United States Patent 7,482,377: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,482,377, titled "PHARMACEUTICAL COMPOSITIONS AND METHODS OF TREATMENT BASED ON DICLOFENAC," is a significant patent in the pharmaceutical industry, particularly in the field of pain management and anti-inflammatory treatments. This patent, granted to Kowa Pharmaceuticals America, Inc., involves new immediate release pharmaceutical compositions containing diclofenac, a widely used nonsteroidal anti-inflammatory drug (NSAID).
Background of the Invention
Diclofenac, known by its chemical name (2,6-dichloro anilino)-2-phenyl-2-acetic acid, is a potent NSAID used for treating various inflammatory conditions. The patent focuses on improving the bioavailability and efficacy of diclofenac through novel formulations and therapeutic regimens[1].
Scope of the Patent
The scope of the patent encompasses several key aspects:
Pharmaceutical Compositions
The patent describes new immediate release pharmaceutical compositions of diclofenac in acid and/or salt form. These compositions are designed to enhance the bioavailability and rapid onset of action of diclofenac, making it more effective for treating acute pain and inflammation[1].
Therapeutic Regimens
The patent also outlines therapeutic regimens involving these new compositions. This includes specific dosing schedules and administration methods to optimize the therapeutic effects of diclofenac while minimizing side effects[1].
Claims of the Patent
The patent includes multiple claims that define the scope of the invention:
Independent Claims
The independent claims are crucial as they define the broadest scope of the invention. For example, Claim 1 might describe the pharmaceutical composition itself, while subsequent independent claims might detail specific formulations, methods of preparation, and therapeutic uses[1].
Dependent Claims
Dependent claims narrow down the scope by adding specific limitations to the independent claims. These could include details about the type of diclofenac salt used, the presence of additional ingredients like alkali metal carbonates or bicarbonates, and specific dosage forms such as tablets or capsules[1].
Claim Construction and Interpretation
The interpretation of patent claims is critical in determining the scope of protection. For instance, in the context of this patent, the claim language regarding the use of alkali metal carbonates or bicarbonates to enhance the Tmax (time to reach maximum plasma concentration) of diclofenac has been subject to legal scrutiny.
- Means-Plus-Function Analysis: The patent claims involving functional language, such as the use of alkali metal bicarbonates to enhance Tmax, are subject to means-plus-function analysis under 35 U.S.C. ยง 112. This requires identifying the claimed function and the corresponding structure in the specification[4].
Patent Landscape
The patent landscape surrounding US 7,482,377 is complex and involves several related patents and legal disputes:
Related Patents
The patent is part of a family of patents related to diclofenac formulations. Other patents in this family include US 6,974,595, US 7,759,394, and US 8,097,651. These patents collectively cover various aspects of diclofenac formulations, including different salts, dosage forms, and therapeutic regimens[4][5].
Litigation and Disputes
The patent has been involved in several legal disputes, particularly regarding patent infringement. For example, Nautilus Neurosciences, Inc., the exclusive licensee of these patents, has sued generic drug manufacturers for alleged infringement of these patents. The disputes often revolve around the interpretation of claim language and the validity of the patents[4][5].
Impact on the Pharmaceutical Industry
The patent has significant implications for the pharmaceutical industry:
Innovation and Competition
The patent encourages innovation by providing a monopoly on the specific formulations and therapeutic regimens described. However, it also limits competition from generic manufacturers, which can delay the availability of cheaper alternatives to consumers[3].
Bioavailability and Efficacy
The improved bioavailability and rapid onset of action of diclofenac formulations under this patent enhance patient care by providing more effective pain management options. This is particularly important for acute pain conditions where rapid relief is crucial[1].
Metrics for Patent Scope
The scope of the 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. For instance, narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].
Global Patent System
The patent is part of the global patent system, with corresponding applications and grants in other jurisdictions. The Global Dossier service provided by the USPTO facilitates access to the file histories of related applications from participating IP Offices, aiding in the management and analysis of global patent portfolios[2].
Conclusion
The United States Patent 7,482,377 is a critical patent in the pharmaceutical industry, particularly for the treatment of pain and inflammation. Its scope, claims, and the surrounding patent landscape are complex and have significant implications for innovation, competition, and patient care.
Key Takeaways
- The patent covers new immediate release pharmaceutical compositions of diclofenac.
- It includes specific therapeutic regimens to enhance bioavailability and efficacy.
- Claim construction and interpretation are crucial for determining the scope of protection.
- The patent is part of a larger family of related patents and has been involved in legal disputes.
- It impacts the pharmaceutical industry by encouraging innovation and limiting competition.
FAQs
What is the main subject of United States Patent 7,482,377?
The main subject is new immediate release pharmaceutical compositions containing diclofenac and therapeutic regimens involving these compositions.
How does the patent improve diclofenac formulations?
The patent improves diclofenac formulations by enhancing bioavailability and rapid onset of action through the use of specific salts and additives like alkali metal carbonates or bicarbonates.
What are the key claims of the patent?
The key claims include descriptions of the pharmaceutical compositions, specific formulations, methods of preparation, and therapeutic uses.
Why is claim construction important for this patent?
Claim construction is important because it determines the scope of protection and has been a point of contention in legal disputes involving this patent.
How does the patent affect the pharmaceutical industry?
The patent affects the industry by encouraging innovation in pain management treatments but also limits competition from generic manufacturers, potentially delaying the availability of cheaper alternatives.
Cited Sources:
- United States Patent and Trademark Office. PHARMACEUTICAL COMPOSITIONS AND METHODS OF TREATMENT BASED ON DICLOFENAC, US 7482,377 B2, January 27, 2009.
- United States Patent and Trademark Office. Search for patents - USPTO, October 18, 2018.
- Marco, Alan C., Sarnoff, Joshua D., and deGrazia, Charles A. Patent Claims and Patent Scope, Hoover Institution, August 18, 2016.
- United States Courts. NAUTILUS NEUROSCIENCES, INC., : et al., : Civil Action, February 27, 2013.
- Justia. NAUTILUS NEUROSCIENCES, INC. et al v. WOCKHARDT USA ..., 2012.
