United States Patent 8,409,616: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,409,616, hereafter referred to as the "616 Patent," is a significant intellectual property asset in the pharmaceutical industry, particularly in the realm of abuse deterrent opioid formulations. This patent was issued to Acura Pharmaceuticals, Inc. in April 2013 and is part of a broader portfolio of patents aimed at preventing the misuse and abuse of opioid analgesics.
Background and Issuance
The 616 Patent was granted by the United States Patent and Trademark Office (USPTO) on April 9, 2013. It is one of several patents held by Acura Pharmaceuticals that focus on developing and commercializing abuse-deterrent technologies for opioid products[4].
Scope of the Patent
The 616 Patent encompasses certain immediate-release abuse deterrent dosage forms of opioid analgesics. Specifically, it covers formulations designed to deter common methods of prescription opioid product misuse and abuse, such as crushing, grinding, or dissolving the drug to achieve a rapid release of the active ingredient.
Key Components
- Abuse Deterrent Formulations: The patent describes specific compositions that include a mixture of active pharmaceutical ingredients and inactive ingredients designed to prevent tampering and abuse.
- Immediate Release: The formulations are immediate-release, meaning they are designed to release the active ingredient quickly, but with built-in mechanisms to prevent rapid release when the formulation is tampered with.
- Opioid Analgesics: The patent focuses on opioid analgesics, such as oxycodone and hydrocodone, which are commonly prescribed for pain management but have a high potential for abuse[4].
Claims of the Patent
The 616 Patent includes several claims that define the scope of the invention. Here are some key claims:
Independent Claims
- Claim 1 typically defines the broadest scope of the invention, outlining the composition of the immediate-release abuse deterrent dosage form.
- Subsequent claims may narrow down the scope by specifying particular ingredients, ratios, or methods of preparation.
Dependent Claims
- These claims build upon the independent claims, providing additional details or limitations that further define the invention. For example, dependent claims might specify the type of opioid used, the amount of inactive ingredients, or the method of manufacturing the dosage form[4].
Patent Landscape
The 616 Patent is part of a larger patent landscape in the field of abuse deterrent opioid formulations. Here are some key aspects of this landscape:
Related Patents
- U.S. Patent No. 7,476,402 (402 Patent): This patent, also held by Acura Pharmaceuticals, covers combinations of kappa and mu opioid receptor agonists and other ingredients intended to deter opioid analgesic product misuse and abuse.
- U.S. Patent No. 7,510,726 (726 Patent): This patent encompasses a wider range of abuse deterrent compositions than the 616 Patent.
- U.S. Patent No. 7,981,439 (439 Patent): This patent covers compositions including any water-soluble drug of abuse intended to deter common methods of prescription opioid product misuse and abuse[4].
Expiration Dates
- The 616 Patent is set to expire in November 2023, which is a critical date for both the patent holder and potential generic competitors.
- Other related patents, such as the 402 Patent and the 726 Patent, also expire in November 2023, while the 439 Patent expires in August 2024[4].
Litigation and Challenges
- The 616 Patent, along with other patents held by Acura Pharmaceuticals, has been the subject of patent infringement actions. The company has filed suits against several generic sponsors who have sought to market generic versions of Acura's products, alleging infringement of the 616 Patent and other related patents[4].
Impact on the Pharmaceutical Industry
The 616 Patent and similar patents have significant implications for the pharmaceutical industry:
Innovation in Abuse Deterrent Technologies
- These patents encourage innovation in the development of abuse deterrent formulations, which are crucial in addressing the opioid epidemic.
- Companies like Acura Pharmaceuticals continue to invest in research and development to create safer opioid products, driven in part by the protection afforded by these patents.
Market Competition
- The expiration of these patents can lead to increased market competition as generic versions of the products become available.
- However, the complex nature of these formulations and the ongoing litigation can delay the entry of generics, allowing the patent holders to maintain market exclusivity for a longer period.
Conclusion
The 616 Patent is a vital component of Acura Pharmaceuticals' intellectual property portfolio, providing protection for their innovative abuse deterrent opioid formulations. Understanding the scope, claims, and patent landscape surrounding this patent is essential for both the company and its competitors as they navigate the complex regulatory and legal environment of the pharmaceutical industry.
Key Takeaways
- The 616 Patent covers immediate-release abuse deterrent dosage forms of opioid analgesics.
- It is part of a broader portfolio of patents held by Acura Pharmaceuticals focused on abuse deterrent technologies.
- The patent expires in November 2023 and has been the subject of patent infringement actions.
- The patent landscape includes related patents that also address abuse deterrent formulations.
- The expiration of these patents will impact market competition and innovation in the pharmaceutical industry.
FAQs
What is the primary focus of the 616 Patent?
The primary focus of the 616 Patent is on immediate-release abuse deterrent dosage forms of opioid analgesics.
Who is the holder of the 616 Patent?
The 616 Patent is held by Acura Pharmaceuticals, Inc.
When does the 616 Patent expire?
The 616 Patent is set to expire in November 2023.
What other patents are related to the 616 Patent?
Related patents include U.S. Patent No. 7,476,402 (402 Patent), U.S. Patent No. 7,510,726 (726 Patent), and U.S. Patent No. 7,981,439 (439 Patent).
Why is the 616 Patent important in the pharmaceutical industry?
The 616 Patent is important because it protects innovative abuse deterrent formulations, which are critical in addressing the opioid epidemic and encouraging further innovation in this area.
Sources
- USPTO - Search for patents - USPTO
- USA.gov - U.S. Patent and Trademark Office (USPTO) | USAGov
- USPTO - Patent Claims Research Dataset - USPTO
- Acura Pharmaceuticals - September 29, 2014 Jeffrey P. Riedler Assistant Director Securities ...
