The Hatch-Waxman Act allows a generic drugmaker to rely on a branded drugmaker’s Food and Drug Administration-approved New Drug Application if the generic drugmaker can show that the generic drug has the same active...more
On June 26, 2020, Chief Judge Leonard Stark dismissed a Hatch-Waxman case without prejudice after Defendant Sandoz Inc. (“Sandoz”) converted its Paragraph IV certifications for certain asserted patents to Paragraph III...more
This October, the U.S. Food and Drug Administration (FDA) will be celebrating its 40th anniversary of the “Orange Book” as a resource for consumers, health care professionals, drug developers, and Hatch-Waxman litigants. ...more