Details for Patent: 8,013,002

Which drugs does patent 8,013,002 protect, and when does it expire?

Patent 8,013,002 protects ESBRIET and is included in two NDAs.

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

Summary for Patent: 8,013,002

Title:	Methods of administering pirfenidone therapy
Abstract:	The present invention relates to methods involving avoiding adverse drug interactions with fluvoxamine and pirfenidone or other moderate to strong inhibitors of CYP enzymes.
Inventor(s):	Bradford; Williamson Ziegler (Ross, CA), Szwarcberg; Javier (San Francisco, CA)
Assignee:	Intermune, Inc. (Brisbane, CA)
Application Number:	13/049,894
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,013,002
Patent Claim Types: see list of patent claims	Use;

Analyzing the Scope and Claims of United States Patent 8,013,002: A Comprehensive Guide

Introduction

Understanding the scope and claims of a patent is crucial for inventors, businesses, and legal professionals. This article will delve into the details of United States Patent 8,013,002, providing a thorough analysis of its scope, claims, and the broader patent landscape.

Understanding Patent Scope and Claims

Before diving into the specifics of Patent 8,013,002, it is essential to understand what patent scope and claims entail.

Patent Scope

The scope of a patent refers to the breadth and depth of protection it offers. It is often measured using metrics such as independent claim length and independent claim count, which can indicate the patent's breadth and clarity[3].

Patent Claims

Patent claims are the legal definitions of what the inventor considers to be their invention. They define the scope of protection granted by the patent. Claims can be independent or dependent, with independent claims standing alone and dependent claims referring back to an independent claim[3].

United States Patent 8,013,002: Overview

To analyze Patent 8,013,002, one must first identify the key elements of the patent.

Patent Title and Abstract

The title and abstract provide a brief overview of the invention. While the specific details of Patent 8,013,002 are not provided here, these sections typically outline the main purpose and functionality of the invention.

Independent and Dependent Claims

Independent claims are the cornerstone of a patent, defining the invention in its broadest terms. Dependent claims narrow down the invention by adding specific limitations or features. For example, if an independent claim describes a method, a dependent claim might specify a particular step or condition within that method.

Description and Drawings

The detailed description and drawings of the patent provide a comprehensive explanation of the invention, including its components, how it works, and any variations or embodiments.

Conducting a Patent Search

To understand the landscape around Patent 8,013,002, conducting a thorough patent search is necessary.

Using USPTO Resources

The United States Patent and Trademark Office (USPTO) offers several tools for patent searching:

• Patent Public Search: A modern web-based application that replaces legacy tools, providing enhanced access to prior art[1].
• Global Dossier: Allows users to view the patent family for a specific application, including related applications from participating IP Offices[1].
• Public Search Facility: Located in Alexandria, VA, this facility provides access to patent and trademark information in various formats[1].

International Patent Offices

Searching international databases is crucial to ensure the invention is not already patented abroad. Resources include:

• European Patent Office (EPO): Provides access to European patent databases and machine translations[1].
• Japan Patent Office (JPO): Offers machine translations of Japanese patents[1].
• World Intellectual Property Organization (WIPO): Features the PATENTSCOPE® Search Service for international patent applications[1].

Analyzing Patent Claims

Claim Language and Scope

The language used in patent claims is critical. Independent claim length and count can be used as metrics to measure patent scope. Narrower claims at publication are often associated with a higher probability of grant and a shorter examination process[3].

Claim Construction

Claim construction involves interpreting the meaning of the claims. This process is crucial in determining the scope of protection and can be a point of contention in patent litigation.

Patent Examination Process

The examination process can significantly impact the scope of patent claims. Here are some key points:

Narrowing Claims

During the examination process, claims are often narrowed down to address examiner objections. This narrowing can affect the breadth of the patent's protection[3].

Office Actions

Office actions indicate issues with the patent application. Addressing these actions can lead to changes in the claims, which in turn affect the patent's scope[1].

Patent Landscape and Prior Art

Understanding the prior art and the broader patent landscape is essential for assessing the novelty and non-obviousness of the invention.

Common Citation Document (CCD)

The CCD application consolidates citation data from participating IP Offices, helping to identify prior art cited by multiple offices[1].

