United States Patent 4,376,858: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,376,858, titled "Human Drug Product Neutrexin™," is a significant patent in the pharmaceutical industry, particularly in the context of drug development and patent law. This analysis will delve into the scope and claims of the patent, as well as its position within the broader patent landscape.
Patent Overview
Patent Number and Title
- Patent Number: 4,376,858
- Title: Human Drug Product Neutrexin™
Inventors and Assignees
The patent was granted to inventors who developed Neutrexin™, a drug product. The assignee of the patent is typically the entity that owns the rights to the invention, often a pharmaceutical company or research institution.
Scope and Claims
Invention Description
The patent describes Neutrexin™, a human drug product designed for therapeutic use. The invention involves specific formulations and methods of preparation for this drug, which is intended to treat certain medical conditions.
Claims
The claims section of the patent outlines the specific aspects of the invention that are protected by law. These claims typically include:
- Composition Claims: Describing the chemical composition of Neutrexin™.
- Method Claims: Outlining the methods of preparing and administering the drug.
- Use Claims: Specifying the medical conditions for which Neutrexin™ is intended to be used[5].
Patent Term Extension
Regulatory Reviews and Extensions
The patent term for U.S. Patent 4,376,858 was extended under 35 U.S.C. § 156(e)(1), which allows for the extension of a patent term if the product claimed by the patent has been subject to certain regulatory reviews by the Food and Drug Administration (FDA) or the Department of Agriculture. For Neutrexin™, the extension was granted due to the FDA's regulatory review process[2].
Calculation of Extension
The extension period is calculated based on the time the product was under regulatory review. In this case, the patent term was extended by 1,286 days, reflecting the period from FDA approval to the patent's original expiration date[2].
Patent Landscape Analysis
Definition and Importance
Patent landscape analysis is a critical tool for understanding the technological and competitive environment surrounding a patent. It involves analyzing vast amounts of patent data to extract legal, business, and technical insights[3].
Relevant Data Sources
For U.S. Patent 4,376,858, relevant data can be collected from various sources, including:
- United States Patent and Trademark Office (USPTO): The primary source for U.S. patent data.
- World Intellectual Property Organization (WIPO): For international patent filings and data.
- European Patent Office (EPO): For European patent filings and data[3].
Key Elements of Patent Landscape Analysis
- Application Number, Filing Date, and Country: These details help identify the patent and its global filings.
- Legal Status: Whether the patent is alive, pending, lapsed, revoked, or expired.
- Expected Expiry Dates: Critical for planning and strategy.
- Patent Trends and Market Developments: Insights into mergers and acquisitions, licensing, litigation, and opposition activities[3].
Position in the Broader Patent Landscape
Technological Domain
Neutrexin™ falls within the pharmaceutical domain, specifically in the area of therapeutic drug products. The patent landscape in this domain is highly competitive, with numerous patents covering various aspects of drug development, formulation, and use.
Competitors and Collaborators
Identifying competitors and potential collaborators is crucial. This involves analyzing patents held by other pharmaceutical companies and research institutions in the same technological domain. For example, other patents related to similar drug products or methods of treatment can indicate market trends and potential areas for collaboration or competition[3].
Regulatory and Legal Context
Bayh-Dole Act
The Bayh-Dole Act, which allows universities and other federal grant recipients to patent inventions created under federal grants, is relevant. Although U.S. Patent 4,376,858 does not specifically mention government funding, understanding the broader regulatory context is important. The Act ensures that inventions arising from federally supported research are utilized effectively and that the government retains certain rights, including march-in rights to ensure public access[1].
Impact on the Pharmaceutical Industry
Market Developments
The patent for Neutrexin™ has contributed to the development of therapeutic drug products. The extension of its patent term under 35 U.S.C. § 156(e)(1) reflects the regulatory approval process and the importance of such drugs in the market.
Litigation and Opposition
Patents in the pharmaceutical industry are often subject to litigation and opposition. Understanding the legal status and any challenges to the patent can provide insights into its stability and the potential for future disputes.
Key Takeaways
- Patent Scope and Claims: U.S. Patent 4,376,858 covers specific formulations and methods related to Neutrexin™.
- Patent Term Extension: The patent term was extended due to FDA regulatory reviews.
- Patent Landscape Analysis: Critical for understanding competitors, market trends, and legal status.
- Regulatory Context: The Bayh-Dole Act and other regulatory frameworks influence the patent's utilization and public access.
- Industry Impact: The patent has contributed to the development of therapeutic drug products and reflects the competitive and regulatory environment of the pharmaceutical industry.
FAQs
What is the primary purpose of U.S. Patent 4,376,858?
The primary purpose of U.S. Patent 4,376,858 is to protect the invention of the human drug product Neutrexin™, including its composition, preparation methods, and therapeutic uses.
How was the patent term for Neutrexin™ extended?
The patent term was extended under 35 U.S.C. § 156(e)(1) due to the FDA's regulatory review process, adding 1,286 days to the original patent term.
What is patent landscape analysis, and why is it important?
Patent landscape analysis is a process that analyzes patent data to provide insights into competitors, market trends, and legal status. It is crucial for strategic decision-making in technological domains.
How does the Bayh-Dole Act relate to U.S. Patent 4,376,858?
Although U.S. Patent 4,376,858 does not specify government funding, the Bayh-Dole Act is relevant in the broader context of patent law, ensuring that inventions from federally supported research are utilized effectively and that the government retains certain rights.
What are some key elements to consider in a patent landscape analysis for pharmaceutical patents?
Key elements include the application number, filing date, country of filing, legal status, expected expiry dates, and insights into market trends, mergers and acquisitions, licensing, litigation, and opposition activities.
Sources
- The Feasibility of Using Bayh-Dole March-In Rights to Lower Drug Prices - National Bureau of Economic Research
- Extension Under 35 U.S.C. 156(e)(1) - United States Patent and Trademark Office
- Navigating Technological Domains with Patent Landscape Analysis - Sagacious Research
- Crystalline trimetrexate salts and their use - Google Patents
- Department of Commerce, Patent and Trademark Office - USPTO
