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License Agreements Food and Drug Administration (FDA)

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

PilieroMazza PLLC

Board Rejects Software Company’s Attempt to Enforce License Agreement Against Government Agency

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Software companies frequently choose to sell their products to the government through resellers as a cost-effective way to reach the federal marketplace with minimal compliance obligations. But even when the government...more

Foley & Lardner LLP

Food & Beverage Supply Chain Desk Reference

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Foley & Lardner’s Food & Beverage Industry Team has authored a new handbook entitled, “Food & Beverage Supply Chain Desk Reference.” For the sake of convenience, the Desk Reference includes quick answers to your legal needs...more

Robins Kaplan LLP

ANDA Litigation Settlements - Winter 2019

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

Goodwin

FDA Approves Ogivri, Mylan’s Biosimilar Version of Herceptin

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Today, the FDA announced that it has approved Mylan’s Ogivri (trastuzumab-dkst) as a biosimilar to Genentech and Roche’s Herceptin (trastuzumab). Ogivri is indicated for adjuvant treatment of breast cancer and treatment of...more

Fenwick & West LLP

Riddle Me This: The Federal Circuit Provides a Measure of Clarity to the Enigmatic Biosimilar Approval Pathway

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In Amgen Inc. v. Sandoz Inc. (No. 2015-1499), a fractured panel of the Federal Circuit Court of Appeals recently decided two issues of first impression relating to the Biologics Price Competition and Innovation Act of 2009...more

Saul Ewing LLP

White Collar Watch - July 2014

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In This Issue: - Move over Big Pharma: Health care is not the only industry susceptible to False Claims Act scrutiny - Third Circuit affirms dismissal of False Claims Act suit, citing contract ambiguity ...more

McDermott Will & Emery

Combining Two Drugs Is Not Always Obvious

Sanofi-Aventis Deutschland GMBH v. Glenmark Pharmaceuticals Inc. - Addressing the obviousness of combining two known hypertension medications, the U.S. Court of Appeals for the Federal Circuit upheld a ruling of...more

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