Details for Patent: 8,796,337

Which drugs does patent 8,796,337 protect, and when does it expire?

Patent 8,796,337 protects GOCOVRI and OSMOLEX ER and is included in two NDAs.

This patent has four patent family members in three countries.

Summary for Patent: 8,796,337

Title:	Composition and method for treating neurological disease
Abstract:	A method of administering amantadine is provided. The method comprises orally administering to a subject a pharmaceutical composition comprising amantadine, or a pharmaceutically acceptable salt thereof, and one or more excipients, wherein at least one of the excipients modifies release of the amantadine. A dose of the composition provides a mean change in amantadine plasma concentration as a function of time (dC/dT) that is less than 40% of the change in amantadine plasma concentration provided by a dose of the same quantity of an immediate release form of amantadine. The change in plasma concentration over time (dC/dT) is measured in a single dose human pharmacokinetic study in a defined time period of 0 to 4 hours after administration. The amantadine, or pharmaceutically acceptable salt thereof, is administered once daily at a dose of 300 to 500 mg per day.
Inventor(s):	Went; Gregory T. (Mill Valley, CA), Fultz; Timothy J. (Pleasant Hill, CA), Porter; Seth (San Carlos, CA), Meyerson; Laurence R. (Las Vegas, NV), Burkoth; Timothy S. (Lake Bluff, IL)
Assignee:	Adamas Pharmaceutical, Inc. (Emeryville, CA)
Application Number:	13/958,153
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,796,337
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

Understanding the Scope and Claims of United States Patent 8,796,337

Introduction

United States Patent 8,796,337, titled "Composition and Method For Treating Neurological Disease," is a significant intellectual property asset in the pharmaceutical industry. This patent, issued to Adamas Pharmaceuticals, protects innovative methods and compositions for treating neurological diseases. Here’s a detailed analysis of its scope, claims, and the broader patent landscape.

Patent Overview

The patent 8,796,337 focuses on compositions and methods for treating neurological diseases, particularly those related to the central nervous system. The claims of this patent are directed towards specific formulations and treatment protocols that have been developed to address these conditions effectively[2].

Scope of the Patent

Claims Analysis

The scope of the patent is defined by its claims, which are the most critical part of any patent application. For patent 8,796,337, the claims outline the specific compositions, methods of preparation, and methods of treatment that are protected. Here are some key aspects:

• Composition Claims: These claims specify the exact formulations of the drugs, including the active ingredients, their concentrations, and any additional components.
• Method Claims: These claims describe the methods of treating neurological diseases using the specified compositions. This includes dosing regimens, administration routes, and any specific procedures or protocols.
• Use Claims: These claims define the specific neurological diseases that the compositions and methods are intended to treat.

Scope Concepts

To understand the scope better, it is helpful to categorize the claims by overarching scope concepts. This involves grouping claims based on similar technological or scientific principles, which can help in analyzing the patent landscape more efficiently[3].

Claim Coverage Matrix

A Claim Coverage Matrix is a useful tool for visualizing which patents and claims are actively protecting the intellectual property. For patent 8,796,337, this matrix would show:

• Active Claims: Which claims are currently protecting the compositions and methods.
• Gaps in Coverage: Areas where the current claims may not provide adequate protection.
• Future Design Opportunities: Potential areas for future innovation and patent filings based on the existing claims.

This matrix helps in identifying whether the current scope of the patent is sufficient to protect the intended technology and highlights any gaps or opportunities for further development[3].

Patent Landscape Analysis

Competitor Patents

Analyzing the patent landscape involves looking at similar patents held by competitors. This includes:

• Patent Families: Identifying related patents filed in different jurisdictions to understand the global protection strategy.
• Citation Data: Using tools like the Common Citation Document (CCD) to see which prior art has been cited by multiple patent offices, indicating the relevance of the invention[4].

For example, if other pharmaceutical companies have filed similar patents, it is crucial to compare their claims and scope to ensure that patent 8,796,337 remains distinct and valuable.

Market Value

The value of a patent like 8,796,337 can be assessed using various valuation methods:

• Cost Approach: The cost of developing the patent, including research and development expenses.
• Income Approach: The future benefits or income generated by the patent, such as royalties or sales.
• Market Approach: The price that a willing buyer would pay for a similar patent, based on historical sales data[1].

Given the significance of neurological treatments, patents in this area can command high prices. For instance, historical data shows that patents in the pharmaceutical and technology sectors can sell for millions of dollars per document[1].

Claim Charts and Technical Review

To ensure that the patent claims are accurately understood and applied, interactive claim charts can be used. These charts, generated by tools like ClaimScape®, help technical experts, engineers, and management to review the claims and determine their applicability to specific products or methods. This process is quick and accurate, highlighting any gaps in current coverage and future design opportunities[3].

Global Patent System Integration

The global patent system plays a crucial role in the analysis of patent 8,796,337. Tools like the Global Dossier and international patent databases (such as those provided by the European Patent Office, Japan Patent Office, and World Intellectual Property Organization) allow for a comprehensive view of related applications and citations across different jurisdictions. This integration helps in understanding the global patent family and ensuring that the patent remains valid and enforceable worldwide[4].

Enforcement and Litigation

To fully leverage the value of patent 8,796,337, it is essential to enforce it against any potential infringers. This involves monitoring for infringement, issuing cease and desist letters, and if necessary, pursuing litigation. For example, Adamas Pharmaceuticals would need to be vigilant in protecting their intellectual property rights, as seen in other cases where companies have been served with complaints related to patent infringement[5].

Key Takeaways

• Claims Analysis: The claims of patent 8,796,337 are critical and define the scope of protection for the compositions and methods.
• Scope Concepts: Categorizing claims by scope concepts helps in efficient analysis and identification of gaps or opportunities.
• Patent Landscape: Analyzing competitor patents and global citations is essential for understanding the patent's value and validity.
• Valuation: The patent's value can be assessed using cost, income, and market approaches.
• Enforcement: Active monitoring and enforcement are necessary to protect the patent's value.

FAQs

Q: What is the main focus of United States Patent 8,796,337? A: The main focus is on compositions and methods for treating neurological diseases.

Q: How are the claims of a patent like 8,796,337 typically categorized? A: Claims are categorized by scope concepts to link similar claims and facilitate analysis.

Q: What tools are available for analyzing the global patent landscape? A: Tools like the Global Dossier, Common Citation Document, and international patent databases are available.

Q: How can the value of a patent like 8,796,337 be determined? A: The value can be determined using cost, income, and market valuation methods.

Q: Why is it important to enforce a patent like 8,796,337? A: Enforcement is crucial to protect the intellectual property rights and maintain the patent's value against potential infringers.

Sources

1. Perpetual Motion Patents - The value of a patent
2. GlobeNewswire - United States Patent Issued to Adamas Pharmaceuticals
3. Schwegman, Lundberg & Woessner - Patent Analytics
4. USPTO - Search for patents
5. ProxyVote - Untitled (related to patent enforcement)

Drugs Protected by US Patent 8,796,337

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-001	Aug 24, 2017	AB	RX	Yes	No	8,796,337					TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-002	Aug 24, 2017		RX	Yes	Yes	8,796,337					TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	Feb 16, 2018		DISCN	Yes	No	8,796,337					TREATMENT OF PARKINSON'S DISEASE
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	Feb 16, 2018		DISCN	Yes	No	8,796,337					TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSON'S DISEASE
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	Feb 16, 2018		DISCN	Yes	No	8,796,337					TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS

International Family Members for US Patent 8,796,337

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2588296
European Patent Office	1845968
European Patent Office	2623099
World Intellectual Property Organization (WIPO)	2006058236