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Genentech’s BPCIA Complaint Against Amgen Dismissed

Today, Judge Gregory Sleet of the U.S. District Court of Delaware orally dismissed Genentech’s lawsuit against Amgen alleging violations of the BPCIA. Judge Sleet did not issue a written opinion, but his order states that...more

PTAB Ruling on CRISPR: No Interference

On Wednesday, February 15, 2017, the Patent Trial and Appeal Board (“PTAB”) ruled in favor of the Broad Institute of MIT and Harvard in a closely watched patent fight with UC Berkeley over the breakthrough CRISPR...more

Supreme Court Grants Cert in Amgen v. Sandoz

On January 13, 2017, the Supreme Court granted Sandoz’s petition for certiorari and Amgen’s cross-petition in Amgen v. Sandoz, case nos. 15-1039 and 15-1195. The two cases were consolidated, and an hour was allotted for oral...more

Solicitor General Supports Cert in Amgen v. Sandoz, Supreme Court Denies Cert in Amgen v. Apotex

Last week, the Solicitor General submitted its brief in Amgen v. Sandoz, arguing that the Supreme Court should review and decide in Sandoz’s favor both questions presented by the parties’ cross-petitions for certiorari. Two...more

Biosimilar Litigation Update

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

Apotex Prevails in Neulasta Biosimilar Litigation, Files for Cert on 180-Day Issue

Among the first generation of biosimilar litigation under the Biologics Price Competition and Innovation Act (BPCIA) is a dispute between Amgen and Apotex over Apotex’s proposed biosimilar versions of Amgen’s Neupogen...more

Amgen and Hospira Square Off Over BPCIA Private Right of Action After Amgen v. Apotex Ruling

Amgen and Hospira have fired off dueling letters to the court in their litigation over Amgen’s Epogen biosimilar, debating whether the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act of 2009...more

Federal Circuit Decides Amgen v. Apotex, Holds that 180-Day Notice of Commercial Marketing is Always Mandatory in Biosimilar...

Yesterday, the Federal Circuit decided Amgen v. Apotex, No. 2016-1308 (Fed. Cir. July 5, 2016), its second decision interpreting the U.S. biosimilar statute, the Biologics Price Competition and Innovation of Act of 2009...more

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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