United States Patent 4,587,258: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,587,258, often associated with the pharmaceutical compound Ramipril, is a significant patent in the field of cardiovascular medicine. This patent, issued to Schering and later licensed to Aventis, has been a focal point in several legal and technological discussions. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background and Scope
Patent Overview
The patent in question, U.S. Patent 4,587,258, pertains to Ramipril, a compound used in the treatment of hypertension and heart failure. Ramipril is an angiotensin-converting enzyme (ACE) inhibitor, which works by relaxing blood vessels and reducing blood pressure[4].
Technological Domain
This patent falls within the domain of pharmaceuticals, specifically cardiovascular drugs. The scope of the patent includes the compound itself, its method of production, and its use in medical treatments.
Claims and Specifications
Main Claims
The patent claims cover the compound Ramipril, its isomers, and methods for its preparation. A key aspect of the patent is the specification that Ramipril is "substantially free of other isomers," which was crucial for its FDA approval and subsequent marketability[4].
Subsequent Patents
The '258 patent was followed by another significant patent, U.S. Patent 5,061,722 ('722 patent), which also pertains to Ramipril but with additional specifications. The '722 patent was issued on October 29, 1991, and it played a critical role in extending the patent protection for Ramipril beyond the expiration of the '258 patent[4].
Patent Landscape Analysis
Defining Scope and Keywords
To analyze the patent landscape around U.S. Patent 4,587,258, one must define the relevant technology field and keywords. Key terms include "Ramipril," "ACE inhibitors," "cardiovascular drugs," and "pharmaceutical compounds"[3].
Search and Organization
Using patent databases, one can retrieve relevant patents related to these keywords. Organizing these patents by factors such as filing date, assignee, and technology subcategories helps in understanding the evolution and impact of these patents[3].
Identifying Trends and Key Players
The analysis reveals that Schering and Aventis were key players in the development and patenting of Ramipril. The trend shows a significant focus on cardiovascular drugs, particularly ACE inhibitors, during the late 20th century[3].
Analyzing Citations and Evolution
Studying how patents reference each other provides insights into their impact and development. The '258 patent was cited in several subsequent patents, including the '722 patent, indicating its foundational role in the field[3].
Legal and Regulatory Aspects
Obviousness and Nonobviousness
The patentability of Ramipril was subject to the obviousness test under 35 U.S.C. § 103. The Supreme Court's decision in KSR International Co. v. Teleflex, Inc. emphasized the need for a more flexible approach to obviousness, considering common sense and marketplace demands. This decision impacted how patents like the '258 patent were evaluated for nonobviousness[1].
Patent Term Extensions
The '258 patent was subject to patent term extensions under 35 U.S.C. § 156. These extensions are granted to compensate for delays in the FDA approval process, ensuring that the patent holder has a reasonable period to market the drug. However, these extensions are limited to a maximum of 14 years from the date of FDA approval[2].
Litigation and Enforcement
Aventis Pharma Deutschland GMBH v. Lupin LTD
A significant legal battle surrounding the '258 patent and its successor, the '722 patent, was the case of Aventis Pharma Deutschland GMBH v. Lupin LTD. Aventis sued Lupin for patent infringement after Lupin filed an Abbreviated New Drug Application (ANDA) to market a generic version of Ramipril. The court found the '722 patent valid and enforceable, rejecting Lupin's defenses of invalidity and unenforceability[4].
Impact on the Pharmaceutical Industry
Market Dominance
The '258 patent and subsequent patents like the '722 patent allowed Aventis to maintain market dominance for Ramipril, preventing generic competition for an extended period. This highlights the strategic importance of patent protection in the pharmaceutical industry.
Innovation and Competition
The patent landscape analysis shows that while these patents protected Aventis's interests, they also spurred innovation in the field of cardiovascular drugs. Other companies were motivated to develop new compounds or improve existing ones to circumvent the patent protections.
Key Takeaways
- Patent Scope and Claims: U.S. Patent 4,587,258 covers the compound Ramipril, its isomers, and methods of preparation, with a focus on its use in cardiovascular treatments.
- Patent Landscape: The analysis reveals Schering and Aventis as key players, with a trend towards cardiovascular drug development, particularly ACE inhibitors.
- Legal and Regulatory: The patent was subject to obviousness tests and patent term extensions, with significant legal battles over its validity and enforceability.
- Industry Impact: The patent protected Aventis's market dominance but also drove innovation in the pharmaceutical industry.
FAQs
What is the main compound covered by U.S. Patent 4,587,258?
The main compound covered by U.S. Patent 4,587,258 is Ramipril, an angiotensin-converting enzyme (ACE) inhibitor used in the treatment of hypertension and heart failure.
How did the Supreme Court's decision in KSR International Co. v. Teleflex, Inc. affect the evaluation of this patent?
The KSR decision introduced a more flexible approach to evaluating obviousness, considering common sense and marketplace demands, which impacted how patents like the '258 patent were assessed for nonobviousness.
What was the outcome of the Aventis Pharma Deutschland GMBH v. Lupin LTD case?
The court found the '722 patent, which succeeded the '258 patent, valid and enforceable, rejecting Lupin's defenses of invalidity and unenforceability.
How did patent term extensions apply to U.S. Patent 4,587,258?
The patent was subject to extensions under 35 U.S.C. § 156 to compensate for delays in FDA approval, but these extensions were limited to a maximum of 14 years from the date of FDA approval.
What insights can be gained from a patent landscape analysis of this patent?
A patent landscape analysis provides insights into ongoing innovations, technological trends, key players, and the competitive landscape, helping in making informed strategic decisions.
Sources
- Nonobviousness in the U.S. Post-KSR for Innovative Drug Companies - Finnegan
- Extension Under 35 U.S.C. 156(e)(1) - OG Date: 29 July 2003 - United States Patent and Trademark Office
- How to Do Patent Landscape Analysis - Goldstein Patent Law
- Aventis Pharma Deutschland GMBH v. Lupin LTD - Casetext
- Antiglaucoma compositions and methods - Patent US-4840772-A - PubChem
