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Biosimilars Approvals: Nepexto Receives European Marketing Authorization, Ziextenzo and Riximyo Receive Health Canada Approval

Goodwin on 6/10/2020

Last week, Lupin and Mylan announced that the European Commission had granted marketing authorization for their biosimilar Nepexto (etanercept) for all indications of the reference product. The marketing authorization follows...more

Another Biosimilar Litigation Settlement: Amgen v. Tanvex (Filgrastim)

Goodwin on 12/23/2019

Following last month’s dismissal of the Amgen v. Kashiv filgrastim biosimilar litigation, yesterday Amgen and Tanvex filed a joint stipulation of dismissal in their BPCIA litigation concerning Tanvex’s filgrastim biosimilar...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, Sandoz, Samsung, and Mylan Launch Biosimilars in Europe (UPDATED)

Goodwin on 11/5/2018

Amgen, Sandoz, Samsung and Mylan all launched adalimumab biosimilars in Europe this past October. On October 16, 2018, Amgen has announced that its adalimumab biosimilar AMGEVITA launched in European markets....more

Amgen and Sandoz Launch Biosimilars in Europe

Goodwin on 10/17/2018

Amgen has announced that its adalimumab biosimilar AMGEVITA launched yesterday in European markets. This is Amgen’s first “inflammation” biosimilar to launch in Europe, and its second biosimilar to launch in Europe overall. ...more

New BPCIA Litigation: AbbVie Files Suit on Sandoz’s HUMIRA (adalimumab) biosimilar

Goodwin on 8/13/2018

Today, AbbVie sued Sandoz regarding its proposed biosimilar to HUMIRA (adalimumab) in the District of New Jersey. The suit alleges infringement under the BPCIA of U.S. Patent Nos. 9,187,559 and 9,750,808. The ‘559 patent is...more

European Commission Grants Marketing Authorization for Adalimumab and Trastuzumab Biosimilars

Goodwin on 8/3/2018

Last week the European Commission granted marketing authorization for two biosimilars. First, Sandoz, a division of Novartis, announced on July 27 that it had received marketing authorization for Hyrimoz, its adalimumab...more

First Decision on Label Carve-Outs for Biosimilars Expected in Enbrel Litigation

Patterson Belknap Webb & Tyler LLP on 6/19/2018

As biosimilar litigation between Amgen, the maker of Enbrel® (etanercept), and Sandoz, the maker of biosimilar ErelziTM (etanercept-szzs) heads toward trial before Judge Claire Cecchi in the District of New Jersey, Sandoz is...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

Federal Circuit Rules Out State-Law Remedies for Failure to Participate in the Biosimilars "Patent Dance"

Perkins Coie on 12/18/2017

On December 14, the Federal Circuit issued a decision that further clarifies the ground rules for disclosures of product information by manufacturers of biosimilar pharmaceutical products. In particular, the Federal Circuit...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

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

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

MBHB Snippets: A review of developments in Intellectual Property Law - Volume 14, Issue 2 (Spring 2016)

McDonnell Boehnen Hulbert & Berghoff LLP on 6/7/2016

Pre-AIA and Post-AIA Issues Presented by the On-Sale Bar - The “on-sale” bar to patentability refers to a sale or offer for sale of an invention that can invalidate the patent for that invention. The...more

Novartis FCPA Enforcement Action, Part I

Thomas Fox - Compliance Evangelist on 3/28/2016

The philosopher George Santayana is usually best remembered for the pithy saying, ‘Those who cannot remember the past are condemned to repeat it.” Santayana was an essayist, poet, professor and novelist. According to...more

BPCIA Statute: Has the Music Stopped or Will the Patent Dance Continue?

K&L Gates LLP on 10/28/2015

In July, a divided Federal Circuit issued a ruling in the Amgen Inc. et al. v. Sandoz Inc., Case No. 2015-1499 appeal and held: (1) the Biologics Price Competition and Innovation Act’s (“BPCIA’s”) “patent dance” provisions...more

BPCIA Statute: Patent Dance Is Optional, But Opting Out Has Consequences

K&L Gates LLP on 7/27/2015

The Federal Circuit issued a ruling on July 21, 2015 in the Amgen Inc. et al. v. Sandoz Inc., Case No. 2015-1499, appeal after hearing oral arguments on June 3, 2015. See BPCIA: A “Choose Your Own Adventure” Statute?...more

Alert: Fractured Federal Circuit Provides Guidance on Biosimilars Patent Dance

Knobbe Martens on 7/22/2015

Both Sides Come Away with Wins in Amgen v. Sandoz - Yesterday, in Amgen, Inc. v. Sandoz, Inc., the Federal Circuit construed multiple provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). ...more

District Court Denies Amgen's Bid to Block Sale of Blockbuster Biosimilar Drug

Wilson Sonsini Goodrich & Rosati on 3/25/2015

On March 19, 2015, Judge Seeborg of the Northern District of California handed a significant victory to Sandoz's efforts to bring the first biosimilar product to market by denying Amgen's partial judgment on the pleadings and...more

The First Biosimilar Application Has Been Approved -- But What About the Patent Issues?

McDonnell Boehnen Hulbert & Berghoff LLP on 3/13/2015

As we reported earlier this week, the U.S. Food and Drug Administration ("FDA") approved the first biosimilar application -- an application by Sandoz to market a biosimilar version of Amgen's NEUPOGEN® (filgrastrim) biologic...more

Sandoz Was Disinvited to the Patent Dance: The Federal Circuit's First Interpretation of the BPCIA Will Have to Wait

Orrick, Herrington & Sutcliffe LLP on 12/19/2014

Since the 1984 enactment of the Drug Price Competition and Patent Term Restoration Act, Hatch-Waxman litigation has dominated the sphere of life-sciences patent litigation. The battle between proprietary and generic...more

Federal Circuit Gives Little Guidance on Biosimilar Patent Validity Challenges

Ballard Spahr LLP on 12/15/2014

Recently, the Federal Circuit had the opportunity to issue its first decision relating to biosimilars patent litigation and the Biologics Price Competition and Innovation Act of 2009 (BPCIA) procedures. Instead, the court...more

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