Details for Patent: 9,011,906

Which drugs does patent 9,011,906 protect, and when does it expire?

Patent 9,011,906 protects QSYMIA and is included in one NDA.

This patent has forty patent family members in seventeen countries.

Summary for Patent: 9,011,906

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:	14/495,250
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,011,906
Patent Claim Types: see list of patent claims	Use; Dosage form;

United States Patent 9,011,906: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 9,011,906, titled "Escalating dosing regimen for effecting weight loss and treating obesity," is a significant patent in the field of medical science, particularly in the treatment of obesity. This patent, assigned to Vivus, Inc., outlines novel topiramate compositions and methods for weight loss. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Background of the Patent

The patent US9011906B2 was granted for an escalating dosing regimen that combines topiramate with other drugs, such as phentermine, to treat obesity and related conditions. The invention is characterized by its specific dosing regimen, which is designed to optimize the therapeutic effects while minimizing side effects[4].

Scope of the Patent

The scope of the patent is defined by its claims, which are the legal boundaries of what the patent protects. Here are some key aspects:

Claim Structure

The claims in this patent are structured to cover both the compositions and the methods of using these compositions. For example, the claims include specific formulations of topiramate and phentermine, as well as the escalating dosing regimen itself. This ensures broad protection for the invention while being specific enough to avoid invalidation due to prior art or abstract idea exceptions[3].

Specific Embodiments

The patent includes specific embodiments of the invention, such as the combination of 3.75 mg phentermine and 23 mg topiramate, which is a well-known formulation under the brand name Qsymia. These specific embodiments are crucial as they provide concrete examples of the invention and help in distinguishing it from prior art[4].

Claims Analysis

Independent Claims

The independent claims are the broadest claims in the patent and define the overall scope of the invention. For instance, Claim 1 might cover the general method of using an escalating dosing regimen of topiramate and phentermine for weight loss. These claims are critical as they set the boundaries for what is considered infringing[4].

Dependent Claims

Dependent claims narrow down the scope of the independent claims by adding additional limitations. These claims help in providing a hierarchy of protection, ensuring that even if the broader claims are challenged, the narrower claims can still stand. For example, a dependent claim might specify the exact dosages or the duration of the treatment[4].

Patent Landscape

Prior Art and Citation Data

The patent landscape for US9011906B2 includes a thorough analysis of prior art. The Common Citation Document (CCD) application, which consolidates citation data from participating IP offices, would be useful here. This ensures that the claims are novel and non-obvious over existing prior art[1].

International Patent Family

The patent is part of an international patent family, with corresponding applications filed in various jurisdictions. Tools like the Global Dossier and search databases from international intellectual property offices (such as the European Patent Office and the Japan Patent Office) can provide insights into the global protection and status of related applications[1].

Litigation and Enforcement

Patents like US9011906B2 are often involved in litigation to enforce their claims against potential infringers. For instance, Vivus, Inc. might engage in legal battles to protect its intellectual property rights, as seen in cases like Vivus, Inc. v. Actavis Labs. FL, Inc.[2].

Importance of Claim Scope

The claim scope in this patent is crucial for its validity and enforceability. A broad claim scope, while desirable, must be balanced against the risk of invalidation. The abstract idea exception, as outlined in Alice v. CLS Bank, is a significant concern. Claims must be anchored to the specific embodiments disclosed in the specification to avoid being deemed too broad or abstract[3].

Classification and Technical Field

The patent is classified under the A61K category, which pertains to medicinal preparations characterized by special physical forms. This classification helps in identifying relevant prior art and in understanding the technical field in which the invention operates. The specific classifications, such as A61K9/14 and A61K9/16, further narrow down the scope to particulate forms and agglomerates, respectively[4].

Practical Implications

Commercial Impact

The commercial impact of this patent is significant, given the market demand for effective weight loss treatments. The specific dosing regimen and formulations protected by this patent can provide a competitive edge in the pharmaceutical market.

Regulatory Compliance

Compliance with regulatory requirements is essential. The patent holder must ensure that the manufacturing and distribution of the drug comply with FDA regulations and other international standards.

Key Takeaways

• Specific Claims: The patent includes specific claims that cover both compositions and methods, ensuring broad yet targeted protection.
• Prior Art Analysis: Thorough analysis of prior art is crucial to ensure novelty and non-obviousness.
• International Protection: The patent is part of an international patent family, providing global protection.
• Litigation: The patent may be involved in litigation to enforce its claims against infringers.
• Claim Scope: Balancing claim scope to avoid invalidation due to abstract idea exceptions is vital.
• Classification: The patent is classified under A61K, helping in identifying relevant prior art and understanding the technical field.

FAQs

Q: What is the main invention protected by US9011906B2?

A: The main invention is an escalating dosing regimen combining topiramate and phentermine for weight loss and treating obesity.

Q: Why is the claim scope important in this patent?

A: The claim scope is important to ensure the patent is valid and enforceable, avoiding invalidation due to being too broad or abstract.

Q: How does the Global Dossier help in patent searching?

A: The Global Dossier provides access to the file histories of related applications from participating IP offices, helping users see the patent family and related data.

Q: What are the potential risks of overly broad claims in a patent?

A: Overly broad claims can be easier to invalidate due to abstract idea exceptions or failure to meet the written description requirement.

Q: Where can one find additional resources for searching and analyzing patents?

A: Additional resources include the USPTO Public Search Facility, Patent and Trademark Resource Centers (PTRCs), and international intellectual property office databases.

Sources

1. USPTO: Search for patents - USPTO. [Online]. Available: https://www.uspto.gov/patents/search
2. CaseMine: Vivus, Inc. v. Actavis Labs. FL, Inc. | Civil Action No. 14-3786 (SRC ... [Online]. Available: https://www.casemine.com/judgement/us/5ca31403342cca16c797f7d6
3. Rimon Law: The Importance of Getting the Claim Scope Right in a US Patent ... [Online]. Available: https://www.rimonlaw.com/the-importance-of-getting-the-claim-scope-right-in-a-us-patent-application-i/
4. Google Patents: US9011906B2 - Escalating dosing regimen for effecting weight loss ... [Online]. Available: https://patents.google.com/patent/US9011906B2/en

Drugs Protected by US Patent 9,011,906

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						FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-002	Jul 17, 2012	AB	RX	Yes	No						FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-003	Jul 17, 2012	AB	RX	Yes	No						FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012	AB	RX	Yes	Yes						FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)

International Family Members for US Patent 9,011,906

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