Aron Fischer

Aron Fischer

Patterson Belknap Webb & Tyler LLP

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Supreme Court Asks Solicitor General to Weigh In on Amgen v. Sandoz

Today, the Supreme Court deferred a decision on certiorari in Amgen v. Sandoz, inviting the Solicitor General to file a brief expressing the views of the United States. Sandoz petitioned for review of one aspect of the...more

6/21/2016 - Biosimilars BPCIA Injunctive Relief Patent Dance Patent Litigation Petition for Writ of Certiorari Pharmaceutical Patents Sandoz v Amgen SCOTUS

Update on Naming Biosimilars

In August 2015, FDA released a long-awaited draft guidance for the nonproprietary names of biologics and biosimilars. The draft guidance recommends that nonproprietary names for biologic products should consist of the “core”...more

6/14/2016 - Biologics Biosimilars Draft Guidance FDA Labeling Pharmaceutical Industry

Amgen Opposes Sandoz’s BPCIA Cert Petition and Files Conditional Cross-Petition on Patent Dance

Amgen has fired back in response to Sandoz’s cert petition in Amgen v. Sandoz, arguing that the Supreme Court should not hear the case—but that if it does, it should also review the Federal Circuit’s holding on the Biologics...more

3/30/2016 - Biosimilars BPCIA Patent Litigation Petition for Writ of Certiorari Pharmaceutical Patents Sandoz v Amgen

Sequenom Seeks Supreme Court Review of Non-invasive Prenatal Diagnosis Patent

On March 21, 2015, Sequenom filed a petition for writ of certiorari to the Supreme Court in Sequenom, Inc. v. Ariosa Diagnostics, et al. (No. 15-1182). In its petition, Sequenom calls its case the “ideal vehicle” for the...more

3/28/2016 - Mayo v. Prometheus Patent-Eligible Subject Matter Petition for Writ of Certiorari Pharmaceutical Patents SCOTUS Sequenom

Sandoz Seeks Cert on 180-Day Issue in Amgen v. Sandoz

Sandoz has filed a petition for a writ of certiorari in Amgen v. Sandoz, seeking Supreme Court review of the Federal Circuit’s ruling that it could not market Zarxio, its biosimilar version of Amgen’s cancer medicine...more

2/19/2016 - Biologics Biosimilars BPCIA FDA Patent Litigation Pharmaceutical Industry Pharmaceutical Patents Popular Prescription Drugs Sandoz v Amgen

U.S. Biosimilar Litigation So Far

The U.S. biosimilars statute, the Biologics Price Competition and Innovation Act (“BPCIA”), was enacted in 2010 as part of the Affordable Care Act. Nearly six years later, the number of reported decisions addressing the...more

2/2/2016 - Biologics Biosimilars BPCIA FDA Patent Dance Patent Litigation Sandoz v Amgen

Amgen Declines to Seek Cert in Amgen v. Sandoz

Amgen has decided not to seek Supreme Court review of the Federal Circuit’s Amgen v. Sandoz decision, as the January 14, 2016 deadline to file has now passed without Amgen petitioning for certiorari. Amgen v. Sandoz is...more

1/20/2016 - Amgen Biosimilars BPCIA FDA Approval Notice Requirements Patent Dance Patent Litigation Petition for Writ of Certiorari Sandoz v Amgen

Florida Federal Court Enjoins Apotex from Selling Neulasta Biosimilar for 180 Days After Approval

On December 9, a federal district court in Florida issued a preliminary injunction prohibiting Apotex from selling a proposed biosimilar version of Amgen’s cancer drug Neulasta for 180 days after the biosimilar is approved. ...more

12/14/2015 - Amgen Apotex Biosimilars BPCIA FDA Approval Notice Requirements Patent Dance Preliminary Injunctions Sandoz v Amgen

Ten Years of Biosimilars in Europe

This fall marks the tenth anniversary of the effective date of the European Medicines Agency’s Guideline on Similar Biological Medicinal Products. As this blog noted previously, the EU’s biosimilar pathway both preceded the...more

12/10/2015 - Biologics Biosimilars BPCIA EU FDA FDA Approval Pharmaceutical Industry

Both Parties Seek En Banc Intervention in Amgen v. Sandoz

Last month, a divided panel of the Federal Circuit issued a split decision in Amgen v. Sandoz (summary; opinion). Amgen (in which Patterson Belknap represented one of the amici supporting Amgen) is the court’s first decision...more

8/31/2015 - Amgen Appeals Biologics BPCIA Commercial Marketing Declaratory Relief Mootness Notice Requirements Patent Dance Patent Infringement Patents Preliminary Injunctions Remedies Sandoz Sandoz v Amgen

First Round of Post-Teva Claim Construction Decisions: Business as Usual?

In its January 2015 decision, Teva Pharms. USA, Inc. v. Sandoz, Inc., the Supreme Court held that the ultimate construction of a patent claim term is a question of law, subject to de novo appellate review, but that the...more

7/1/2015 - Claim Construction Clear Error Standard De Novo Standard of Review Patents Pharmaceutical Industry Pharmaceutical Patents Teva v Sandoz

Federal Circuit Oral Arguments in Amgen v. Sandoz

On June 3, the parties in Amgen v. Sandoz presented oral arguments to the Federal Circuit as part of their dispute over the Biologics Price Competition and Innovation Act (BPCIA). The appeal is focused on two questions:...more

6/13/2015 - Amgen Appeals Biosimilars BPCIA Commercial Marketing FDA FDA Approval Injunctions Oral Argument Patent Dance Sandoz v Amgen TRO

Amgen v. Sandoz: Federal Circuit Grants Injunction Pending Appeal

Yesterday the Federal Circuit granted Amgen’s motion for an injunction pending appeal in Amgen v. Sandoz, the first appeal to squarely address the patent litigation provisions of the Biologics Price Competition and Innovation...more

5/7/2015 - Appeals Biosimilars BPCIA FDA Patent Litigation Patents Pharmaceutical Patents Preliminary Injunctions Sandoz v Amgen

Amgen v. Sandoz BPCIA Dispute Heads to the Federal Circuit

After a series of preliminary skirmishes, the first full-fledged litigation under the Biologics Price Reduction and Innovation Act is Amgen’s lawsuit against Sandoz concerning Sandoz’s Zarxio, a biosimilar version of Amgen’s...more

4/27/2015 - Biosimilars BPCIA Patent Litigation Patents Pharmaceutical Industry Pharmaceutical Patents Sandoz v Amgen

Supreme Court Nixes Aereo TV, Holding That Internet Streaming of Broadcast TV to Subscribers Violates Copyright Law

On June 25, 2014, the United States Supreme Court decided ABC v. Aereo, one of the more important (and most closely watched) copyright cases of the digital era. The Court’s 6-3 decision that streaming-TV startup Aereo...more

7/17/2014 - ABC ABC v Aereo Aereo Broadcasting Copyright Copyright Infringement Public Performance Rights SCOTUS The Copyright Act

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