophthalmic NSAID.
Q: How do independent claim length and count affect patent scope?
A: Shorter independent claims and fewer claims generally indicate a narrower patent scope, associated with a higher probability of grant and shorter examination processes.
Q: What is the estimated generic launch date for bromfenac formulations?
A: The estimated generic launch date is around November 11, 2033, based on the expiration of key patents.
Q: Why is the litigation history of Prolensa relevant to this patent?
A: Litigations involving Prolensa can impact the generic launch date if any of the patents are invalidated, affecting the broader patent landscape for bromfenac formulations.
Q: How might a small claims patent court impact pharmaceutical patents?
A: A small claims patent court could provide a more accessible and cost-effective way for small entities to resolve patent disputes, potentially reducing litigation costs and fostering innovation.
Sources
- Pharsight: Prolensa patent expiration.
- USPTO: Patent Claims Research Dataset.
- SSRN: Patent Claims and Patent Scope.
- Google Patents: US10085958B2 - Bromfenac bioavailability.
- ACUS: U.S. Patent Small Claims Court.
