Bryan Walsh

Bryan Walsh

Hogan Lovells

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Republican FTC renews challenges to Orange Book patent listings

On May 21, 2025 the Federal Trade Commission (FTC) issued renewed warning letters to five companies regarding over 200 allegedly improperly-listed patents in the Food and Drug Administration (FDA)’s Orange Book. Announcing...more

5/27/2025  /  Antitrust Violations , Drug Pricing , Enforcement Actions , FDA Approval , FTC Act , Generic Drugs , Hatch-Waxman , Orange Book , Patent Litigation , Pharmaceutical Patents

Reissued patents get Hatch-Waxman PTE based on original patent date, CAFC rules

The U.S. Court of Appeals for the Federal Circuit (CAFC) recently considered a novel question regarding calculation of the regulatory review period for patent term extension (PTE) under 35 USC § 156 for reissued patents....more

4/9/2025  /  CAFC , FDA Approval , Food and Drug Administration (FDA) , Hatch-Waxman , Patent Litigation , Patent Term Extensions , Pharmaceutical Industry , Pharmaceutical Patents , Statutory Interpretation , USPTO
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