Kristin Anne Connarn

Kristin Anne Connarn

Hogan Lovells

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Latest Posts › Food and Drug Administration (FDA)

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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 ยง 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

New Orange & Purple Book laws increase transparency of patent information for drugs, biologics

On January 5, 2021, President Trump signed into law H.R. 1503, the "Orange Book Transparency Act of 2020," which amends provisions governing the types of patents and exclusivity-related information for approved drugs listed...more

1/21/2021  /  Biologics , Food and Drug Administration (FDA) , Life Sciences , New Legislation , Orange Book , Patents , Pharmaceutical Patents , Purple Book , Regulatory Reform , Transparency
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