News & Analysis as of

Hospira

Knobbe Martens

Federal Circuit Review - September 2021

Knobbe Martens on

Arguments to the Patent Office That Contradict Information Submitted to the FDA Support an Inference of Deceptive Intent In Belcher Pharmaceuticals v. Hospira, Inc., Appeal No. 20-1799, the Federal Circuit held that a...more

Proskauer - Life Sciences

“About-Face” Representations to FDA Will Be Used Against You

Confronting a life sciences patentee with its statements to regulatory bodies (such as the FDA) is a textbook defense strategy in patent litigation.  After all, communications with regulatory bodies are often performed by...more

Knobbe Martens

Arguments to the Patent Office That Contradict Information Submitted to the FDA Support Inference of Deceptive Intent

Knobbe Martens on

BELCHER PHARMACEUTICALS v. HOSPIRA, INC. Before Reyna, Taranto, and Stoll. Appeal from the District of Delaware. Summary: A patentee committed inequitable conduct by advancing an argument during patent prosecution...more

Goodwin

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

Goodwin on

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

Motion to Dismiss Denied in Amgen v. Hospira BPCIA

Goodwin on

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

Robins Kaplan LLP

Par Pharm., Inc. v. Hospira, Inc.

Robins Kaplan LLP on

Adrenalin® (epinephrine injection) - Case Name: Par Pharm., Inc. v. Hospira, Inc., No. 2020-1273, 2020 WL 6846347 (Fed. Cir. Nov. 23, 2020) (Circuit Judges Dyk, Taranto, and Stoll presiding; Opinion by Taranto, J.)...more

McDonnell Boehnen Hulbert & Berghoff LLP

Par Pharmaceutical, Inc. v. Hospira, Inc. (Fed. Cir. 2020)

It has long been understood that claim construction can, and frequently is, dispositive in patent litigation.  This truism was the basis for the Federal Circuit affirming the District Court's decision against a generic drug...more

Goodwin

Delaware Court Denies Motion to Consolidate Filgrastim Cases Against Pfizer

Goodwin on

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

Robins Kaplan LLP

Hospira, Inc. v. Fresenius Kabi USA, LLC

Robins Kaplan LLP on

Case Name: Hospira, Inc. v. Fresenius Kabi USA, LLC, 946 F.3d 1322 (Fed. Cir. Jan. 9, 2020) (Circuit Judges Lourie, Dyk, and Moore presiding; Opinion by Lourie, J.) (Appeal from N.D. Ill., Pallmeyer, J.)....more

Robins Kaplan LLP

Belcher Pharms., LLC v. Hospira, Inc.

Robins Kaplan LLP on

Case Name: Belcher Pharms., LLC v. Hospira, Inc., No. 17-775-LPS, 2020 WL 1650535 (D. Del. Mar. 31, 2020) (Stark, J.) - Drug Product and Patent(s)-in-Suit: epinephrine injection; U.S. Patent No. 9,283,197 (“the ’197...more

Goodwin

Amgen Sues Pfizer and Hospira for Patent Infringement related to Hospira’s Filgrastim Biosimilar

Goodwin on

Last week, Amgen filed a new complaint against Pfizer and Hospira under the BPCIA for infringement related to Hospira’s filgrastim biosimilar. The action is related to newly granted U.S. Patent No. 10,577,392, which is...more

McDonnell Boehnen Hulbert & Berghoff LLP

DOE Infringers Petition for Certiorari over PHE "Tangential Relationship" Test

Recently, the Federal Circuit has taken up issues relating to infringement under the doctrine of equivalents (DOE) and a related doctrine, prosecution history estoppel (PHE), that limits the scope of equivalents that can be...more

McDonnell Boehnen Hulbert & Berghoff LLP

Life Sciences Court Report - March 2020

About Life Sciences Court Report:  We will periodically report on recently filed biotech and pharma litigation. Allergan USA, Inc. v. Prollenium US Inc. 1-20-cv-00104; filed January 23, 2020 in the District Court of Delaware...more

Goodwin

Amgen Responds to Hospira’s Motion For Rehearing En Banc of the Safe Harbor Ruling in the Epoetin Biosimilar Dispute

Goodwin on

We previously reported that Hospira filed a petition for rehearing en banc of the Federal Circuit’s affirmance of a $70 million damages award to Amgen in the parties’ BPCIA litigation regarding Hospira’s RETACRIT (epoetin...more

Goodwin

District Court Postpones Trial in Amgen v. Hospira Filgrastim Biosimilar Litigation

Goodwin on

As we previously reported, Amgen sued Pfizer and its affiliate Hospira in July 2018 based on Hospira’s submission of an aBLA for a biosimilar of NEULASTA (filgrastim). That same month, Pfizer obtained FDA-approval and, in...more

Goodwin

Amgen Sues Pfizer Over Proposed Neulasta Biosimilar

Goodwin on

On February 11, 2020 Amgen sued Pfizer and its affiliate Hospira for patent infringement based on their proposed biosimilar of NEULASTA (pegfilgrastim). Pegfilgrastim is indicated for decreasing the incidence of infection in...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

Goodwin

Hospira Asks Federal Circuit to Take Fresh Look at Safe Harbor Ruling in Epoetin Biosimilar Dispute

Goodwin on

Last month, a three-judge panel of the Federal Circuit affirmed a Delaware district court’s judgment of infringement against Hospira and $70 million damages award to Amgen in the parties’ BPCIA litigation regarding Hospira’s...more

McDonnell Boehnen Hulbert & Berghoff LLP

Genentech, Inc. v. Hospira, Inc. (Fed. Cir. 2020)

Last week, the Federal Circuit affirmed invalidation of claims to methods for reducing Protein A leaching in affinity column chromatographic methods important inter alia in purifying monoclonal antibodies, in Genentech, Inc....more

McDonnell Boehnen Hulbert & Berghoff LLP

Hospira, Inc. v. Fresenius Kabi USA, LLC (Fed. Cir. 2020)

It seems that memes can be as compelling in the law as in social media, and the meme of the moment in patent law is inherency, particularly as applied to obviousness determinations (see, for example, Persion Pharmaceuticals...more

Morgan Lewis

Federal Circuit: Inherency in an Obviousness Analysis

Morgan Lewis on

The US Court of Appeals for the Federal Circuit held that data obtained after an asserted patent’s priority date may be used to demonstrate what is “necessarily present” in a prior art embodiment. Although the district court...more

Goodwin

Federal Circuit Affirms Biosimilar-Related IPR Appeals; Bevacizumab Injunction Appeal Progresses

Goodwin on

Below we provide an update on some recent developments from this and recent weeks in biosimilar-related cases on appeal before the Federal Circuit. Genentech v. Hospira & U.S., Fed. Cir. Case No. 18-1933 – protein...more

Knobbe Martens

Non-Prior Art Evidence May Be Used to Prove Inherency

Knobbe Martens on

HOSPIRA, INC. V. FRESENIUS KABI USA, LLC - Before Lourie, Dyk, and Moore.  Appeal from the U.S. District Court for the Northern District of Illinois. Summary:  Evidence of the properties of claimed embodiments may be...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

146 Results
 / 
View per page
Page: of 6

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide