United States Patent 5,658,590: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,658,590, titled "Treatment of attention-deficit/hyperactivity disorder," is a method-of-use patent that covers the use of atomoxetine (also known as tomoxetine) for treating Attention-Deficit/Hyperactivity Disorder (ADHD). Here, we will delve into the scope, claims, and the patent landscape surrounding this invention.
Background and Invention
The patent, filed on January 11, 1995, and granted on August 19, 1997, was developed by researchers working with Dr. Joseph Biederman and Massachusetts General Hospital (MGH) to conduct clinical trials on the efficacy of atomoxetine in treating ADHD[1][4].
Scope of the Patent
The patent specifically covers a method of treating ADHD by administering an effective amount of atomoxetine to a patient in need of such treatment. This scope is narrowly defined to the therapeutic use of atomoxetine for ADHD, distinguishing it from other potential uses of the drug.
Claims of the Patent
The primary claim of the patent is straightforward:
- Claim 1: A method of treating attention-deficit/hyperactivity disorder comprising administering to a patient in need of such treatment an effective amount of tomoxetine[4].
This claim is central to the patent's validity and has been the subject of legal disputes regarding its enablement and utility.
Enablement and Utility
The patent's validity was challenged on the grounds of enablement and utility. The defendants argued that the patent specification did not establish utility because no test results were submitted at the time of filing, and a person of ordinary skill in the art would not have recognized the claimed method's utility from the specification alone. However, the court ultimately denied the motion for summary judgment, acknowledging that post-filing date test results could confirm the utility of the invention, even though they could not establish it if it was not already present in the specification[4].
Clinical Trials and Evidence
Preparations for the first clinical trial to test atomoxetine for ADHD began before the patent application was filed, but the first patient did not receive the drug until after the filing date. The results of this trial, conducted by MGH, were gathered by May 1995 and supported the utility of atomoxetine in treating ADHD. These results were crucial in establishing the patent's validity[4].
Patent Landscape
Related Patents and Applications
The patent is part of a broader family of patents and applications filed in various jurisdictions, including the United States, Hungary, China, and the Czech Republic. These filings reflect the global interest in atomoxetine as a treatment for ADHD and other conditions[1].
International Patent Offices
The patent landscape for atomoxetine is complex, with multiple international patent offices involved. For instance, the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO) provide searchable databases that include information on patents related to atomoxetine[2].
Patent Analytics and Claim Coverage
To fully understand the patent landscape, companies often use patent analytics tools. These tools help in categorizing patents by claims and scope concepts, making it easier to identify gaps or opportunities in intellectual property protection. For example, ClaimScape® software can generate interactive claim charts to review patent coverage and determine if there are gaps in current claim coverage[3].
Legal Disputes and Challenges
The patent has been involved in several legal disputes, particularly regarding its validity and the interpretation of its claims. In one notable case, the court had to decide whether post-filing date test results could establish the utility of the invention. The court ruled that while these results could support the assertion of utility, they could not establish it if it was not already present in the specification[4].
Key Takeaways
- Specific Use: The patent is specifically for the use of atomoxetine in treating ADHD.
- Enablement and Utility: The patent's validity was challenged but upheld with the support of post-filing clinical trial results.
- Global Patent Family: The patent is part of a broader family of patents filed in multiple jurisdictions.
- Patent Analytics: Tools like ClaimScape® are essential for analyzing and managing the patent landscape.
- Legal Disputes: The patent has been subject to legal challenges, particularly regarding its enablement and utility.
FAQs
What is the primary claim of United States Patent 5,658,590?
The primary claim is for a method of treating attention-deficit/hyperactivity disorder by administering an effective amount of tomoxetine to a patient in need of such treatment.
What were the main challenges to the patent's validity?
The main challenges were related to enablement and utility, with defendants arguing that the patent specification did not establish utility without post-filing test results.
How were the clinical trials conducted for this patent?
The clinical trials were conducted by researchers working with Dr. Joseph Biederman and Massachusetts General Hospital (MGH), with preparations beginning before the patent application was filed.
What tools are used to analyze the patent landscape for such inventions?
Tools like ClaimScape® software are used to categorize patents by claims and scope concepts, helping to identify gaps or opportunities in intellectual property protection.
Are there international patents related to this invention?
Yes, there are related patents and applications filed in various international jurisdictions, including the European Patent Office, Japan Patent Office, and others.
Sources
- US5658590A - Treatment of attention-deficit/hyperactivity disorder - Google Patents
- Search for patents - USPTO
- Patent Analytics | Intellectual Property Law - SLWIP
- Case 2:07-cv-03770-DMC-JAD Document 539 Filed 02/23 - GovInfo
