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Supreme Court of the United States › Sandoz v Amgen

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... more +
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 -
McDermott Will & Emery

Amending a Range? Better Enable It

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In a post-grant review appeal, the US Court of Appeals for the Federal Circuit explained that patent claims reciting a range must enable the full scope of that range and, under the Administrative Procedure Act (APA), the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Top Stories of 2017: #5 to #9

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After reflecting upon the events of the past twelve months, Patent Docs presents its 11th annual list of top patent stories. For 2017, we identified nineteen stories that were covered on Patent Docs last year that we believe...more

Goodwin

Year in Review: Top Five Legal Developments of 2017

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Here are our picks for the top-five most significant legal developments regarding biosimilars in 2017...more

Jones Day

Federal Circuit Rules BPCIA Preempts State Law

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On December 14, 2017, the U.S. Court of Appeals for the Federal Circuit again interpreted the Biologics Price Competition and Innovation Act ("BPCIA"). In Amgen Inc. et al. v. Sandoz Inc., 15-cv-1499 (Fed. Cir. 2017), the...more

Mintz - Intellectual Property Viewpoints

Federal Circuit Rules that BPCIA Preempts State Law Biosimilars Claims

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In an opinion issued on December 14, 2017, the United States Court of Appeals for the Federal Circuit held that the 2010 Biologics Price Competition and Innovation Act (“BPCIA”) preempts the use of state law to penalize...more

Ladas & Parry LLP

Skipping The Patent Dance: U.S. Supreme Court In Amgen V Sandoz Makes It More Difficult For Patent Owners To Delay Marketing Of...

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On June 12, 2017, in a unanimous decision authored by Justice Thomas in Amgen Inc. v. Sandoz Inc., the United States Supreme Court considered the complex statutory scheme that attempts to expedite resolution of patent...more

Knobbe Martens

Federal Circuit Review - July 2017

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District Court Abused Discretion in Not Finding Case Exceptional - In Rothschild Connected Devices v. Guardian Protection Services, Appeal No. 2016-2521, the Federal Circuit held that a district court abused its discretion...more

Jones Day

Jones Day’s Review of Business-Related Cases in the Supreme Court’s October Term 2016

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During what many have labeled a “quiet Term,” the U.S. Supreme Court, working with only eight justices for most of the session, still delivered at least 30 rulings of particular interest to business and industry. These...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

You Can Dance If You Want To

Sterne, Kessler, Goldstein & Fox P.L.L.C. on

In borrowing a page from the '80s band "Men Without Hats," on June 12, 2017, the U.S. Supreme Court brought greater certainty for both biosimilar applicants and originator companies. In Sandoz Inc. v. Amgen Inc., the Supreme...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Global Patent Prosecution Newsletter - July 2017

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Biosimilars Around the World - Last month’s Supreme Court ruling in Sandoz v. Amgen brought greater certainty to both biosimilar applicants and originators in the United States. The July 2017 issue of Sterne Kessler’s...more

Robinson+Cole Health Law Diagnosis

Supreme Court Decision Allows Faster Marketing of Biosimilars

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On Monday, June 12, 2017, the United States Supreme Court in a unanimous decision held that manufacturers making biosimilars of biologic drugs did not have to wait until after gaining federal approval of the biosimilar to...more

Hogan Lovells

ITC Section 337 – Quarterly Highlights

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SCOTUS Narrows Opportunity For ITC Section 337 Jurisdiction Over Imported Biosimilars Based On 180-Day Notice Provision - In Amgen Inc. v. Sandoz Inc., 794 F.3d 1347, 1357-58 (Fed. Cir. 2015), the Federal Circuit held that...more

Foley & Lardner LLP

Does Amgen Have Viable State Law Claims Against Sandoz Arising From The Zarxio Biosimilar Patent Dispute?

