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Venable LLP

Spotlight On: Biosimilar Litigations - August 2025

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Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more

Goodwin

Biosimilar Legal Decisions to Keep an Eye out for in 2019

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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

Goodwin

AbbVie and Sandoz Settle Adalimumab Biosimilar Patent Disputes

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On October 11, 2018, AbbVie and Sandoz announced that they reached a global resolution of all intellectual property-related litigation concerning Sandoz’s Hyrimoz™, a proposed biosimilar of Humira® (adalimumab). According to...more

Goodwin

Sandoz Responds to Show Cause Order in Adalimumab IPR Appeal

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As we previously reported, Sandoz appealed the PTAB’s decision not to institute an IPR regarding AbbVie’s U.S. Patent No. 9,512,216, which relates to a method for treating moderate to severe chronic plaque psoriasis using...more

Goodwin

New BPCIA Litigation: AbbVie Files Suit on Sandoz’s HUMIRA (adalimumab) biosimilar

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Today, AbbVie sued Sandoz regarding its proposed biosimilar to HUMIRA (adalimumab) in the District of New Jersey. The suit alleges infringement under the BPCIA of U.S. Patent Nos. 9,187,559 and 9,750,808. The ‘559 patent is...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

Sandoz Files Petition for IPR on Abbvie Adalimumab Patent

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Today Sandoz filed IPR2018-00002, directed to AbbVie’s U.S. Patent No. 9,512,216. According to the petition, the ’216 patent claims a subcutaneously-administered dosing regimen for the anti-TNF-a antibody adalimumab, the...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

Goodwin

Sandoz Files Two Petitions for IPR of Two AbbVie Patents Related to Humira

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Sandoz has filed a petition for inter partes review of AbbVie’s U.S. Patent No. 8,802,100 (IPR2017-01823), which claims stable formulations of an anti-TNFa antibody identified in the petition as Humira® (adalimumab). Sandoz...more

Patterson Belknap Webb & Tyler LLP

Biosimilars in Europe: 2016 Year in Review and What’s Ahead

Europe’s biosimilar market continues to develop, with biosimilars in new classes approved and pending in applications before the European Medicines Agency (EMA). 22 biosimilars are approved in eight different product classes...more

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