United States Patent 11,135,216: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 11,135,216, titled "Sublingual and buccal film compositions," is a significant patent in the field of pharmaceuticals, particularly for the treatment of narcotic dependence. This patent, held by Indivior PLC, is crucial for understanding the innovative approaches to drug delivery and the legal landscape surrounding generic drug approvals.
Background of the Invention
The patent relates to compositions, methods of manufacture, products, and methods of use for films containing therapeutic actives, specifically buprenorphine and naloxone. These films are designed for sublingual or buccal administration, providing a therapeutically effective dosage for treating narcotic dependence[1][4].
Key Components of the Invention
Polymeric Carrier Matrix
The film dosage composition includes a polymeric carrier matrix, which is essential for the stability and delivery of the therapeutic agents. This matrix ensures the film's self-supporting nature and its ability to adhere to the buccal mucosa[1][4].
Therapeutic Agents: Buprenorphine and Naloxone
The composition includes a therapeutically effective amount of buprenorphine or its pharmaceutically acceptable salt, along with naloxone or its pharmaceutically acceptable salt. Buprenorphine is an opioid partial agonist, while naloxone is an opioid antagonist, which together help in managing opioid dependence[1][4].
Buffer System
A buffer is included to optimize the pH of the composition, which is critical for the absorption of buprenorphine. In some embodiments, the buffer also inhibits the absorption of naloxone when administered orally, ensuring that naloxone's antagonist effects are localized to the gastrointestinal tract if the film is ingested[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
- Claims related to the composition of the film, including the polymeric carrier matrix, buprenorphine, naloxone, and the buffer system.
- Claims related to the method of manufacture of the film, including extrusion processes.
- Claims related to the method of use, including the administration of the film to the oral cavity of a user[1][4].
Patent Landscape and Disputes
Settlement with Actavis
Recently, Indivior PLC settled a patent dispute with Actavis Laboratories UT, Inc., a subsidiary of Teva Pharmaceuticals. Under this settlement, Indivior granted Actavis a license to U.S. Patent No. 11,135,216, allowing Actavis to launch generic buprenorphine and naloxone sublingual film products in the United States starting January 31, 2025, unless the unexpired patent claims are found invalid or unenforceable before that date[2][5].
Impact on Generic Drug Market
This settlement is significant as it paves the way for generic competition in the market for buprenorphine and naloxone sublingual films. It reflects the ongoing dynamics in the pharmaceutical industry where patent disputes often shape the availability and pricing of critical medications.
Patent Scope and Quality
The scope of this patent is defined by its claims, which are specific to the composition and method of use of the sublingual and buccal films. The patent's quality is reflected in its detailed descriptions and the inclusion of various embodiments, which provide a clear understanding of the invention's boundaries. However, debates around patent quality often involve metrics such as independent claim length and count, which can indicate the breadth and clarity of the patent claims[3].
Clinical Significance
The invention is clinically significant as it provides an effective and convenient method for treating narcotic dependence. The sublingual and buccal films offer a non-invasive delivery system that can enhance patient compliance and reduce the risk of misuse compared to traditional oral tablets.
Global Reach and Impact
Indivior PLC, the holder of this patent, is a global pharmaceutical company with a presence in 37 countries. The company's commitment to developing medicines for addiction and serious mental illnesses underscores the global impact of this patent. The availability of generic versions, as facilitated by the settlement, will further expand access to these treatments worldwide[2].
Future Developments and Pipeline
Indivior continues to develop new product candidates to address substance use disorders, including alcohol and cannabis use disorders. The settlement and the impending launch of generic products do not diminish the company's focus on innovation but rather highlight the evolving landscape of pharmaceutical development and intellectual property management[2].
Key Takeaways
- Innovative Drug Delivery: The patent introduces a novel method of drug delivery using sublingual and buccal films for treating narcotic dependence.
- Settlement and Generic Competition: The settlement with Actavis allows for the launch of generic products, increasing market competition and potentially reducing costs.
- Global Impact: The patent and its related products have a significant global impact, especially in the treatment of substance use disorders.
- Ongoing Innovation: Indivior continues to innovate in the field of addiction treatment, expanding its portfolio to address other chronic conditions.
Frequently Asked Questions
What is the primary use of the sublingual and buccal films described in U.S. Patent 11,135,216?
The primary use is for the treatment of narcotic dependence, utilizing buprenorphine and naloxone.
Who is the holder of U.S. Patent 11,135,216?
The patent is held by Indivior PLC.
What is the significance of the settlement between Indivior and Actavis?
The settlement allows Actavis to launch generic buprenorphine and naloxone sublingual film products in the U.S., starting January 31, 2025, unless the patent claims are found invalid.
How does the buffer system in the film composition work?
The buffer system optimizes the pH of the composition to enhance the absorption of buprenorphine and, in some embodiments, inhibits the absorption of naloxone when administered orally.
What is the global reach of Indivior PLC and its products?
Indivior PLC has a global presence with its products available in 37 countries worldwide.
Cited Sources:
- Justia Patents: "Sublingual and buccal film compositions" - U.S. Patent No. 11,135,216.
- Indivior: "Indivior Settles Patent Dispute with Teva Subsidiary Actavis" - Press Release.
- Hoover Institution: "Patent Claims and Patent Scope" - Paper.
- Google Patents: "Sublingual and buccal film compositions" - U.S. Patent No. 8,475,832.
- Morningstar: "IN BRIEF: Indivior agrees settlement with Actavis over patent dispute".
