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Last Updated: December 22, 2024

Details for Patent: 8,420,674


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Which drugs does patent 8,420,674 protect, and when does it expire?

Patent 8,420,674 protects ESBRIET and is included in two NDAs.

This patent has twenty-one patent family members in fourteen countries.

Summary for Patent: 8,420,674
Title:Method of providing pirfenidone therapy to a patient
Abstract: The invention relates to methods for decreasing adverse events associated with pirfenidone (5-methyl-1-phenyl-2-(1H)-pyridone) therapy. The invention discloses an optimized dose escalation scheme that results in the patient having increased tolerance to adverse events associated with the administration of pirfenidone. The invention also discloses a starter pack that may be used in conjunction with the dose escalation scheme.
Inventor(s): Bradford; Williamson Z. (Ross, CA)
Assignee: Intermune, Inc. (Brisbane, CA)
Application Number:12/831,944
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,420,674
Patent Claim Types:
see list of patent claims
Use; Dosage form;
Patent landscape, scope, and claims:

United States Patent 8,420,674: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 8,420,674, titled "Method of Providing Pirfenidone Therapy to a Patient," was granted on April 16, 2013. This patent is part of a series of patents related to pirfenidone therapy, a treatment for idiopathic pulmonary fibrosis (IPF) and other conditions. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Background of Pirfenidone Therapy

Pirfenidone is a small molecule with anti-fibrotic and anti-inflammatory properties, used primarily in the treatment of IPF. The drug has been the subject of extensive research and patent activity due to its therapeutic potential[2].

Patent Overview

Title and Abstract

The patent titled "Method of Providing Pirfenidone Therapy to a Patient" describes methods for administering pirfenidone to patients, particularly focusing on reducing adverse events associated with the therapy. The abstract outlines the invention's purpose and the specific methods involved in the treatment regimen.

Inventors and Assignees

The patent was issued to the inventors who developed the specific methods of pirfenidone administration. The assignee, typically the company or organization that owns the rights to the patent, is responsible for maintaining and enforcing the patent rights[2].

Scope of the Patent

Claims

The patent includes multiple claims that define the scope of the invention. These claims are categorized into independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims build upon the independent claims and provide additional details.

  • Independent Claims: These claims define the core method of providing pirfenidone therapy, including the dosage regimen, administration schedule, and patient monitoring.
  • Dependent Claims: These claims specify additional aspects such as the dosage amounts, frequency of administration, and specific patient populations[2].

Detailed Claim Analysis

The claims in this patent are structured to cover various aspects of the therapy:

  • Claim 1: Describes the method of providing pirfenidone therapy, including the initial dosage and titration schedule.
  • Claim 2: Specifies the dosage amount and frequency of administration.
  • Claim 3: Outlines the monitoring of patients for adverse events and adjustments to the treatment regimen based on patient response[2].

Patent Landscape

Related Patents

The patent landscape surrounding US 8,420,674 includes several other patents related to pirfenidone therapy. These patents cover different aspects of the treatment, such as:

  • U.S. Patent No. 8,013,002: Methods of administering pirfenidone therapy.
  • U.S. Patent No. 8,318,780: Methods of administering pirfenidone therapy with a focus on patient populations.
  • U.S. Patent No. 8,592,462: Pirfenidone treatment for patients with atypical liver function[2].

Competitive Analysis

The competitive landscape in the field of pirfenidone therapy is intense, with multiple companies and research institutions involved in developing and patenting various methods and formulations. This patent is part of a broader strategy to protect intellectual property related to pirfenidone therapy.

Litigation and Enforcement

Patents related to pirfenidone therapy, including US 8,420,674, have been involved in litigation to enforce patent rights against potential infringers. For example, the plaintiffs in a case against Shilpa Medicare Limited asserted several patents, including this one, to protect their exclusive rights to the therapy[2].

