United States Patent 7,405,203: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,405,203, titled "Pharmaceutical Compositions Including Low Dosages of Desmopressin," is a significant patent in the pharmaceutical industry, particularly in the treatment of disorders such as central diabetes insipidus and nocturnal enuresis. This article delves into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
Issuance and Assignment
The U.S. Patent No. 7,405,203 was issued on July 29, 2008, and is assigned to Allergan, Inc.[1].
Inventorship
The patent lists Seymour H. Fein as the sole inventor, although there are disputes regarding the correct inventorship, as claimed by Ferring Pharmaceuticals Inc. in a civil action[1].
Scope of the Patent
Subject Matter
The patent covers pharmaceutical compositions that include low doses of desmopressin. Desmopressin is a synthetic analogue of the natural hormone vasopressin and is used to treat various conditions, including central diabetes insipidus and nocturnal enuresis. The patent specifically addresses the discovery that low doses of desmopressin, yielding blood plasma levels lower than 10 pg/ml, can be clinically effective while avoiding the side effect of hyponatremia[1].
Clinical Significance
The low-dose desmopressin formulations are crucial because they balance efficacy with safety. High doses of desmopressin can lead to hyponatremia, a condition characterized by abnormally low sodium levels in the blood, which can be life-threatening. The patented compositions ensure that patients receive effective treatment without this significant side effect[1].
Claims of the Patent
Key Claims
The patent includes several claims that define the scope of the invention. Here are some key aspects:
- Claim 1: This claim typically outlines the broadest definition of the invention, which in this case involves pharmaceutical compositions containing low doses of desmopressin.
- Claim 19: This claim, among others, specifies the dosages and formulations of desmopressin that are considered within the scope of the patent[2].
Claim Language and Scope
The claims are written to ensure that the patent covers a specific range of dosages and formulations while excluding others. The language used is precise to define the boundaries of the invention and to distinguish it from prior art. For example, the claims specify that the blood plasma levels of desmopressin should be lower than 10 pg/ml to be considered within the scope of the patent[1].
Patent Landscape
Related Patents
The U.S. Patent No. 7,405,203 is part of a series of patents related to desmopressin formulations. Other patents in this series include U.S. Patent Nos. 7,579,321 and 7,799,761, all of which are assigned to Allergan, Inc. and list Fein as the sole inventor. These patents collectively cover various aspects of low-dose desmopressin formulations and their clinical applications[1].
Litigation and Disputes
There have been legal disputes regarding the inventorship of these patents. Ferring Pharmaceuticals Inc. has filed a civil action claiming that the true inventors of the discoveries related to low-dose desmopressin formulations are Jens Peter Norgaard and Thomas Senderovitz, who worked for Ferring[1].
Impact on Innovation
The scope and claims of this patent have significant implications for innovation in the pharmaceutical industry. Patents with broad claims can sometimes stifle innovation by limiting the ability of other companies to develop similar products. However, narrower claims, as seen in this patent, can encourage further research and development by defining a clear boundary around the protected invention[3].
Measuring Patent Scope
Metrics for Patent Scope
Research has shown that patent scope can be measured using metrics such as independent claim length and independent claim count. These metrics help in understanding the breadth and clarity of the patent claims. For instance, narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].
Examination Process
The examination process for patents tends to narrow the scope of patent claims. This is evident from the changes in claim length and count during the examination process. The duration of the examination also plays a role, with longer examinations often resulting in more significant narrowing of the claims[3].
Global Patent System
International Search Resources
The global patent system provides various resources for searching and analyzing patents. Tools like the Patent Public Search, Global Dossier, and Common Citation Document (CCD) facilitate access to prior art and help in understanding the patent landscape internationally. These resources are crucial for ensuring that patents are not overly broad and do not infringe on existing patents[4].
Key Takeaways
- Patent Scope and Claims: The U.S. Patent No. 7,405,203 has specific claims that define low-dose desmopressin formulations, ensuring clinical efficacy while avoiding side effects.
- Litigation and Inventorship: Disputes over inventorship highlight the importance of accurate attribution in patent law.
- Impact on Innovation: The patent's scope encourages further research by defining clear boundaries around the protected invention.
- Global Patent System: International search resources are essential for navigating the patent landscape and ensuring compliance with existing patents.
FAQs
What is the main subject matter of U.S. Patent No. 7,405,203?
The main subject matter is pharmaceutical compositions including low doses of desmopressin, used to treat conditions like central diabetes insipidus and nocturnal enuresis.
Who is listed as the inventor of U.S. Patent No. 7,405,203?
Seymour H. Fein is listed as the sole inventor, although there are disputes regarding the correct inventorship.
What are the key claims of the patent?
The key claims specify the dosages and formulations of desmopressin that yield blood plasma levels lower than 10 pg/ml, ensuring clinical efficacy without significant side effects.
How does the patent impact innovation in the pharmaceutical industry?
The patent's narrow claims encourage further research and development by defining a clear boundary around the protected invention, thus promoting innovation.
What resources are available for searching and analyzing patents internationally?
Resources include the Patent Public Search, Global Dossier, Common Citation Document (CCD), and databases from various international intellectual property offices.
Sources
- Ferring International Center S.A., and Ferring Pharmaceuticals Inc. v. Allergan, Inc., et al. - Case 1:12-cv-02650-RWS Document 73 Filed 08/21/13.
- Judge Sweet Holds “Transmucosal” Delivery Does Not Require... - JD Supra.
- Patent Claims and Patent Scope - SSRN.
- Search for patents - USPTO - United States Patent and Trademark Office.
