News & Analysis as of September 19, 2024

Supreme Court of the United States › Amgen v Sandoz

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The United States Supreme Court is the highest court of the United States and is charged with interpreting federal law, including the United States Constitution. The Court's docket is largely discretionary with only a limited number of cases granted review each term. The Court is comprised of one chief justice and eight associate justices, who are nominated by the President and confirmed by the Senate to hold lifetime positions. less -

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

McDonnell Boehnen Hulbert & Berghoff LLP on 11/9/2022

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

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

McDonnell Boehnen Hulbert & Berghoff LLP on 12/18/2017

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

Amgen v. Sandoz: Sandoz Requests Remand to District Court

Goodwin on 7/3/2017

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...

Patterson Belknap Webb & Tyler LLP on 6/14/2017

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

How Will The Supreme Court Choreograph The Biosimilar Patent Dance?

Foley & Lardner LLP on 5/3/2017

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

Mintz on 5/1/2017

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

Goodwin on 4/26/2017

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

Upcoming Oral Arguments in BPCIA Litigation

Goodwin on 2/22/2017

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

Supreme Court Announces Briefing Schedule in Amgen v. Sandoz

Goodwin on 1/26/2017

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

Akin Gump Strauss Hauer & Feld LLP on 1/24/2017

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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Supreme Court of the United States › Amgen v Sandoz

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