Details for Patent: 8,609,701

Which drugs does patent 8,609,701 protect, and when does it expire?

Patent 8,609,701 protects ESBRIET and is included in two NDAs.

This patent has sixty-four patent family members in thirty-nine countries.

Summary for Patent: 8,609,701

Title:	Pirfenidone treatment for patients with atypical liver function
Abstract:	Methods are provided for administering pirfenidone to a patient that has exhibited abnormal biomarkers of liver function in response to pirfenidone administration. The methods include administering to a patient pirfenidone at doses lower than the full target dosage for a time period, followed by administering to the patient pirfenidone at the full target dosage. The methods also include administering pirfenidone at the full target dose with no reduction and administering permanently reduced doses of pirfenidone.
Inventor(s):	Bradford; Williamson Ziegler (Ross, CA), Szwarcberg; Javier (San Francisco, CA)
Assignee:	Intermune, Inc. (Brisbane, CA)
Application Number:	13/128,569
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,609,701
Patent Claim Types: see list of patent claims	Use;

United States Patent 8,609,701: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 8,609,701, titled "Pirfenidone Treatment for Patients with Atypical Liver Function," is a significant patent in the pharmaceutical industry, particularly in the treatment of idiopathic pulmonary fibrosis (IPF). This patent is part of a broader set of patents held by Genentech related to the use and administration of pirfenidone.

Background of Pirfenidone

Pirfenidone, marketed as Esbriet®, was first studied as an investigational new drug in 1973. It was approved in Japan in 2008 and later in the United States in 2014 for the treatment of IPF[1][4].

Patent Overview

Patent Title and Number

• Patent Title: Pirfenidone Treatment for Patients with Atypical Liver Function
• Patent Number: 8,609,701
• Issue Date: December 17, 2013[2][4].

Claims of the Patent

The patent claims methods for managing certain side effects associated with pirfenidone administration, specifically focusing on liver function.

Liver Function Test (LFT) Patents

The LFT patents, including the '701 patent, describe methods for administering pirfenidone to patients who have exhibited abnormal biomarkers of liver function. These claims include various strategies for adjusting the dose of pirfenidone in response to liver function abnormalities:

• Temporarily reducing the dose of pirfenidone and then returning to the full dose.
• Maintaining the full dose of pirfenidone.
• Reducing the dose of pirfenidone.
• Discontinuing pirfenidone for a week and then returning to the full dose or a reduced dose[4].

Specific Claims

• Claim 9 of the '729 patent (similar in scope to claims in the '701 patent): This claim involves administering pirfenidone at doses lower than 2400 mg/day for a time period, followed by administering pirfenidone at doses of 2400 mg/day or 2403 mg/day, where the biomarkers of liver function include alanine transaminase and aspartate transaminase[4].

Patent Landscape

Related Patents

The '701 patent is part of a suite of patents related to pirfenidone treatment, including:

• U.S. Patent 7,566,729 (’729 patent)
• U.S. Patent 7,635,707 (’707 patent)
• U.S. Patent 8,592,462 (’462 patent)
• U.S. Patent 8,013,002 (’002 patent)
• U.S. Patent 7,816,383 (’383 patent)[2][4].

Litigation and Legal Challenges

Genentech asserted these patents in a Hatch-Waxman suit against Sandoz, which had submitted Abbreviated New Drug Applications (ANDAs) for a generic version of pirfenidone. The litigation centered on whether Sandoz’s generic product would induce infringement of Genentech’s LFT and Drug-Drug Interaction (DDI) patents[1][4].

District Court and Federal Circuit Decisions

• The District Court found the LFT claims unpatentable for obviousness, citing prior art such as the Azuma reference and the PIRESPA label. The Federal Circuit affirmed this decision, stating that the claims did not represent a novel application of an existing drug but rather routine clinical practices[1][4].

