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Hospira Patent Infringement

Knobbe Martens

Federal Circuit Review - September 2021

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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

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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

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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

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

Robins Kaplan LLP

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

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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

Robins Kaplan LLP

Hospira, Inc. v. Fresenius Kabi USA, LLC

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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.

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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

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 Sues Pfizer Over Proposed Neulasta Biosimilar

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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

Goodwin

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

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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

Morgan Lewis

Federal Circuit: Inherency in an Obviousness Analysis

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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

Knobbe Martens

Non-Prior Art Evidence May Be Used to Prove Inherency

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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

Goodwin

Year in Review: Top Five Legal Developments of 2019 Impacting Biosimilars

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As we close out another calendar year, we look back at the top legal developments of 2019 that could influence the market for biologics and biosimilars. These five major court decisions will likely impact the legal strategy...more

Knobbe Martens

Safe Harbor Defense Under 35 U.S.C. §271(e)(1) Requires That the Accused Activity Is Solely for Uses Reasonably Related to...

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AMGEN INC. v. HOSPIRA, INC. Before Moore, Bryson, and Chen.  Appeal from the United States District Court for the District of Delaware. Summary: Biological engineering activity that would otherwise constitute patent...more

Robins Kaplan LLP

Eli Lilly and Co. v. Hospira, Inc.

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WHILE THE DISTRICT COURT’S FINDING OF LITERAL INFRINGEMENT WAS REVERSED, THE FEDERAL CIRCUIT AFFIRMED THE DISTRICT COURT’S FINDING OF INFRINGEMENT UNDER THE DOCTRINE OF EQUIVALENT BECAUSE THE NARROWING AMENDMENT WAS...more

Foley & Lardner LLP

Doctrine Of Equivalents Not Barred By Claim Amendments

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Recent Federal Circuit decisions demonstrate that the doctrine of equivalents is alive and well, and not always barred by claim amendments. In both Ajinomoto Co. v. ITC and Eli Lilly and Co. v. Hospira, Inc., the Federal...more

McDonnell Boehnen Hulbert & Berghoff LLP

Eli Lilly & Co. v. Hospira, Inc. (Fed. Cir. 2019)

In its decision in a consolidated appeal, Eli Lilly & Co. v. Hospira, Inc. and Eli Lilly & Co. v. Dr. Reddy's Laboratories, Ltd., the Federal Circuit had the occasion to apply the Supreme Court's distinction regarding the...more

Robins Kaplan LLP

Hospira, Inc. v. Fresenius Kabi USA, LLC

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Case Name: Hospira, Inc. v. Fresenius Kabi USA, LLC, Civ. Nos. 16 C 651, 17 C 7903, 2018 U.S. Dist. LEXIS 212916 (N.D. Ill. Dec. 17, 2018) (Pallmeyer, J.)....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

Goodwin

Hospira Appeals $80 Million Judgment in Epoetin Alfa Biosimilar Case

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As we reported, last month in the Amgen v. Hospira litigation concerning Hospira’s Retacrit™ (epoetin alfa) biosimilar, the Delaware district court entered final judgment against Hospira, awarding Amgen $70 million in damages...more

Goodwin

Final Judgment Entered Against Hospira for Infringing Amgen’s Epoetin Patent

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As we have previously reported, a jury in September 2017 issued a $70,000,000 verdict against Hospira based on its drug substance manufacturing activity in 2013-2015 in connection with its biosimilar of Amgen’s Epogen®...more

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