Search Published Sequences

For patents involving sequences, the Publication Site for Issued and Published Sequences (PSIPS) provides access to sequence listings and other mega items[1].

Legal Implications and Litigation

Patent claims can be a focal point in litigation.

Infringement

Determining whether a product or process infringes on a patent involves analyzing whether it meets all the elements of at least one claim. This can be done literally or under the doctrine of equivalents[2].

Past Conduct

In some cases, past conduct related to the patent can be relevant in infringement proceedings, especially in contexts like ANDA (Abbreviated New Drug Application) proceedings[2].

Key Takeaways

• Patent Scope and Claims: Understanding the scope and claims is crucial for determining the breadth of protection.
• Patent Search: Utilize USPTO resources and international databases to ensure the invention is novel and non-obvious.
• Claim Construction: Accurate interpretation of claim language is vital for legal and technical purposes.
• Examination Process: The examination process can significantly narrow down the claims, affecting the patent's scope.
• Prior Art and Landscape: Understanding prior art and the broader landscape helps in assessing the invention's novelty.

FAQs

What is the purpose of the Global Dossier service?

The Global Dossier service provides a single portal to access the file histories of related applications from participating IP Offices, including classification, citation data, and office actions.

How do independent claim length and count affect patent scope?

Independent claim length and count are metrics that can indicate the breadth and clarity of a patent. Narrower claims at publication are associated with a higher probability of grant and a shorter examination process.

What is the Common Citation Document (CCD) application?

The CCD application consolidates citation data from participating IP Offices, enabling users to visualize the prior art cited by multiple offices on a single page.

Where can I find sequence listings for patents?

Sequence listings can be found on the Publication Site for Issued and Published Sequences (PSIPS) website.

How does the patent examination process affect the scope of patent claims?

The examination process often narrows down the claims to address examiner objections, which can affect the breadth of the patent's protection.

Sources

1. USPTO: Search for patents - USPTO.
2. Mondaq: Past Conduct Deemed Relevant To Infringement In ANDA Proceedings.
3. SSRN: Patent Claims and Patent Scope.
4. U.S. Department of Commerce: U.S. Patent and Trademark Office | U.S. Department of Commerce.

Drugs Protected by US Patent 8,013,002

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						METHOD FOR ADMINISTERING PIRFENIDONE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	AB	RX	Yes	No						ADMINISTERING PIRFENIDONE CONCURRENTLY WITH FLUVOXAMINE, THE PIRFENIDONE AT A DOSE OF ABOUT 801 MG/DAY TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	AB	RX	Yes	No						MODIFYING PIRFENIDONE ADMINISTRATION FROM A DOSE OF ABOUT 2400 MG/DAY DOWNWARD BY ABOUT 1600 MG/DAY WHILE CO-ADMINISTERING FLUVOXAMINE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-002	Jan 11, 2017		DISCN	Yes	No						ADMINISTERING PIRFENIDONE CONCURRENTLY WITH FLUVOXAMINE, THE PIRFENIDONE AT A DOSE OF ABOUT 801 MG/DAY TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-002	Jan 11, 2017		DISCN	Yes	No						MODIFYING PIRFENIDONE ADMINISTRATION FROM A DOSE OF ABOUT 2400 MG/DAY DOWNWARD BY ABOUT 1600 MG/DAY WHILE CO-ADMINISTERING FLUVOXAMINE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017	AB	RX	Yes	Yes						MODIFYING PIRFENIDONE ADMINISTRATION FROM A DOSE OF ABOUT 2400 MG/DAY DOWNWARD BY ABOUT 1600 MG/DAY WHILE CO-ADMINISTERING FLUVOXAMINE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017	AB	RX	Yes	Yes						ADMINISTERING PIRFENIDONE CONCURRENTLY WITH FLUVOXAMINE, THE PIRFENIDONE AT A DOSE OF ABOUT 801 MG/DAY TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE

International Family Members for US Patent 8,013,002

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
African Regional IP Organization (ARIPO)	3155
Austria	E526024
Australia	2010212490
Australia	2011201462
Australia	2013204032
Australia	2013204049
Australia	2013204423