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Inter Partes Review (IPR) Proceeding Pfizer

Venable LLP

Federal Circuit Affirms PTAB’s Unpatentability Findings in Gene Therapy Hemgenix® IPRs

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On May 22, 2025, the CAFC affirmed the PTAB’s (Board) Final Written Decisions in Pfizer’s IPR2021-00925 and IPR2021-00926 finding all challenged claims of uniQure’s U.S. Patent No. 9,982,248 (“the ’248 patent”) unpatentable...more

Knobbe Martens

Routine Optimization of Result-Effective Variable Can Bridge Gaps in Prior Art

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PFIZER INC. v. SANOFI PASTEUR INC. - Before Lourie, Bryson, and Stark.  Appeal from the Patent Trial and Appeal Board....more

McDermott Will & Emery

Optimizing Obviousness: Routine Optimization Can Fill in Prior Art Gaps

McDermott Will & Emery on

In an appeal from a Patent Trial & Appeal Board finding of invalidity, the US Court of Appeals for the Federal Circuit held that the result-effective variable doctrine can apply even when there is no overlap between a claimed...more

McDonnell Boehnen Hulbert & Berghoff LLP

Pfizer Inc. v. Sanofi Pasteur Inc. (Fed. Cir. 2024)

Last week, the Federal Circuit handed down its opinion in Pfizer Inc. v. Sanofi Pasteur Inc., affirming the Patent Trial and Appeal Board's (PTAB) determination that all claims of U.S. Patent No. 9,492,559 challenged in...more

Jones Day

PTAB Declines To Enter Adverse Judgment Against Pre-Institution Disclaimed Claims

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Although the Federal Circuit had previously held that the PTAB may enter adverse judgment when a patent owner disclaims all claims challenged in an inter partes review (“IPR”) petition before an institution decision, in...more

McDonnell Boehnen Hulbert & Berghoff LLP

Pfizer Inc. v. Chugai Pharmaceuticals Co. (Fed. Cir. 2020)

The Federal Circuit continued its explication of the standing issue for unsuccessful petitioners in inter partes review (see "Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corp. (Fed. Cir. 2020)") in Pfizer Inc. v....more

Goodwin

Federal Circuit Finds Pfizer’s RUXIENCE Plans Insufficient to Establish Standing to Appeal IPR

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On April 27, 2020, the Federal Circuit issued a non-precedential opinion ruling that Pfizer failed to establish Article III standing in a pair of IPR appeals.  At the PTAB, Pfizer had challenged the validity of Chugai’s...more

Herbert Smith Freehills Kramer

Biosimilar Litigation Trends and Lessons Learned in 2019

It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more

Goodwin

Biosimilar Appellate Roundup: Upcoming Oral Arguments and Decisions

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On December 6, 2019, the Federal Circuit will hear oral argument in a rituximab-related appeal by Biogen.  The appeal stems from a final written decision of the Patent Trial and Appeal Board (PTAB) in an inter partes review...more

Goodwin

Biosimilar IPR Appeal Updates

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Following the Celltrion and Pfizer settlements of the trastuzumab litigation, the Federal Circuit granted the request of the Director of the PTO to intervene under 35 U.S.C. § 143 (i.e., defend a PTAB decision when a...more

Goodwin

Year in Review: Top Five Biosimilar Legal Developments of 2018

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Here are our picks for the top five most significant legal developments of 2018 that may impact the biosimilar industry: 1. New Law Requiring FTC/DOJ Review Of Biosimilar Patent Litigation Settlements - With the...more

Goodwin

United States Intervenes in Genentech Constitutional Challenge

Goodwin on

We have covered Pfizer’s development of biosimilars of Genentech’s Avastin® (bevacizumab) and Herceptin® (trastuzumab) and its related IPR filings IPR2016-01771 and IPR2016-01837. Following written decisions invalidating...more

