United States Patent 5,001,161: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,001,161, titled "Pharmaceutical composition comprising metoprolol succinate," is a significant patent in the pharmaceutical industry, particularly in the field of cardiovascular medications. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
The patent, filed on March 25, 1988, and granted on March 19, 1991, pertains to a pharmaceutical composition containing metoprolol succinate, a therapeutically active compound used in the treatment of hypertension and other cardiovascular conditions[4].
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific aspects of the invention that are protected. Here, the claims focus on the pharmaceutical composition itself, including the formulation and the method of preparation.
Claims Overview
The patent includes multiple claims that describe the composition, its components, and the process for its preparation. Key claims include:
- The pharmaceutical composition comprising metoprolol succinate.
- The specific formulation of the composition, including the type and amount of excipients.
- The method of preparing the composition, which involves mixing and compressing the ingredients into a tablet form[4].
Claims Analysis
Independent Claims
Independent claims are those that stand alone and do not depend on other claims. For U.S. Patent 5,001,161, these claims typically describe the core aspects of the invention, such as the composition and its preparation method.
Dependent Claims
Dependent claims build upon the independent claims and provide additional details or variations. These claims might specify particular ratios of ingredients, specific excipients, or additional steps in the preparation process.
Claim Construction
The construction of claims is crucial for understanding the patent's scope. The language used in the claims must be clear and specific to avoid ambiguity. In the case of U.S. Patent 5,001,161, the claims are constructed to ensure that the protected invention is clearly defined and distinguishable from prior art[4].
Patent Landscape
Prior Art
Prior art refers to existing knowledge and inventions in the field that predate the patent application. For U.S. Patent 5,001,161, prior art includes other pharmaceutical compositions and methods related to metoprolol and its derivatives. For example, patents like U.S. 3873600A and U.S. 4256752A are cited as prior art, indicating that the inventors were aware of and differentiated their invention from these earlier works[4].
Related Patents
Several patents are related to U.S. Patent 5,001,161, either as continuations, divisions, or through common subject matter. For instance:
- U.S. Patent 5,081,154A: This patent, also related to metoprolol succinate, describes a new therapeutically active compound and its pharmaceutical preparations. It shares a common priority date and filing history with U.S. Patent 5,001,161[4].
- U.S. Patent 4,780,318A: This patent is a parent application to U.S. Patent 5,001,161 and describes an oral pharmaceutical composition containing metoprolol succinate. It is part of the same patent family[4].
International Patent Landscape
The patent landscape extends beyond the United States, with corresponding patents filed in other countries. For example, the European Patent Office (EPO) and other international intellectual property offices have similar patents related to metoprolol succinate. These include EP0277127B1 and EP0067539B1, which describe controlled release pharmaceutical compositions[4].
Litigation and Validity
Obviousness-Type Double Patenting
There have been legal challenges to the validity of U.S. Patent 5,001,161. For instance, in the case of In re Metoprolol Succinate Patent Litigation, defendants moved for summary judgment arguing that the claims of the '161 and '154 patents were invalid for obviousness-type double patenting over Claim 8 of the '318 patent. This highlights the ongoing legal scrutiny and challenges that patents can face[5].
Economic and Market Impact
Market Dominance
Patents like U.S. Patent 5,001,161 can significantly impact the market by granting exclusive rights to the patent holder. This can lead to market dominance, as seen with AstraZeneca's control over Toprol-XL, a medication containing metoprolol succinate. The patent protection allowed AstraZeneca to maintain a competitive edge until the patent expired[2].
Licensing and Royalties
The economic impact also extends to licensing and royalties. Patent holders can license their technology to other companies, generating revenue through royalties. This can be particularly lucrative in the pharmaceutical industry, where patented drugs can command high prices due to their exclusivity.
Search and Analysis Tools
USPTO Resources
For conducting a thorough analysis of patents like U.S. Patent 5,001,161, the United States Patent and Trademark Office (USPTO) provides several resources:
- Patent Public Search: A modern interface for searching prior art and related patents.
- Global Dossier: A service that provides access to file histories of related applications from participating IP offices.
- Patent and Trademark Resource Centers (PTRCs): Local resources that offer training in patent search techniques[1].
International Databases
International databases such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO) are also crucial for a comprehensive analysis. These databases offer access to global patent collections and machine translations, facilitating a broader understanding of the patent landscape[1].
Key Takeaways
- Scope and Claims: U.S. Patent 5,001,161 is focused on a pharmaceutical composition containing metoprolol succinate, with claims that define the composition and its preparation method.
- Patent Landscape: The patent is part of a larger landscape that includes related patents and prior art, both domestically and internationally.
- Litigation and Validity: The patent has faced legal challenges, including arguments of obviousness-type double patenting.
- Economic Impact: The patent has significant economic implications, including market dominance and revenue generation through licensing and royalties.
- Search and Analysis Tools: Various resources are available for conducting thorough patent searches and analyses.
FAQs
Q: What is the main subject of U.S. Patent 5,001,161?
A: The main subject is a pharmaceutical composition comprising metoprolol succinate, used in the treatment of hypertension and other cardiovascular conditions.
Q: How do the claims of U.S. Patent 5,001,161 define the invention?
A: The claims define the specific composition, its components, and the method of preparation, ensuring the invention is clearly distinguished from prior art.
Q: What are some related patents to U.S. Patent 5,001,161?
A: Related patents include U.S. Patent 5,081,154A and U.S. Patent 4,780,318A, which are part of the same patent family and describe similar pharmaceutical compositions.
Q: What legal challenges has U.S. Patent 5,001,161 faced?
A: The patent has faced challenges related to obviousness-type double patenting, as seen in the case of In re Metoprolol Succinate Patent Litigation.
Q: How can one conduct a thorough analysis of U.S. Patent 5,001,161?
A: One can use resources such as the USPTO's Patent Public Search, Global Dossier, and international databases like those provided by the EPO and WIPO.
Sources
- USPTO: Search for patents - USPTO.
- Law360: U.S. Patent Number 5,001,161 : Articles :: Law360.
- USPTO: Patent Claims Research Dataset - USPTO.
- Google Patents: Metoprolol succinate - US5081154A - Google Patents.
- Gale: In re Metoprolol Succinate Patent Litigation: composition claims ...
