News & Analysis as of

Inter Partes Review (IPR) Proceeding Pfizer Patent Trial and Appeal Board

Venable LLP

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

Venable LLP on

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

Knobbe Martens on

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

Jones Day on

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

Goodwin on

On April 27, 2020, the Federal Circuit issued a non-precedential opinion ruling that Pfizer failed to establish Article III standing in a pair of IPR appeals.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-Related Appeals Pending before the Federal Circuit

Goodwin on

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

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

Fish & Richardson

The Herceptin® Battle Moves into the District Court

Fish & Richardson on

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

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

Goodwin on

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

Jones Day

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

Jones Day on

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

Fish & Richardson on

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

Knobbe Martens

PTAB Institutes Two IPRs in Hospira v. Genentech Avastin Dispute

Knobbe Martens on

Bevacizumab (Avastin®) is the subject of the widely watched “patent dance” dispute between Genentech and Amgen regarding Amgen’s proposed biosimilar. Hospira, however, (now owned by Pfizer) has chosen a different path in...more

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