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A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous... more +
A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous thirty days. less -
Manatt, Phelps & Phillips, LLP

Supreme Court Holds Invalid Cholesterol Drug Patent That Covered Millions of Undisclosed Antibodies

Manatt, Phelps & Phillips, LLP on

In Amgen Inc. v. Sanofi, the Supreme Court unanimously held that “[i]f a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent specification must enable a person skilled in...more

Axinn, Veltrop & Harkrider LLP

The Pleading Standard for Complex Technology? It's Complex.

Axinn, Veltrop & Harkrider LLP on

Can a patentee really just take a pass on alleging that an accused product meets a limitation in an asserted claim, even where the case involves complex technology? That's the upshot of the court's decision in Lindis Biotech,...more

A&O Shearman

Half an hour for a bifurcation: UPC Central Division rejects preliminary objection after first oral hearing

A&O Shearman on

The decision concerns the time of filing and admissibility of a revocation action at the Central Division when a parallel infringement action is filed at a local division (Art. 33(4) UPCA). Art 33(4) UPCA states that...more

Levenfeld Pearlstein, LLC

Enablement Unchanged: Amgen v. Sanofi and the Future of Software Patents

Levenfeld Pearlstein, LLC on

In a unanimous ruling, the Supreme Court of the United States (SCOTUS) addressed the enablement requirement under Section 112 of the Patent Act, placing this into sharper focus with the Amgen v. Sanofi case. This landmark...more

Burns & Levinson LLP

Amgen v. Sanofi and Points Beyond

Burns & Levinson LLP on

A week ago Thursday, the Supreme Court issued its decision in the Amgen v. Sanofi case, affirming the judgment of the Court of Appeals for the Federal Circuit, that the claims of the two patents Amgen asserted against Sanofi...more

Procopio, Cory, Hargreaves & Savitch LLP

5 Takeaways from the U.S. Supreme Court Decision in Amgen v. Sanofi

Procopio, Cory, Hargreaves & Savitch LLP on

The U.S. Supreme Court’s unanimous decision in Amgen Inc. v. Sanofi (referred to as the Amgen decision) likely makes it more difficult for life sciences companies to obtain broad patents claiming an entire genus of antibodies...more

McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court Renders Decision in Amgen v. Sanofi: Three Takeaways

McDonnell Boehnen Hulbert & Berghoff LLP on

The Supreme Court handed down its decision in Amgen v. Sanofi today. In Justice Gorsuch’s unanimous opinion, the Court held that the scope of the claims at issue were much broader than the 26 expressly disclosed antibodies....more

McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court Decides Amgen v. Sanofi; Status Quo Extended

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The Supreme Court handed down its decision in Amgen v. Sanofi today. In Justice Gorsuch’s unanimous opinion, the Court held that the scope of the claims at issue were much broader than the 26 expressly disclosed antibodies....more

Troutman Pepper

How the Supreme Court’s Clarification of Enablement in Amgen May Affect the Future of Patent Law

Troutman Pepper on

On November 4, the U.S. Supreme Court granted Amgen’s petition to review the “enablement requirement” of Section 112 of the Patent Act. See generally Amgen Inc., v. Sanofi, No. 21-757 (U.S. 2022). The Court’s decision will...more

Goodwin

BREAKING NEWS: Genentech and Amgen Settle HERCEPTIN and AVASTIN Biosimilar Disputes

Goodwin on

Today, Genentech and Amgen jointly filed stipulations in the U.S. District Court for the District of Delaware dismissing their BPCIA litigations concerning Amgen’s biosimilars of Genentech’s HERCEPTIN (trastuzumab) and...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

Kramer Levin Naftalis & Frankel LLP

Biosimilar Maker Leverages IPR to Avoid Patent Dance and Obtain Early Market Entry

Kramer Levin Naftalis & Frankel LLP on

Amgen Inc. and Alexion Pharmaceuticals Inc. settled three Inter Partes Review (IPR) proceedings concerning patents covering Alexion’s blockbuster humanized monoclonal antibody drug Soliris®, with Amgen obtaining a...more

Goodwin

Federal Circuit Hears Oral Argument in Bevacizumab Preliminary Injunction Appeal

Goodwin on

Today, a panel of the Federal Circuit (Judges Moore, O’Malley, and Hughes) heard oral argument in Genentech v. Amgen. The case is on appeal from the District of Delaware, where the court denied Genentech’s motion for...more

Smart & Biggar

First decision under amended PMNOC Regulations: Federal Court finds Amgen’s filgrastim patent obvious

Smart & Biggar on

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

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

Goodwin

Amgen v. Sanofi Praulent® Litigation Once Again on Appeal before the Federal Circuit

Goodwin on

We have previously reported on the Amgen v. Sanofi Praulent® litigation, which has been ongoing since late 2014. After the parties stipulated to infringement, a jury in the District of Delaware found in favor of Amgen and the...more

Goodwin

District Court of Delaware Construes “Following Fermentation” in Genentech v. Amgen Trastuzumab and Bevacizumab Cases

Goodwin on

We have previously reported on the BPCIA Genentech v. Amgen cases relating to trastuzumab and bevacizumab. This week, Judge Connolly construed the term “following fermentation” as it relates to U.S. Patent No. 8,574,869 (“the...more

Goodwin

BREAKING NEWS: Federal Circuit Rejects Genentech’s Bid to Block Sales of Amgen’s Trastuzumab Biosimilar

Goodwin on

Following the oral argument two days ago, the U.S. Court of Appeals for the Federal Circuit today affirmed the lower court’s denial of Genentech’s motion for a preliminary injunction to enjoin sales of Amgen’s KANJINTI...more

McDonnell Boehnen Hulbert & Berghoff LLP

Life Sciences Court Report - March 2020

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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

McDonnell Boehnen Hulbert & Berghoff LLP

Life Sciences Court Report - February 2020

McDonnell Boehnen Hulbert & Berghoff LLP on

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...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

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

Goodwin

Biosimilar Appellate Update: Genentech v. Immunex, Genentech v. Amgen, Janssen v. Celltrion

Goodwin on

Below we provide an update on some recent developments from several biosimilar-related cases on appeal before the Federal Circuit. Genentech v. Immunex Rhode Island, Fed. Cir. Case No. 19-2155 – briefing complete in...more

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