Understanding the Scope and Claims of U.S. Patent 7,148,359: A Detailed Analysis
Introduction
U.S. Patent 7,148,359, often referenced in legal and pharmaceutical contexts, is a significant patent that has been the subject of various legal disputes and analyses. This patent is associated with AbbVie Inc. and pertains to a specific formulation of a drug. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape in which it exists.
Background of the Patent
U.S. Patent 7,148,359 was granted to AbbVie Inc. (formerly part of Abbott Laboratories) and is related to the drug formulation of a combination of active ingredients. This patent is one of several that have been central to the company's intellectual property strategy, particularly in the context of protecting its pharmaceutical products.
Scope of the Patent
The scope of U.S. Patent 7,148,359 is defined by its claims, which outline the specific invention and the rights granted to the patent holder. The patent generally covers a particular formulation and method of use for a drug, which is crucial for understanding its market exclusivity and the potential for generic competition.
- Claims: The patent includes multiple claims that describe the drug formulation, its composition, and the methods of use. These claims are critical because they define the boundaries of what is protected under the patent. For example, the claims might specify the exact ratio of active ingredients, the formulation process, and any approved methods of using the drug[5].
Types of Patents Listed in the Orange Book
Patents like U.S. Patent 7,148,359 are typically listed in the Orange Book, a publication by the FDA that compiles patent and exclusivity information for approved drug products. The Orange Book includes three main types of patents:
- Drug Substance Patents: These patents cover the active ingredient itself.
- Drug Product Patents: These patents cover the formulation or composition of the drug.
- Method of Use Patents: These patents cover specific methods of using the drug for which approval is sought or has been granted[2].
Impact on Generic Competition
The presence of multiple patents, including U.S. Patent 7,148,359, can significantly impact the timing of generic competition. Here are a few key points:
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Market Exclusivity: The patent can extend the market exclusivity period for the innovator drug, delaying the entry of generic competitors. For instance, even if some patents expire, later patents directed to follow-on innovation can remain in force, allowing the innovator to maintain market exclusivity[1][2].
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Litigation Settlements: Generic manufacturers may launch their products before all listed patents expire if they reach a settlement with the patent owner. This can occur if the generic manufacturer does not infringe on the unexpired patents or if a litigation settlement allows for an earlier launch date[1].
Legal Disputes and Claim Construction
U.S. Patent 7,148,359 has been involved in several legal disputes, particularly regarding claim construction. Claim construction is the process of interpreting the meaning of the claims in a patent, which is crucial for determining infringement.
- Court Cases: In cases like AbbVie Inc. et al. v. Mylan Pharmaceuticals Inc. et al., the court has had to interpret the disputed terms found in the patent. These interpretations can significantly affect the scope of protection and the potential for generic competition[5].
Follow-On Innovation and Patent Landscape
Follow-on innovation, where companies file patents for improvements to existing drugs, can further complicate the patent landscape. These improvements might include new dosage forms, routes of administration, or expanded indications for the drug.
- Examples: Patents for follow-on innovations, such as once-daily dosage forms or new indications, can extend the life of the original patent and maintain market exclusivity. For example, patents related to drugs like LYRICA and IMBRUVICA have shown how follow-on innovation can impact the timing of generic launches[1].
Conclusion
U.S. Patent 7,148,359 is a critical component of AbbVie Inc.'s intellectual property portfolio, influencing the market dynamics for its associated drug products. Understanding the scope and claims of this patent, as well as its place within the broader patent landscape, is essential for both innovator companies and generic manufacturers.
Key Takeaways
- Patent Scope: The patent's claims define its scope, including the formulation, composition, and methods of use.
- Impact on Generic Competition: Multiple patents can delay generic competition by extending market exclusivity.
- Legal Disputes: Claim construction is crucial in legal disputes and can affect the patent's scope and infringement determinations.
- Follow-On Innovation: Patents for improvements to existing drugs can further extend market exclusivity.
FAQs
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What is the significance of U.S. Patent 7,148,359 in the pharmaceutical industry?
- This patent is significant because it protects a specific drug formulation and method of use, influencing the market exclusivity and potential for generic competition.
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How do patents listed in the Orange Book affect generic drug launches?
- Patents listed in the Orange Book can delay generic drug launches by extending the market exclusivity period for innovator drugs.
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What is claim construction in the context of patent law?
- Claim construction is the process of interpreting the meaning of the claims in a patent, which is crucial for determining infringement.
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How does follow-on innovation impact the patent landscape?
- Follow-on innovation can extend the life of the original patent and maintain market exclusivity through new patents for improvements such as new dosage forms or expanded indications.
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Can generic manufacturers launch their products before all listed patents expire?
- Yes, generic manufacturers can launch their products before all listed patents expire if they do not infringe on the unexpired patents or if a litigation settlement allows for an earlier launch date.
Sources
- USPTO Drug Patent and Exclusivity Study Report - USPTO
- USPTO-FDA Report on Drug Patent and Exclusivity - USPTO
- A novel approach to understand patents from the drug discovery - bioRxiv
- Amorphous form of lopinavir and ritonavir mixture - Google Patents
- ABBVIE INC. et al. v. Mylan Pharmaceuticals Inc... - Morris James LLP
