Details for Patent: 8,754,109

Which drugs does patent 8,754,109 protect, and when does it expire?

Patent 8,754,109 protects ESBRIET and is included in two NDAs.

This patent has forty patent family members in thirty countries.

Summary for Patent: 8,754,109

Title:	Pirfenidone therapy and inducers of cytochrome P450
Abstract:	The present invention relates to methods involving avoiding adverse drug interactions with pirfenidone and CYP inducers, such as smoking.
Inventor(s):	Bradford; Williamson Z. (Ross, CA), Szwarcberg; Javier (San Francisco, CA)
Assignee:	Intermune, Inc. (Brisbane, CA)
Application Number:	13/513,472
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,754,109
Patent Claim Types: see list of patent claims	Use;

Detailed Analysis of the Scope and Claims of United States Patent 8,754,109

Introduction

United States Patent 8,754,109, titled "Pirfenidone Therapy and Inducers of Cytochrome P450," is a patent that addresses specific methods and formulations related to the use of pirfenidone, a drug commonly used in the treatment of idiopathic pulmonary fibrosis (IPF). This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Background of Pirfenidone

Pirfenidone is a small molecule with anti-fibrotic and anti-inflammatory properties, approved for the treatment of IPF. The drug works by reducing fibrosis and inflammation in the lungs, thereby slowing the progression of the disease[2].

Scope of the Patent

The patent 8,754,109 focuses on methods of administering pirfenidone therapy, particularly in the context of avoiding adverse interactions with inducers of Cytochrome P450 (CYP450). CYP450 enzymes are crucial in the metabolism of many drugs, and inducers of these enzymes can significantly affect the efficacy and safety of pirfenidone.

Key Aspects

• Therapeutic Methods: The patent describes specific therapeutic regimens involving pirfenidone, taking into account the presence of CYP450 inducers. This includes adjusting the dosage or timing of pirfenidone administration to mitigate potential drug interactions[2].
• Drug Interactions: The patent highlights the importance of managing interactions between pirfenidone and substances that induce CYP450 enzymes, such as certain medications, smoking, or other environmental factors.
• Patient Safety: The methods outlined in the patent aim to ensure the safe and effective use of pirfenidone, minimizing the risk of adverse effects due to drug interactions.

Claims of the Patent

The claims of the patent are detailed and specific, covering various aspects of pirfenidone therapy:

Independent Claims

• Claim 1 typically defines the broadest scope of the invention, such as a method of administering pirfenidone to a patient who is also exposed to a CYP450 inducer.
• Subsequent claims may narrow down the scope by specifying particular dosages, administration schedules, or monitoring protocols[2].

Dependent Claims

• These claims build upon the independent claims, adding additional limitations or specifications. For example, a dependent claim might specify the type of CYP450 inducer or the method of monitoring the patient's response to the therapy.

Patent Landscape Analysis

To understand the strategic implications of this patent, it is essential to analyze the broader patent landscape.

Competitor Activity

• Other companies and research institutions may have patents related to pirfenidone or similar therapeutic areas. Analyzing these patents can reveal competitive strategies and potential areas for innovation or collaboration[3].

Technology Saturation

• A patent landscape analysis can show whether the technology area related to pirfenidone and CYP450 interactions is highly saturated. High saturation might indicate a mature technology area, suggesting the need to pivot to newer inventive spaces[3].

Global Patent Family

• The patent 8,754,109 may be part of a larger global patent family, with corresponding patents in other jurisdictions. Tools like the Global Dossier and PATENTSCOPE can help identify related applications and patents worldwide[4].

Strategic Insights

A comprehensive patent landscape analysis can provide several strategic insights:

Identifying Gaps

• By mapping the patent portfolio of competitors and identifying gaps, companies can focus their R&D efforts on unexplored areas, reducing the risk of infringement and increasing the potential for innovation[3].

Monitoring Competitor Activity

• Tracking the patent filings and grants of competitors can help in anticipating market moves and adjusting business strategies accordingly.

Licensing and Collaboration

• Understanding the patent landscape can facilitate licensing agreements or collaborations, allowing companies to leverage each other's intellectual property to advance their technologies.

