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Patent Litigation Amgen v 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

McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court Grants Certiorari in Amgen v. Sanofi: High Court Will Tackle Proper Enablement Standard

The Supreme Court on Friday, Nov. 3, granted Amgen’s petition for certiorari on the second of the Questions Presented in its petition...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

Sandoz Files Responsive Brief in Amgen v. Sandoz Appeal

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As we previously reported, the district court granted Sandoz’s motion for summary judgment of non-infringement in the ongoing Amgen v. Sandoz litigation, which relates to Sandoz’s filgrastim and pegfilgrastim biosimilars....more

Goodwin

Filgrastim, pegfilgrastim biosimilar litigation updates

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Below is a rundown of some recent developments in BPCIA litigations concerning biosimilars of Neupogen® (filgrastim) and/or Neulasta® (pegfilgrastim). Amgen v. Adello (filgrastim) - As we previously reported, in March,...more

Goodwin

Filgrastim and Pegfilgrastim Litigation Updates

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Over the past several weeks, there have been numerous developments in U.S. patent litigation activity relating to biosimilars of Neupogen® (filgrastim) and Neulasta® (pegfilgrastim). Below is a summary of these developments....more

Goodwin

Breaking News: Summary Judgment of Non-Infringement for Sandoz in Filgrastim/Pegfilgrastim Case

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As we previously reported, in Amgen v. Sandoz, which relates to both Sandoz’s filgrastim biosimilar (Zarxio) and its pegfilgrastim biosimilar, Sandoz had filed motions for summary judgment regarding non-infringement of...more

McDonnell Boehnen Hulbert & Berghoff LLP

Amgen Inc. v. Sandoz Inc. (Fed. Cir. 2017) -- One Last Dance . . .

Last June, in Sandoz Inc. v. Amgen Inc., the Supreme Court handed down its interpretation of the Biologics Price Competition and Innovation Act ("BPCIA") for the approval of biosimilar drugs. As we reported at the time, the...more

Goodwin

Analysis of Amgen v. Sandoz Federal Circuit Opinion

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The Federal Circuit Court of Appeals issued its long-awaited decision in the remand of Amgen v. Sandoz from the U.S. Supreme Court. In that decision, the Federal Circuit held that Amgen’s state law claims, based on the...more

Goodwin

BPCIA Litigation Roundup (Fall 2017)

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Below is our fall update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates (Summer...more

Goodwin

Updates on Sandoz’s Pegfilgrastim Biosimilar / Amgen v. Sandoz

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Today, Sandoz announced that its biosimilar of Neulasta® (pegfilgrastim) has been accepted by the European Medicines Agency (EMA) for regulatory review. According to the press release, the data package submitted as part of...more

Goodwin

U.S. Argues Amgen’s State Law Claim Preempted by BPCIA, Supporting Sandoz

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Yesterday, in the remanded appeal in Amgen v. Sandoz, the United States submitted an amicus brief to the Federal Circuit that generally supports Sandoz’s position that Amgen’s state-law claim for an injunction under...more

Goodwin

BPCIA Litigation Roundup (Summer 2017)

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Below is our summer update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates...more

Goodwin

Amgen v. Sandoz: Pegfilgrastim Litigation Update

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On July 17, 2017, in the ongoing Amgen v. Sandoz litigation regarding Sandoz’s proposed biosimilar of Neulasta® (pegfilgrastim), the magistrate judge ordered, among other things, that Amgen is entitled to discovery from...more

Epstein Becker & Green

Benefits Litigation Update – Summer 2017

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Welcome to the Summer edition of Benefits Litigation Update, brought to you by The ERISA Industry Committee (ERIC) and the law firm Epstein Becker & Green. With a new Administration and executive branch, we are already...more

Goodwin

Amgen v. Sandoz: Federal Circuit Vacates Opinion and Mandate, Reinstates Appeal, Orders Further Briefing on Remanded Issues

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As we previously reported, following the Supreme Court’s decision in Sandoz v. Amgen, Sandoz requested a remand to the District Court to answer the two questions that the Supreme Court had remanded to the Federal Circuit,...more

Patterson Belknap Webb & Tyler LLP

Supreme Court Decides Amgen v. Sandoz: Patent Dance Cannot Be Enforced by Federal Injunction, Notice of Commercial Marketing Can...

On June 12, 2017, the Supreme Court decided Amgen v. Sandoz, the landmark case about the meaning of the Biologics Price Competition and Innovation Act (BPCIA). First, the Supreme Court held that no federal injunction is...more

Goodwin

BPCIA Litigation Roundup (Spring 2017)

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Below is our spring update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates...more

Goodwin

Amgen v. Sandoz Jury Trial Pushed Off

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A Stipulation and Scheduling Order for Trial (Order) entered on May 19, 2017 in the Amgen v. Sandoz litigation rescheduled trial for March 26, 2018 (from December 18, 2017), and pushed back other pre-trial deadlines....more

Goodwin

Reminder: Supreme Court Arguments on April 26th in Amgen v. Sandoz

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As a reminder to our readers, tomorrow the Supreme Court will hear oral arguments in Amgen v. Sandoz regarding the following questions: ..Whether a biosimilar applicant is required by 42 U.S.C. § 262(l)(2)(A) to provide...more

Goodwin

Upcoming Oral Arguments in BPCIA Litigation

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On Friday, the United States Supreme Court set oral arguments in Amgen v. Sandoz for April 26, 2017. Today, the United States Court of Appeals for the Federal Circuit announced that oral arguments in Amgen v. Hospira...more

Goodwin

BPCIA Litigation Roundup (Midwinter 2017)

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Below is our midwinter update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates...more

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