News & Analysis as of

Amgen v Hospira

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Parties in Amgen v. Hospira Filgrastim Litigation Stipulate to Dismissal of All Claims

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On September 2, 2021, the parties in the Amgen v. Hospira (D. Del., No. 18-1064) Neupogen®/filgrastim litigation submitted a stipulation and proposed order to dismiss all claims and counterclaims in the litigation, with...more

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Summary Judgment Practice Scheduled in Amgen v. Hospira Pegfilgrastim Case

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As we previously reported, Judge Connolly of the District of Delaware stayed the dispute between Amgen and Hospira last month, pending a determination on whether the Court should entertain summary judgment practice on the...more

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Amgen v. Hospira Pegfilgrastim Case Stayed Pending Potential Summary Judgment Practice

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On June 16, 2021, the District Court for the District of Delaware issued a claim construction order construing a key term in the ongoing patent dispute between Amgen and Hospira over Hospira’s proposed biosimilar of Amgen’s...more

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Delaware Court Denies Motion to Consolidate Filgrastim Cases Against Pfizer

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The U.S. District Court for the District of Delaware has denied Amgen’s motion to consolidate a recently filed action against Pfizer and its affiliate Hospira relating to Hospira’s filgrastim biosimilar with an ongoing...more

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Pfizer Moves to Dismiss Amgen’s Suit Over Proposed Neulasta Biosimilar

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As we previously reported, on February 11, 2020, Amgen sued Pfizer and its affiliate Hospira, alleging that their proposed biosimilar of Amgen’s NEULASTA (pegfilgrastim) would infringe U.S. Patent No. 8,273,707 (“the ’707...more

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Federal Circuit Denies Hospira’s Petition to Rehear Safe Harbor Ruling in Epoetin Biosimilar Dispute

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The Federal Circuit has declined to reconsider its December 2019 affirmance of the district court ruling in the Amgen v. Hospira (epoetin alfa) dispute.  As we have previously reported, that ruling upheld a jury verdict...more

Patterson Belknap Webb & Tyler LLP

Hospira Seeks En Banc Review of the Federal Circuit’s “Safe Harbor” Ruling in Amgen v. Hospira

In December, in Amgen v. Hospira, 944 F.3d 1327 (Fed. Cir. 2019), a panel of the Federal Circuit issued the first decision applying the statutory Safe Harbor of 35 U.S.C. § 271(e)(1) to BPCIA patent litigation. ...more

Kramer Levin Naftalis & Frankel LLP

Biosimilar Litigation Trends and Lessons Learned in 2019

It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more

Nelson Mullins Riley & Scarborough LLP

A Different Analysis for Manufacturing Method Patents under the 35 U.S.C. § 271 (e)(1) Safe Harbor Provision?

On December 16, 2019, the Federal Circuit affirmed a Delaware jury verdict finding that Hospira infringed Amgen’s method of manufacturing patent on erythropoietin (EPO) and that Amgen was entitled to $70 million in damages...more

Patterson Belknap Webb & Tyler LLP

Federal Circuit Clarifies Limits of Safe Harbor Defense in Amgen v. Hospira

Recently, in Amgen Inc. v. Hospira, Inc., the Federal Circuit clarified the limits of the Safe Harbor defense in cases involving patented manufacturing methods....more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - December 2019 #3

PATENT CASE OF THE WEEK - Blackbird Tech LLC v. Health in Motion LLC, Appeal No. 2018-2393 (Fed. Cir. Dec. 16, 2019) - In this week’s Case of the Week, the Federal Circuit affirmed a fee award against prevailing...more

Morgan Lewis

Federal Circuit: Finding the Safe Harbor in Drug Development's Choppy Waters

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The US Court of Appeals for the Federal Circuit recently upheld the district court’s denial of a judgment as a matter of law (JMOL) or, alternatively, motion for a new trial, reinforcing the fine line that exists between...more

Mintz - Intellectual Property Viewpoints

Federal Circuit affirms Safe Harbor ruling and $70 million award in Amgen Inc. v. Hospira, Inc.

On December 16, 2019, the Court of Appeals for the Federal Circuit issued an opinion that fully upheld the District of Delaware’s denial of Hospira, Inc.’s motion for judgment as a matter of law (JMOL), or alternative motion...more

Goodwin

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

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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

McDonnell Boehnen Hulbert & Berghoff LLP

Amgen Inc. v. Hospira, Inc. (Fed. Cir. 2019)

The Federal Circuit has grappled with, divisively in some instances, the extent to which the safe harbor provisions of 35 U.S.C. § 271(e)(1) extend to activities not strictly for obtaining regulatory approval, such as...more

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Biosimilar Appellate Roundup: Upcoming Oral Arguments and Decisions

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On December 6, 2019, the Federal Circuit will hear oral argument in a rituximab-related appeal by Biogen.  The appeal stems from a final written decision of the Patent Trial and Appeal Board (PTAB) in an inter partes review...more

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Biosimilar-Related Patent Litigation Updates

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Here are some recent developments in U.S. legal proceedings relating to biosimilars: On December 10, 2018, in the Southern District of Florida, Apotex filed a motion to dismiss the patent infringement complaint that Amgen...more

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Amgen Files Cross-Appeal In Epoetin Alfa Biosimilar Case

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Early last month, we reported that in the Amgen v. Hospira BPCIA litigation concerning Hospira’s Retacrit™ (epoetin alfa) biosimilar, Hospira had filed an appeal to the Federal Circuit from the Delaware district court’s final...more

Wilson Sonsini Goodrich & Rosati

District Court Case Highlights Nuances Associated with Determining If a Generic or Biosimilar Applicant Is Entitled to Protection...

A recent case at the U.S. District Court for the District of Delaware demonstrates how nuanced safe harbor protection under 35 U.S.C. § 271(e)(1) "non-infringement" can be for a pharmaceutical company developing a biosimilar...more

McDonnell Boehnen Hulbert & Berghoff LLP

Amgen Inc. v. Hospira, Inc. (D. Del. 2018)

Intent Matters in Safe Harbor under BPCIA - Earlier this week, Judge Richard G. Andrews, U.S. District Court Judge for the District of Delaware decided a veritable plethora of post-trial motions (by both parties) in Amgen...more

Goodwin

BREAKING NEWS: Jury’s $70M Award Against Hospira for Infringing Amgen’s Epoetin Patent Survives Post-Trial Motions

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As we previously reported, last September a District of Delaware jury issued a verdict that Hospira’s manufacture of 14 batches of drug substance in connection with its proposed biosimilar of Amgen’s Epogen® (epoetin alfa)...more

Goodwin

BPCIA Litigation Updates: Bevacizumab, Trastuzumab, Filgrastim

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More than a dozen BPCIA patent litigations are currently pending in various U.S. district courts. Below are some highlights of activity in some of those cases from this month....more

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Amgen v. Hospira: A Summary of the Parties’ Responsive JMOL Briefs

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As we previously reported, Amgen and Hospira both filed motions asking the Court to partially set aside the jury verdict in the Amgen v. Hospira litigation. In its motion, Hospira had asked the Court to set aside the jury...more

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BPCIA Litigation Roundup (Fall 2017)

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Below is our fall update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates (Summer...more

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Additional Updates: Amgen v. Hospira

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Further to our update yesterday on the Amgen v. Hospira litigation, the parties in the case filed several additional motions yesterday. Following its filing of a motion for judgment as a matter of law under Federal Rule of...more

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