United States Patent 9,132,096: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,132,096, titled "Abuse Resistant Pharmaceutical Compositions," is a significant patent in the field of pharmaceuticals, particularly focusing on formulations designed to deter drug abuse. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent, issued to Recro Gainesville LLC, addresses the critical issue of drug abuse by developing pharmaceutical compositions that resist tampering and misuse. This is particularly important for drugs like hydrocodone, which are commonly abused due to their opioid content[4].
Scope of the Patent
The scope of the patent encompasses pharmaceutical compositions that include active ingredients susceptible to abuse, such as hydrocodone. These compositions are designed to prevent or deter improper administration, such as crushing, grinding, or dissolving the drug to achieve a rapid release of the active ingredient.
Key Components
- Active Ingredients: The patent specifies the use of active ingredients like hydrocodone bitartrate, which is a common opioid analgesic.
- Abuse-Deterrent Mechanisms: The compositions include various mechanisms to prevent abuse, such as gelling agents, beads, and other formulation technologies that make it difficult to manipulate the drug for rapid release[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Claim 1
Claim 1 is the broadest claim and describes a pharmaceutical composition comprising:
- Hydrocodone bitartrate as the active ingredient.
- A gelling agent that forms a gel upon exposure to an aqueous medium.
- Beads or other particulate forms that contain the active ingredient and the gelling agent[4].
Subsequent Claims
Subsequent claims narrow down the scope by specifying:
- The types of gelling agents used (e.g., povidone, hydroxypropyl methyl cellulose).
- The presence of other excipients like silicon dioxide and talc.
- The specific dosage forms, such as capsules or tablets.
- The methods of preparing these compositions[4].
Patent Landscape
The patent landscape surrounding U.S. Patent 9,132,096 is complex and involves several related patents and ongoing litigation.
Related Patents
- U.S. Patent 8,758,813: This patent also deals with abuse-deterrent drug formulations and shares some similarities in the use of fatty acids and other excipients to prevent tampering[1].
- U.S. Patent 9,132,096: As discussed, this patent focuses on hydrocodone bitartrate extended-release capsules with abuse-resistant features[4].
Litigation
The patent has been involved in several legal disputes, particularly with generic pharmaceutical manufacturers. For example:
- Recro Gainesville LLC vs. Actavis Laboratories FL, Inc.: This litigation involves allegations of patent infringement by Actavis for their submission of an Abbreviated New Drug Application (ANDA) for generic hydrocodone bitartrate extended-release capsules. Recro claims that Actavis's actions would infringe on the '096 patent[2].
Patent Analytics and Claim Coverage
To fully understand the protection and gaps in the patent landscape, patent analytics tools are crucial.
Claim Coverage Matrix
A Claim Coverage Matrix can help identify which patents and claims are actively protecting the intellectual property related to abuse-resistant pharmaceutical compositions. This tool categorizes patents by claims and broader scope concepts, making it easier to filter, search, and analyze large numbers of patent claims[3].
Claim Charts
Interactive claim charts generated by tools like ClaimScape® can be reviewed by technical experts to determine whether specific scope concepts are applicable to target products or methods. These charts help in identifying gaps in current coverage and highlighting future design opportunities[3].
Industry Impact
The impact of this patent on the pharmaceutical industry is significant:
Abuse Deterrence
The development of abuse-resistant formulations directly addresses the growing concern of opioid abuse. By making it difficult to manipulate drugs for rapid release, these formulations help in reducing the likelihood of improper administration and subsequent abuse[4].
Market Competition
The patent's involvement in litigation highlights the competitive nature of the pharmaceutical market. Generic manufacturers must navigate complex patent landscapes to avoid infringement, which can delay market entry and impact their competitive positioning[2].
Regulatory Considerations
Regulatory bodies, such as the FDA, play a crucial role in approving these abuse-resistant formulations. The submission of ANDAs and the subsequent approval process are critical steps that generic manufacturers must follow, ensuring that their products do not infringe on existing patents[2].
Key Takeaways
- Abuse-Resistant Formulations: U.S. Patent 9,132,096 focuses on developing pharmaceutical compositions that resist tampering and misuse, particularly for drugs like hydrocodone.
- Claims and Scope: The patent includes specific claims related to the composition, including the use of gelling agents and beads, and the methods of preparation.
- Patent Landscape: The patent is part of a broader landscape involving related patents and ongoing litigation with generic manufacturers.
- Industry Impact: The patent significantly impacts the pharmaceutical industry by addressing opioid abuse and influencing market competition.
- Regulatory Considerations: Regulatory approval processes are critical for ensuring compliance with existing patents.
FAQs
Q: What is the primary focus of U.S. Patent 9,132,096?
A: The primary focus is on developing abuse-resistant pharmaceutical compositions, particularly for drugs like hydrocodone bitartrate.
Q: What mechanisms are used to deter drug abuse in these compositions?
A: Mechanisms include the use of gelling agents, beads, and other formulation technologies that prevent rapid release of the active ingredient.
Q: Which companies are involved in the litigation related to this patent?
A: Recro Gainesville LLC and Actavis Laboratories FL, Inc. are involved in the litigation, with Recro alleging patent infringement by Actavis.
Q: How does the patent affect the pharmaceutical market?
A: The patent affects market competition by requiring generic manufacturers to navigate complex patent landscapes to avoid infringement, potentially delaying their market entry.
Q: What role do regulatory bodies play in the approval of these formulations?
A: Regulatory bodies like the FDA are crucial in approving these formulations, ensuring that generic products do not infringe on existing patents.
Sources
- US8758813B2 - Abuse-deterrent drug formulations - Google Patents
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE - RPX Insight
- Patent Analytics - Schwegman, Lundberg & Woessner, P.A.
- US9132096B1 - Abuse resistant pharmaceutical compositions - Google Patents
- Case 1:16-cv-00138-GMS Document 45 Filed 10/12/16 - RPX Insight
