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Amgen Sandoz

Venable LLP

Amgen and Sandoz Settle Prolia® / Xgeva® Biosimilar Litigation

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Amgen and Sandoz reached a settlement in Case No. 1:23-cv-02406 (D.N.J.) on April 29 just hours before a New Jersey District Court Judge (Christine O’Hearn) was scheduled to announce her ruling on Amgen’s preliminary...more

Morgan Lewis

Blockbuster Biologics Review | Issue 21

Morgan Lewis on

Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more

Robins Kaplan LLP

Amgen Inc. v. Sandoz Inc. Otezla® (Apremilast)

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Case Name: Amgen Inc. v. Sandoz Inc., Nos. 2022-1147, 2022-1149, 2022-1150, 2022-1151, 2023 WL 2994166 (Fed. Cir. Apr. 19, 2023) (Circuit Judges Lourie, Cunningham, and Stark presiding; Opinion by Lourie, J.) (Appeal from...more

Goodwin

HUMIRA (adalimumab) Biosimilar Launches

Goodwin on

​​​​​​​In the last week, seven adalimumab biosimilars referencing HUMIRA entered the U.S. market:  Boehringer Ingelheim’s CYLTEZO (adalimumab-adbm); Sandoz’s HYRIMOZ (adalimumab-adaz); Organon and Samsung Bioepis’s HADLIMA...more

Goodwin

Amgen Files BPCIA Complaint Against Sandoz Regarding Denosumab

Goodwin on

On May 1, 2023, Amgen filed a BPCIA complaint in the District of New Jersey against Sandoz related to Sandoz’s denosumab biosimilar of Amgen’s PROLIA® and XGEVA®. This is Amgen’s first BPCIA case filed with respect to a...more

Smart & Biggar

Supreme Court of Canada denies Amgen leave to appeal decision invalidating its filgrastim patent

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As previously reported, Amgen sought leave to appeal a decision of the Federal Court of Appeal (2020 FCA 188) affirming Justice Southcott’s decision that the relevant claims of its filgrastim (NEUPOGEN) patent were invalid...more

Fish & Richardson

Biosimilars 2020 Year in Review

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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

Kramer Levin Naftalis & Frankel LLP

US Biosimilar Market Expands As BPCIA Turns 10

The 10th anniversary of the U.S. biosimilar pathway the Biologics Price Competition and Innovation Act of 2009 (BPCIA) is quickly approaching and marks an expansion of the U.S. biosimilar market. The BPCIA, signed into law...more

Fish & Richardson

Biosimilars - 2019 Year in Review

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Introduction - In many ways, 2019 was a notable year for biosimilars in the U.S. FDA approved the 26th biosimilar product and the 13th biosimilar product was launched in the U.S. market. These developments were...more

Goodwin

Another Biosimilar Litigation Settlement: Amgen v. Tanvex (Filgrastim)

Goodwin on

Following last month’s dismissal of the Amgen v. Kashiv filgrastim biosimilar litigation, yesterday Amgen and Tanvex filed a joint stipulation of dismissal in their BPCIA litigation concerning Tanvex’s filgrastim biosimilar...more

Fish & Richardson

The Doctrine of Equivalents in BPCIA Litigation

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As of the end of 2019, reference product sponsors (“RPSs”) have filed dozens of patent infringement cases against biosimilar manufacturers under the Biologics Price Competition and Innovation Act (“BPCIA”). The doctrine of...more

Patterson Belknap Webb & Tyler LLP

2019 Year-End Biosimilar Litigation Roundup

As 2019 draws to a close, a handful of actions regarding biologics are pending in the federal courts. The current cases are listed below, in order from most-recently-filed to oldest....more

Goodwin

Amgen and Kashiv Ask District Court to Dismiss Their Filgrastim Biosimilar Litigation

