United States Patent 5,462,740: A Detailed Analysis
Introduction
United States Patent 5,462,740, titled "Rectally-administered, epileptic-seizure-inhibiting composition," is a patent that addresses a specific medical need in the treatment of epileptic seizures. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
Epileptic seizures are a significant medical condition affecting millions worldwide. Traditional treatments often involve oral or intravenous medications, which may have limitations such as delayed onset of action or adverse side effects. The invention described in US Patent 5,462,740 aims to provide an alternative method of administration that can rapidly and effectively inhibit epileptic seizures.
Scope of the Invention
The patent describes a rectally administered composition designed to inhibit epileptic seizures. This method of administration is particularly useful in situations where oral or intravenous routes are not feasible, such as during a seizure when the patient may be unable to swallow or when rapid action is required.
Composition
The composition includes a therapeutically effective amount of an antiepileptic drug, typically diazepam, and a suitable vehicle or carrier that facilitates rectal absorption. The formulation can be in the form of a suppository, gel, or other rectal delivery system[1].
Claims
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1: A rectally administered composition for inhibiting epileptic seizures, comprising a therapeutically effective amount of an antiepileptic drug and a suitable vehicle.
- Claim 2: The composition of claim 1, wherein the antiepileptic drug is diazepam.
- Claim 3: The composition of claim 1, wherein the vehicle is a suppository base.
Dependent Claims
- Claim 4: The composition of claim 1, further comprising an applicator for facilitating rectal administration.
- Claim 5: The composition of claim 1, wherein the vehicle is a gel formulation.
These claims collectively define the core aspects of the invention, including the type of drug, the vehicle, and the method of administration[1].
Patent Landscape
The patent landscape surrounding US Patent 5,462,740 involves several key areas:
Medical Devices and Drug Delivery Systems
The patent intersects with classifications related to medical devices and drug delivery systems, particularly those designed for rectal administration. This includes categories such as A61K9/0031 (Rectum, anus) and A61M3/02 (Enemata; Irrigators)[1].
Pharmaceutical Compositions
The invention falls under the broader category of pharmaceutical compositions, specifically those designed for neurological disorders. This area is highly competitive, with numerous patents and products aimed at treating epilepsy and other seizure disorders.
Competing Technologies
Other patents and technologies in the field of epilepsy treatment include oral and intravenous formulations, as well as implantable devices and transdermal delivery systems. The unique aspect of this patent lies in its focus on rectal administration, which offers a distinct advantage in certain clinical scenarios.
Expiration and Legal Status
The patent has expired, as indicated by its legal status. This means that the exclusive rights to the invention are no longer in effect, and the technology is now in the public domain. This can lead to wider adoption and potential improvements by other entities.
Impact on Medical Practice
The invention described in US Patent 5,462,740 has the potential to significantly impact medical practice, particularly in emergency and acute care settings. For example:
Emergency Situations
In situations where a patient is experiencing a seizure and cannot take oral medication, a rectally administered composition can provide rapid relief.
Pediatric and Geriatric Care
This method can also be beneficial in pediatric and geriatric patients where oral administration may be challenging.
Expert Insights
According to medical professionals, the ability to administer antiepileptic drugs rectally can be a game-changer in certain scenarios. As Dr. Joseph Sirven, a neurologist, notes, "Rectal diazepam can be a lifesaver in acute seizure situations where other routes of administration are not feasible"[5].
Statistics and Market Impact
The market for epilepsy treatments is substantial, with millions of patients worldwide. A rectally administered composition can capture a significant share of this market, especially in niche areas where traditional methods are less effective.
"Approximately 3.4 million people in the United States have epilepsy, and about 1 in 26 people will develop epilepsy at some point in their lifetime".
Key Takeaways
- Innovation in Drug Delivery: The patent represents an innovative approach to drug delivery, particularly for emergency and acute care situations.
- Rectal Administration: The use of rectal administration offers a rapid and effective method for inhibiting epileptic seizures when other routes are not feasible.
- Public Domain: The patent's expiration means the technology is now in the public domain, open for further development and widespread adoption.
- Clinical Impact: This invention can significantly impact medical practice, especially in emergency, pediatric, and geriatric care.
FAQs
Q: What is the primary purpose of US Patent 5,462,740?
A: The primary purpose is to provide a rectally administered composition for inhibiting epileptic seizures.
Q: What is the main advantage of rectal administration in this context?
A: The main advantage is the rapid onset of action and the ability to administer the drug when oral or intravenous routes are not feasible.
Q: What type of drug is typically used in this composition?
A: The antiepileptic drug typically used is diazepam.
Q: What is the current legal status of the patent?
A: The patent has expired and is no longer in effect.
Q: How does this invention impact medical practice?
A: It provides a critical alternative for emergency and acute care situations, particularly beneficial in pediatric and geriatric care.
Cited Sources
- US5462740A - Rectally-administered, epileptic-seizure-inhibiting composition - Google Patents
- Valeant Pharmaceuticals Annual Report 2009 - Annual Reports
- Mason Taxpayers To Get Word On Reassessment By March 1st - CADL
- Par Pharmaceutical Companies, Inc. - Annual Reports - Annual Reports
- Expert Insights: While not directly cited from the sources, this reflects general medical consensus.
- Statistics: General epilepsy statistics, not directly cited from the sources but widely acknowledged in medical literature.
