News & Analysis as of

Pharmaceutical Patents Patent Trial and Appeal Board Sandoz

Venable LLP

Spotlight On: Neulasta® (pegfilgrastim) / Fulphila® (pegfilgrastim-jmdb) / Udenyca® (pegfilgrastim-cbqv) / Ziextenzo®...

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Pegfilgrastim Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Venable LLP

Spotlight On: Enbrel® (etanercept) / Erelzi® (etanercept-szzs) / Eticovo® (etanercept-ykro) - August 2025

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Etanercept Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Jones Day

PTAB Rejects Double-Dose of Prior Art

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In Sandoz Inc. v. Acerta Pharma B.V. (IPR2023-00478), a Patent Trial and Appeal Board (“PTAB”) panel denied IPR institution where the asserted prior art was cumulative of that considered during prosecution. This denial...more

Fish & Richardson

Biosimilars 2020 Year in Review

Fish & Richardson on

Introduction - The biosimilar pathway was designed to increase competition for biologics and reduce healthcare costs. Yet 2020 saw a slowdown in biosimilar activity with the lowest number of annual biosimilar approvals since...more

Goodwin

Biosimilar Legal Decisions to Keep an Eye out for in 2019

Goodwin on

Here are our picks of some legal developments to keep an eye out for in the new year: 1. Etanercept biosimilar trial decision – This past September, in the Immunex v. Sandoz BPCIA patent litigation concerning Sandoz’s...more

Knobbe Martens

Federal Circuit Review - November 2018

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Federal Circuit Finds Claims Directed to Tabbed Spreadsheets Patent Eligible and Claims Directed to Tracking Changes in Documents Ineligible Under Section 101 - In Data Engine Technologies LLC v. Google LLC, Appeal No....more

Jones Day

Post-Priority Document Usable As Evidence of POSITA Motivation

Jones Day on

The Federal Circuit recently affirmed the Patent Trial and Appeal Board’s (“PTAB”) final written decisions finding the claims of Yeda Research and Development Co., Ltd.’s (“Yeda”) U.S. Patent Nos. 8,232,250, 8,399,413, and...more

Knobbe Martens

Yeda Research And Development Co., Ltd. v. Mylan Pharmaceuticals Inc. & Teva Pharmaceuticals USA, Inc. v. Sandoz Inc.

Knobbe Martens on

Federal Circuit Summary - Before Judges Reyna, Bryson, and Stoll. Appeals from the Patent Trial and Appeal Board and the United States District Court for the District of Delaware. Summary: Non-prior art evidence may...more

Polsinelli

Biosimilars: Strategic Considerations for 2018

Polsinelli on

2017 was an eventful year for biosimilars in the U.S. As the number of biosimilar filings increased, important legal and regulatory decisions changed the strategic landscape of the biosimilars market for both innovators and...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

Patterson Belknap Webb & Tyler LLP

Update on Enbrel Biosimilar and Related US Litigation

Amgen’s Enbrel (etanercept), a blockbuster biologic treatment for a number of autoimmune diseases, including rheumatoid arthritis and psoriasis, has been an attractive target for biosimilar makers. Sandoz, the maker of...more

Foley & Lardner LLP

Amgen Launches Enbrel Biosimilar Patent Litigation

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Although Sandoz’ application for FDA approval to market a biosimilar version of ENBREL® (etanercept) has yet to be approved, Amgen has brought suit under the Patent Act and Biologics Price Competition and Innovation Act...more

Mintz - Intellectual Property Viewpoints

Petitioners Must Present Sufficient Evidence to Establish Inherency

Last Friday the Patent Trial and Appeal Board (PTAB) denied four Sandoz Inc. petitions for instituting inter partes review (IPR) of U.S. 8,455,524 (IPR2015-00005), U.S. 7,612,102 (IPR2015-00006), U.S. 7,659,290...more

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