News & Analysis as of

Motion to Dismiss Pharmaceutical Patents

McDonnell Boehnen Hulbert & Berghoff LLP

Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc. (Fed. Cir. 2024)

The Federal Circuit once again had an opportunity to opine on the extent of behavior by a generic drugmaker who opts to accept a "section viii carve-out" in its FDA approval (resulting in a so-called "skinny label) on...more

Knobbe Martens

Federal Circuit Review | June 2024

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Reliably Determining Reasonable Royalty Rates from Lump Sum Licenses - In Ecofactor, Inc. V. Google LLC, Appeal No. 23-1101, The Federal Circuit held that license agreements containing a lump sum payment “based on” a royalty...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - May 2024 #3

Copan Italia SPA v. Puritan Med. Prods. Co. LLC, Appeal No. 2022-1943 (Fed. Cir. May 14, 2024) The Federal Circuit’s only precedential opinion concerning a patent case this week had nothing to do with patent law....more

Rothwell, Figg, Ernst & Manbeck, P.C.

The Current mRNA/LNP Patent Litigation Landscape

Several patent litigations have been filed involving mRNA pioneers such as Moderna, Inc. and BioNTech, Inc. (with Pfizer) over the past year relating to sales of the Moderna and BioNTech/Pfizer COVID-19 vaccine products...more

Jones Day

Inducement Suit Proceeds Against Insurance Company for Encouraging Use of Generic Drug

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The case relates to so-called "skinny labels," in which the filer of an Abbreviated New Drug Application ("ANDA") seeks FDA approval to market a generic version of a branded drug, but "carves out" from its label certain...more

Jones Day

Board Requires Settlement Agreement to Dismiss Pre-Institution Proceeding

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Biofrontera AG (“Petitioner”) filed an unopposed motion to dismiss the petition during the preliminary phase of the proceedings.  Here, DUSA Pharmaceuticals, Inc. (“Patent Owner”) had not yet filed a Preliminary Response, and...more

Goodwin

Litigation Update: AbbVie v. Alvotech hf (Adalimumab)

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We have previously reported on AbbVie’s first and second wave suits against Alvotech hf (Alvotech) in the Northern District of Illinois regarding an adalimumab biosimilar. In the first wave suit, on October 5, 2021 AbbVie...more

Haug Partners LLP

The Federal Circuit Analyzes Venue Requirements in Hatch-Waxman Cases

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Since the Supreme Court’s decision in TC Heartland (137 S. Ct. 1514 (2017)), the venue statute for patent cases, 28 U.S.C. § 1400(b), has been interpreted to mean that venue is proper only where the defendant “resides” or...more

McDonnell Boehnen Hulbert & Berghoff LLP

Celgene Corp. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2021)

The question of the proper court for a branded pharmaceutical maker to bring suit against an Abbreviated New Drug Application filer under the Hatch-Waxman Act is surprisingly unsettled seeing as the Act was enacted in 1984. ...more

Schwabe, Williamson & Wyatt PC

‎Latest Federal Court Cases - August 2021 #2

Our Case of the Week this week is a re-write of our Case of the Week on October 5, 2020. The case involves a drug that could be used for multiple therapeutic purposes. A patent covered use of the product for a specific...more

Proskauer - Life Sciences

A Guiding Light for the Research Safe Harbor and “Research Tools”?

Allele v. Pfizer – The Basics. On April 23, 2021 Pfizer, Inc., BioNTechSE, and BioNTech US, Inc. (“Pfizer and BioNTech”) filed a joint reply supporting of their previously filed motion to dismiss a patent infringement...more

Goodwin

Genentech and Centus Settle Bevacizumab Litigation

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On November 12, 2020, Genentech filed a complaint in the Eastern District of Texas alleging that the Centus Biotherapeutics, Ltd., Fujifilm Kyowa Kirin Biologics Co., Ltd., Fujifilm Corp., and Kyowa Kirin Co, Ltd....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

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - March 2021

The March 2021 issue of Sterne Kessler's MarkIt to Market® newsletter discusses fair use cases for photographs and three recent developments in the cannabis space. We also highlight recent accolades earned by Sterne Kessler's...more

McDonnell Boehnen Hulbert & Berghoff LLP

Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2020)

Somewhat remarkably, there is no settled Federal Circuit precedent regarding where a patentee can bring suit against a generic competitor in Hatch-Waxman litigation under 35 U.S.C. § 271(e)(2).  While recognizing that this...more

Goodwin

Judge Holds AbbVie Did Not Violate Antitrust Laws With Humira Patent Thicket

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We have previously reported on the class action suit against AbbVie alleging misconduct and antitrust violations in connection with AbbVie’s assertion of its patents against biosimilar manufacturers to prevent the sale of...more

Goodwin

Recent Developments in Humira (adalimumab) Antitrust Suit

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We have previously reported on the class action suit against AbbVie alleging misconduct and antitrust violations in connection with AbbVie’s assertion of patents to prevent the sale of biosimilar versions of Humira® in the...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

McDonnell Boehnen Hulbert & Berghoff LLP

Biogen Int'l v. Banner Life Sciences LLC (Fed. Cir. 2020)

In 1984, Senator Orrin Hatch (R-UT) and Rep. Henry Waxman (D-CA) shepherded a grand legislative compromise through Congress that balanced the rights and solved inefficient regulatory consequences for both branded and generic...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

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

Goodwin on

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

Robins Kaplan LLP

AstraZeneca AB v. Mylan Pharms. Inc.

Robins Kaplan LLP on

BECAUSE DELAWARE WAS AN IMPROPER VENUE FOR DEFENDANT MYLAN, AND DEFENDANT 3M DEMONSTRATED THAT VARIOUS FACTORS WEIGHED IN FAVOR OF A TRANSFER, THE CASE WAS TRANSFERRED TO THE NORTHERN DISTRICT OF WEST VIRGINIA. Case...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

Robins Kaplan LLP

Duke Univ. v. Akorn, Inc.

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THE COURT GRANTED PLAINTIFFS’ MOTION TO DISMISS DEFENDANT’S ANTITRUST AND PATENT MISUSE COUNTERCLAIMS AND RELATED AFFIRMATIVE DEFENSES. Case Name: Duke Univ. v. Akorn, Inc., Civ. No. 3:18-cv-14035-BRM-TJB, 2019 U.S. Dist....more

Robins Kaplan LLP

ANDA Litigation Settlements - Fall 2019

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Please see full Chart below for more information....more

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