United States Patent 7,030,106: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,030,106, titled "Sterol absorption inhibitor compositions," is a significant patent in the pharmaceutical industry, particularly in the field of cholesterol management. This patent, assigned to Schering Corporation (now part of Merck & Co., Inc.), protects compositions and methods related to sterol absorption inhibitors. Here is a detailed analysis of its scope, claims, and the surrounding patent landscape.
Background of the Invention
The patent 7,030,106 was filed on July 22, 2003, and granted on April 18, 2006. It is part of a series of patent applications and continuations, indicating a thorough and iterative development process. The invention was made under a joint research agreement involving Merck & Co., Inc., Schering Corporation, and MSP Singapore LLC[5].
Claims and Scope
Independent Claims
The patent includes several independent claims that define the scope of the invention. Here are some key claims:
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Claim 1: This claim describes a composition comprising at least one peroxisome proliferator-activated receptor (PPAR) activator and at least one sterol absorption inhibitor represented by a specific formula. This combination is designed to enhance the therapeutic effects of both components[4].
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Claim 2: This claim specifies the PPAR activator and the sterol absorption inhibitor in more detail, including their chemical structures and acceptable salts, solvates, or prodrugs[4].
Dependent Claims
The dependent claims further narrow down the scope by specifying particular embodiments of the composition, such as the types of PPAR activators and sterol absorption inhibitors, their ratios, and pharmaceutical formulations.
Composition Details
The patent describes compositions that include:
- PPAR Activators: These are compounds that activate peroxisome proliferator-activated receptors, which play a role in lipid metabolism and glucose homeostasis.
- Sterol Absorption Inhibitors: Specifically, the patent mentions compounds like ezetimibe, which inhibit the absorption of sterols in the intestine, thereby reducing cholesterol levels[4].
Therapeutic Combinations
The patent highlights therapeutic combinations that include these components. For example, the combination of a PPAR activator with a sterol absorption inhibitor is designed to provide synergistic effects in managing cholesterol levels and other metabolic disorders[5].
Patent Landscape
Family Patents
The patent 7,030,106 is part of a larger family of patents related to sterol absorption inhibitors and their combinations. Understanding the full scope of these family patents is crucial for strategizing market entry and avoiding infringement. For instance, other patents like US7612058 and US7030106 (now expired) also protect various aspects of sterol absorption inhibitors, including methods of administration and specific compositions[2][4].
Exclusivity and Expiration
The patent 7,030,106 has expired, as indicated by its legal status. This expiration opens up opportunities for generic manufacturers to enter the market. However, it is essential to analyze the broader patent landscape, including international patents and ongoing legal events, to identify markets with weaker patent protection[2].
Generic Launch
The expiration of key patents like 7,030,106 allows for the launch of generic versions of the drug. For example, the expiration of patents related to Zetia (ezetimibe) has enabled generic manufacturers to produce and market their own versions of the drug, which can significantly impact the market dynamics[2].
Economic and Strategic Impact
Valuation
The value of patents like 7,030,106 can be substantial. While the exact value of this specific patent is not publicly disclosed, similar patents in the pharmaceutical industry have been valued in the hundreds of millions of dollars. For instance, the sale of patent portfolios by companies like Novell and Nortel involved billions of dollars, highlighting the significant economic value of intellectual property in this sector[1].
Licensing and Litigation
Patents with broad claims and significant therapeutic impact, like 7,030,106, can be subject to licensing agreements and litigation. The clarity and validity of the claims are crucial in determining the patent's enforceability and its potential for generating revenue through licensing or litigation[3].
Metrics for Patent Scope
The scope of a patent can be measured using metrics such as independent claim length and independent claim count. These metrics can provide insights into the breadth and clarity of the patent claims. For example, narrower claims at publication are associated with a higher probability of grant and a shorter examination process, which can be relevant for patents like 7,030,106[3].
Conclusion
United States Patent 7,030,106 is a critical patent in the pharmaceutical industry, particularly in the management of cholesterol levels. Understanding its claims, scope, and the surrounding patent landscape is essential for both innovators and generic manufacturers. The expiration of this patent has opened up opportunities for generic entry, while the broader patent landscape continues to influence market strategies.
Key Takeaways
- Claims and Scope: The patent protects compositions and methods involving PPAR activators and sterol absorption inhibitors.
- Patent Landscape: Part of a larger family of patents, with some patents now expired.
- Economic Impact: Significant economic value, with potential for licensing and litigation.
- Generic Launch: Expiration allows for generic entry, impacting market dynamics.
- Metrics for Patent Scope: Independent claim length and count can measure patent breadth and clarity.
FAQs
What is the primary focus of United States Patent 7,030,106?
The primary focus is on compositions and methods involving PPAR activators and sterol absorption inhibitors for managing cholesterol levels.
Who is the assignee of this patent?
The assignee is Schering Corporation, now part of Merck & Co., Inc.
What is the current legal status of this patent?
The patent has expired.
How does the expiration of this patent affect the market?
The expiration allows generic manufacturers to produce and market their own versions of the drug, potentially reducing prices and increasing competition.
What metrics can be used to measure the scope of a patent?
Metrics such as independent claim length and independent claim count can be used to measure the scope and clarity of patent claims.
Cited Sources
- The Value of a Patent - Perpetual Motion Patents
- Zetia Patent Expiration - Pharsight
- Patent Claims and Patent Scope - SSRN
- US7030106B2 - Sterol absorption inhibitor compositions - Google Patents
- United States Patent 7,718,643 B2 - Google Patents