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In Sandoz Inc. v. Amgen Inc. (which you can read more about here), the Supreme Court held that 42 USC § 262(l)(9)(C) sets forth the exclusive federal remedy for failing to provide a copy of the biosimilar application to the...more

BakerHostetler

The Supreme Court Delivers a Win for Biosimilar Manufacturers in Sandoz v. Amgen

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On June 12, 2017, the Supreme Court issued a unanimous opinion in Sandoz v. Amgen, interpreting key provisions of the Biologics Price Competition and Innovation Act (BPCIA) in favor of biosimilar manufacturers...more

McDonnell Boehnen Hulbert & Berghoff LLP

SCOTUS: Supreme Court Lifts Biosimilars by Allowing Early Commercial Marketing Notice

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The Supreme Court handed down its opinion in Sandoz Inc. v. Amgen Inc., marking the first time the Court has interpreted the Biologics Price Competition and Innovation Act (“BPCIA”) for the approval of biosimilar drugs. On...more

Jones Day

Supreme Court: Biosimilar Applicants May Provide Commercial Marketing Notice Before FDA Approval

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On June 12, 2017, the U.S. Supreme Court decided two important questions under the Biologics Price Competition and Innovation Act ("BPCIA"), which provides an abbreviated pathway for the approval of generic biologics: (i) the...more

McDermott Will & Emery

Supreme Court Analyzes Key Provisions of Biologics Price Competition and Innovation Act of 2009

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In a unanimous decision, the United States Supreme Court has clarified certain portions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), concluding (1) that biosimilar makers do not have to wait for...more

Mintz - Health Care Viewpoints

SCOTUS Ruling Gives a Boost to Biosimilars; FDA Continues to Advance Products Through AdComs

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On a sweltering hot D.C. morning, those of us anxiously awaiting the Supreme Court’s opinion in its first case involving biosimilar biological products finally exhaled. The June 12, 2017 opinion followed the parties’ oral...more

McGuireWoods LLP

Supreme Court Interprets BPCIA Provisions Relating to the ‘Patent Dance’

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On June 12, 2017, the U.S. Supreme Court interpreted two provisions of the Biologics Price Competition & Innovation Act (BPCIA) relating to patent infringement suits. The Court held that, under the BPCIA, (1) a biologic...more

BakerHostetler

Branded Biologic Products Lose 180 Days of Patent Exclusivity in Unanimous Decision From Supreme Court

BakerHostetler on

On June 13, 2017, the U.S. Supreme Court issued its opinion in Sandoz v. Amgen. In doing so, it answered two questions raised under the Biologics Price Competition and Innovation Act of 2009 (BPCI). First, is an injunction...more

Weintraub Tobin

U.S. Supreme Court Allows Early Notice For Biosimilars

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In SANDOZ INC. v. AMGEN INC. et al., the United States Supreme Court in a unanimous opinion ruled that biosimilar makers can give their required 180-day statutory notice of sales before their products win approval by the...more

Mintz - Intellectual Property Viewpoints

Amgen v. Sandoz: The Supreme Court’s First Biosimilars Ruling

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In a unanimous decision issued on June 12, 2017, the Supreme Court for the first time interpreted key provisions of the 2010 Biologics Price Competition and Innovation Act (“BPCIA”). See Sandoz Inc. v. Amgen Inc., No. 15-1195...more

Snell & Wilmer

Supreme Court Permits Biosimilar Drugs to Be Marketed Sooner

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On June 12, 2017, in Sandoz Inc. v. Amgen Inc., the United States Supreme Court unanimously held that a drug manufacturer may give a required 180-day notice of its intent to market a biosimilar drug before receiving FDA...more

Jackson Walker

SCOTUS Simplifies Market Entry Process for Biosimilar Products

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Yesterday’s unanimous ruling by the U.S. Supreme Court in Sandoz v. Amgen injects much needed certainty into a difficult statute and streamlines the process for biosimilar products to enter the marketplace following FDA...more

Kilpatrick

U.S. Supreme Court Finds that Dancing with Biosimilars is NOT Mandatory

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The U.S. Supreme Court had a busy day on Monday (June 12, 2017) issuing four unanimous decisions in recently argued cases. Of particular note is the final decision in the Supreme Court’s 2016 term – the consolidated case of...more

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