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Amgen v Hospira Biosimilars

Goodwin

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

Goodwin

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

Goodwin

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

Goodwin

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

Goodwin

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

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

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

Goodwin

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

Goodwin

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

Goodwin

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

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

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

Goodwin

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

Goodwin

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

McDermott Will & Emery

No Right to Discovery of Unidentified Patents During BPCIA Litigation

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Addressing for the first time the issue of whether a sponsor has the right to obtain discovery related to infringement of non-asserted patents in a biosimilar litigation, the US Court of Appeals for the Federal Circuit...more

Goodwin

Amgen v. Hospira: Litigation Update

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With the September 18, 2017 trial date fast approaching, the district court in Amgen v. Hospira last week denied Hospira’s motion for summary judgment of non-infringement of its proposed biosimilar of Epogen®/Procrit®...more

Patterson Belknap Webb & Tyler LLP

Federal Circuit Confirms Innovators Must Sue Blind When Biosimilar Makers Withhold Information

On August 10, 2017, the Federal Circuit issued its decision in Amgen v. Hospira. It dismissed Amgen’s interlocutory appeal from a discovery order on jurisdictional grounds and denied a writ of mandamus ordering the district...more

McDonnell Boehnen Hulbert & Berghoff LLP

Amgen Inc. v. Hospira, Inc. (Fed. Cir. 2017)

In the third installment of the "Amgen v." trilogy of BPCIA Federal Circuit cases, the Court in Amgen Inc. v. Hospira, Inc. answered a question that had been lingering since the very first case -- can a reference product...more

Goodwin

Amgen Seeks Preliminary Injunction Against Hospira’s Launch of Epoetin Alfa Biosimilar

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On Friday, in the ongoing Amgen v. Hospira district court litigation regarding Hospira’s proposed biosimilar of Epogen®/Procrit® (epoetin alfa), Amgen filed a motion for preliminary injunction seeking to enjoin Hospira from...more

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