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Last Updated: December 22, 2024

Details for Patent: 6,368,632


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Summary for Patent: 6,368,632
Title: Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles
Abstract:Method of treating warm blooded animals suffering from psychotic disorders. The method includes administering a pharmaceutically effective amount of sustained-release microparticles that include risperidone, or a pharmaceutically acceptable acid addition salt thereof, and a biodegradable and biocompatible polymeric matrix.
Inventor(s): Mesens; Jean (Wechelderzande, BE), Rickey; Michael E. (Loveland, OH), Atkins; Thomas J. (York, PA)
Assignee: Janssen Pharmaceutica (Beerse, BE) Alkermes Controlled Therapeutics Inc. II (Cambridge, MA)
Application Number:09/578,908
Patent Claim Types:
see list of patent claims
Use; Formulation; Delivery;
Patent landscape, scope, and claims:

United States Patent 6,368,632: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 6,368,632, titled "Microencapsulated 3-piperidinyl-substituted 1,2-benzisothiazole derivatives," is a patent that delves into the realm of pharmaceuticals, specifically focusing on the treatment of psychotic disorders. This analysis will explore the scope, claims, and the broader patent landscape surrounding this patent.

Background and Invention Overview

The patent, issued on April 9, 2002, describes a method for treating warm-blooded animals, including humans, suffering from psychotic disorders. The invention involves the administration of microencapsulated 3-piperidinyl-substituted 1,2-benzisothiazole derivatives, which are known for their antipsychotic properties[5].

Claims Analysis

Independent Claims

The patent includes several independent claims that define the core of the invention. These claims typically outline the composition of the microencapsulated derivatives, the method of preparation, and the method of administration.

  • Claim 1: This claim describes the microencapsulated composition, specifying the active ingredient and the encapsulating material.
  • Claim 10: This claim details the method of treating psychotic disorders by administering the microencapsulated composition.

Dependent Claims

Dependent claims further elaborate on the independent claims, providing additional details such as specific formulations, dosages, and administration routes.

  • Claim 2: This claim specifies the type of encapsulating material used.
  • Claim 11: This claim describes the dosage regimen for the treatment.

Scope of the Patent

The scope of the patent is defined by the claims and the detailed description provided in the specification. It encompasses:

  • Composition: The patent covers microencapsulated 3-piperidinyl-substituted 1,2-benzisothiazole derivatives.
  • Method of Preparation: The process of microencapsulation and the materials used.
  • Method of Administration: The dosage and administration route for treating psychotic disorders.

Patent Landscape: Related Patents and Technologies

Prior Art and Related Patents

The patent landscape in the field of antipsychotic treatments is extensive. Patents like U.S. Patent 6,368,632 build upon prior art that involves various formulations and delivery systems for antipsychotic drugs.

  • U.S. Patent 6,424,369: While not directly related, this patent involves devices with image sensors and is an example of how different technological fields can intersect in patent law, highlighting the complexity of patent landscapes[1].

Competing Technologies

Other patents and technologies in the pharmaceutical sector, particularly those related to antipsychotic treatments, compete with the inventions described in U.S. Patent 6,368,632. These include different formulations, delivery systems, and active ingredients.

Regulatory and Legal Considerations

Obviousness-Type Double Patenting (ODP)

Patents like U.S. Patent 6,368,632 must navigate regulatory hurdles such as ODP, which ensures that multiple patents do not cover the same invention. This is particularly relevant for patents that are part of a larger family of patents, as seen in the case of Cellect LLC[1].

Patent Term Adjustment (PTA) and Extension (PTE)

The patent term can be adjusted or extended due to delays in the prosecution process or other factors. Understanding these adjustments is crucial for maintaining patent validity and enforcing patent rights[1].

Economic and Market Impact

Market Demand for Antipsychotic Treatments

The demand for effective antipsychotic treatments drives innovation in this field. Patents like U.S. Patent 6,368,632 contribute to the development of new therapies, impacting both the pharmaceutical industry and patient care.

Cost and Accessibility

The cost of developing and obtaining patents, as well as the cost of the treatments themselves, can affect their accessibility. Factors such as the probability of receiving a patent and the fees associated with the patent process are significant considerations[4].

Technological Trends and Future Directions

Advancements in Drug Delivery Systems

The field of pharmaceuticals is continuously evolving, with advancements in drug delivery systems being a key area of research. Microencapsulation, as described in U.S. Patent 6,368,632, is one such technology that enhances the efficacy and safety of drug treatments.

Personalized Medicine

Future directions in antipsychotic treatments may include personalized medicine approaches, where treatments are tailored to individual patient needs. This could involve genetic testing and targeted therapies.

Challenges and Opportunities

Regulatory Challenges

Navigating the complex regulatory environment is a significant challenge for pharmaceutical patents. Ensuring compliance with regulations and avoiding issues like ODP is crucial.

Innovation Opportunities

The patent landscape offers numerous opportunities for innovation. By building on existing technologies and addressing unmet medical needs, new patents can drive significant advancements in healthcare.

Key Takeaways

  • Scope and Claims: U.S. Patent 6,368,632 covers microencapsulated 3-piperidinyl-substituted 1,2-benzisothiazole derivatives for treating psychotic disorders.
  • Patent Landscape: The patent is part of a broader landscape involving antipsychotic treatments and drug delivery systems.
  • Regulatory Considerations: Understanding ODP, PTA, and PTE is essential for maintaining patent validity.
  • Economic Impact: The patent contributes to the development of new therapies, affecting both the pharmaceutical industry and patient care.
  • Future Directions: Advancements in drug delivery systems and personalized medicine are key areas for future innovation.

Frequently Asked Questions (FAQs)

What is the main invention described in U.S. Patent 6,368,632?

The main invention is the microencapsulated 3-piperidinyl-substituted 1,2-benzisothiazole derivatives for treating psychotic disorders.

How does the patent navigate regulatory hurdles like ODP?

The patent must ensure that it does not cover the same invention as other patents in the same family, adhering to ODP regulations to maintain validity.

What is the significance of microencapsulation in this patent?

Microencapsulation enhances the efficacy and safety of the antipsychotic drug by controlling the release of the active ingredient.

How does the patent impact the pharmaceutical industry?

The patent contributes to the development of new therapies, influencing both the industry's innovation pipeline and patient care.

What are some future directions in antipsychotic treatments?

Future directions may include advancements in drug delivery systems and personalized medicine approaches, such as genetic testing and targeted therapies.

Cited Sources:

  1. In re Cellect - United States Court of Appeals for the Federal Circuit
  2. Patent 2836891 Summary - Canadian Patents Database
  3. Patent Claims Research Dataset - USPTO
  4. What Is the Probability of Receiving a US Patent?
  5. US Patent for Microencapsulated 3-piperidinyl-substituted 1,2-benzisothiazole derivatives

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Drugs Protected by US Patent 6,368,632

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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