United States Patent 11,419,914: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 11,419,914, titled "Safe desmopressin administration," is a significant patent in the field of pharmaceuticals, particularly concerning the administration of desmopressin, a synthetic hormone used to treat conditions such as nocturnal enuresis (bedwetting) and central diabetes insipidus. This article provides a comprehensive analysis of the patent's scope, claims, and its position within the broader patent landscape.
Background of Desmopressin
Desmopressin is a synthetic analogue of vasopressin, a natural hormone that helps regulate water balance in the body. It is commonly administered via intranasal spray or injection to manage conditions associated with excessive urine production.
Patent Overview
Publication and Status
The patent, US11419914B2, was published on August 16, 2022, and is currently active. It is part of a family of patents related to the administration of desmopressin[1].
Inventors and Assignees
The patent lists the inventors and assignees involved in its development. Understanding these parties is crucial for determining the ownership and potential licensing or collaboration opportunities.
Claims and Scope
Primary Claims
The patent primarily claims a family of intranasal spray dispensers designed to administer uniform low doses of desmopressin. These claims focus on the method and apparatus for delivering precise doses to achieve safe antidiuresis in humans[1].
Detailed Claim Analysis
- Claim 1: This claim typically outlines the broadest scope of the invention, often describing the overall system or method.
- Dependent Claims: These claims build upon the independent claims, providing more specific details about the invention, such as the composition of the spray, the mechanism of the dispenser, and the dosing regimen.
Scope Concepts
The claims can be categorized using scope concepts, which help in filtering and analyzing large numbers of patent claims. This approach, as described in patent analytics, allows for a more efficient understanding of the patent landscape and identifies gaps or opportunities in current coverage[3].
Patent Landscape
Competitive Landscape
The patent landscape for desmopressin administration includes various other patents and products. Analyzing this landscape helps in understanding the competitive environment and potential infringement risks. Companies like Ferring Pharmaceuticals, which have significant patents in this area, are key players to consider.
Related Patents
Other patents related to desmopressin administration or similar therapeutic areas can influence the scope and validity of US11419914B2. For instance, patents related to delivery mechanisms, dosage forms, or treatment methods for similar conditions could intersect with the claims of this patent.
Technological and Market Impact
Technological Advancements
The patent represents a technological advancement in the administration of desmopressin, ensuring safe and uniform dosing. This innovation can improve patient compliance and reduce side effects associated with variable dosing.
Market Impact
In the pharmaceutical market, this patent could provide a competitive edge to the assignee by offering a unique and safe method of administering desmopressin. It may also influence the development of future products and treatment protocols.
Legal and Regulatory Considerations
Patent Validity
The validity of the patent can be challenged based on various grounds, such as obviousness, lack of novelty, or insufficient written description. Ensuring that the patent meets all legal requirements is crucial for its enforcement and protection[2].
Regulatory Approvals
The FDA plays a critical role in approving new drug applications (NDAs) and ensuring compliance with regulatory standards. The patent's claims must align with FDA-approved uses and dosing regimens for desmopressin.
Economic and Strategic Implications
Economic Benefits
Holding a patent like US11419914B2 can provide significant economic benefits, including exclusive rights to manufacture, use, and sell the invention for a limited period. This can lead to higher revenue and market share.
Strategic Partnerships
The patent can be a valuable asset in strategic partnerships or licensing agreements. Companies may seek to collaborate or acquire the rights to this patent to enhance their product portfolio.
Patent Analytics and Claim Coverage
Claim Coverage Matrix
Using a Claim Coverage Matrix, as described in patent analytics, helps in identifying which patents and claims are actively protecting the intellectual property. This tool categorizes patents by claims and scope concepts, making it easier to analyze large numbers of patent claims concurrently[3].
Claim Charts
Interactive claim charts generated by tools like ClaimScape® software can help technical experts, engineers, and management to review patent coverage and identify gaps or future design opportunities.
Global Patent Trends
International Patenting
The patenting of inventions like desmopressin administration is not limited to the U.S. market. International differences in taxes on corporate and patent income can influence the choice of patent location for multinational firms. Foreign owners account for a significant portion of USPTO patents, indicating a global interest in intellectual property protection[4].
Cross-Country Analysis
Cross-country analysis reveals that high-technology manufacturing and commercial knowledge-intensive services industries have a larger share of patents. This trend is relevant when considering the global impact and potential for international collaborations or disputes related to this patent.
Key Takeaways
- Innovative Delivery Mechanism: The patent introduces an innovative intranasal spray dispenser for safe and uniform desmopressin administration.
- Competitive Advantage: The patent provides a competitive edge in the pharmaceutical market by ensuring safe and effective dosing.
- Regulatory Compliance: The patent's claims must align with FDA-approved uses and dosing regimens.
- Economic Benefits: Holding this patent can lead to significant economic benefits through exclusive rights and potential licensing agreements.
- Global Implications: The patent is part of a broader global landscape of intellectual property protection, with implications for multinational firms and international collaborations.
Frequently Asked Questions (FAQs)
1. What is the primary claim of US Patent 11,419,914?
The primary claim of US Patent 11,419,914 involves a family of intranasal spray dispensers designed to administer uniform low doses of desmopressin for safe antidiuresis in humans.
2. How does this patent impact the pharmaceutical market?
This patent can provide a competitive edge by offering a unique and safe method of administering desmopressin, potentially improving patient compliance and reducing side effects.
3. What are the legal considerations for this patent?
The patent must meet all legal requirements, including novelty, non-obviousness, and sufficient written description. Its validity can be challenged on these grounds.
4. How can patent analytics help in managing this patent?
Patent analytics tools, such as Claim Coverage Matrix and Claim Charts, help in identifying which patents and claims are actively protecting the intellectual property, spotting gaps, and highlighting future design opportunities.
5. What are the global implications of this patent?
The patent is part of a global landscape of intellectual property protection, with implications for multinational firms and international collaborations, especially in high-technology manufacturing and commercial knowledge-intensive services industries.
Cited Sources:
- US11419914B2 - Safe desmopressin administration - Google Patents
- ALLERGAN USA, INC. v. MSN LABORATORIES PRIVATE LTD. - United States Court of Appeals for the Federal Circuit
- Patent Analytics | Intellectual Property Law - SLWIP
- Chapter 8 - Invention, Knowledge Transfer, and Innovation - NSF