United States Patent 9,370,501: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 9,370,501, titled "Treatment of Pain with Topical Diclofenac," is a significant patent in the pharmaceutical industry, particularly in the realm of pain management. This patent, held by Horizon Pharma, protects a method for applying topical agents to treat pain, specifically using a formulation of diclofenac sodium. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent in question is part of a series of patents related to Pennsaid, a topical NSAID solution that contains 2% diclofenac sodium. This specific patent, U.S. Patent No. 9,370,501, focuses on a method for treating pain by applying a topical diclofenac formulation to a patient’s knee, among other treatment areas[1].
Scope of the Patent
The scope of U.S. Patent 9,370,501 is defined by its claims, which outline the specific methods and formulations protected under this patent. Here are the key aspects:
Method of Application
The patent describes a method for applying a topical diclofenac formulation to a patient’s knee. This method includes applying the gel formulation, waiting for the area to dry, and then applying sunscreen or insect repellent to the treated area. Additionally, it includes counseling the patient to avoid taking unprescribed acetaminophen while using the topical diclofenac formulation[1].
Formulation Composition
The protected formulation includes diclofenac sodium, along with a thickening agent and a polyhydric alcohol. This composition is designed to enhance the drying time, increase transdermal flux, and improve pharmacokinetic absorption compared to previous formulations[1].
Claims Analysis
The claims in U.S. Patent 9,370,501 are crucial as they define the boundaries of what is protected under this patent.
Independent Claims
The independent claims in this patent are broad and cover the core method of applying the topical diclofenac formulation. These claims are designed to capture the essential steps and components of the invention, ensuring comprehensive protection.
Dependent Claims
Dependent claims build upon the independent claims, adding specific details and limitations. For example, dependent claims might specify the concentration of diclofenac sodium, the type of thickening agent used, or the particular steps involved in the application process. These claims help to narrow down the scope and provide additional layers of protection[2].
Strategic Claim Management
The management of claims in this patent is a testament to the strategic approach often employed in patent filings. Here are some key strategies:
Maximizing Claim Count
The patent application includes a careful selection of claims to maximize the breadth and flexibility of the patent. This involves ensuring that the full quota of claims allowed by the filing fee is utilized, which in the U.S., can be up to 20 claims, including 3 independent claims[2].
Claim Consolidation
During the patent prosecution phase, claims may be amended or consolidated to align with the USPTO's requirements for patentability. This process can involve combining multiple dependent claims into broader independent claims, which helps in facilitating application approval and strengthening the patent's defensive capabilities[2].
Patent Landscape and Litigation
The patent landscape surrounding U.S. Patent 9,370,501 is complex, particularly given the involvement of generic drug manufacturers.
Paragraph IV Certifications
Generic drugmakers Actavis and Lupin filed ANDAs (Abbreviated New Drug Applications) with the FDA, challenging the validity and enforceability of the patents, including U.S. Patent No. 9,370,501. These filings included Paragraph IV certifications, asserting that the patents were either invalid or would not be infringed by the generic versions[1].
Litigation and Regulatory Approval
Horizon Pharma responded to these challenges by suing Actavis and Lupin, seeking monetary relief and a delay in the FDA approval of the generic formulations until the patents expire. This litigation highlights the ongoing battles in the pharmaceutical industry over patent rights and generic competition[1].
Impact on Innovation and Commercial Success
The protection afforded by U.S. Patent 9,370,501 has significant implications for innovation and commercial success.
Incentives for Innovation
Strong patent protection can incentivize further innovation by ensuring that the inventor or assignee can recoup their investment in research and development. This patent, by protecting a specific method and formulation, encourages continued research in pain management and topical NSAID solutions[3].
Commercial Success
The strategic management of claims in this patent enhances its value in licensing discussions and infringement disputes. By ensuring a robust and nuanced protection, Horizon Pharma can better defend its market position and negotiate favorable licensing agreements[2].
Key Takeaways
- Method of Application: The patent protects a specific method for applying a topical diclofenac formulation, including steps like drying the area and applying sunscreen or insect repellent.
- Formulation Composition: The protected formulation includes diclofenac sodium, a thickening agent, and a polyhydric alcohol, enhancing drying time, transdermal flux, and pharmacokinetic absorption.
- Strategic Claim Management: The patent employs a strategic approach to claim management, maximizing the number of claims and consolidating them to ensure broad and flexible protection.
- Patent Landscape: The patent is part of a complex landscape involving generic drug manufacturers and litigation over patent validity and enforceability.
- Impact on Innovation: Strong patent protection incentivizes innovation and ensures the inventor can recoup their investment in research and development.
FAQs
Q: What is the main focus of U.S. Patent 9,370,501?
A: The main focus is on a method for treating pain by applying a topical diclofenac formulation to a patient’s knee.
Q: What are the key components of the protected formulation?
A: The formulation includes diclofenac sodium, a thickening agent, and a polyhydric alcohol.
Q: Why is strategic claim management important in this patent?
A: It ensures the patent utilizes its full entitlement of claims, enhancing its breadth, flexibility, and defensive capabilities.
Q: What is the significance of Paragraph IV certifications in this context?
A: These certifications are made by generic drugmakers to assert that the patents are either invalid or will not be infringed by the generic versions.
Q: How does this patent impact innovation in pain management?
A: It incentivizes further innovation by protecting the inventor's method and formulation, allowing them to recoup their investment in research and development.
Sources
- Horizon Pharma sues Actavis, Lupin for Paragraph IV certifications ... - IP Watchdog
- Maximizing Patent Value: A Strategic Approach to Claim Management - Harrity & Harrity, LLP
- Patent Claims and Patent Scope - SSRN
- Search for patents - USPTO - United States Patent and Trademark Office
- Provisional Patent Applications: FAQ - Cooley GO
