News & Analysis as of

Amgen v Sandoz

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

by Goodwin on

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

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

by Goodwin on

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

BPCIA Litigation Roundup (Summer 2017)

by Goodwin on

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

Amgen v. Sandoz: Pegfilgrastim Litigation Update

by Goodwin on

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

Benefits Litigation Update – Summer 2017

by Epstein Becker & Green on

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

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

by Goodwin on

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

Amgen v. Sandoz: Sandoz Requests Remand to District Court

by Goodwin on

As we have previously reported, on June 12, 2017, the Supreme Court issued a unanimous opinion in Amgen v. Sandoz holding that notice of commercial marketing may be given prior to FDA approval. The Court also held that no...more

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

BPCIA Litigation Roundup (Spring 2017)

by Goodwin on

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

Amgen v. Sandoz Jury Trial Pushed Off

by Goodwin on

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

How Will The Supreme Court Choreograph The Biosimilar Patent Dance?

by Foley & Lardner LLP on

On April 26, 2017, the Supreme Court heard oral arguments in Amgen v. Sandoz, where the parties have asked the Court to interpret two of the biosimilar patent dance provisions of the Biologics Price Competition and Innovation...more

Amgen v. Sandoz: The Supreme Court’s First Tussle with the BPCIA

by Mintz Levin on

On April 26, 2017, the U.S. Supreme Court heard oral argument in the much-anticipated Amgen v. Sandoz case, representing the first time the Court has had to grapple with the Biologics Price Competition and Innovation Act...more

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

by Goodwin on

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

Benefits Litigation Update – Spring 2017

by Epstein Becker & Green on

Welcome to the Spring edition of Benefits Litigation Update, brought to you by The ERISA Industry Committee (ERIC) and the law firm Epstein Becker & Green. As a new Congress, and a new executive branch, work on major...more

Abbvie Files Amicus Brief in Amgen V. Sandoz Supreme Court Case

by Goodwin on

On February 17, 2016, we reported that Amgen and Sandoz had both petitioned the U.S. Supreme Court for review of the Federal Circuit’s decision in Amgen v. Sandoz, each seeking to advance their respective positions on whether...more

Chemistry & Nanotechnology Developments to Watch in 2017

As cases and outcomes make their way into the news this year, we will be watching the following developments closely and sharing them with the IP community....more

SCOTUS to Weigh In on Two Biosimilar Patents, Provisions of the BPCIA in 2017

2017 is shaping up to be a big year for biosimilars and for the Biologics Price Competition and Innovation Act of 2009 (BPCIA) specifically. The Supreme Court is scheduled to hear oral arguments on April 26, 2017, that will...more

Genentech v. Amgen: Amgen Seeks Dismissal Under Amgen v. Sandoz

by Goodwin on

As we previously reported, Genentech earlier this month filed a declaratory judgment action against Amgen. In this litigation, Genentech claims that Amgen has violated the patent dance provisions of the BPCIA by disclosing...more

Upcoming Oral Arguments in BPCIA Litigation

by Goodwin on

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

BPCIA Litigation Roundup (Midwinter 2017)

by Goodwin on

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

Supreme Court Announces Briefing Schedule in Amgen v. Sandoz

by Goodwin on

The Supreme Court has ordered a briefing schedule in Amgen v. Sandoz. Because the Court granted and consolidated Sandoz’s petition and Amgen’s conditional cross-petition, the Court has adopted a four-brief schedule,...more

Supreme Court Grants Cert in BPCIA Case

On January 13, 2017, the Supreme Court granted certiorari to two related petitions brought by Amgen, Inc. and Sandoz, Inc. to resolve disputes regarding the interpretation of the Biologics Price Competition and Innovation Act...more

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