Goodwin

Hoffman-La Roche Disclaims Patent Claims in Response to IPR

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As we previously reported, Pfizer filed a petition for IPR of certain claims of Hoffman-La Roche’s U.S. Patent No. 8,314,225 (IPR2018-01219). According to the petition, the challenged claims “purport to claim nucleic acid...more

Goodwin

Biosimilar-Related Appeals Pending before the Federal Circuit

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There are presently seven biosimilar-related appeals pending before the Federal Circuit. Two of those appeals, Amgen v. Sandoz (Case No. 18-1551) and Amgen v. Coherus (Case No. 18-1993), are from district court judgments in...more

Goodwin

Rituximab and Adalimumab IPR Updates

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On November 11, 2017, Pfizer, Inc. filed a petition for inter partes review (IPR) of Biogen and Genentech’s US Patent No. 8,545,843, which relates to a method of treating vasculitis with rituximab. (IPR2018-00086.) On May 31,...more

Goodwin

Trastuzumab IPR Updates

Goodwin on

Last month, the PTAB issued decisions on two petitions, IPR2017-02063 and IPR2018-00016, filed by Pfizer against one of Genentech’s Herceptin® (trastuzumab) patents, U.S. Patent No. 7,846,441 (“the ‘441 patent”). The ‘441...more

Goodwin

IPR Updates

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Below are IPR updates from this week. LANTUS - On December 13, 2017, the Board instituted two IPRs on Mylan’s petitions (IPR2017-01526 and IPR2017-01528) challenging Sanofi’s U.S. Patent Nos. 7,713,930 and 7,476,652,...more

Goodwin

IPR Updates

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Below are recent updates in biosimilar-related IPR proceedings: GENERAL BIOLOGICS PATENTS - On December 1, 2017, the Board granted institution of four IPRs on Celltrion’s petitions (IPR2017-01373 and IPR2017-01374) and...more

Fish & Richardson

The Herceptin® Battle Moves into the District Court

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On November 17, 2017, Genentech filed suit against Pfizer in the District of Delaware, alleging that Pfizer’s biosimilar of Herceptin® infringes forty Genentech patents covering Herceptin® and its methods of use and...more

Goodwin

IPR Updates

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Here are some updates since our last IPR update: HUMIRA - On November 6, 2017, Sandoz filed an IPR Petition challenging AbbVie’s U.S. Patent No. 9,187,559 (IPR2018-00156). ...more

McDonnell Boehnen Hulbert & Berghoff LLP

PTAB Life Sciences Report - October 2017

About the PTAB Life Sciences Report:  Each month we will report on developments at the PTAB involving life sciences patents. Sun Pharmaceuticals Industries, Ltd. v. Novartis AG - PTAB Petition: IPR2017-01929; filed...more

Goodwin

Recent IPR Updates

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The PTAB has been a busy place for biologics patents in the past few weeks. Here are some of the highlights...more

Knobbe Martens

Hospira Finds Mixed Results in Instituting IPRs Against Genentech Patents for Herceptin®

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Hospira (owned by Pfizer) filed five IPR petitions against Genentech patents that Genentech asserted were directed to Herpceptin® (trastuzumab). The PTAB has now instituted IPRs in three of the five petitions and denied the...more

Jones Day

Genentech to Defend 3 of 4 Herceptin® Patents Challenged by Hospira

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At least 19 IPRs have been filed against seven of Genentech’s patents covering its blockbuster antibody drug Herceptin® (trastuzumab). On July 27, 2017, the PTAB instituted IPRs filed by Hospira, Inc. (a subsidiary of Pfizer)...more

Fish & Richardson

Pfizer Takes Aim at Herceptin® Patent at the PTAB

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Pfizer has shown its muscle in the biosimilars field, purchasing Hospira in 2015 and launching the second biosimilar on the U.S. market, Inflectra® (infliximab), a biosimilar of Johnson & Johnson’s Remicade®. Pfizer is now...more

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