Popular, Sandoz v Amgen

Federal Circuit Walks Back Its “Exceptional” Stance on the Doctrine of Equivalents in the Latest Amgen v. Sandoz Decision

Patterson Belknap Webb & Tyler LLP on 9/6/2019

In Amgen’s long-running dispute with biosimilar-maker Sandoz over biosimilar versions of Amgen’s filgrastim (Neupogen®) and pegfilgrastim (Neulasta®) biologics, the Federal Circuit earlier this year affirmed summary judgment...more

Federal Circuit Affirms Noninfringement in BPCIA Case

Locke Lord LLP on 6/13/2019

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

Amgen v. Sandoz - New Developments in Biosimilars Litigation

K&L Gates LLP on 5/24/2019

INTRODUCTION & BACKGROUND - On May 8, 2019 in Amgen, Inc. v. Sandoz International GmbH, the Federal Circuit Court affirmed the district court’s judgment, concluding that the district court correctly construed the claims and...more

It’s 2018: The Impact Of IP Decisions From 2017

Ladas & Parry LLP on 4/12/2018

2017 saw a bumper crop of Supreme Court decisions on intellectual property matters around the world including eight by the United States Supreme Court, two by the Canadian Supreme Court, and two by the United Kingdom Supreme...more

Declaratory Judgment Litigation Brought by Biosimilar Manufacturers

Fish & Richardson on 2/26/2018

Courts have begun to shape the contours of the Biologics Price Competition and Innovation Act (“BPCIA”) and the progress of biosimilar litigation, but the use of declaratory judgment actions by biosimilar manufacturers...more

Federal Circuit Rules BPCIA Preempts State Law

Jones Day on 12/27/2017

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

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

Ladas & Parry LLP on 8/21/2017

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

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

Jones Day on 7/25/2017

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

Sandoz Inc. V. Amgen Inc. Clears The Way For Potential Earlier Launch Of Biosimilars

Locke Lord LLP on 6/14/2017

In Sandoz Inc. v. Amgen Inc., No. 15-1039 (U.S. June 12, 2017) the Supreme Court held (i) that biosimilar applicants may provide the requisite 180-days’ notice of commercial marketing to the reference product sponsor even...more

Supreme Court Decides Sandoz, Inc. v. Amgen, Inc.

Faegre Drinker Biddle & Reath LLP on 6/13/2017

On June 12, 2017, the Supreme Court decided Sandoz, Inc. v. Amgen, Inc., Nos. 15-1039, 15-1195, in which it held that (a) a manufacturer of a licensed biological product cannot obtain federal injunctive relief to enforce 42...more

Biosimilars: Supreme Court Grants Certiorari in Amgen v. Sandoz

Fenwick & West Life Sciences Group on 1/23/2017

On Friday, January 13, the Supreme Court granted certiorari in Amgen v. Sandoz (Nos. 15-1039 & 15-1195). The Supreme Court originally deferred its decision on the parties’ certiorari petitions in order to consider the...more

Solicitor General Recommends that Supreme Court Grant Certiorari in Sandoz v. Amgen

McDonnell Boehnen Hulbert & Berghoff LLP on 12/13/2016

The Federal Circuit's decision in Amgen v. Sandoz, regarding litigation "under" (or at least based upon) the Biologics Price Control and Innovation Act (BPCIA), interpreted for the first time two provisions of the law. The...more

Litigation Update: Amgen and Sandoz Stipulate to Dismiss ‘784 Patent

Goodwin on 12/5/2016

The parties in Amgen v. Sandoz (N.D. Cal.) (filgrastim, pegfilgrastim) have submitted a joint stipulation to dismiss, without prejudice, Amgen’s U.S. Patent No. 5,824,784 patent from the litigation. The ‘784 patent is...more

Amgen Crystallizes Disagreement in Appeal of Discovery Row

Fish & Richardson on 11/18/2016

Amgen advanced further arguments in a November 8, 2016 brief before the Federal Circuit, crystallizing the point of disagreement between it and defendant-appellee Hospira. The issue before the court is whether, during...more

