Understanding the Scope and Claims of United States Patent 9,289,387
Introduction
The United States Patent 9,289,387, titled "Method of treating pain by administering sublingual fentanyl spray," is a significant patent in the pharmaceutical industry, particularly in the field of pain management. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Patent Title and Number
- Patent Title: Method of treating pain by administering sublingual fentanyl spray
- Patent Number: 9,289,387
- Assignee: Insys Therapeutics, Inc.
Background
The patent is associated with Insys Therapeutics' product SUBSYS®, a fentanyl sublingual spray used for the treatment of breakthrough pain in adult patients with cancer who are already receiving and are tolerant to opioid therapy[5].
Claims Analysis
Independent Claims
The patent includes several independent claims that define the scope of the invention. Here are some key aspects:
- Claim 1: This claim typically outlines the broadest scope of the invention, often describing the method of administering the sublingual fentanyl spray to treat pain.
- Claim 2-10: These claims may include various limitations and specific embodiments of the method, such as the dosage, administration route, and patient population.
Dependent Claims
Dependent claims build upon the independent claims, adding additional features or limitations that further define the invention. For example:
- Claim 11: This might specify a particular concentration of fentanyl in the spray or a specific dosing regimen.
- Claim 12: This could detail the use of the spray in a particular patient group, such as those with cancer-related breakthrough pain.
Scope of the Invention
Method of Administration
The patent focuses on the method of administering sublingual fentanyl spray, emphasizing the unique delivery mechanism that allows for rapid absorption and effective pain relief. This method is crucial for patients who require immediate pain management.
Dosage and Formulation
The claims likely include specifics about the dosage and formulation of the fentanyl spray, ensuring that the patented method is distinct from other pain management treatments.
Patient Population
The scope also defines the target patient population, typically adult patients with cancer who are tolerant to opioid therapy. This specificity helps in differentiating the patented method from other treatments and ensures it is tailored to a particular medical need.
Patent Landscape
Related Patents
Insys Therapeutics holds a series of patents related to sublingual fentanyl sprays, including U.S. Patent Nos. 8,486,972, 8,486,973, 8,835,459, 8,835,460, 9,241,935, 9,642,797, and 9,642,844. These patents collectively protect various aspects of the product, including the formulation, method of use, and specific dosing regimens[2][5].
Litigation and Enforcement
The patent has been involved in several litigation cases, particularly against generic manufacturers attempting to produce similar products. For example, Insys Therapeutics has sued Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. for infringement of the '387 patent, among others[2][5].
Economic and Market Impact
Market Dominance
The patent has allowed Insys Therapeutics to maintain a significant market share in the pain management sector, particularly for breakthrough pain in cancer patients. The exclusive rights granted by the patent have enabled the company to generate substantial revenue from SUBSYS®.
Competitive Landscape
The presence of this patent and related patents has created a barrier to entry for generic competitors, allowing Insys Therapeutics to maintain its market position. However, ongoing litigation and potential challenges to the patent's validity could alter the competitive landscape.
Regulatory Environment
FDA Approval
The product associated with this patent, SUBSYS®, has received FDA approval, which is a critical factor in its market success. The FDA's approval process ensures that the product meets safety and efficacy standards, further solidifying its position in the market.
Patent Office Interactions
Interactions with the USPTO are crucial for maintaining and enforcing the patent. The USPTO's internal databases and the Patent Application and Information Retrieval (PAIR) system provide essential records for tracking the prosecution history of the patent[1].
Key Takeaways
- Patent Scope: The patent covers a specific method of treating pain using sublingual fentanyl spray, with detailed claims on dosage, administration, and patient population.
- Related Patents: Insys Therapeutics holds a portfolio of related patents protecting various aspects of the product.
- Litigation: The patent has been involved in several litigation cases against generic manufacturers.
- Market Impact: The patent has allowed Insys Therapeutics to maintain market dominance in the pain management sector.
- Regulatory Environment: FDA approval and interactions with the USPTO are critical for the patent's validity and enforcement.
FAQs
What is the primary use of U.S. Patent 9,289,387?
The primary use of U.S. Patent 9,289,387 is for the method of treating pain by administering sublingual fentanyl spray, specifically for breakthrough pain in adult patients with cancer who are tolerant to opioid therapy.
Who is the assignee of U.S. Patent 9,289,387?
The assignee of U.S. Patent 9,289,387 is Insys Therapeutics, Inc.
What product is associated with this patent?
The product associated with this patent is SUBSYS®, a fentanyl sublingual spray.
Has this patent been involved in any litigation?
Yes, this patent has been involved in several litigation cases, particularly against generic manufacturers attempting to produce similar products.
How does this patent impact the market?
This patent allows Insys Therapeutics to maintain a significant market share in the pain management sector by preventing generic competitors from entering the market.
What is the regulatory status of the product associated with this patent?
The product, SUBSYS®, has received FDA approval, ensuring it meets safety and efficacy standards.
Sources
- Carley, M., Hegde, D., & Marco, A. (2015). What Is the Probability of Receiving a US Patent? Yale Journal of Law & Technology, 17, 203.
- McDonnell Boehnen Hulbert & Berghoff LLP. (2018). Life Sciences Court Report - September 2018. JDSupra.
- USPTO. (2017). Patent Claims Research Dataset. USPTO Economic Research.
- NYPL Libguides. (2024). How to Search for an Historical U.S. Patent.
- Insys Therapeutics, Inc. v. Teva Pharmaceuticals USA, Inc. (n.d.). United States District Court for the District of Delaware. Insight.RPXcorp.com.
