News & Analysis as of

35 U.S.C. § 271(e)(1) Patent Litigation

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

Womble Bond Dickinson

Is the Federal Circuit’s Holding that the Presumption Against Extraterritoriality Making Unavailable Damages Based on a Patentee’s...

Womble Bond Dickinson on

Case at a Glance: The Court will consider whether the text of 35 U.S.C. § 271(f) imposes liability on those supplying from the United States components of a patented invention “in such a manner as to actively induce the...more

Patterson Belknap Webb & Tyler LLP

All-or-Nothing Damages Strategy Leaves Promega with Nothing

The Federal Circuit’s recent decision in Promega Corp. v. Life Technologies Corp. is a cautionary tale that failure to present evidence of damages closely tied to each alternative basis of liability may result in a hollow...more

Patterson Belknap Webb & Tyler LLP

Following Biosimilar Trial, Jury Awards Amgen $70 Million for Pfizer’s Pre-Approval Infringement of Now-Expired EPO Patent

In one of the first Biologics Price Competition and Innovation Act (BPCIA) litigations to reach trial, a jury on Friday awarded Amgen $70 million in damages for Pfizer’s infringement of one of Amgen’s expired patents...more

McDonnell Boehnen Hulbert & Berghoff LLP

Icon Health & Fitness, Inc. v. Polar Electro Oy (D. Utah 2017)

Claims Lacking Details Found to be Directed to Patent-Ineligible Subject Matter - In the U.S. District Court for the District of Utah (Central Division), Polar filed a motion for judgment on the pleadings contending that...more

McDermott Will & Emery

US Supreme Court Rules Export of Single Component of Patented Combination Does Not Impose Liability under Section 271(f)(1)

McDermott Will & Emery on

On February 22, 2017, in reversing the decision of the US Court of Appeals for the Federal Circuit, an essentially unanimous US Supreme Court ruled that the “supply of a single component of a multi-component invention for...more

McDonnell Boehnen Hulbert & Berghoff LLP

SCOTUS: Section 271(f)(1) Does not Embrace the Supply of a Single Component

In an opinion by Justice Sotomayor, the Supreme Court today reversed the Federal Circuit's decision in Life Tech. Corp. v. Promega Corp. involving the proper scope of infringement under 35 U.S.C. § 271(f)(1). This provision...more

Fenwick & West Life Sciences Group

Will the Supreme Court Review Whether FDA-Mandated Bioequivalence Testing to Maintain Approval Falls Within the § 271(e)(1) Safe...

The Supreme Court has been asked to review whether the safe harbor established by 35 U.S.C. § 271(e)(1) encompasses a generic drug manufacturer’s bioequivalence testing performed only as a condition of maintaining FDA...more

Kelley Drye & Warren LLP

Supreme Court To Review § 271(f)(1) Liability For Exporting A Component Of A Patented Invention (Life Tech V. Promega)

On June 27, 2016, the U.S. Supreme Court decided to review the Federal Circuit’s ruling of infringement under 35 U.S § 271(f)(1) based on supplying from the United States a component of a patented invention. This case may...more

Kelley Drye & Warren LLP

En banc Federal Circuit broadens multiple-actor direct infringement (Akamai v. Limelight)

Today, the Federal Circuit sitting en banc changed direction again on § 271(a) direct infringement and ruled that Limelight was liable for direct infringement based on substantial evidence supporting the jury verdict of...more

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