Detailed Analysis of the Scope and Claims of United States Patent 5,214,052
Introduction to the Patent
United States Patent No. 5,214,052, issued on May 25, 1993, is a pivotal patent in the pharmaceutical industry, particularly in the domain of anticoagulant medications. This patent, entitled "Method for Dissolving Arginineamides and Pharmaceutical Compositions Containing Them," is assigned to Mitsubishi Chemical Corporation (MCC) and has been the subject of several significant legal battles.
Background of the Patent
The '052 patent was filed on July 28, 1988, as a continuation of a patent application that traces back to a Japanese priority date of July 28, 1987. The patent was extended under 35 U.S.C. § 156, with its term ending on June 30, 2014[4].
Claims of the Patent
The '052 patent includes four claims, two of which are independent and two that are dependent.
Independent Claims
- Claim 1: This claim is directed towards a method for dissolving an arginineamide (Argatroban) and/or its salt in a solvent system containing ethanol, water, and a saccharide[1][4].
- Claim 3: Similar to Claim 1, but directed towards a pharmaceutical composition for injection rather than a method. This claim specifies a pharmaceutical composition comprising Argatroban, ethanol, water, and a saccharide[1][4].
Dependent Claims
- Claim 2: Depends on Claim 1 and limits the saccharide to at least one of the following: sorbitol, glucose, glycerin, and sucrose[1].
- Claim 4: Identical to Claim 2 but depends on Claim 3 instead[1].
Scope of the Patent
The patent covers both the method of dissolving Argatroban and the pharmaceutical composition itself. Argatroban, an anticoagulant, is used to control abnormal blood clotting during surgical procedures. The solvent system specified in the patent is crucial for the stability and efficacy of the drug.
Legal Disputes and Litigation
The '052 patent has been involved in several legal disputes, particularly with generic drug manufacturers seeking to market their own versions of Argatroban.
Mitsubishi Chemical Corp. v. Barr Laboratories, Inc.
In this case, Barr Laboratories filed an Abbreviated New Drug Application (ANDA) with the FDA to market a generic version of Argatroban Injection. Mitsubishi Chemical Corporation and other plaintiffs alleged that Barr's proposed product would infringe the '052 patent. The defendants conceded infringement but argued that the patent was invalid due to anticipation or obviousness under 35 U.S.C. § 102 and § 103, respectively[4].
GlaxoSmithKline PLC v. Hikma Pharm. Co. Ltd.
In another significant case, GlaxoSmithKline PLC and other plaintiffs sued Hikma Pharmaceutical Co. for patent infringement. Hikma had filed an NDA for a generic version of Argatroban, which the plaintiffs alleged would infringe the '052 patent. The case involved expedited trial proceedings to resolve the dispute efficiently[1][5].
Patent Landscape Analysis
To understand the broader context of the '052 patent, a patent landscape analysis is essential.
Defining Scope and Keywords
The analysis begins by defining the technology field and specific terms related to anticoagulant pharmaceuticals, particularly those involving Argatroban and similar compounds[3].
Searching and Organizing Patents
Using databases, relevant patents are identified based on the chosen keywords. These patents are then organized by factors such as filing date, assignee, and geographical distribution. Visual aids like heat maps and citation networks can reveal trends and key players in the field[3].
Identifying Trends and Key Players
The analysis recognizes patterns in patent filings, pinpointing significant contributors and emerging technologies. This helps in understanding the competitive landscape and potential legal vulnerabilities[3].
Analyzing Citations and Evolution
Studying how patents reference each other provides insights into their impact and technological development. This analysis can gauge the influence of the '052 patent and its position within the broader technological evolution[3].
Insights from Patent Landscape Analysis
A patent landscape analysis offers several critical insights:
- Technological Trends: It reveals ongoing innovations and predicts future technological trends in the anticoagulant pharmaceutical domain.
- Key Players: It identifies significant contributors, including Mitsubishi Chemical Corporation, GlaxoSmithKline PLC, and other major players in the field.
- Competitive Landscape: It provides a comprehensive view of the competitive landscape, highlighting areas of high patent activity and potential white spaces.
- Legal Vulnerabilities: It helps in assessing the strength of the patent portfolio and potential legal vulnerabilities, such as invalidity challenges or infringement risks[3].
Impact of the '052 Patent
The '052 patent has been a cornerstone in the development and marketing of Argatroban, influencing both the method of dissolving the drug and the pharmaceutical composition itself. Its impact is evident in the legal battles it has been a part of, where it has been defended vigorously against generic manufacturers.
"The '052 patent has been the subject of prior litigation, including a significant case against Barr Laboratories, Inc., where the court had to determine whether the patent was valid and whether Barr's generic product infringed upon it"[4].
Key Takeaways
- Patent Claims: The '052 patent includes method and composition claims related to dissolving Argatroban in a solvent system.
- Legal Disputes: The patent has been involved in several legal disputes with generic drug manufacturers.
- Patent Landscape: A comprehensive analysis reveals trends, key players, and potential legal vulnerabilities in the anticoagulant pharmaceutical domain.
- Technological Impact: The patent has significantly influenced the development and marketing of Argatroban.
Frequently Asked Questions (FAQs)
Q: What is the main subject of United States Patent 5,214,052?
A: The main subject is a method for dissolving arginineamides (Argatroban) and pharmaceutical compositions containing them.
Q: Who is the assignee of the '052 patent?
A: The assignee is Mitsubishi Chemical Corporation (MCC).
Q: What is the significance of the solvent system in the '052 patent?
A: The solvent system, containing ethanol, water, and a saccharide, is crucial for the stability and efficacy of Argatroban.
Q: What legal disputes has the '052 patent been involved in?
A: The patent has been involved in disputes with generic drug manufacturers, including Barr Laboratories and Hikma Pharmaceutical Co.
Q: How does a patent landscape analysis help in understanding the '052 patent?
A: It provides insights into technological trends, key players, competitive landscape, and potential legal vulnerabilities in the anticoagulant pharmaceutical domain.
Sources Cited
- GlaxoSmithKline PLC v. Hikma Pharm. Co. - Casetext
- United States Court of Appeals for the Federal Circuit - Mitsubishi Chemical v. Barr Labs
- How to Do Patent Landscape Analysis - Goldstein Patent Law
- Mitsubishi Chemical Corp. v. Barr Laboratories, Inc. - Casetext
- GlaxoSmithKline PLC v. Hikma Pharm. Co. Ltd. - Robins Kaplan
