Details for Patent: 6,814,978

Summary for Patent: 6,814,978

Title:	Process for preparing a soft tablet
Abstract:	The invention relates to a process for preparing a soft tablet capable of being chewed or disintegrated in the oral cavity. The tablet is prepared by forming a tablet having a friability of less than about 2% from a mixture comprising a pharmaceutically active ingredient, an excipient in the form of a hydrate, and a water-swellable excipient, and then applying sufficient energy, preferably in the form of heat, to the tablet for a sufficient time to decrease the hardness of the tablet by at least about 20%.
Inventor(s):	Bunick; Frank J. (Randolph, NJ), Luber; Joseph (Quakertown, PA)
Assignee:	McNeil-PPC, Inc. (Skillman, NJ)
Application Number:	09/752,601
Patent Claim Types: see list of patent claims	Compound; Dosage form; Composition; Process;

Understanding the Scope and Claims of United States Patent 6,814,978

Introduction

United States Patent 6,814,978, titled "Orally Disintegrating Tablet," is a significant patent in the pharmaceutical industry, particularly in the development of oral disintegrating tablets (ODTs). This patent, assigned to Johnson & Johnson Consumer Inc., addresses the formulation and properties of ODTs, which are designed for rapid disintegration and ease of administration.

Background

Orally disintegrating tablets have gained popularity due to their convenience and ease of use, especially for patients who have difficulty swallowing traditional tablets. The patent in question focuses on improving the properties of these tablets to enhance their performance.

Inventors and Assignee

The patent was invented by Jen-Chi Chen, Kenneth Day, and Christopher E. Szymczak, and is assigned to Johnson & Johnson Consumer Inc., based in Skillman, NJ[1].

Patent Date and Number

The patent was granted on November 7, 2006, and is identified as US 6,814,978 B2[1].

Claims Overview

The patent includes several claims that define the scope of the invention. Here are the key aspects:

Claim Structure

The patent consists of multiple claims, each detailing specific aspects of the orally disintegrating tablet. These claims include:

• The composition of the tablet, including the types of materials used.
• The physical properties of the tablet, such as density and disintegration time.
• The method of manufacturing the tablet[1].

Independent Claims

Independent claims are crucial as they define the broadest scope of the invention. For US 6,814,978, these claims typically involve the combination of specific materials and their properties, such as:

• A dielectric water-containing material with specific bound water content and dielectric loss.
• A second material with defined water solubility and dielectric loss characteristics[1].

Dependent Claims

Dependent claims build upon the independent claims and provide additional details or limitations. These claims may specify particular ratios of materials, additional components, or specific manufacturing steps.

Patent Scope

The scope of the patent is defined by the claims and is critical for determining what is protected under the patent.

Claim Language and Scope

The claim language must be clear and specific to avoid ambiguity. For US 6,814,978, the claims are structured to ensure that the invention is well-defined and distinguishable from prior art. The scope includes the unique combination of materials and their properties that enable rapid disintegration and low density[1].

Impact on Patent Quality

The clarity and breadth of patent claims can significantly impact patent quality. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process, indicating better patent quality[3].

Patent Landscape

Prior Art and Related Patents

The patent landscape for orally disintegrating tablets is extensive, with numerous prior patents and publications. The inventors of US 6,814,978 have referenced several prior patents and publications to distinguish their invention from existing technologies[1].

Competitors and Similar Patents

Other companies and inventors have also developed orally disintegrating tablets, each with their unique formulations and manufacturing processes. The patent landscape is competitive, with multiple players vying for market share in this segment.

Manufacturing Process

The manufacturing process for the orally disintegrating tablets described in US 6,814,978 involves specific steps to ensure the desired properties are achieved.

Materials and Formulation

The patent details the use of a dielectric water-containing material and a second material with specific water solubility and dielectric loss characteristics. These materials are combined in a way that ensures the tablet disintegrates rapidly and has a low density[1].

Quality Control

The manufacturing process includes quality control measures to ensure the tablets meet the specified criteria for disintegration time and density.

Regulatory and Legal Aspects

USPTO Guidelines

The patent application and examination process for US 6,814,978 would have followed the guidelines set by the United States Patent and Trademark Office (USPTO). This includes conducting a preliminary search for prior art and ensuring the claims are clear and specific[2].

Litigation and Disputes

Patents in the pharmaceutical industry are often subject to litigation and disputes. The clarity and scope of the claims in US 6,814,978 would be crucial in any legal proceedings to determine infringement or validity[5].

Market Impact

Consumer Benefits

The orally disintegrating tablets described in US 6,814,978 offer significant benefits to consumers, particularly those with swallowing difficulties. The rapid disintegration and ease of administration make these tablets a preferred option.

Market Competition

The market for orally disintegrating tablets is competitive, with several companies offering similar products. The unique formulation and properties described in US 6,814,978 provide a competitive edge for Johnson & Johnson Consumer Inc.

Key Takeaways

• Clear Claims: The patent includes clear and specific claims that define the scope of the invention.
• Unique Formulation: The combination of materials and their properties ensures rapid disintegration and low density.
• Manufacturing Process: The process involves specific steps to achieve the desired properties.
• Regulatory Compliance: The patent adheres to USPTO guidelines and ensures regulatory compliance.
• Market Impact: The orally disintegrating tablets offer significant consumer benefits and provide a competitive edge in the market.

FAQs

1. What is the main focus of United States Patent 6,814,978?

   • The main focus is on the development of orally disintegrating tablets with properties of rapid disintegration and low density.

2. Who are the inventors of this patent?

   • The inventors are Jen-Chi Chen, Kenneth Day, and Christopher E. Szymczak.

3. What is the significance of the materials used in the patent?

   • The materials used have specific properties such as bound water content and dielectric loss, which are crucial for the tablet's performance.

4. How does the patent impact the market for orally disintegrating tablets?

   • The patent provides a competitive edge due to the unique formulation and properties of the tablets.

5. What are the regulatory considerations for this patent?

   • The patent adheres to USPTO guidelines and ensures regulatory compliance through clear and specific claims.

Citations

[1] United States Patent - googleapis.com [2] Applying for Patents - USPTO [3] Patent Claims and Patent Scope - Hoover Institution [4] Magnesium hydroxide: Uses, Interactions, Mechanism of Action - DrugBank [5] AMERICAN NATIONAL v. SLEEP NUMBER CORPORATION - CAFC

Drugs Protected by US Patent 6,814,978

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