United States Patent 8,840,928: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,840,928, issued to Collegium Pharmaceutical, Inc., is a significant patent that covers the DETERx® technology platform, a innovative drug delivery system designed to provide abuse-deterrent properties for opioids and other drugs prone to abuse. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this technology.
Background of the DETERx® Technology
The DETERx® technology platform is a microsphere-in-capsule formulation developed primarily to deter common methods of tampering such as chewing, crushing, insufflation, and extraction for IV injection. This platform is versatile, enabling patients with difficulty swallowing to administer the contents onto food or via a gastrostomy tube while maintaining the extended-release properties of the product[2].
Scope of the Patent
The patent covers a broad range of applications for the DETERx® technology, including its use with opioids and other drugs that are commonly abused. The claims provide protection for the specific formulation and method of delivery, ensuring that the product maintains its extended-release properties while preventing misuse. This scope is critical for Collegium Pharmaceutical, as it strengthens their intellectual property portfolio and protects their lead product, Oxycodone DETERx®[2].
Claims of the Patent
The patent includes several key claims that define the invention and its applications:
- Formulation Claims: These claims describe the microsphere-in-capsule formulation and the specific components used, such as fatty acids and other excipients, which contribute to the abuse-deterrent properties[5].
- Method of Use Claims: These claims outline the methods by which the formulation is administered, including the ability to open the capsule and administer the contents onto food or via a gastrostomy tube[5].
- Abuse-Deterrent Claims: These claims highlight the specific features that prevent tampering, such as resistance to chewing, crushing, and extraction[5].
Patent Landscape
Related Patents and Applications
The DETERx® technology is part of a larger portfolio of U.S. and international patents and patent applications. Collegium Pharmaceutical has secured multiple patents related to this technology, with this particular patent being the sixth issued U.S. patent in the series. Additionally, there are pending patent applications in the U.S., Canada, Japan, and other countries, which further solidify the company's intellectual property position[2].
Competing Technologies
The patent landscape for abuse-deterrent opioid formulations is competitive, with several other companies developing similar technologies. For example, Xtampza ER, another abuse-deterrent opioid product, is protected by a series of patents in the U.S., Europe, Canada, Japan, and Australia. These competing technologies highlight the importance of robust patent protection in this field[4].
International Protection
The global patent system plays a crucial role in protecting the DETERx® technology. Through international filings and agreements, Collegium Pharmaceutical ensures that its technology is protected across various jurisdictions. Tools like the Global Dossier and Common Citation Document (CCD) facilitate the management of international patent applications and citations, enhancing the global patent landscape[1].
Economic and Regulatory Impact
Market Protection
The issuance of this patent and others in the series provides Collegium Pharmaceutical with significant market protection. This protection is essential for maintaining a competitive edge and ensuring that the company can recoup its investment in research and development[2].
Regulatory Compliance
The patent aligns with regulatory guidelines, such as the FDA's Draft Guidance on "Abuse-Deterrent Opioids - Evaluation and Labeling." Compliance with these regulations is crucial for product approval and labeling, which in turn affects market acceptance and reimbursement[2].
Industry Expert Insights
According to Michael Heffernan, CEO of Collegium Pharmaceutical, "These newly allowed claims continue to strengthen and expand our overall patent coverage for the DETERx® technology platform." This statement underscores the strategic importance of robust patent protection in the pharmaceutical industry[2].
Statistical Significance
The issuance of this patent is part of a broader trend in patent activity in the pharmaceutical sector. The USPTO's Patent Claims Research Dataset provides insights into patent scope and claims trends, highlighting the increasing complexity and breadth of patent claims in recent years[3].
Conclusion
United States Patent 8,840,928 is a pivotal patent in the field of abuse-deterrent pharmaceutical formulations. It provides broad coverage for the DETERx® technology platform, ensuring that Collegium Pharmaceutical maintains a strong intellectual property position. The scope and claims of this patent, along with the broader patent landscape, underscore the importance of robust patent protection in the highly competitive and regulated pharmaceutical industry.
Key Takeaways
- Broad Coverage: The patent provides broad coverage for the DETERx® technology, including its formulation and method of use.
- Abuse-Deterrent Properties: The technology is designed to prevent common methods of tampering with opioids and other drugs.
- Global Protection: The patent is part of a larger international portfolio, ensuring protection across various jurisdictions.
- Regulatory Compliance: The patent aligns with FDA guidelines on abuse-deterrent opioids.
- Market Protection: The patent provides significant market protection, allowing Collegium Pharmaceutical to maintain a competitive edge.
FAQs
What is the DETERx® technology platform?
The DETERx® technology platform is a microsphere-in-capsule formulation designed to provide abuse-deterrent properties for opioids and other drugs prone to abuse.
How does the DETERx® technology prevent tampering?
The technology prevents tampering through its formulation, which resists chewing, crushing, insufflation, and extraction for IV injection.
What are the key claims of United States Patent 8,840,928?
The key claims include formulation claims, method of use claims, and abuse-deterrent claims.
How does this patent fit into Collegium Pharmaceutical's broader intellectual property strategy?
This patent is part of a larger portfolio of U.S. and international patents and patent applications, strengthening Collegium Pharmaceutical's intellectual property position.
What is the significance of international patent protection for the DETERx® technology?
International patent protection ensures that the technology is protected across various jurisdictions, facilitating global market access and compliance with international regulatory standards.
