United States Patent 7,777,050: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,777,050, titled "N3 alkylated benzimidazole derivatives as MEK inhibitors," is a significant patent in the field of pharmaceuticals, particularly in the treatment of hyperproliferative diseases such as cancer and inflammation. This patent, now expired, was an important asset for its assignees and played a crucial role in the development of MEK inhibitors.
Background and Invention Overview
The patent, filed on March 18, 2008, and granted on August 17, 2010, describes a class of compounds known as N3 alkylated benzimidazole derivatives. These compounds are identified as MEK inhibitors, which are critical in the treatment of various hyperproliferative diseases[4].
Claims and Scope
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims are centered around the chemical structure of the N3 alkylated benzimidazole derivatives and their use as MEK inhibitors. Specifically, the claims describe the general formula of these compounds, their pharmaceutical compositions, and methods for treating diseases using these compounds[4].
Dependent Claims
Dependent claims further specify the independent claims by detailing specific substituents, pharmaceutical formulations, and methods of administration. These claims help to narrow down the scope and provide a clearer definition of what is protected under the patent[4].
Chemical Structure and Compounds
The patent describes compounds of the general formula:
[ \text{N3 alkylated benzimidazole derivatives} ]
These compounds are characterized by their ability to inhibit MEK (Mitogen-Activated Protein Kinase Kinase), a key enzyme in the MAPK signaling pathway, which is often dysregulated in cancer and other hyperproliferative diseases[4].
Use in Treating Hyperproliferative Diseases
The primary use of these compounds is in the treatment of hyperproliferative diseases, including various types of cancer and inflammatory conditions. The patent outlines methods for using these compounds alone or in combination with other therapeutic agents, such as anti-tumor agents or radiation therapy[1][4].
Pharmaceutical Compositions and Formulations
The patent also covers pharmaceutical compositions containing the N3 alkylated benzimidazole derivatives. These compositions can be formulated in various ways, including tablets, capsules, and injectable solutions, to facilitate different routes of administration[4].
Patent Landscape and Related Patents
Family of Patents
This patent is part of a larger family of patents related to MEK inhibitors. Other patents in this family include U.S. Patent Nos. 7,425,637, 7,576,114, 7,842,816, and 8,193,229, among others. These patents collectively cover various aspects of MEK inhibitors, including different chemical structures, methods of synthesis, and therapeutic applications[1][2].
Litigation and Infringement
The patent was listed in the FDA's Orange Book for the drug MEKTOVI, which is used to treat melanoma with specific BRAF mutations. The expiration of this patent, along with others related to MEKTOVI, has led to litigation over generic versions of the drug. For example, Array BioPharma Inc. has sued Teva Pharmaceuticals, Inc. for patent infringement related to the submission of an Abbreviated New Drug Application (ANDA) for a generic version of MEKTOVI[2].
Expiration and Impact
The patent expired on March 13, 2023, which has significant implications for the pharmaceutical industry. The expiration allows for the potential entry of generic versions of MEK inhibitors into the market, which could increase accessibility and reduce costs for patients. However, it also means that the original patent holders no longer have exclusive rights to manufacture and sell these compounds[2][5].
Patent Scope and Quality
The scope of this patent, like many others, has been a subject of discussion in the context of patent quality. Metrics such as independent claim length and count can be used to measure patent scope. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and shorter examination processes[3].
Industry Impact and Future Directions
The expiration of U.S. Patent 7,777,050 and related patents opens up opportunities for new entrants in the market and potentially drives innovation in the field of MEK inhibitors. However, it also underscores the need for continuous research and development to maintain a competitive edge in the pharmaceutical industry.
Key Takeaways
- Compound Description: The patent covers N3 alkylated benzimidazole derivatives as MEK inhibitors.
- Therapeutic Use: These compounds are used in treating hyperproliferative diseases, including cancer and inflammation.
- Patent Family: Part of a larger family of patents related to MEK inhibitors.
- Litigation: Involved in litigation over generic versions of MEKTOVI.
- Expiration: Expired on March 13, 2023, allowing for potential generic entries.
- Industry Impact: Opens up market opportunities and drives innovation in MEK inhibitors.
Frequently Asked Questions (FAQs)
What are MEK inhibitors, and why are they important?
MEK inhibitors are drugs that block the activity of the MEK enzyme, which is involved in cell signaling pathways. They are crucial in treating hyperproliferative diseases like cancer because they can help control or stop the growth of cancer cells.
What is the significance of U.S. Patent 7,777,050 in the pharmaceutical industry?
This patent is significant because it covers a class of compounds that are effective MEK inhibitors, which are used in the treatment of various cancers and inflammatory conditions. Its expiration allows for the potential entry of generic versions into the market.
How does the expiration of this patent affect the pharmaceutical industry?
The expiration of this patent means that the original patent holders no longer have exclusive rights to manufacture and sell these compounds. This can lead to increased competition, lower prices, and greater accessibility for patients.
What other patents are related to U.S. Patent 7,777,050?
This patent is part of a family of patents that include U.S. Patent Nos. 7,425,637, 7,576,114, 7,842,816, and 8,193,229, among others, all related to MEK inhibitors.
What is the current status of litigation involving this patent?
The patent was involved in litigation related to the submission of an Abbreviated New Drug Application (ANDA) for a generic version of MEKTOVI. Array BioPharma Inc. sued Teva Pharmaceuticals, Inc. for patent infringement, but the patent has since expired, resolving some of these issues.
Cited Sources:
- United States Patent and Trademark Office. US8513293B2 - Alkylated (1H-benzoimidazol-5-yl)-(4-substituted phenyl)-amine compounds and methods of use thereof.
- United States District Court for the District of Delaware. Array BioPharma Inc. v. Teva Pharmaceuticals, Inc.
- Hoover Institution. Patent Claims and Patent Scope.
- Google Patents. US7777050B2 - N3 alkylated benzimidazole derivatives as MEK inhibitors.
- PharmaCompass. US Patent 7777050 | Expiration | Dates.
