United States Patent 7,659,282: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,659,282, titled "Pharmaceutical Compositions Comprising Dextromethorphan and Quinidine for the Treatment of Neurological Disorders," is a crucial patent in the pharmaceutical industry, particularly for the treatment of pseudobulbar affect (PBA). This patent, held by Avanir Pharmaceuticals, Inc., has been the subject of significant legal and scientific scrutiny. Here, we delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background and Inventors
The '282 patent was issued on February 9, 2010, and it claims priority to U.S. Provisional application No. 60/396,661, filed on July 17, 2002. The named inventors are Gerald Yakatan, James Berg, Laura E. Pope, and Richard A. Smith[1][4].
Scope of the Patent
The '282 patent pertains to pharmaceutical compositions that include dextromethorphan (DM) and quinidine (Q) for the treatment of neurological disorders, specifically pseudobulbar affect (PBA). PBA is a condition characterized by episodes of sudden uncontrollable and inappropriate laughing or crying. The patent covers the use of these active ingredients in a specific formulation designed to treat this debilitating condition[1][4].
Claims of the Patent
The '282 patent includes several claims that define the scope of the invention. Here are some key aspects:
- Independent Claims: The patent has multiple independent claims, with Claim 1 being the primary independent claim. These claims specify the composition and method of treatment using DM and Q[1].
- Dependent Claims: The patent also includes several dependent claims that further detail the composition, dosage forms, and methods of administration. These claims build upon the independent claims and provide additional specificity to the invention[1].
Patent Expiration Date
The '282 patent is set to expire on August 13, 2026. This expiration date is critical as it marks the end of the exclusive rights granted to Avanir Pharmaceuticals for this specific formulation and treatment method[2].
Legal and Litigation History
The '282 patent has been involved in significant litigation. Avanir Pharmaceuticals prevailed in a patent trial against several generic drug manufacturers, including Actavis South Atlantic LLC, where the court upheld the validity of the '282 and '484 patents and found that the proposed generic formulations infringed these patents. This ruling ensured market exclusivity for NUEDEXTA, the FDA-approved product for PBA, until 2026[1][4][5].
Impact on Market Exclusivity
The court's decision in favor of Avanir Pharmaceuticals has provided the company with over 12 years of market exclusivity for NUEDEXTA. This exclusivity is crucial for maintaining a competitive edge in the market and ensuring that patients continue to have access to this unique treatment for PBA[4].
Patent Landscape and Related Patents
The '282 patent is part of a broader patent portfolio related to the treatment of neurological disorders using DM and Q. Other relevant patents include:
- U.S. Patent RE38,115: This patent relates to formulations containing DM and Q for the treatment of chronic or intractable pain[1].
- U.S. Patent 8,227,484: This patent also pertains to the use of DM and Q for treating neurological disorders, including PBA, and shares a similar scope with the '282 patent[1].
Metrics for Patent Scope
The scope of the '282 patent can be analyzed using metrics such as independent claim length and independent claim count. These metrics help in understanding the breadth and clarity of the patent claims. Research has shown that narrower claims, as measured by these metrics, are associated with a higher probability of grant and a shorter examination process[3].
Conclusion on Patent Quality
The '282 patent has been subject to rigorous examination and litigation, which has validated its claims and ensured its strength. The patent's clarity and specificity, as well as the court's rulings, have reinforced its position in the patent landscape. This underscores the importance of well-defined and narrowly scoped patent claims in maintaining patent quality and encouraging innovation[3].
Key Takeaways
- Patent Scope: The '282 patent covers specific pharmaceutical compositions of DM and Q for treating PBA.
- Claims: The patent includes multiple independent and dependent claims defining the composition and treatment method.
- Expiration Date: The patent expires on August 13, 2026.
- Legal History: Avanir Pharmaceuticals has successfully defended the patent against generic manufacturers.
- Market Exclusivity: The patent ensures market exclusivity for NUEDEXTA until 2026.
- Related Patents: Part of a broader portfolio including RE38,115 and 8,227,484 patents.
FAQs
What is the primary use of the '282 patent?
The '282 patent is primarily used for the treatment of pseudobulbar affect (PBA) using a pharmaceutical composition containing dextromethorphan (DM) and quinidine (Q).
Who are the inventors of the '282 patent?
The inventors are Gerald Yakatan, James Berg, Laura E. Pope, and Richard A. Smith.
What is the expiration date of the '282 patent?
The patent is set to expire on August 13, 2026.
What was the outcome of the litigation involving the '282 patent?
Avanir Pharmaceuticals prevailed in the litigation, with the court upholding the validity of the patent and finding infringement by proposed generic formulations.
What is the impact of the '282 patent on market exclusivity?
The patent ensures market exclusivity for NUEDEXTA, the FDA-approved product for PBA, until 2026.
How is the scope of the '282 patent measured?
The scope can be measured using metrics such as independent claim length and independent claim count, which help in assessing the breadth and clarity of the patent claims.
Sources
- Avanir Pharmaceuticals, Inc. v. Actavis South Atlantic LLC - Casetext
- Generic Nuedexta Availability - Drugs.com
- Patent Claims and Patent Scope - Hoover Institution
- Avanir Pharmaceuticals Prevails in NUEDEXTA Patent Trial - PR Newswire
- Avanir Pharms., Inc. v. Actavis South Atlantic LLC (D. Del.) - Robins Kaplan