Tools and Resources for Patent Searching

Several tools and resources are available for conducting a thorough patent search and landscape analysis:

USPTO Resources

• The USPTO's Patent Public Search tool and the Global Dossier service are invaluable for searching U.S. and international patents, respectively[4].

International Databases

• Databases such as esp@cenet from the European Patent Office, PATENTSCOPE from WIPO, and others provide access to global patent collections and machine translations, which can be crucial for a comprehensive analysis[4].

Training and Assistance

• The USPTO's Patent and Trademark Resource Centers (PTRCs) and the Public Search Facility offer training and assistance in patent search techniques, which can be beneficial for both beginners and experienced researchers[4].

Key Takeaways

• Specific Therapeutic Methods: The patent 8,754,109 outlines specific methods for administering pirfenidone in the presence of CYP450 inducers, ensuring safe and effective therapy.
• Comprehensive Patent Landscape: Analyzing the broader patent landscape helps in identifying competitive strategies, technology saturation, and potential areas for innovation.
• Global Implications: Understanding the global patent family and using tools like Global Dossier and PATENTSCOPE can provide a holistic view of the intellectual property landscape.
• Strategic Decision-Making: A thorough patent landscape analysis is crucial for making informed long-term decisions about R&D and business strategies.

FAQs

Q: What is the main focus of United States Patent 8,754,109? A: The main focus is on methods of administering pirfenidone therapy while avoiding adverse interactions with inducers of Cytochrome P450.

Q: Why is it important to manage interactions between pirfenidone and CYP450 inducers? A: Managing these interactions is crucial to ensure the safe and effective use of pirfenidone, minimizing the risk of adverse effects.

Q: What tools can be used for conducting a comprehensive patent landscape analysis? A: Tools such as the USPTO's Patent Public Search, Global Dossier, PATENTSCOPE, and other international databases are essential for a thorough analysis.

Q: How can a patent landscape analysis help in strategic decision-making? A: It helps in identifying gaps in the technology area, monitoring competitor activity, and making informed decisions about R&D and business strategies.

Q: Where can one find training and assistance for patent search techniques? A: The USPTO's Patent and Trademark Resource Centers (PTRCs) and the Public Search Facility offer training and assistance in patent search techniques.

Sources

1. Clemson University Libraries - Research and Course Guides: Patent Searching, Advanced[1].
2. United States District Court for the District - Case 1:19-cv-00111-UNA Document 1 Filed 01/18/19[2].
3. AcclaimIP - Patent Landscape Analysis - Uncovering Strategic Insights[3].
4. United States Patent and Trademark Office - Search for patents[4].

Drugs Protected by US Patent 8,754,109

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 AVOID REDUCED EFFICACY BY AVOIDING SMOKING OR BY AVOIDING ANOTHER STRONG CYP1A2 INDUCER
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	AB	RX	Yes	No						ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT ADMINISTRATION OF A STRONG INDUCER OF CYP1A2, INCLUDING CIGARETTE SMOKE, TO AVOID REDUCED PIRFENIDONE EFFICACY
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-002	Jan 11, 2017		DISCN	Yes	No						ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT ADMINISTRATION OF A STRONG INDUCER OF CYP1A2, INCLUDING CIGARETTE SMOKE, TO AVOID REDUCED PIRFENIDONE EFFICACY
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017	AB	RX	Yes	Yes						ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT ADMINISTRATION OF A STRONG INDUCER OF CYP1A2, INCLUDING CIGARETTE SMOKE, TO AVOID REDUCED PIRFENIDONE EFFICACY

Foreign Priority and PCT Information for Patent: 8,754,109

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	10250378	Mar 3, 2010
Canada	2710014	Oct 8, 2010

PCT Information
PCT Filed	December 03, 2010	PCT Application Number:	PCT/US2010/058936
PCT Publication Date:	June 09, 2011	PCT Publication Number:	WO2011/069089

International Family Members for US Patent 8,754,109

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E523197
Australia	2010212488
Brazil	112012013155
Canada	2710014
Chile	2012000952
Cyprus	1112075
Denmark	2308491