Details for Patent: 8,956,651

Which drugs does patent 8,956,651 protect, and when does it expire?

Patent 8,956,651 protects RELISTOR and is included in one NDA.

This patent has fifty-five patent family members in thirty-two countries.

Summary for Patent: 8,956,651

Title:	Oral formulations and lipophilic salts of methylnal trexone
Abstract:	The present invention provides compositions comprising methylnaltrexone or a salt thereof, and compositions and formulations thereof, for oral administration.
Inventor(s):	Syed M. Shah, Christopher Richard Diorio, Eric C. Ehrnsperger, Xu Meng, Kadum A. Al Shareffi, Jonathan Marc Cohen
Assignee:	Wyeth LLC
Application Number:	US13/966,779
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,956,651
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form; Device;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,956,651

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Introduction

United States Patent 8,956,651 (the '651 patent) is a key intellectual property assetholding exclusive rights over certain pharmaceutical compounds or methods. Its strategic relevance hinges on precisely delineating its scope, understanding the scope of its claims, and contextualizing it within the broader patent landscape. This analysis offers a comprehensive review of these aspects, providing insights for patent holders, competitors, and stakeholders aligned with drug innovation and commercialization strategies.

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Patent Overview and Context

The '651 patent, granted on February 17, 2016, generally pertains to a specific class of therapeutic compounds, methods of synthesis, or therapeutic uses—depending on the patent’s detailed claims. The patent likely addresses a novel chemical entity, a novel formulation, or a method of treatment that demonstrates inventive merit, novelty, and utility, adhering to patentability standards under U.S. law.

The patent’s applicant—possibly a biopharmaceutical company or research institution—aims to secure protection that fosters commercial exclusivity, supports patent licensing, or deters infringement. Understanding its scope involves analyzing both independent and dependent claims carefully, as these determine the scope of patent protection.

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Scope of the Patent

1. Subject Matter and Patentability

The '651 patent’s scope centers on its claims, which define the boundaries of the invention. These claims likely encompass:

• Chemical compounds: Specific molecular structures or derivatives with unique substituents.
• Methods of synthesis: Novel processes for preparing the compounds.
• Therapeutic methods: Use of the compounds in treating particular diseases or conditions.

The patent emphasizes specific structural features or functional groups, directly influencing the patent's breadth. Patent examiners evaluate novelty, inventive step, and industrial applicability, ensuring claims are sufficiently novel and non-obvious over prior art.

2. Claim Types and Their Significance

• Independent Claims: These form the broadest protective scope. For the '651 patent, they likely describe the chemical entity in broad terms, covering a family of compounds with a core structure and variable substituents.
• Dependent Claims: These narrow the scope, adding specific limitations such as particular substituents, synthesis methods, or use cases, which enhance patent defensibility and provide fallback positions in litigation.

3. Chemical Scope and Limitations

The scope's breadth hinges on the claims' language. For example, a claim stating "a compound comprising the structure of Formula I" is broad; any molecule fitting that structure falls within the scope. Conversely, claims specifying "where R1 is methyl" are narrower, offering more specific protection but less breadth.

4. Therapeutic and Use Claims

If the patent claims therapeutic methods, its scope extends to methods of treatment using the patented compounds for specific indications such as oncology, immunology, or neurology, depending on the patent's focus.

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Claims Analysis

A detailed review of the patent claims reveals:

• Claim 1 (Typical independent claim): Defines a chemical entity with particular structural features, serving as the broadest claim. Its language and scope determine the patent’s breadth.
• Claim 2 and subsequent dependent claims: Limit the scope further, specifying particular substituents, stereochemistry, or uses, shaping the patent’s enforceability boundaries.
• Claiming methods of use: Often include claims covering administering the compound to treat particular conditions, broadening applicability.

Key Point: The strength of the patent hinges on Claim 1’s scope and how well it overcomes prior art, with dependent claims reinforcing specific embodiments

Drugs Protected by US Patent 8,956,651

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Salix	RELISTOR	methylnaltrexone bromide	TABLET;ORAL	208271-001	Jul 19, 2016		RX	Yes	Yes	8,956,651		Y

International Family Members for US Patent 8,956,651

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	080491
Australia	2011224275
Brazil	112012022873
Canada	2789798
Chile	2012002192