Details for Patent: 8,580,299

Which drugs does patent 8,580,299 protect, and when does it expire?

Patent 8,580,299 protects QSYMIA and is included in one NDA.

This patent has forty patent family members in seventeen countries.

Summary for Patent: 8,580,299

Title:	Escalating dosing regimen for effecting weight loss and treating obesity
Abstract:	The present invention is drawn to novel topiramate compositions as well as methods for effecting weight loss, e.g., in the treatment of obesity and related conditions, including conditions associated with and/or caused by obesity per se. The present invention features an escalating dosing regimen adapted for the administration of topiramate and optionally a sympathomimetic agent such as phentermine or bupropion, in the treatment of obesity and related conditions.
Inventor(s):	Najarian; Thomas (Los Osos, CA), Tam; Peter Y. (Redwood City, CA), Wilson; Leland F. (Menlo Park, CA)
Assignee:	Vivus, Inc. (Mountain View, CA)
Application Number:	12/481,548
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,580,299
Patent Claim Types: see list of patent claims	Use; Dosage form;

United States Patent 8,580,299: A Detailed Analysis of Scope and Claims

Introduction

United States Patent 8,580,299, issued to VIVUS, Inc., is a crucial patent that extends the exclusivity and protection for Qsymia, a drug used for the treatment of obesity. This patent is part of a broader patent strategy that significantly impacts the pharmaceutical landscape.

Background of Qsymia

Qsymia, a combination of phentermine and topiramate, is an oral medication approved by the FDA for the treatment of obesity in adults with a body mass index (BMI) of 30 kg/m² or higher, or in adults with a BMI of 27 kg/m² or higher who have at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol[5].

Patent Overview

Patent Number and Title

The patent in question is U.S. Patent No. 8,580,299, titled "Methods for effecting weight loss using Qsymia."

Issuance and Exclusivity

This patent was issued on November 13, 2013, and it extends the patent protection for Qsymia until June 2029, adding nine years to the previous expiration date of June 2020[5].

Scope of the Patent

Claim Construction

The patent claims cover specific methods for achieving weight loss using Qsymia. The claims are centered around the combination of phentermine and topiramate and the dosages at which these components are administered.

• Claim 1: This claim specifies a method for effecting weight loss in a patient having a body mass index of at least 30 kg/m², or a patient with a BMI of at least 27 kg/m² and at least one condition associated with obesity. The method involves administering a combination of phentermine and topiramate in specific dosages[2].

Key Components

• Phentermine and Topiramate: The patent specifically covers the combination of these two drugs. Phentermine is an immediate-release component, while topiramate is a controlled-release component. The dosages range from 2 to 8 mg of phentermine and 15 to 50 mg of topiramate[5].

Claim Language and Scope

Independent Claims

The independent claims in this patent define the core methods of using Qsymia for weight loss. These claims are critical because they delineate the exact scope of what is protected under the patent.

• Claim Language: The language used in the claims is precise and focused on the specific combination and dosages of phentermine and topiramate. This precision is essential for defining the invention and distinguishing it from other treatments[2].

Dependent Claims

Dependent claims further specify the methods and conditions under which Qsymia is administered. These claims often provide additional details that narrow down the scope but are still within the framework set by the independent claims.

Patent Landscape and Impact

Market Exclusivity

The issuance of this patent significantly extends the market exclusivity for Qsymia, providing VIVUS, Inc. with a longer period to exclusively market and sell the drug. This extension is crucial for the company's revenue and competitive positioning in the obesity treatment market[5].

Litigation and Infringement

Patent disputes, such as the one between VIVUS and Actavis, highlight the importance of claim construction in determining patent infringement. The courts must carefully interpret the claim language to determine whether generic versions of Qsymia infringe on VIVUS's patents[2].

Technological and Therapeutic Impact

This patent contributes to the broader therapeutic landscape by protecting a specific and effective treatment for obesity. The extended patent protection ensures that VIVUS can continue to invest in research and development, potentially leading to further innovations in obesity treatment.

Metrics for Measuring Patent Scope

Independent Claim Length and Count

Research suggests that the scope of a patent can be measured by the length and count of independent claims. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].

Global Patent System Integration

Global Dossier and Common Citation Document

Tools like the Global Dossier and Common Citation Document (CCD) facilitate the integration of global patent systems. These tools help in tracking related applications and citations across different IP offices, which can be crucial for managing and enforcing patents like U.S. Patent 8,580,299[4].

Key Takeaways

• Extended Exclusivity: The patent extends the market exclusivity for Qsymia until June 2029.
• Specific Claims: The patent claims are precise and focused on the combination and dosages of phentermine and topiramate.
• Litigation Impact: The patent is significant in litigation, particularly in determining infringement by generic manufacturers.
• Therapeutic Impact: The patent protects an effective treatment for obesity, ensuring continued investment in research and development.
• Global Integration: Tools like the Global Dossier and CCD aid in managing and enforcing this patent globally.

FAQs

Q: What is the main subject of U.S. Patent 8,580,299?

A: The main subject is the methods for effecting weight loss using Qsymia, a combination of phentermine and topiramate.

Q: How does this patent extend the exclusivity for Qsymia?

A: The patent extends the market exclusivity for Qsymia from June 2020 to June 2029.

Q: What are the key components covered by this patent?

A: The key components are the specific dosages of phentermine (2-8 mg) and topiramate (15-50 mg) used in combination for weight loss.

Q: Why is claim construction important in this patent?

A: Claim construction is crucial for determining the scope of the invention and resolving patent infringement disputes.

Q: How does this patent impact the broader therapeutic landscape?

A: It protects an effective treatment for obesity, ensuring continued investment in research and development, and contributes to the therapeutic options available for patients.

Sources

1. Bioworld: U.S. patent disclosures.
2. Casetext: Vivus, Inc. v. Actavis Labs. FL, Inc.
3. SSRN: Patent Claims and Patent Scope.
4. USPTO: Search for patents.
5. GlobeNewswire: VIVUS Announces Issuance of Two Key U.S. Patents for Qsymia.

Drugs Protected by US Patent 8,580,299

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012	AB	RX	Yes	No	8,580,299					FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2, AND PATIENTS AGE 12-17 WITH BMI >=30 KG/M2 AND IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX), EACH HAVING A WEIGHT-RELATED COMORBIDITY
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-002	Jul 17, 2012	AB	RX	Yes	No	8,580,299					FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2, AND PATIENTS AGE 12-17 WITH BMI >=30 KG/M2 AND IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX), EACH HAVING A WEIGHT-RELATED COMORBIDITY
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-003	Jul 17, 2012	AB	RX	Yes	No	8,580,299					FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2, AND PATIENTS AGE 12-17 WITH BMI >=30 KG/M2 AND IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX), EACH HAVING A WEIGHT-RELATED COMORBIDITY
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012	AB	RX	Yes	Yes	8,580,299					FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2, AND PATIENTS AGE 12-17 WITH BMI >=30 KG/M2 AND IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX), EACH HAVING A WEIGHT-RELATED COMORBIDITY

International Family Members for US Patent 8,580,299

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2009257572
Australia	2009257573
Brazil	PI0914985
Brazil	PI0914991
European Patent Office	2317997		CA 2021 00049	Denmark
European Patent Office	2317997		CR 2021 00049	Denmark
European Patent Office	2317997		2190050-1	Sweden