United States Patent 9,937,164: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,937,164, titled "Opioid formulations," is a significant patent in the field of pharmaceuticals, particularly in the treatment of pain and opioid dependence. This patent, granted to Camurus AB, outlines innovative formulations and methods for the controlled release of opioids.
Background
The patent was filed on July 26, 2013, and granted on April 10, 2018. It is part of a broader landscape of pharmaceutical patents focused on opioid formulations and their applications in pain management and opioid maintenance therapy[4].
Scope of the Patent
Depot Precursor Formulation
The patent describes a depot precursor formulation that includes a controlled-release matrix, an oxygen-containing organic solvent, and at least 12% by weight of at least one active agent, such as buprenorphine or its salts. This formulation is designed to provide a sustained release of the active agent, which is crucial for managing pain and opioid dependence[4].
Components of the Formulation
- Controlled-Release Matrix: This matrix is essential for the slow and controlled release of the active pharmaceutical ingredient (API).
- Oxygen-Containing Organic Solvent: This solvent helps in the preparation and stability of the formulation.
- Active Agent: Buprenorphine or its salts are the primary active agents, known for their efficacy in treating opioid dependence and pain[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Claim 1: Depot Precursor Formulation
This claim specifies the composition of the depot precursor formulation, including the controlled-release matrix, the oxygen-containing organic solvent, and the active agent[4].
Claim 2: Depot Composition
This claim describes the depot composition resulting from the depot precursor formulation, emphasizing the controlled release of the active agent[4].
Claim 3: Methods of Treatment
This claim outlines the methods of using the depot compositions for pain management, opioid maintenance, and related therapies[4].
Patent Landscape
Related Patents
The patent landscape surrounding US 9,937,164 includes other patents related to opioid formulations and controlled-release technologies. For example:
- US 10022367: This patent, granted to Indivior UK Limited, also deals with extended-release pharmaceutical formulations for opioids, specifically buprenorphine[1].
- US 10864166: This patent, assigned to Adare Pharmaceuticals, Inc., involves pharmaceutical compositions with solubility-enhancing polymers and enteric coatings, relevant to the delivery of weakly basic active pharmaceutical ingredients[1].
Competitors and Collaborators
Companies like Camurus AB, Indivior UK Limited, and Adare Pharmaceuticals, Inc. are key players in the opioid formulation patent landscape. These companies often engage in research collaborations and competitive strategies to advance their intellectual property portfolios[1][4].
Patent Analytics and Claim Coverage
To fully understand the protection and gaps in the patent landscape, patent analytics tools are crucial. These tools help in categorizing patents by claims and scope concepts, enabling a comprehensive analysis of the patent landscape.
Claim Coverage Matrix
A Claim Coverage Matrix can be used to identify which patents and claims are actively protecting the intellectual property related to opioid formulations. This matrix helps in spotting gaps in current coverage and highlighting future design opportunities[3].
Claim Charts
Interactive claim charts generated by tools like ClaimScape® software can be reviewed by technical experts to determine the applicability of scope concepts to target products or methods. This approach ensures that all claims and associated scope concepts are accurately analyzed and updated over time[3].
Legal and Regulatory Aspects
The validity and enforcement of patent claims are critical. Issues such as obviousness-type double patenting (ODP) and the written description requirement must be carefully considered to ensure the patent's validity. For instance, the case of Allergan USA, Inc. v. MSN Laboratories Private Ltd. highlights the importance of addressing ODP and claim distinctness in patent litigation[2].
Market Impact and Clinical Significance
The opioid formulations described in US 9,937,164 have significant market and clinical implications. These formulations are approved by the FDA for the treatment of opioid dependence and have shown efficacy in clinical studies. The controlled-release mechanism helps in reducing the risk of abuse and improving patient compliance[4].
Future Directions
The patent landscape for opioid formulations is continuously evolving. Future directions may include the development of new formulations with improved efficacy and safety profiles, as well as advancements in delivery technologies. Companies will need to stay vigilant in monitoring and adapting to changes in the patent landscape to maintain their competitive edge.
Key Takeaways
- Innovative Formulation: The patent introduces a novel depot precursor formulation for controlled-release of opioids.
- Comprehensive Claims: The patent includes detailed claims covering the formulation, depot composition, and methods of treatment.
- Competitive Landscape: The patent is part of a broader landscape involving multiple companies and related patents.
- Patent Analytics: Tools like Claim Coverage Matrix and Claim Charts are essential for analyzing and maintaining the patent portfolio.
- Clinical Significance: The formulations have significant clinical implications for treating opioid dependence and pain.
FAQs
What is the primary active agent in the depot precursor formulation described in US 9,937,164?
The primary active agent is buprenorphine or its salts.
What is the purpose of the oxygen-containing organic solvent in the formulation?
The oxygen-containing organic solvent helps in the preparation and stability of the formulation.
How does the controlled-release matrix function in the depot composition?
The controlled-release matrix ensures the slow and controlled release of the active pharmaceutical ingredient.
Which companies are key players in the opioid formulation patent landscape?
Companies like Camurus AB, Indivior UK Limited, and Adare Pharmaceuticals, Inc. are key players.
What tools can be used to analyze the patent landscape for opioid formulations?
Tools such as Claim Coverage Matrix and Claim Charts generated by ClaimScape® software can be used.
Cited Sources:
- Justia Patents: Sustained Or Differential Release Patents and Patent Applications.
- CAFC: ALLERGAN USA, INC. v. MSN LABORATORIES PRIVATE LTD.
- SLWIP: Patent Analytics | Intellectual Property Law.
- Google Patents: US9937164B2 - Opioid formulations.
