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Last Updated: January 6, 2025

Details for Patent: 9,192,616


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Which drugs does patent 9,192,616 protect, and when does it expire?

Patent 9,192,616 protects GIAZO and is included in one NDA.

This patent has thirty-six patent family members in twelve countries.

Summary for Patent: 9,192,616
Title:Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives
Abstract: A method of increasing the bioavailability of balsalazide by administration of an oral dosage form with food is provided, as well as an article of manufacture comprising an oral dosage form of balsalazide in a suitable container and associated with printed labeling which describes the increased bioavailability of the medication in the container when taken with food.
Inventor(s): Johnson; Lorin (Palo Alto, CA)
Assignee: Salix Pharmaceuticals, Inc. (Raleigh, NC)
Application Number:13/439,594
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 9,192,616

Introduction

United States Patent 9,192,616, titled "Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives," is a patent that delves into the formulations and applications of specific chemical compounds. To analyze this patent, we need to examine its claims, scope, and the broader patent landscape it operates within.

Patent Overview

The patent, issued on November 17, 2015, pertains to the use of 2-hydroxy-5-phenylazobenzoic acid derivatives, particularly in the context of treating various medical conditions such as ulcerative colitis, radiation enteritis, irritable bowel syndrome, and other gastrointestinal diseases[3].

Claim Scope

Importance of Claim Scope

The scope of the claims in a patent is crucial for determining the extent of protection and the validity of the patent. A well-defined claim scope ensures that the patent is neither too broad nor too narrow, avoiding potential invalidation and ensuring enforceability[2].

Claims in US 9,192,616

The claims in this patent are directed towards specific formulations and uses of the 2-hydroxy-5-phenylazobenzoic acid derivatives. Here are some key aspects:

  • Independent Claims: These claims define the broadest scope of the invention. For example, Claim 1 might describe the general formulation of the compound, while subsequent claims might narrow down to specific applications or methods of administration.
  • Dependent Claims: These claims build upon the independent claims, providing additional details or limitations. They help in securing a stronger patent by covering various aspects of the invention[2].

Metrics for Measuring Claim Scope

Research suggests that metrics such as independent claim length and independent claim count can be used to measure patent scope. Patents with narrower claims at publication tend to have a higher probability of grant and a shorter examination process[4].

Claim Language and Scope

Broad vs. Narrow Claims

While broader claims offer more extensive protection, they are also more challenging to get granted and easier to invalidate. The claims in US 9,192,616 must be balanced to ensure they are anchored to the embodiments disclosed in the specification without being overly broad. This balance is critical to avoid running afoul of the abstract idea exception, as seen in cases like Alice v. CLS Bank[2].

Specific Embodiments

The patent claims must be directed to specific means or methods to ensure they are enforceable. For instance, claims might specify the exact formulation, dosage, and method of administration for treating particular conditions. This specificity helps in distinguishing the invention from prior art and ensures that the claims are not too abstract[2].

Prior Art and Citation Analysis

Common Citation Document (CCD)

To understand the prior art landscape, tools like the Common Citation Document (CCD) can be used. The CCD consolidates citation data from multiple patent offices, helping to identify prior art that may affect the validity of the claims in US 9,192,616[1].

Global Dossier

The Global Dossier service provides access to the file histories of related applications from participating IP Offices. This can help in identifying any office actions or citations that might impact the claims of the patent[1].

International Patent Landscape

Searchable Databases

To ensure the novelty and non-obviousness of the invention, it is essential to search international patent databases. Resources like the European Patent Office's esp@cenet, the Japan Patent Office, and the World Intellectual Property Organization's PATENTSCOPE can provide insights into similar patents filed globally[1].

Classification and Categories

The patent is classified under various categories, including:

  • A23L: Foods, foodstuffs, or non-alcoholic beverages, particularly modifying nutritive qualities.
  • A61K: Medicinal preparations containing organic active ingredients, specifically salicylic acid derivatives[3].

Practical Applications and Uses

The patent outlines several practical applications of the 2-hydroxy-5-phenylazobenzoic acid derivatives, including:

  • Treatment of Gastrointestinal Diseases: The compounds are used to treat conditions such as ulcerative colitis, radiation enteritis, and irritable bowel syndrome.
  • Administration: The patent specifies various methods of administration, including food and other forms[3].

Legal Status and Maintenance

The legal status of the patent is active, indicating that it is currently in force. However, maintaining a patent requires periodic payments and adherence to legal requirements to keep it active.

Key Takeaways

  • Balanced Claim Scope: The claims must be balanced between being broad enough to offer protection and narrow enough to avoid invalidation.
  • Specific Embodiments: Claims should be directed to specific means or methods to ensure enforceability.
  • Prior Art Analysis: Tools like CCD and Global Dossier are essential for understanding the prior art landscape.
  • International Search: Searching international patent databases is crucial for ensuring novelty and non-obviousness.
  • Classification: Understanding the classification categories helps in identifying the patent's place within the broader patent landscape.

FAQs

Q1: What is the main subject of United States Patent 9,192,616? The main subject is the formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives, particularly for treating gastrointestinal diseases.

Q2: Why is claim scope important in a patent application? Claim scope is crucial because it determines the extent of protection and the validity of the patent. A well-defined claim scope ensures the patent is neither too broad nor too narrow.

Q3: How can one measure the scope of patent claims? Metrics such as independent claim length and independent claim count can be used to measure patent scope. These metrics have been validated to have explanatory power for several correlates of patent scope.

Q4: What are the risks of having overly broad claims in a patent? Overly broad claims can be easier to invalidate and may fall under the abstract idea exception, as seen in cases like Alice v. CLS Bank. This can lead to the patent being invalidated.

Q5: How can one ensure the novelty and non-obviousness of a patent? Searching international patent databases and using tools like the Common Citation Document (CCD) and Global Dossier can help in identifying prior art and ensuring the novelty and non-obviousness of the invention.

Sources

  1. USPTO - Search for Patents: "How to Conduct a Preliminary U.S. Patent Search: A Step by Step Strategy."
  2. Rimon Law: "The Importance of Getting the Claim Scope Right in a US Patent Application."
  3. Google Patents: "US9192616B2 - Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives."
  4. SSRN: "Patent Claims and Patent Scope."

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Drugs Protected by US Patent 9,192,616

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 DISCN Yes No ⤷  Subscribe ⤷  Subscribe TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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