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Amgen Motion to Dismiss

Goodwin

Motion to Dismiss Denied in Amgen v. Hospira BPCIA

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At the end of last month, Judge Connolly denied defendants Hospira and Pfizer’s motion to dismiss following a telephone conference with the parties.  We previously reported back in February 2020 that Amgen sued Pfizer and its...more

Smart & Biggar

First decision under amended PMNOC Regulations: Federal Court finds Amgen’s filgrastim patent obvious

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UPDATE: On November 3, 2020, the Federal Court of Appeal dismissed Amgen’s appeal. See our article here. On April 16, 2020, Justice Southcott of the Federal Court issued the first decision under the amended Patented...more

Goodwin

Litigation Update: Genentech’s Motion to Dismiss Amgen’s Counterclaims Denied in Avastin Biosimilar Litigation

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On February 11, 2020, in the Biogen v. Amgen BPCIA litigation regarding MVASI (bevacizumab-awwb), Amgen’s biosimilar of AVASTIN, Judge Colm Connolly of the Delaware District Court denied most of Genentech’s motion to dismiss...more

Kramer Levin Naftalis & Frankel LLP

Biosimilars in 2020: What’s Ahead

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Obama in March 2010. This year, the BPCIA turns 10. While the U.S. Biosimilars Pathway has...more

Goodwin

Amneal Seeks Dismissal as Defendant in Amgen v. Adello Filgrastim Biosimilar Suit

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In March this year, Amgen sued Adello Biologics under the BPCIA in the District of New Jersey for infringement of seventeen patents, based on Adello’s submission of an aBLA for a biosimilar of Neupogen® (filgrastim). In...more

Smart & Biggar

Federal Court dismisses first motion for early dismissal under amended PMNOC Regulations

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In public reasons released on July 30, 2018, the Federal Court dismissed the first motion for summary dismissal brought under section 6.08 of the amended Patented Medicines (Notice of Compliance) Regulations (PMNOC...more

Goodwin

Genentech Seeks to Dismiss and Strike Amgen’s Counterclaims and Certain Defenses in Bevacizumab Biosimilar Litigation

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As we previously reported, on May 22, 2018 in Genentech v. Amgen, which concerns Amgen’s Mvasi® (bevacizumab-awwb) biosimilar, Genentech filed a motion to dismiss and to strike Amgen’s counterclaims and certain affirmative...more

Jones Day

Delaware District Dismisses BPCIA "Private Right" Claim; Says Controversy not Sufficiently Immediate

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In a recent decision involving the Biologics Price Competition and Innovation Act ("BPCIA") (Genentech, Inc. and City of Hope v. Amgen Inc.) the Delaware District Court dismissed a claim seeking to enforce a statement of...more

Goodwin

Court Grants Amgen’s Motion To Dismiss Genentech’s Declaratory Judgment Counts in Mvasi™ Litigation, and Sets June 2020 Trial Date

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We previously reported that in the ongoing Genentech v. Amgen litigation regarding Amgen’s proposed bevacizumab biosimilar, Mvasi™, Amgen moved to dismiss Genentech’s declaratory judgement counts relating to when Amgen could...more

Fox Rothschild LLP

Judge Sleet Grants Amgen’s Motion To Dismiss Genetech’s Commercial Marketing Claim Without Prejudice

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By Memorandum Opinion entered by The Honorable Gregory M. Sleet in Genentech, Inc. et al. v. Amgen Inc., Civil Action No. 17-1407-GMS (D.Del. April 17, 2018), the Court granted defendant Amgen’s motion to dismiss the claim of...more

Goodwin

Amgen’s Motion to Dismiss Genentech’s Complaint in the Delaware Mvasi Litigation

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As we previously reported, Genentech has filed two pending cases (Case Nos. 1:17-cv-01407 and 1:17-cv-01471) in the District of Delaware related to Amgen’s proposed Mvasi (bevacizumab-awwb), a biosimilar of Genentech’s...more