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On November 22, 2019, the parties in the Amgen v. Kashiv BPCIA litigation, concerning Kashiv’s proposed biosimilar of NEUPOGEN (filgrastim), submitted a stipulation of dismissal indicating that they have “agree[d] to the...more

McDermott Will & Emery

Rare but Not Exceptional: Doctrine of Equivalents Does Not Require Exceptional Case

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On petition for panel rehearing, the US Court of Appeals for the Federal Circuit stripped the phrase “applies only in exceptional cases and” from its previous opinion, but otherwise denied the petition. Amgen, Inc. v. Sandoz...more

Smart & Biggar

Amended PMNOC Regulations: Second Anniversary Update

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September 21, 2019 was the second anniversary of the coming into force of the amended Patented Medicines (Notice of Compliance) Regulations (Regulations) heralding significant changes to the landscape for pharmaceutical...more

McDermott Will & Emery

Maintaining Order in Process Claims

The US Court of Appeals for the Federal Circuit affirmed a summary judgment non-infringement ruling, finding that where both the claim language and the specification require that the disclosed steps be performed in the order...more

Locke Lord LLP

Federal Circuit Affirms Noninfringement in BPCIA Case

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On May 8, 2019, the Federal Circuit issued a precedential opinion affirming a district court’s finding of noninfringement in an action brought under the Biologics Price Competition and Innovation Act (“BPCIA”). Amgen Inc. et...more

Dechert LLP

Federal Circuit Panel Describes the Doctrine of Equivalents as Applying “Only in Exceptional Cases”

Dechert LLP on

In a patent owner’s declaratory judgment action under the Biologics Price Competition and Innovation Act (“BPCIA”) a Federal Circuit panel in Amgen Inc. v. Sandoz Inc., Appeal No. 2018-1551 (Fed. Cir. May 8, 2019) narrowly...more

Goodwin

Sandoz Initiates Declaratory Judgment Action Against Amgen Concerning Manufacturing of Filgrastim and Pegfilgrastim Biosimilars

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On February 21, 2019, Sandoz initiated a lawsuit against Amgen in the Northern District of California seeking a declaration that its biosimilar filgrastim and pegfilgrastim products do not infringe the Amgen’s ’997 patent. ...more

Fish & Richardson

Discovery Disputes Related to Manufacturing in BPCIA Litigation

Fish & Richardson on

Many reference product sponsors (“RPSs”) of biologic products have sought extensive patent protection for their manufacturing processes, and RPSs commonly assert those patents against biosimilar manufacturers in Biologics...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

Biosimilar Pipeline Developments: Rituximab, Adalimumab, Eculizumab, Infliximab, Pegfilgrastim

Goodwin on

Below are some recent updates regarding biosimilar pipelines from around the globe. On November 2, 2018, Sandoz announced that it has decided “not [to] pursue its submission for biosimilar rituximab in the US at this time...more

Goodwin

Amgen, Sandoz, Samsung, and Mylan Launch Biosimilars in Europe (UPDATED)

Goodwin on

Amgen, Sandoz, Samsung and Mylan all launched adalimumab biosimilars in Europe this past October. On October 16, 2018, Amgen has announced that its adalimumab biosimilar AMGEVITA launched in European markets....more

Goodwin

Amgen and Sandoz Launch Biosimilars in Europe

Goodwin on

Amgen has announced that its adalimumab biosimilar AMGEVITA launched yesterday in European markets. This is Amgen’s first “inflammation” biosimilar to launch in Europe, and its second biosimilar to launch in Europe overall. ...more

Patterson Belknap Webb & Tyler LLP

FDA Approves Pfizer’s Biosimilar of Neupogen® as Amgen and Pfizer Litigate Patent Infringement

On July 20, 2018, FDA approved Pfizer’s biosimilar of Amgen’s Neupogen® (filgrastim). Pfizer’s product, Nivestym™, is the second biosimilar of Neupogen to be approved after Sandoz’s Zarxio®, the first approved biosimilar in...more

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