Biosimilar Litigation Update

Patterson Belknap Webb & Tyler LLP on 10/26/2016

With the U.S. biosimilar pathway created by the Biologics Price Competition and Innovation Act (BPCIA) now fully up and running, there are now seven ongoing biosimilar litigations in the U.S. Here are brief updates on recent...more

Amgen’s Federal Circuit Appeal: the Importance of Manufacturing Information to Biosimilar Litigation

Patterson Belknap Webb & Tyler LLP on 9/19/2016

Amgen has filed its appeal brief in Amgen v. Hospira, following the Federal Circuit’s denial of Hospira’s motion to dismiss the appeal for lack of jurisdiction. The appeal presents an important question for biosimilar...more

AbbVie v. Amgen: The Litigation Phase for a HUMIRA® Biosimilar Begins

McDonnell Boehnen Hulbert & Berghoff LLP on 8/10/2016

To date, Amgen has been the reference product sponsor for many biosimilar applications. Correspondingly, Amgen has been the Plaintiff in many of the litigations that have been based on the provisions of the Biosimilar Price...more

Federal Circuit: A Biosimilar Applicant Must Provide Notice of Intent to Market a Biosimilar Product, No Exceptions

Fenwick & West Life Sciences Group on 7/21/2016

On July 5, 2016, in Amgen v. Apotex (No. 2016-1308), the Federal Circuit again held that a biosimilar applicant must provide its biologic competitor with 180 days’ notice of intent to commercially market a biosimilar product....more

Fall-Out from the Federal Circuit’s Decision in Amgen v. Apotex

Fish & Richardson on 7/14/2016

The repercussions of Amgen v. Apotex, No. 2016-1308 (Fed. Cir. July 5, 2016) (“Apotex”), continue as BPCIA litigants submit letters to their respective judges addressing the Federal Circuit’s latest ruling on the Act’s notice...more

Amgen v. Apotex: Analysis of the Fed. Cir. Opinion

Goodwin on 7/8/2016

As we posted on July 5, 2016, the Federal Circuit has issued its decision in Amgen v. Apotex, affirming the district court’s (S.D. Fla, J. Cohn) order preliminarily enjoining Apotex from launching its biosimilar version of...more

Amgen v. Sandoz Biosimilar Litigation Update: Sandoz Follows the Patent Dance With Neulasta

Patterson Belknap Webb & Tyler LLP on 6/30/2016

Amgen v. Sandoz Biosimilar Litigation Update: Sandoz Follows the Patent Dance With Neulasta - Prominent among the first generation of U.S. biosimilar litigations under the Biologics Price Competition and Innovation Act...more

Amgen v. Sandoz Update -- Supreme Court Seeks Views of United States

McDonnell Boehnen Hulbert & Berghoff LLP on 6/22/2016

In other Supreme Court news from Monday, June 20, 2016, the Court invited the Solicitor General to file briefs in the Sandoz v. Amgen (No. 15-1039) and Amgen v. Sandoz (No. 15-1195) appeals to express the views of the United...more

Amgen v. Sandoz SCOTUS Appeal on Hold Until October

Fish & Richardson on 6/22/2016

The Supreme Court on Monday called for the views of the Solicitor General regarding the petitions for certiorari filed by both parties in Amgen v. Sandoz. The case arose after Sandoz filed an aBLA for Zarxio®, a biosimilar of...more

Supreme Court asks SG for views on Sandoz, Amgen petitions: Analysis and Next Steps

Goodwin on 6/21/2016

As we posted on June 20, the Supreme Court has invited the Solicitor General to file briefs regarding the Sandoz v. Amgen and Amgen v. Sandoz petitions for certiorari. Below we provide further analysis and commentary on the...more

Amgen Appeals Ruling on Requirement to Produce Manufacturing Information for a Biosimilar Product under Amgen v. Sandoz

Patterson Belknap Webb & Tyler LLP on 6/21/2016

Amgen has appealed a partial denial of its motion to compel in Amgen v. Hospira, No. 15-cv-839, currently pending in the District of Delaware. The case, filed last September, concerns Hospira’s proposed biosimilar of Amgen’s...more

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