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Patents

FTC Seeks to Remove Medical Patents from FDA’s Orange Book

November 21, 2023

The Federal Trade Commission has challenged more than 100 medical patents the agency believes are improperly listed in the FDA Orange Book, a compendium of drug products the FDA has deemed safe and...

Large Entity or Small Entity: A Confusion in the Distinction Could Cause You to Lose Your Patent

September 09, 2021

Anyone who has obtained a patent can attest that it is an expensive endeavor. The United States Patent and Trademark Office (USPTO) requires a fee for nearly every step taken by the applicant....

HHS Orders FDA to Stand Down on LDTs

August 24, 2020

The Department of Health and Human Services issued an Aug. 19 rescission order to the FDA directing the agency to cease requiring any premarket reviews for lab-developed tests (LDTs), a change...