Goodwin

Magistrate Judge Recommends Dismissal of Amgen v. Coherus (Pegfilgrastim) Suit

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We have been following the Delaware Amgen v. Coherus (pegfilgrastim case). In response to Amgen’s Complaint, Coherus filed a motion to dismiss the entire suit arguing that Amgen’s Complaint failed to state a plausible claim...more

Goodwin

Genentech Moves To Dismiss Amgen’s California Bevacizumab DJ Action

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We previously reported on Amgen’s complaint in the Central District of California seeking a declaratory judgment that 27 Genentech patents are not infringed by Genentech’s bevacizumab biosimilar (Mvasi®). On November 15,...more

Goodwin

Genentech to Move to Dismiss Amgen DJ Complaint Regarding Mvasi (Bevacizumab-AWWB)

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We previously reported on Amgen’s complaint, in the Central District of California, seeking a declaratory judgment that MvasiTM (bevacizumab-awwb) does not infringe 27 Genentech patents, that those patents are invalid, and...more

Goodwin

Coherus Requests Stay Of Discovery in Amgen v. Coherus

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We previously reported, Amgen filed a BPCIA suit against Coherus Biosciences, Inc., relating to its aBLA for its pegfilgrastim (Neulasta®) biosimilar. In response, Coherus filed a motion to dismiss the suit arguing that...more

Patterson Belknap Webb & Tyler LLP

Amgen’s Federal Circuit Appeal to Address Important BPCIA Disclosure Issue

The Federal Circuit has now issued two decisions interpreting the Biologics Price Competition and Innovation Act of 2009 (BPCIA). In Amgen v. Sandoz, the first decision to interpret the BPCIA, the majority held that...more

Goodwin

Amgen v. Hospira: Amgen’s Appeal to the Fed. Cir. Will Proceed on the Merits

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As we reported, in a litigation regarding Hospira’s planned biosimilar for Amgen’s epoetin alfa, sold under the brand names Epogen and Procrit, in May, 2016, the District Court (D.Del., J. Andrews) denied Amgen’s motion to...more

Fish & Richardson

Federal Circuit Denies Motion to Dismiss Appeal of BPCIA-Related Discovery Order

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The Federal Circuit has denied Hospira’s motion to dismiss Amgen’s appeal of a discovery order in an underlying BPCIA district court litigation (Civil Action No. 15-cv-00839, D. Del.) and has instructed the parties to address...more

Goodwin

Court Denies Hospira’s Motion to Dismiss BPCIA Notice Claims in Amgen v. Hospira

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The District Court (D. Del., J. Andrews) has denied Hospira’s Motion to Dismiss in Amgen v. Hospira. As we’ve covered previously (see our posts here and here), Hospira moved to dismiss Count I of Amgen’s amended...more

Goodwin

Amgen’s Appeal of District Court Discovery Rulings in Amgen v. Hospira

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As we covered in a previous post, the Court in Amgen v. Hospira ruled on some novel issues relating to litigation under the BPCIA during a hearing on discovery issues a few months ago. Background: To recap: this...more

Patterson Belknap Webb & Tyler LLP

Judge Dismisses Amgen’s BPCIA Declaratory Judgment Action Against Sandoz

Judge Chesler of the U.S. District Court for the District of New Jersey has dismissed one of Amgen’s pending lawsuits against Sandoz under the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act...more

McDermott Will & Emery

ANDA Update - Volume 2, Number 2

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180-Day Notice Period for Biosimilar Approval Is Always Mandatory and Enforceable by Injunction - Amgen Inc., v. Apotex Inc., (Fed. Cir. July 5, 2016) - A year after analyzing the patent dance and notice...more

Fish & Richardson

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

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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

Goodwin

Amgen v. Hospira: Court Considers Issues Regarding the Scope of Discovery and the RPS’s Ability to Assert Additional Patents in...

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In a recent hearing held in Amgen v. Hospira, the parties offered arguments on some novel issues relating to litigation under the BPCIA, particularly: - ..Whether a reference product sponsor (“RPS”) can compel a...more

Bryan Cave Leighton Paisner

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

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