Details for Patent: 5,378,474

Summary for Patent: 5,378,474

Title:	Sustained release pharmaceutical composition
Abstract:	The present invention relates to a pharmaceutical pellet composition having a core element including at least one highly soluble active ingredient and a core coating which is partially soluble at a highly acidic pH. The pharmaceutical composition provides a slow release of active ingredient at a highly acidic pH and provides a constant, relatively faster rate of release at a more alkaline pH such as that of the intestine. Oral administration of the pharmaceutical pellet composition of the present invention to a patient is effective to deliver to the blood levels of active ingredient within the therapeutic range and to maintain such levels over an extended period of time.
Inventor(s):	Morella; Angelo M. (Campbelltown, AU), Fisher; Mark C. (Birkenhead, AU)
Assignee:	F. H. Faulding & Co. Limited (Parkside, AU)
Application Number:	08/021,276
Patent Claim Types: see list of patent claims	Composition; Formulation; Dosage form; Compound;

Analyzing the Scope and Claims of United States Patent 5,378,474

Introduction

United States Patent 5,378,474, titled "Sustained Release Pharmaceutical Composition," is a significant patent in the pharmaceutical industry. To understand its impact and the landscape it occupies, it is crucial to delve into its scope, claims, and the broader patent landscape.

Patent Overview

Publication Number and Authority

• The patent number is US5378474A, and it was granted by the United States Patent and Trademark Office (USPTO)[5].

Prior Art and Classification

• The patent is classified under several categories, including A61K9/00, A61K9/48, A61K9/50, and others, indicating its relevance to medicinal preparations, particularly those in specific physical forms like microcapsules and pellets[5].

Scope of the Patent

The patent describes a sustained release pharmaceutical pellet composition designed to deliver active ingredients over an extended period. Here are the key aspects of its scope:

Active Ingredients and Composition

• The patent details a composition that includes a core containing an active ingredient and a coating layer. The coating can include up to 50% of a plasticizer such as diethyl phthalate[5].

Physical Form

• The composition is specifically designed as pellets or microcapsules, which are solid microparticles or pellets surrounded by a distinct coating layer. This form is crucial for the sustained release mechanism[5].

Coating Material

• The coating material can be organic macromolecular compounds, such as polyethylene glycol or poly(lactide-co-glycolide), which play a critical role in the release profile of the active ingredient[5].

Claims Analysis

The claims of a patent are its most critical components, as they define the legal boundaries of the invention.

Independent Claims

• Claim 1 typically sets the broadest scope of the invention. For US5378474A, this would involve the basic structure of the sustained release pharmaceutical pellet composition, including the core and the coating layer[5].

Dependent Claims

• Dependent claims narrow down the scope by adding specific details or limitations to the independent claims. For example, Claim 7 might specify the inclusion of a particular plasticizer in the coating layer[5].

Patent Landscape Analysis

To understand the position of US5378474A within the broader patent landscape, several tools and resources can be utilized:

Cooperative Patent Classification (CPC)

• The CPC database can be searched to find relevant classification schemes and related patents. This helps in identifying similar inventions and understanding the competitive landscape[4].

Global Dossier

• Using the Global Dossier service provided by the USPTO, one can access the file histories of related applications from participating IP Offices. This includes seeing the patent family for a specific application and related citation data[1].

Patent Public Search

• The Patent Public Search tool allows for enhanced access to prior art and can be used to search for similar patents and applications. This tool has replaced legacy search tools like PubEast and PubWest[1].

International Patent Offices

• Searching databases from other international intellectual property offices, such as the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO), can provide a global perspective on similar inventions[1].

Patent Analytics

To fully understand the value and coverage of US5378474A, patent analytics can be employed:

Claim Coverage Matrix

• A Claim Coverage Matrix can show which patents and claims are actively protecting the intellectual property and where gaps or opportunities exist. This involves categorizing patents by claims and scope concepts[3].

Claim Charts

• Interactive claim charts generated by tools like ClaimScape® can help in reviewing patent coverage with technical experts. These charts can highlight areas where there are gaps in current coverage and indicate future design opportunities[3].

Legal Status and Expiration

• The legal status of US5378474A indicates that it has expired, meaning the exclusive rights granted by the patent are no longer in effect. This is important for understanding whether the technology is now in the public domain[5].

Impact on the Pharmaceutical Industry

The sustained release pharmaceutical composition described in US5378474A has significant implications for the pharmaceutical industry:

Drug Delivery Mechanisms

• The invention provides a method for delivering active ingredients over an extended period, which can improve patient compliance and the efficacy of treatments.

Competitive Landscape

• The patent's expiration means that similar compositions can now be developed without infringing on the original patent, potentially leading to new innovations and competition in the market.

Key Takeaways

• Patent Scope: US5378474A covers a sustained release pharmaceutical pellet composition with a core and a coating layer.
• Claims Analysis: The patent includes independent and dependent claims that define the invention's boundaries.
• Patent Landscape: Tools like CPC, Global Dossier, and Patent Public Search help in understanding the competitive landscape.
• Patent Analytics: Claim Coverage Matrix and Claim Charts are useful for evaluating the patent's coverage and identifying gaps.
• Legal Status: The patent has expired, placing the technology in the public domain.

FAQs

1. What is the main subject of United States Patent 5,378,474?

   • The main subject is a sustained release pharmaceutical pellet composition designed to deliver active ingredients over an extended period.

2. How can one search for similar patents to US5378474A?

   • One can use tools like the Patent Public Search, Global Dossier, and databases from international intellectual property offices.

3. What is the significance of the coating layer in the patent?

   • The coating layer, which can include plasticizers, is crucial for the sustained release mechanism of the active ingredient.

4. How can patent analytics help in evaluating US5378474A?

   • Patent analytics tools like Claim Coverage Matrix and Claim Charts help in understanding the patent's coverage, identifying gaps, and highlighting future design opportunities.

5. What is the current legal status of US5378474A?

   • The patent has expired, meaning the exclusive rights granted by the patent are no longer in effect.

Sources

1. USPTO - Search for patents
   • https://www.uspto.gov/patents/search
2. USA.gov - U.S. Patent and Trademark Office (USPTO)
   • https://www.usa.gov/agencies/u-s-patent-and-trademark-office
3. SLWIP - Patent Analytics
   • https://www.slwip.com/services/patent-analytics/
4. Clemson University - Advanced Patent Searching
   • https://clemson.libguides.com/advanced_patent_searching
5. Google Patents - US5378474A
   • https://patents.google.com/patent/US5378474A/en

Drugs Protected by US Patent 5,378,474

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

Foreign Priority and PCT Information for Patent: 5,378,474

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Australia	PJ2192	Jan 06, 1989

International Family Members for US Patent 5,378,474

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	4773290
Australia	617573
Austria	133862
Austria	167629
Canada	2007181
Germany	69025208
Germany	69032445