United States Patent 9,474,750: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 9,474,750, titled "Opioid agonist/opioid antagonist/acetaminophen combinations," is a significant patent in the pharmaceutical industry, particularly in the field of pain management. This patent, issued to address the complexities of opioid therapy, combines opioid agonists, opioid antagonists, and acetaminophen to create safer and more effective oral dosage forms.
Background
The patent addresses a critical need in the pharmaceutical industry by providing a formulation that reduces the risks associated with opioid use, such as respiratory depression and the development of opioid tolerance and physical dependency. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Scope of the Invention
Overview
The invention described in US Patent 9,474,750 involves oral dosage forms that combine an opioid agonist, an opioid antagonist, and acetaminophen. This combination is designed to provide effective pain relief while minimizing the adverse effects commonly associated with opioid use[4].
Dosage Forms
The patent details various dosage forms, including tablets, liquids, troches, lozenges, aqueous or oily suspensions, multiparticulate formulations, emulsions, hard or soft capsules, syrups, and elixirs. These forms can be tailored to provide immediate or sustained release of the active ingredients, enhancing the therapeutic efficacy and safety profile of the medication[4].
Active Ingredients
- Opioid Agonist: The patent specifies the use of an opioid agonist, which is different from hydrocodone, to provide pain relief.
- Opioid Antagonist: Naltrexone is used as the opioid antagonist to mitigate the adverse effects of opioid use.
- Acetaminophen: Included to enhance pain relief and reduce the dosage of opioids required[4].
Claims
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims are crucial as they outline the specific combinations and formulations that are protected under the patent.
- Claim 1: This claim describes the oral dosage form comprising a combination of an opioid agonist, an opioid antagonist, and acetaminophen, with specific ratios and release profiles[4].
Dependent Claims
Dependent claims further specify the invention by detailing various aspects such as the types of dosage forms, the release mechanisms (immediate or sustained), and the inclusion of pharmaceutically acceptable excipients.
- Claim 2: This claim specifies the dosage form as a tablet, with the opioid agonist and antagonist in immediate release form, and acetaminophen in sustained release form[4].
Patent Landscape
Prior Art
The patent landscape for opioid agonist/opioid antagonist combinations is complex, with numerous prior art references. The Common Citation Document (CCD) application, for instance, consolidates prior art cited by multiple patent offices, helping to identify relevant prior art for this family of patents[1].
Related Patents
Other patents in the same field often focus on different combinations or delivery mechanisms. For example, patents related to sustained-release formulations or different opioid agonists and antagonists are common. The Claim Coverage Matrix and scope concepts, as used in patent analytics, can help identify gaps and opportunities in the patent landscape[3].
Legal and Regulatory Considerations
Patent Validity
Patents are accompanied by a presumption of validity, but they can be challenged through inter partes review (IPR) or other legal proceedings. The construction of claim terms and the determination of claim indefiniteness are critical legal issues that can affect the validity of a patent[2].
Small Claims Patent Court
There have been discussions and studies on the feasibility of a small claims patent court, which could impact how patent disputes, including those related to pharmaceutical patents, are handled. Such a court could provide a more streamlined and cost-effective way to resolve patent disputes[5].
Practical Applications
Clinical Benefits
The combination of an opioid agonist, opioid antagonist, and acetaminophen offers several clinical benefits, including reduced respiratory depression and a slower rate of opioid tolerance and physical dependency development. This makes the formulation safer and more effective for long-term pain management[4].
Market Impact
This patent has significant implications for the pharmaceutical market, particularly in the area of pain management. It provides a competitive edge to the patent holder by offering a unique and safer formulation that can attract both healthcare providers and patients.
Claim Charts and Patent Analytics
To fully understand the coverage and value of this patent, claim charts and patent analytics tools are essential. These tools help in categorizing patents by claims and scope concepts, making it easier to identify gaps in coverage and future design opportunities. The ClaimScape® software, for example, generates interactive claim charts that can be reviewed by technical experts to determine the applicability of the scope concepts to target products or methods[3].
Key Takeaways
- Combination Therapy: The patent combines an opioid agonist, opioid antagonist, and acetaminophen to provide safer and more effective pain relief.
- Dosage Forms: Various dosage forms are described, including immediate and sustained release formulations.
- Legal Considerations: The patent's validity can be challenged through legal proceedings, and its scope is defined by independent and dependent claims.
- Market Impact: The patent offers a competitive edge in the pharmaceutical market by providing a unique and safer formulation for pain management.
- Patent Analytics: Tools like claim charts and scope concepts are crucial for understanding the patent landscape and identifying opportunities.
FAQs
What is the main purpose of the combination therapy described in US Patent 9,474,750?
The main purpose is to provide effective pain relief while minimizing the adverse effects associated with opioid use, such as respiratory depression and the development of opioid tolerance and physical dependency.
What types of dosage forms are described in the patent?
The patent describes various dosage forms, including tablets, liquids, troches, lozenges, aqueous or oily suspensions, multiparticulate formulations, emulsions, hard or soft capsules, syrups, and elixirs.
How does the inclusion of an opioid antagonist enhance the safety of the formulation?
The opioid antagonist, such as naltrexone, helps to mitigate the adverse effects of opioid use, reducing the risk of respiratory depression and the development of opioid tolerance and physical dependency.
What is the role of acetaminophen in the formulation?
Acetaminophen is included to enhance pain relief and reduce the dosage of opioids required, thereby improving the safety profile of the medication.
How can patent analytics tools help in understanding the scope and value of this patent?
Patent analytics tools, such as claim charts and scope concepts, help in categorizing patents by claims and scope concepts, making it easier to identify gaps in coverage and future design opportunities.
Sources
- USPTO - Search for patents - USPTO
- CAFC - VASCULAR SOLUTIONS LLC v. MEDTRONIC, INC.
- SLWIP - Patent Analytics | Intellectual Property Law
- Google Patents - Opioid agonist/opioid antagonist/acetaminophen combinations
- ACUS - U.S. Patent Small Claims Court
