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Greenbaum, Rowe, Smith & Davis LLP

First Circuit Decision Regarding Anti-Kickback Statute Standard Widens Circuit Split and Creates Potential for Supreme Court...

The U.S. Court of Appeals for the First Circuit, in United States v. Regeneron, has joined the Sixth and Eighth Circuits in adopting the “but-for” standard to find that a violation of the Anti-Kickback Statute (AKS) triggers...more

DLA Piper

The Federal Circuit Widens The ITC as a Venue for Life Sciences

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Federal Circuit reshapes foundational requirements for viability of a case in the ITC - Pharmaceutical and life sciences companies have historically been rare participants before the International Trade Commission (ITC) – in...more

Fish & Richardson

Federal Circuit Evaluates Enablement for Antibody Claims for the First Time Since Amgen v. Sanofi in Baxalta Inc. et al. v....

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On May 18, 2023, the Supreme Court in Amgen Inc. v. Sanofi unanimously affirmed the Federal Circuit’s holding that U.S. Patent Nos. 8,829,165 and 8,859,741 did not enable certain functional genus claims describing a class of...more

A&O Shearman

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

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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

Skadden, Arps, Slate, Meagher & Flom LLP

Inside the Courts – An Update From Skadden Securities Litigators - May 2023

Supreme Court Hears Argument on Traceability Requirement in Circuit-Split Slack v. Pirani - Key Points - - Before the end of June, the U.S. Supreme Court is expected to issue a decision in a high-profile securities case...more

Goodwin

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

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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

Goodwin

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

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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

WilmerHale

Unprecedented State Law on Pharmaceutical “Reverse Payments” Goes Into Effect

WilmerHale on

A new California law, Preserving Access to Affordable Drugs, AB-824 (the Act), which is aimed at curbing reverse-payment patent settlements, took effect on January 1. The Act codifies a presumption that any transfer of value...more

Goodwin

BREAKING NEWS: Federal Circuit Affirms Amgen’s $70 Million Damages Award Against Pfizer Unit

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This morning, a three-judge panel of the U.S. Court of Appeals for the Federal Circuit issued a 24-page opinion affirming the district court’s judgment in favor of Amgen in its four-year long BPCIA patent ligation against...more

Goodwin

Biosimilar Appellate Roundup: Upcoming Oral Arguments and Decisions

Goodwin on

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

Robins Kaplan LLP

Financial Daily Dose 11.19.2019 | Top Story: T-Mobile Chief John Legere to Leave Company in April

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T-Mobile chief and fan-of-magenta John Legere has announced that he’ll be stepping down in April at the end of his current contract. Legere will be succeeded by Mike Sievert, the carrier’s current president and COO....more

Skadden, Arps, Slate, Meagher & Flom LLP

Cross-Border Investigations Update - September 2019

This issue of Skadden’s semiannual Cross-Border Investigations Update takes a close look at recent cases, regulatory activity and other key developments, including a review of the first year of GDPR enforcement, analysis of...more

McCarter & English, LLP

License To Sell Kills Patent: Supreme Court Holds Confidential Sales May Invalidate Patents In Helsinn Healthcare S.A. V. Teva...

Can a confidential agreement between a pharmaceutical company and a distributor constitute a patent-invalidating offer for sale of a pharmaceutical product, even if information about the product is never revealed to the...more

Carlton Fields

State Of Louisiana, As Absent Class Member, Escapes CAFA Settlement Trap

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The Third Circuit Court of Appeals affirmed a Pennsylvania district court decision holding the Eleventh Amendment to the United States Constitution prevented a private party from enjoining the state of Louisiana from bringing...more

Orrick, Herrington & Sutcliffe LLP

The World in US Courts: Orrick's Quarterly Review of Decisions Applying US Law to Global Business and Cross-Border Activities

Alien Tort Statute (ATS)/Torture Victims Protection Act (TVPA)/Anti-Terrorism Act (ATA) - District Court Dismisses ATS Claim Where Alleged Conduct in US Was Not Directly Linked to Injuries Claimed in Other Countries - ...more

Patterson Belknap Webb & Tyler LLP

Amgen’s Federal Circuit Appeal: the Importance of Manufacturing Information to Biosimilar Litigation

Amgen has filed its appeal brief in Amgen v. Hospira, following the Federal Circuit’s denial of Hospira’s motion to dismiss the appeal for lack of jurisdiction. The appeal presents an important question for biosimilar...more

Proskauer Rose LLP

Third Circuit Rejects Presumption of Irreparable Harm for Injunctive Relief under Lanham Act

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Following a series of recent appellate decisions across the spectrum of intellectual property disciplines, including the fields of patent, copyright and trade secrets, the Court of Appeals for the Third Circuit has ruled that...more

McDermott Will & Emery

A Compound Is Obvious Where Only Minor Changes to a Prior Art “Lead Compound” Are Required to Make the Claimed Compound

Bristol-Myers Squibb Co. v. Teva Pharms USA, Inc. - Addressing the obviousness of a claimed compound where a person of skill would need to make only minor changes to a lead compound to arrive at the claimed invention,...more

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