Details for Patent: 5,002,776

Summary for Patent: 5,002,776

Title:	Controlled absorption diltiazem formulations
Abstract:	A controlled absorption diltiazem pellet formulation for oral administration comprises a core of diltiazem or a pharmaceutically acceptable salt thereof in association with an organic acid, and a multi-layer membrane surrounding the core and containing a major proportion of a pharmaceutically acceptable film-forming water insoluble synthetic polymer and optionally a minor proportion of a pharmaceutically acceptable film-forming, water soluble synthetic polymer. The number of layers in the membrane and the ratio of the water soluble to water insoluble polymer, when said water soluble polymer is present, being effective to permit release of diltiazem from the pellet at a rate allowing controlled absorption thereof over not less than a twelve hour period following oral administration. The pellet has a dissolution rate in vitro which when measured in a dissolution apparatus (paddle) according to U.S. Pharmacopoeia XXI in 0.05 M KCl at pH 7.0 results in not more than 35% of the total diltiazem being released after 2 hours of measurement. Not more than 60% of the total diltiazem is released after four hours of measurement and 100% of the diltiazem is released no earlier than after 8 hours of measurement in said apparatus.
Inventor(s):	Geoghegan; Edward J. (Athlone, IE), Mulligan; Seamus (Athlone, IE), Panoz; Donald E. (Tuckers Town, BM)
Assignee:	Elan Corporation, PLC (Athlone, IE)
Application Number:	07/273,192
Patent Claim Types: see list of patent claims	Formulation; Compound; Dosage form; Device; Process;

United States Patent 5,002,776: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 5,002,776, titled "Controlled Absorption Diltiazem Formulations," is a significant patent in the pharmaceutical field, particularly in the development of controlled-release drug formulations. This analysis will delve into the scope and claims of the patent, as well as the broader patent landscape surrounding this invention.

Patent Overview

Publication Number and Authority

The patent, US5002776A, was granted by the United States Patent and Trademark Office (USPTO) and is categorized under the authority of the United States[4].

Prior Art and Legal Status

The patent was filed on October 27, 1987, and granted on March 19, 1991. It has since expired, as indicated by its legal status[4].

Invention Description

The patent describes a controlled absorption diltiazem pellet formulation designed for oral administration. Diltiazem, a calcium channel blocker, is used to treat hypertension and certain heart conditions. The formulation ensures a steady release of the drug over a prolonged period, typically not less than 12 hours, which helps maintain a steady state equilibrium in chronically ill patients[4].

Scope of the Patent

Claims

The patent includes several claims that define the scope of the invention. These claims are crucial as they outline what is protected under the patent.

• Claim 1: This claim describes the controlled absorption diltiazem pellet formulation, including the core of diltiazem or its pharmaceutically acceptable salt, and the coating layers that control the release rate[4].
• Subsequent Claims: These claims specify various aspects of the formulation, such as the composition of the coating layers, the method of preparation, and the dosage forms (e.g., twice-daily formulations)[4].

Detailed Description

The patent provides a detailed description of the invention, including the best mode of carrying out the invention. This includes the materials used, the process of manufacturing the pellets, and the expected performance characteristics of the formulation[4].

Patent Claims Analysis

Claim Structure

The claims are structured to ensure broad protection while being specific enough to distinguish the invention from prior art. For example, Claim 1 is broad, covering the general formulation, while subsequent claims narrow down to specific details such as the coating layers and release rates[4].

Dependency Relationship

The claims may have a dependency relationship, where some claims depend on others to fully define the scope of the invention. This is common in pharmaceutical patents where multiple claims work together to protect different aspects of the formulation and its method of use[2].

Patent Landscape Analysis

Technological Domain

The patent is part of the broader technological domain of controlled-release drug formulations. This domain is highly competitive, with numerous patents and ongoing research aimed at improving drug delivery systems.

Competitors and Market Trends

• Competitors: Other pharmaceutical companies have developed similar controlled-release formulations for various drugs. Analyzing these patents can reveal market trends and competitive strategies[3].
• Market Trends: The demand for controlled-release formulations is driven by the need for improved patient compliance and reduced side effects. Market trends include the development of new materials and technologies to enhance drug delivery[3].

