Amgen

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Court Report - February 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Astellas Pharma Inc. et al. v. Apotex Inc. et al. 1:15-cv-00857; filed September 22, 2015 in the District Court of...more

PTAB Denies Amgen’s IPR in Win for AbbVie – Article “Suggests a High Degree of Unpredictability” in the Art at Time of Invention

The Patent Trial and Appeal Board recently denied institution of Amgen’s inter partes review against an AbbVie patent covering HUMIRA® (currently, the best-selling drug in the world). ...more

U.S. Supreme Court Clarifies the Scope of ERISA Fiduciary Obligations in Recent Stock Drop Decision

In recent years, plaintiffs’ lawyers have brought numerous ERISA breach of fiduciary duty lawsuits against employers that offer employer stock funds in their 401(k) plans. These lawsuits are typically brought on behalf of...more

Supreme Court Revisits Stock Drop Fiduciary Standards

In Amgen v. Harris, the Supreme Court for the second time considered whether the plan participants sufficiently stated a claim against the plan fiduciaries for breach of fiduciary duty under ERISA by continuing to provide...more

The Supreme Court Meant What It Said On Employer Stock Funds

On January 25, 2016, in Amgen, Inc. v. Harris, 2016 WL 280886, the Supreme Court sent a strong message to the lower courts, plaintiffs and ERISA fiduciaries that pleading standards for breach of fiduciary duty prudence claims...more

What Amgen and Tackett Tell Us About ERISA Litigation Trend Lines

Two recent Supreme Court decisions, and a recent Sixth Circuit analysis on remand from the Supreme Court, offer a roadmap of sorts on ERISA litigation. In both decisions, the Supreme Court did away with presumptions, and at...more

Be Careful What You Wish For – Dudenhoeffer May Do “More Harm Than Good” For ERISA “Stock Drop” Plaintiffs

In its June 2014 decision in Dudenhoeffer v. Fifth Third Bank, the U.S. Supreme Court unanimously declined to recognize a “presumption of prudence” that had favored retirement-plan fiduciaries faced with allegations of...more

Supreme Court’s Amgen Order Confirms That Fifth Third Bancorp’s ERISA Stock-Drop Pleading Standard Has Teeth

In a recent per curiam order granting the plan fiduciaries’ petition for certiorari and reversing the Ninth Circuit, the United States Supreme Court made clear that it expects lower courts to faithfully apply the pleading...more

SCOTUS Meant What It Said & Said What It Meant: Dudenhoeffer Imposes Higher Pleading Standards

In a rebuke to the Ninth Circuit, the Supreme Court granted the Amgen defendants’ petition for certiorari, reversed the Ninth Circuit’s judgment and remanded the case for further proceedings consistent with its opinion in the...more

Supreme Court Rejects ERISA Stock-Drop Complaint for Failing Dudenhoeffer Pleading Standards

Earlier this week, the Supreme Court emphatically reversed the Court of Appeals for the Ninth Circuit in an ERISA stock-drop lawsuit. The Supreme Court concluded that the Ninth Circuit failed to properly apply the rigorous...more

Harris v. Amgen

On January 25, 2016, the United States Supreme Court issued an opinion in Harris v. Amgen that will impact the pleading standard for stock drop litigation. The plaintiffs in Harris are former employees of Amgen Inc. who...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

PTAB Denies Challenge Of Abbvie Humira Patents

The USPTO Patent Trial and Appeal Board (PTAB) denied institution of two Inter Partes Review challenges brought by Amgen, Inc. against two Humira patents covering stable formulations of anti-human Tumor Necrosis Factor alpha...more

The Federal Circuit Will Hear Apotex’s Appeal from a Preliminary Injunction Under the BPCIA in Early 2016

In Amgen v. Apotex, Judge Cohn of the Southern District of Florida recently enjoined Apotex from selling its proposed biosimilar of Amgen’s Neulasta for 180 days following FDA approval. In Amgen v. Sandoz, 794 F.3d 1347...more

Biosimilar Pre-Marketing Notice Always Required

Judge Cohn of the U.S. District Court for the Southern District of Florida has issued another decision interpreting the complicated provisions of the Biologics Price Competition and Innovation Action (BPCIA), ruling that the...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

Court Rules that Apotex Must Give Amgen Notice Upon Biosimilar Licensure

Since August 2015, Amgen and Apotex have been locked in litigation in the US District Court for the Southern District of Florida related to Apotex’s pegfilgrastim product, which is purported to be biosimilar to Amgen’s...more

BPCIA: Amgen Begins the Patent Dance With AbbVie

On November 25, 2015, Amgen Inc. (“Amgen”) announced it submitted its first biologics license application (“BLA”) to the FDA under the Section 351(k) biosimilar approval pathway provided in the Biologics Price Competition and...more

Enbrel Biosimilar in Europe and US

On November 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion, recommending marketing authorization of Benepali, the first biosimilar of Enbrel...more

Amgen Uses Agreement to Litigate Patents Under the BPCIA to Rebuff Sham Litigation Claims

Last month, in a case under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) involving Apotex’s proposed biosimilar of Amgen’s Neulasta (pegfilgrastim), Apotex accused Amgen of sham litigation for bringing a...more

Court Report - November 2015 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Amgen Inc. et al. v. Apotex Inc. et al. 0:15-cv-61631; filed August 6, 2015 in the Southern District of Florida. •...more

FDA Rejects Hospira’s EPO Biosimilar Application

After the FDA approved the first U.S. biosimilar, Sandoz’s Zarxio (filgrastim-sndz), earlier this year, many predicted that the floodgates would open for biosimilar products. That has not been the case. No other U.S....more

Apotex Follows the BPCIA “Patent Dance” Again

The first biosimilar makers to file regulatory applications with FDA attempted to bypass all or a subset of the patent litigation provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Apotex, the...more

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

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

A Split Decision Remains Split; No en banc Review of Amgen v. Sandoz

On October 16, 2015, the Court of Appeals for the Federal Circuit (“Federal Circuit”) opted not to rehear its previously issued split decision in the court’s first analysis of the Biologics Price Competition and Innovation...more

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