Details for Patent: 6,977,253

Which drugs does patent 6,977,253 protect, and when does it expire?

Patent 6,977,253 protects EQUETRO and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 6,977,253

Title:	Methods for the treatment of bipolar disorder using carbamazepine
Abstract:	Carbamazepine, in extended release form, is useful in the treatment of patients suffering from bipolar disorder. In order to minimize the time it takes to reach efficacy, carbamazepine, in extended release form, can be administered to the patient at an initial daily dose which is then increased in daily increments until clinical efficacy is achieved.
Inventor(s):	Kalali; Amir H. (San Diego, CA), Tulloch; Simon J. (Gaithersburg, MD)
Assignee:	Shire Pharmaceutical Development Inc. (Rockville, MD)
Application Number:	10/848,383
Patent Claim Types: see list of patent claims	Use;

Analyzing the Scope and Claims of United States Patent 6,977,253

Introduction to Patent 6,977,253

United States Patent 6,977,253, hereafter referred to as the '253 patent, is a significant intellectual property asset that has been the subject of interest in the pharmaceutical industry. This patent, which has recently expired on May 19, 2024, was associated with the drug Equetro, a formulation of carbamazepine used for treating certain neurological conditions.

Understanding the Patent

Drug Patents and Exclusivity

A drug patent, like the '253 patent, assigns exclusive legal rights to the patent holder to protect the proprietary chemical formulation, brand name, trademark, product dosage form, ingredient formulation, or manufacturing process. These patents typically expire 20 years from the date of filing, although various factors can extend or shorten this period[2].

Scope of the Patent

Claims and Coverage

The '253 patent includes a range of claims that define the scope of protection for the patented invention. These claims are crucial as they delineate what is considered infringing and what is not. For a patent like the '253, the claims would likely cover specific aspects of the carbamazepine formulation, such as its chemical composition, dosage form, and possibly the manufacturing process.

Claim Analysis

To understand the scope of the '253 patent, one must analyze its claims in detail. Here are some key points to consider:

• Chemical Composition: The patent would specify the exact formulation of carbamazepine, including any unique combinations of ingredients or specific concentrations.
• Dosage Form: Claims might cover the specific form in which the drug is administered, such as tablets, capsules, or suspensions.
• Manufacturing Process: The patent could include claims related to the method of manufacturing the drug, ensuring that any similar process would be considered an infringement[2].

Patent Landscape

Related Patents and Applications

When analyzing the patent landscape surrounding the '253 patent, it is essential to identify related patents and applications. This includes:

• Patent Family: Using tools like the Global Dossier, one can identify other related applications filed at participating IP Offices, including the IP5 Offices (USPTO, EPO, JPO, KIPO, and CNIPA). This helps in understanding the broader scope of protection and any potential overlaps or gaps[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 comprehensive view of the prior art landscape[1].

International Patent Offices

To ensure global protection, it is crucial to search for similar patents in other countries. Databases such as the European Patent Office's esp@cenet, the Japan Patent Office's database, and the World Intellectual Property Organization's PATENTSCOPE provide access to international patent collections. This helps in identifying whether similar inventions have been patented abroad[1].

Patent Analytics and Claim Coverage

Claim Coverage Matrix

Using patent analytics tools, such as those described by Schwegman, one can create a Claim Coverage Matrix. This matrix categorizes patents by claims and overarching scope concepts, helping to identify which patents and claims are actively protecting the intellectual property. It also highlights gaps or opportunities in the current coverage[3].

Interactive Claim Charts

Tools like ClaimScape® generate interactive claim charts that can be reviewed by technical experts to determine whether a particular scope concept is applicable to a target product or method. This approach is quick and accurate, helping to identify areas where claim coverage is lacking and highlighting future design opportunities[3].

Expiration and Post-Expiration Implications

Patent Expiration

The '253 patent expired on May 19, 2024, which means that the exclusive rights granted to the patent holder have ceased. This opens up the market for generic versions of the drug, as other manufacturers can now produce and market similar formulations without infringing on the expired patent[2].

Generic Availability

Following the expiration of the patent, generic versions of Equetro can be expected to enter the market. This typically leads to increased competition and potentially lower prices for consumers, as multiple manufacturers can produce the drug[2].

Key Takeaways

• Patent Scope: The '253 patent covers specific aspects of the carbamazepine formulation, including chemical composition, dosage form, and manufacturing process.
• Claim Analysis: Detailed analysis of claims is essential to understand the scope of protection and identify potential gaps or opportunities.
• Patent Landscape: Understanding related patents and applications, both domestically and internationally, is crucial for comprehensive patent strategy.
• Patent Analytics: Tools like Claim Coverage Matrix and interactive claim charts are invaluable for managing and optimizing patent portfolios.
• Post-Expiration: The expiration of the '253 patent allows for the entry of generic versions, increasing market competition and potentially lowering prices.

FAQs

1. What is the significance of the '253 patent expiration? The expiration of the '253 patent means that the exclusive rights to the carbamazepine formulation have ceased, allowing other manufacturers to produce and market generic versions.

2. How do patent analytics tools help in managing patent portfolios? Patent analytics tools help by categorizing patents by claims and scope concepts, identifying gaps or opportunities in coverage, and providing interactive claim charts for easy review by technical experts.

3. What databases can be used to search for international patents? Databases such as the European Patent Office's esp@cenet, the Japan Patent Office's database, and the World Intellectual Property Organization's PATENTSCOPE can be used to search for international patents.

4. What is the Common Citation Document (CCD) application? The CCD application consolidates prior art cited by all participating offices for the family members of a patent application, providing a comprehensive view of the prior art landscape.

5. How does the Global Dossier service benefit patent searchers? The Global Dossier service provides access to the file histories of related applications from participating IP Offices, allowing users to see the patent family for a specific application and access dossier, classification, and citation data.

Sources

1. USPTO - Search for patents https://www.uspto.gov/patents/search
2. Drugs.com - Generic Equetro Availability https://www.drugs.com/availability/generic-equetro.html
3. SLWIP - Patent Analytics https://www.slwip.com/services/patent-analytics/

Drugs Protected by US Patent 6,977,253

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-001	Dec 10, 2004		RX	Yes	No						THE RECOMMENDED INITIAL DOSE OF EQUETRO IS 400MG/DAY GIVEN IN DIVIDED DOSES, TWICE DAILY. THE DOSE SHOULD BE ADJUSTED IN 200MG DAILY INCREMENTS TO ACHIEVE OPTIMAL CLINICAL RESPONSE.
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-002	Dec 10, 2004		RX	Yes	No						THE RECOMMENDED INITIAL DOSE OF EQUETRO IS 400MG/DAY GIVEN IN DIVIDED DOSES, TWICE DAILY. THE DOSE SHOULD BE ADJUSTED IN 200MG DAILY INCREMENTS TO ACHIEVE OPTIMAL CLINICAL RESPONSE.
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-003	Dec 10, 2004		RX	Yes	Yes						THE RECOMMENDED INITIAL DOSE OF EQUETRO IS 400MG/DAY GIVEN IN DIVIDED DOSES, TWICE DAILY. THE DOSE SHOULD BE ADJUSTED IN 200MG DAILY INCREMENTS TO ACHIEVE OPTIMAL CLINICAL RESPONSE.

International Family Members for US Patent 6,977,253

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2452588