Patent Trends and Filing Year Analysis

• Filing Year Trends: Analyzing the filing years of related patents can indicate the evolution of technology in this domain. For instance, a surge in filings in the late 1980s and early 1990s might reflect a period of significant innovation in controlled-release formulations[3].
• Top Filing Countries: Identifying the top countries where similar patents are filed can provide insights into global research and development activities in this field[3].

Legal Status and Expiry Dates

Understanding the legal status and expiry dates of related patents is crucial for strategic planning. For example, the expiry of US5002776A allows other companies to develop similar formulations without infringing on the original patent[3].

Advanced Patent Landscape Reports

Insights and Decision-Making

Advanced patent landscape reports can provide detailed insights into patent trends, market developments, and competitive activities. These reports often include charts and graphs that illustrate key metrics such as patent filing trends, litigation activities, and licensing agreements[3].

Identifying Gaps and Opportunities

By categorizing and analyzing the collected data, IP experts can identify gaps in the market, key inventors, and top filing countries. This information is invaluable for making strategic decisions about research and development, licensing, and litigation[3].

Tools and Resources for Patent Search

USPTO Resources

• Patent Public Search: This tool provides enhanced access to prior art and is essential for conducting preliminary patent searches[1].
• Global Dossier: This service allows users to access the file histories of related applications from participating IP Offices, which can be useful in understanding the global patent landscape[1].
• Patent and Trademark Resource Centers (PTRCs): These centers offer local search resources and training in patent search techniques, which can be beneficial for detailed analysis[1].

Common Citation Document (CCD)

The CCD application consolidates prior art cited by all participating offices for the family members of a patent application, providing a single point of access to up-to-date citation data[1].

Key Takeaways

• Patent Scope and Claims: The patent US5002776A protects a specific controlled absorption diltiazem pellet formulation, with claims that define the composition, method of preparation, and performance characteristics.
• Patent Landscape: The patent is part of a competitive technological domain with ongoing research and development in controlled-release drug formulations.
• Tools and Resources: Advanced tools like the USPTO's Patent Public Search, Global Dossier, and CCD are essential for conducting thorough patent searches and landscape analyses.
• Strategic Insights: Analyzing patent trends, legal status, and expiry dates can provide valuable insights for strategic decision-making in the pharmaceutical industry.

FAQs

What is the main invention described in US5002776A?

The main invention is a controlled absorption diltiazem pellet formulation designed for oral administration, ensuring a steady release of the drug over a prolonged period.

What are the key claims of the patent?

The key claims include the composition of the pellet formulation, the coating layers, the method of preparation, and the dosage forms such as twice-daily formulations.

How does the patent fit into the broader technological domain?

The patent is part of the technological domain of controlled-release drug formulations, a highly competitive area with significant ongoing research and development.

What tools can be used for conducting a thorough patent search related to this invention?

Tools such as the USPTO's Patent Public Search, Global Dossier, and Common Citation Document (CCD) are useful for conducting thorough patent searches and landscape analyses.

Why is understanding the legal status and expiry dates of related patents important?

Understanding the legal status and expiry dates helps in identifying opportunities for developing similar formulations without infringing on existing patents and in making strategic decisions about research, licensing, and litigation.

Sources

1. USPTO - Search for patents. Retrieved from https://www.uspto.gov/patents/search
2. USPTO - Patent Claims Research Dataset. Retrieved from https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
3. Sagacious Research - Navigating Technological Domains with Patent Landscape Analysis. Retrieved from https://sagaciousresearch.com/blog/navigating-technological-domains-with-patent-landscape-analysis/
4. Google Patents - US5002776A. Retrieved from https://patents.google.com/patent/US5002776A/en
5. USPTO - Applying for Patents. Retrieved from https://www.uspto.gov/patents/basics/apply

Drugs Protected by US Patent 5,002,776

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: 5,002,776

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Ireland	3158/87	Nov 20, 1987
Ireland	822/88	Mar 22, 1988

International Family Members for US Patent 5,002,776

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2377588
Austria	241987
Austria	66813