Detailed Analysis of the Scope and Claims of United States Patent 5,614,520
Introduction
United States Patent 5,614,520, issued on March 25, 1997, is a significant patent in the pharmaceutical sector, particularly related to 2-arylthiazole derivatives and their pharmaceutical compositions. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Inventors and Assignees
The patent was granted to a group of inventors including Shiro Kondo, Hisashi Fukushima, Masaichi Hasegawa, Masahiro Tsuchimoto, Ikuo Nagata, Yoshio Osada, Keiji Komoriya, and Hisao Yamaguchi. The assignee of the entire interest in this patent is Teijin Pharma Limited, a Japanese corporation[1].
Patent Claims
The patent claims cover a range of aspects related to 2-arylthiazole derivatives, including their composition of matter, methods of use, and manufacturing processes.
Composition of Matter
The patent claims include compounds that are 2-arylthiazole derivatives, characterized by specific structural elements. For example, Claim 1 describes a compound where:
- X is a carboxyl, C1-5 alkoxycarbonyl, carbamoyl, or C1-4 alkyl (mono- or di-substituted) aminocarbonyl group.
- R is an unsubstituted or substituted 5- to 7-membered heterocyclic ring or a specific group such as COR" (where R" is an unsubstituted or substituted C1-10 alkyl, aryl, or aralkyl group, among others)[1].
Methods of Use
The patent also claims methods of using these compounds, particularly in pharmaceutical compositions. These methods involve the use of the 2-arylthiazole derivatives for therapeutic purposes, although the specific therapeutic indications are not detailed in the patent claims themselves[1].
Manufacturing Processes
The claims include processes for preparing these compounds, such as forming a salt of the 2-arylthiazole derivative by combining the starting batch with a base, isolating the salt, and preparing a pharmaceutical composition from the isolated salt[1].
Scope of the Patent
The scope of the patent is broad, covering various aspects of the 2-arylthiazole derivatives.
Structural Variability
The patent allows for a wide range of structural variations within the 2-arylthiazole derivatives, including different substituents and functional groups. This variability is crucial for developing a range of compounds with potentially different therapeutic profiles[1].
Pharmaceutical Compositions
The patent claims encompass pharmaceutical compositions that include the 2-arylthiazole derivatives, either alone or in combination with other active ingredients or excipients. This is significant for the formulation of drugs that can be administered in various forms[1].
Patent Landscape
The patent landscape surrounding U.S. Patent 5,614,520 involves several key aspects.
Related Patents
Other patents, such as U.S. Patent 8,969,582, reference the 5,614,520 patent in the context of related chemical compounds and pharmaceutical applications. For instance, the 8,969,582 patent discusses febuxostat, an active ingredient in ULORIC(R), and mentions the 5,614,520 patent in the background section[4].
Extension and Expiration
The patent term for U.S. Patent 5,614,520 was set to expire on March 25, 2014. However, Teijin Pharma Limited sought an extension of the patent term under 35 U.S.C. § 156, which allows for extensions due to delays in the FDA approval process[1].
Litigation and Enforcement
While U.S. Patent 5,614,520 itself is not directly involved in recent litigation, the principles of patent infringement and validity seen in other pharmaceutical patent cases (e.g., the case involving United Therapeutics Corporation and Liquidia Technologies, Inc.) highlight the importance of carefully construing claims and demonstrating infringement or non-infringement in pharmaceutical patents[2].
Economic and Research Implications
The Patent Claims Research Dataset by the USPTO provides insights into the scope and trends of patent claims, including those related to pharmaceutical patents. This dataset can help in understanding the broader context of patent scope measurements and how patents like 5,614,520 fit into the larger landscape of pharmaceutical innovation[3].
Key Takeaways
- Broad Structural Claims: The patent covers a wide range of 2-arylthiazole derivatives with various structural variations.
- Pharmaceutical Applications: The claims include methods of use and pharmaceutical compositions, making the patent significant for therapeutic applications.
- Patent Term Extension: The patent term was subject to extension under 35 U.S.C. § 156 due to FDA approval delays.
- Related Patents: Other patents reference this patent, indicating its relevance in the broader pharmaceutical patent landscape.
- Litigation Principles: The patent highlights the importance of claim construction and infringement analysis in pharmaceutical patent cases.
FAQs
What is the main subject of U.S. Patent 5,614,520?
The main subject of U.S. Patent 5,614,520 is 2-arylthiazole derivatives and their pharmaceutical compositions.
Who are the inventors of U.S. Patent 5,614,520?
The inventors include Shiro Kondo, Hisashi Fukushima, Masaichi Hasegawa, Masahiro Tsuchimoto, Ikuo Nagata, Yoshio Osada, Keiji Komoriya, and Hisao Yamaguchi.
What is the significance of the structural variability in the patent claims?
The structural variability allows for the development of a range of compounds with potentially different therapeutic profiles, making the patent broadly applicable in pharmaceutical research.
Was the patent term extended?
Yes, Teijin Pharma Limited sought an extension of the patent term under 35 U.S.C. § 156 due to delays in the FDA approval process.
How does this patent fit into the broader patent landscape?
The patent is referenced in other related patents and is part of the larger landscape of pharmaceutical innovation, as seen in datasets and research by the USPTO.
Cited Sources
- U.S. Patent and Trademark Office, "Application for Extension of Patent Term Under 35 U.S.C. § 156 U.S. Patent No. 5,614,520" [PDF].
- District of Delaware, "Civil Action No. 20-755-RGA" [PDF].
- U.S. Patent and Trademark Office, "Patent Claims Research Dataset".
- U.S. Patent and Trademark Office, "U.S. Patent No. 8,969,582 B2" [PDF].