Search and Retrieval

Patent Databases

To find this patent and related ones, one can use various patent databases:

  • USPTO Database: The United States Patent and Trademark Office (USPTO) database provides full-text searches for patents from 1976 onwards and limited information for earlier patents.
  • Google Patents: Offers a simpler interface for quick review of matches and includes non-patent literature. It supports searches by classification, field, and keyword[4].

Classification and Field Searching

Effective searching involves identifying relevant classifications and fields:

  • Cooperative Patent Classification (CPC): Use CPC classes and subclasses to narrow down the search to specific areas of technology.
  • Field Searching: Search by inventor, assignee, or patent number to find specific patents or those held by known entities[4].

Data and Statistics

Patent Claims Research Dataset

The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents granted between 1976 and 2014. This dataset can be used to analyze the scope and claims of patents like US 8,420,674, offering insights into claim-level statistics and document-level statistics[3].

Key Takeaways

  • Patent Scope: The patent covers specific methods of administering pirfenidone therapy to reduce adverse events.
  • Claims Analysis: The claims are structured to protect the core method and various aspects of the therapy.
  • Patent Landscape: The patent is part of a broader landscape of patents related to pirfenidone therapy, with significant competitive and litigation activity.
  • Search and Retrieval: Utilize patent databases and classification systems to find and analyze related patents.

FAQs

What is the main focus of U.S. Patent 8,420,674?

The main focus of U.S. Patent 8,420,674 is on methods for providing pirfenidone therapy to patients, particularly aimed at reducing adverse events associated with the treatment.

How can I search for patents related to pirfenidone therapy?

You can search using the Cooperative Patent Classification (CPC) scheme, field searching by inventor or assignee, and keyword searches in databases like the USPTO and Google Patents.

What other patents are related to U.S. Patent 8,420,674?

Related patents include U.S. Patent No. 8,013,002, U.S. Patent No. 8,318,780, and U.S. Patent No. 8,592,462, all of which pertain to different aspects of pirfenidone therapy.

Why is the patent landscape for pirfenidone therapy complex?

The patent landscape is complex due to the involvement of multiple companies and research institutions, leading to extensive patenting and litigation activities to protect intellectual property.

How can I access the full text and images of U.S. patents?

The full text and images of U.S. patents, including those from 1790 to the present, are available through the USPTO website and other databases like Google Patents and the European Patent Office's Espacenet[1][4].

Sources

  1. NYPL Libguides: How to Search for an Historical U.S. Patent.
  2. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT: Case 1:20-cv-00624-UNA Document 1 Filed 05/08/20.
  3. USPTO: Patent Claims Research Dataset.
  4. UVM Libraries Research Guides: Patents and Trademarks.

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Drugs Protected by US Patent 8,420,674

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Genentech Inc ESBRIET pirfenidone CAPSULE;ORAL 022535-001 Oct 15, 2014 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF A FIBROSIS CONDITION ⤷  Subscribe
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-001 Jan 11, 2017 AB RX Yes No ⤷  Subscribe ⤷  Subscribe PIRFENIDONE DOSE ESCALATION REGIMEN FOR TREATMENT OF FIBROSIS AS 801 MG/DAY FOR DAYS 1-7 OF THE REGIMEN, 1602 MG/DAY FOR DAYS 8-14 OF THE REGIMEN, AND 2403 MG/DAY FOR AT LEAST DAY 15 OF THE REGIMEN ⤷  Subscribe
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-002 Jan 11, 2017 DISCN Yes No ⤷  Subscribe ⤷  Subscribe PIRFENIDONE DOSE ESCALATION REGIMEN FOR TREATMENT OF FIBROSIS AS 801 MG/DAY FOR DAYS 1-7 OF THE REGIMEN, 1602 MG/DAY FOR DAYS 8-14 OF THE REGIMEN, AND 2403 MG/DAY FOR AT LEAST DAY 15 OF THE REGIMEN ⤷  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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