Details for Patent: 7,108,866

Summary for Patent: 7,108,866

Title:	Chronotherapeutic diltiazem formulations and the administration thereof
Abstract:	A controlled-release Galenical preparation of pharmaceutically acceptable Diltiazem including the pharmaceutically acceptable salts thereof, suitable for evening dosing every 24 hours containing from about 120 mg to about 540 mg or more (as desired) of the form of Diltiazem associated with excipients to provide controlled (sustained) release of the form of Diltiazem for providing a C.sub.max of Diltiazem in the blood at between about 10 hours and about 15 hours after administration, the preparation comprising the form of Diltiazem in oral sustained-release dosage form in which the Diltiazem is adapted to be released after administration over a prolonged period of time and exhibits when given to humans(i) a higher bioavailability when given at night compared to when given in the morning without food according to FDA guidelines or criteria and(ii) bioequivalence when given in the morning with and without food according to the same FDA guidelines or criteria.
Inventor(s):	Albert; Kenneth Stephen (Mt. Kisco, NY), Maes; Paul Jose (Oakville, CA)
Assignee:	Biovall Laboratories International SRL (St. Michael, BB)
Application Number:	09/567,451
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form; Formulation;

Analyzing the Scope and Claims of United States Patent 7,108,866: A Comprehensive Guide

Introduction

Understanding the scope and claims of a patent is crucial for inventors, researchers, and businesses to navigate the complex landscape of intellectual property. This article will delve into the specifics of United States Patent 7,108,866, titled "Chronotherapeutic diltiazem formulations and the administration thereof," and provide a detailed analysis of its claims and the broader patent landscape.

Overview of the Patent

Patent Number and Title

United States Patent 7,108,866, titled "Chronotherapeutic diltiazem formulations and the administration thereof," was granted to address specific needs in the pharmaceutical field, particularly in the treatment of hypertension and angina.

Publication and Prior Art

The patent was published on September 19, 2006, with a prior art date of August 18, 1999. This indicates that the invention was conceived and filed several years before its publication and grant[4].

Claims Analysis

Independent and Dependent Claims

The patent includes a series of independent and dependent claims that define the scope of the invention. Independent claims stand alone and define the invention, while dependent claims build upon the independent claims and provide additional details.

• Independent Claim 1: This claim typically defines the broadest scope of the invention, such as the composition and method of administration of the chronotherapeutic diltiazem formulation.
• Dependent Claims: These claims narrow down the invention by specifying particular aspects, such as the dosage form, the timing of administration, and the specific pharmaceutical salts used[4].

Claim Construction

Claim construction is the process of interpreting the meaning of the claims. This is crucial for determining the scope of protection and for identifying potential infringement. The claims in US 7,108,866 would be constructed to understand the exact boundaries of what is protected, including the specific formulations, administration methods, and any limitations or exclusions[4].

Patent Scope and Coverage

Patent Scope Measurements

The scope of a patent can be measured using various metrics, such as the number of claims, the breadth of the claims, and the dependency between claims. For US 7,108,866, the scope would be evaluated based on how broadly or narrowly the claims are written, and how they relate to each other. The USPTO's Patent Claims Research Dataset can provide insights into claim-level statistics and document-level statistics, which can help in understanding the patent's scope[3].

Prior Art and Novelty

The patent's validity depends on its novelty and non-obviousness over prior art. The Common Citation Document (CCD) application can be used to consolidate prior art citations from multiple patent offices, helping to assess whether the invention in US 7,108,866 was novel and non-obvious at the time of filing[1].

Patent Landscape

Global Patent Family

To understand the full extent of the patent's protection, it is essential to look at the global patent family. The Global Dossier service provided by the USPTO allows users to see related applications filed at participating IP offices, including the dossier, classification, and citation data for these applications. This helps in identifying whether similar patents have been granted or applied for in other countries[1].

International Search Resources

Searching international patent databases, such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO), can reveal whether similar inventions have been patented abroad. This is crucial for global market strategy and to avoid potential infringement[1].

Legal Status and Expiration

Current Legal Status

As of the current date, US 7,108,866 has expired, which means that the exclusive rights granted by the patent are no longer in effect. This is indicated by the legal status listed in the patent documentation[4].

Implications of Expiration

The expiration of a patent means that the invention is now in the public domain, and anyone can use, manufacture, and sell the invention without infringing on the original patent. This can have significant implications for the pharmaceutical industry, as generic versions of the drug can now be produced.

Practical Considerations

Patent Search and Clearance

For companies or individuals considering developing or using a similar formulation, conducting a thorough patent search is essential. Resources like the USPTO's Patent Public Search tool and the Patent and Trademark Resource Centers (PTRCs) can help in identifying existing patents and ensuring that any new development does not infringe on existing rights[1].

Litigation and Enforcement

Although US 7,108,866 has expired, understanding the claims and scope of the patent can still be relevant for historical litigation or for assessing the validity of similar patents that may still be in force. The study on a potential small claims patent court highlights the ongoing need for efficient and cost-effective mechanisms for resolving patent disputes[5].

Key Takeaways

• Claims Analysis: Understanding the independent and dependent claims is crucial for defining the scope of the invention.
• Patent Scope: The scope of the patent can be measured using various metrics, including claim-level and document-level statistics.
• Global Patent Family: Examining the global patent family helps in identifying related applications and protecting the invention globally.
• Legal Status: The expiration of the patent means the invention is now in the public domain.
• Practical Considerations: Conducting thorough patent searches and understanding the claims are essential for avoiding infringement and ensuring compliance.

FAQs

Q: What is the main subject of United States Patent 7,108,866?

A: The main subject is chronotherapeutic diltiazem formulations and their administration, particularly for treating hypertension and angina.

Q: How can I determine the scope of a patent?

A: The scope can be determined by analyzing the independent and dependent claims, using metrics from the USPTO's Patent Claims Research Dataset, and evaluating prior art and novelty.

Q: What happens when a patent expires?

A: When a patent expires, the invention enters the public domain, and anyone can use, manufacture, and sell the invention without infringing on the original patent.

Q: How can I search for related patents globally?

A: You can use the Global Dossier service and search international patent databases such as those provided by the EPO, JPO, and WIPO.

Q: Why is it important to conduct a thorough patent search?

A: Conducting a thorough patent search helps in identifying existing patents and ensuring that any new development does not infringe on existing rights.

Sources

1. USPTO - Search for patents: https://www.uspto.gov/patents/search
2. USA.gov - U.S. Patent and Trademark Office: https://www.usa.gov/agencies/u-s-patent-and-trademark-office
3. USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
4. Google Patents - US7108866B1: https://patents.google.com/patent/US7108866B1/en
5. ACUS - U.S. Patent Small Claims Court: https://www.acus.gov/research-projects/us-patent-small-claims-court

Drugs Protected by US Patent 7,108,866

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: 7,108,866

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Canada	2292247	Dec 10, 1999
Canada	2307547	May 04, 2000

International Family Members for US Patent 7,108,866

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	4903700
Austria	430561
Canada	2292247
Canada	2307547
Canada	2566590