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Patents Technology Prescription Drugs

McDermott Will & Emery

The Devil Is in the Details: Bioequivalence, In Vitro Testing Not Enough to Establish Infringement

McDermott Will & Emery on

Addressing for the first time the issue of whether bioequivalence data and in vitro testing can show that an abbreviated new drug application (ANDA) product with different immediate and delayed release portions infringed on a...more

Fenwick & West LLP

FTC Employs New Tactic in Effort Against Drug Makers Alleged to Have Improperly Listed Patents in the FDA’s Orange Book

Fenwick & West LLP on

On Nov. 7, 2023, the Federal Trade Commission (FTC) announced it is disputing the listing of more than 100 patents in the Food and Drug Administration’s (FDA) “Approved Drug Products with Therapeutic Equivalence Evaluations,”...more

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