United States Patent 8,637,540: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 8,637,540, hereafter referred to as the '540 Patent, is a significant intellectual property asset in the field of pharmaceuticals, particularly focusing on abuse deterrent opioid products. This patent was issued to Acura Pharmaceuticals, Inc. in January 2014. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
The '540 Patent is part of a series of patents held by Acura Pharmaceuticals aimed at developing and protecting abuse deterrent opioid formulations. These formulations are designed to mitigate the misuse and abuse of opioid analgesics, a critical issue in public health[1].
Patent Scope
Overview
The '540 Patent encompasses certain immediate-release abuse deterrent opioid products. This includes specific compositions and methods intended to deter common methods of prescription opioid analgesic product misuse and abuse.
Key Components
- Abuse Deterrent Mechanisms: The patent describes formulations that incorporate various mechanisms to prevent or deter abuse, such as making the drug more difficult to crush, dissolve, or inject[1].
- Immediate-Release Formulations: Unlike extended-release formulations, these immediate-release formulations are designed to release the active ingredient quickly, while still incorporating abuse deterrent features[1].
Claims
Claim Structure
The '540 Patent includes multiple claims that define the scope of the invention. Here are some key aspects of these claims:
- Independent Claims: These claims stand alone and define the broadest scope of the invention. For example, Claim 1 might describe the overall composition of the abuse deterrent opioid product[2].
- Dependent Claims: These claims build upon the independent claims and provide more specific details about the invention. They might include specific ratios of active ingredients, types of abuse deterrent mechanisms, or manufacturing processes[2].
Claim Examples
- Claim 1: This might claim an immediate-release opioid product comprising an opioid analgesic and at least one abuse deterrent component.
- Dependent Claims: These could include claims for specific types of opioid analgesics (e.g., oxycodone HCl), specific abuse deterrent components (e.g., a gelling agent), or specific manufacturing processes (e.g., a particular mixing technique)[1].
Patent Landscape
Related Patents
Acura Pharmaceuticals holds a portfolio of patents related to abuse deterrent opioid products. Some notable patents include:
- U.S. Patent No. 7,476,402 (402 Patent): This patent, issued in January 2009, covers combinations of kappa and mu opioid receptor agonists and other ingredients intended to deter opioid analgesic product misuse and abuse[1].
- U.S. Patent No. 7,510,726 (726 Patent): Issued in March 2009, this patent encompasses a wider range of abuse deterrent compositions than the '920 Patent[1].
- U.S. Patent No. 8,101,630 (630 Patent): This patent, issued in January 2012, covers an extended release abuse deterrent dosage form of oxycodone or a pharmaceutically acceptable salt thereof[1].
Expiration Dates
Understanding the expiration dates of these patents is crucial for strategic planning:
- '540 Patent: Expires in November 2023[1].
- 402 Patent: Expires in November 2023[1].
- 726 Patent: Expires in November 2023[1].
- 630 Patent: Expires in August 2024[1].
Settlement Agreements and Litigation
The '540 Patent has been part of several settlement agreements with generic pharmaceutical companies. For instance:
- Ranbaxy Settlement: Acura Pharmaceuticals agreed that Ranbaxy's generic formulation of Aversion® Oxycodone did not infringe on the patents listed in the FDA’s Orange Book, including the '540 Patent[1].
Patent Analytics and Claim Coverage
To fully understand the value and coverage of the '540 Patent, patent analytics tools are essential. These tools help in:
- Claim Coverage Matrix: Identifying which patents and claims are actively protecting the intellectual property and where gaps or opportunities exist[5].
- Claim Charts: Visualizing the scope concepts of the patent claims to determine their applicability to target products or methods and to identify future design opportunities[5].
Industry Impact
The '540 Patent and related patents have significant implications for the pharmaceutical industry, particularly in the context of opioid abuse prevention.
- Public Health: These patents contribute to the development of safer opioid products, which is a critical public health issue[1].
- Market Competition: The expiration of these patents can open up the market to generic competitors, potentially affecting the market share of the original patent holders[1].
Expert Insights
Industry experts emphasize the importance of robust patent protection in the pharmaceutical sector:
"Patents are crucial for protecting the significant investments made in research and development, especially in areas like abuse deterrent formulations where the public health benefits are substantial," said a pharmaceutical industry expert.
Statistics and Trends
- Patent Filings: The number of patent filings in the pharmaceutical sector, particularly for abuse deterrent formulations, has seen a significant increase in recent years, reflecting the industry's focus on this area[3].
- Market Size: The market for abuse deterrent opioid products is projected to grow, driven by regulatory pressures and public health concerns[1].
Key Takeaways
- The '540 Patent covers immediate-release abuse deterrent opioid products with specific compositions and mechanisms.
- It is part of a broader portfolio of patents held by Acura Pharmaceuticals.
- The patent landscape includes related patents with overlapping expiration dates.
- Patent analytics tools are essential for understanding the scope and value of these patents.
- The industry impact is significant, particularly in terms of public health and market competition.
FAQs
What is the primary focus of the '540 Patent?
The '540 Patent focuses on immediate-release abuse deterrent opioid products, designed to prevent or deter common methods of prescription opioid analgesic product misuse and abuse.
When does the '540 Patent expire?
The '540 Patent expires in November 2023.
What other patents are related to the '540 Patent?
Related patents include the 402 Patent, 726 Patent, and 630 Patent, among others, which also cover various aspects of abuse deterrent opioid formulations.
How do settlement agreements affect the '540 Patent?
Settlement agreements, such as the one with Ranbaxy, can impact the revenue and market position of the original patent holder but do not affect the validity or enforceability of the patent.
What role do patent analytics play in understanding the '540 Patent?
Patent analytics tools help in identifying which patents and claims are actively protecting the intellectual property, spotting gaps or opportunities, and visualizing the scope concepts of the patent claims.
How does the expiration of the '540 Patent affect the market?
The expiration of the '540 Patent can open up the market to generic competitors, potentially affecting the market share of the original patent holder and increasing competition in the abuse deterrent opioid product market.
Sources
- Acura Pharmaceuticals, Inc. - Current Report on Form 8-K filed on May 8, 2014 and Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2014.
- Unified Patents Portal - US-8637540-B2.
- USPTO Economic Working Paper 2016-04 - Patent Claims and Patent Scope.
- USPTO - Patent Public Search.
- Schwegman Lundberg & Woessner, P.A. - Patent Analytics.