Impact on Generic Drug Approval

The decision has significant implications for generic drug manufacturers. Sandoz’s ability to market a generic version of pirfenidone was contingent on the outcome of this litigation. The Federal Circuit’s ruling that the LFT patents were obvious and thus unpatentable cleared a major hurdle for Sandoz to proceed with its ANDA approval[1][4].

Economic and Market Implications

The patent landscape around pirfenidone is crucial for both the original drug manufacturer, Genentech, and generic manufacturers like Sandoz. The approval of generic versions can significantly impact the market share and pricing of the original drug. For patients, generic alternatives can provide more affordable treatment options for IPF[4].

Conclusion

The United States Patent 8,609,701 is a critical component of the intellectual property strategy surrounding pirfenidone. The patent's claims and the legal challenges associated with it highlight the complexities of pharmaceutical patent law and the ongoing battles between innovator companies and generic manufacturers.

Key Takeaways

• Patent Scope: The '701 patent covers methods for managing liver function side effects during pirfenidone treatment.
• Litigation: Genentech’s assertion of this patent in a Hatch-Waxman suit against Sandoz was central to determining the legality of Sandoz’s generic product.
• Legal Outcome: The Federal Circuit ruled that the LFT claims were obvious and thus unpatentable.
• Market Impact: The decision facilitates the entry of generic versions of pirfenidone into the market, potentially affecting pricing and market share.

FAQs

What is the primary focus of the United States Patent 8,609,701?

The primary focus of the patent is on methods for managing liver function side effects during the administration of pirfenidone for treating idiopathic pulmonary fibrosis (IPF).

Which company holds the patent, and what is the drug in question?

Genentech holds the patent, and the drug in question is pirfenidone, marketed as Esbriet®.

What was the outcome of the litigation involving this patent?

The Federal Circuit ruled that the Liver Function Test (LFT) claims of the patent were obvious and thus unpatentable, allowing Sandoz to proceed with its generic version of pirfenidone.

How does this patent impact generic drug manufacturers?

The patent's invalidation clears a significant hurdle for generic manufacturers like Sandoz to market their versions of pirfenidone, potentially increasing competition and reducing prices.

What are the implications for patients with IPF?

The approval of generic versions of pirfenidone can provide patients with more affordable treatment options for IPF.

Sources

1. PCK IP: Past Conduct Deemed Relevant to Infringement in ANDA Proceedings[1].
2. Insight.RPXCorp: IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT[2].
3. USPTO: Patent Claims Research Dataset[3].
4. CAFC: GENENTECH, INC. v. SANDOZ INC.[4].

Drugs Protected by US Patent 8,609,701

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	8,609,701					CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN USE OF PIRFENIDONE
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	AB	RX	Yes	No	8,609,701					FULL DAILY DOSING FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	AB	RX	Yes	No	8,609,701					DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING A SUB-1600 MG/DAY DOSE, FOLLOWED BY ADMINISTERING AT LEAST 1602 MG/DAY
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	AB	RX	Yes	No	8,609,701					DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400 MG/DAY DOSE, FOLLOWED BY FULL DAILY DOSE
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	AB	RX	Yes	No	8,609,701					DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE, FOLLOWED BY ADMINISTERING AT LEAST 1602 MG/DAY
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	AB	RX	Yes	No	8,609,701					DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, FOLLOWED BY FULL DAILY DOSE
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	AB	RX	Yes	No	8,609,701					DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, THEN SUB-1600 MG/DAY, THEN AT LEAST 1602 MG/DAY

Foreign Priority and PCT Information for Patent: 8,609,701

PCT Information
PCT Filed	November 09, 2009	PCT Application Number:	PCT/US2009/063702
PCT Publication Date:	May 14, 2010	PCT Publication Number:	WO2010/054294

International Family Members for US Patent 8,609,701

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E503480
Australia	2009313302
Australia	2010212371
Australia	2011200385
Australia	2012205256
Brazil	PI0921022
Canada	2709997