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The Hatch-Waxman Act established a framework to balance patent protection and generic drug entry through Paragraph IV certifications and a 30-month automatic stay on FDA approvals during patent litigation. However, brand manufacturers have leveraged serial patent litigation—filing successive infringement suits on new…
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Serial Patent Litigation Under Hatch-Waxman Delays Affordable Generic Drugs for Years The Hatch-Waxman Act established a framework to balance patent protection and generic drug entry through Paragraph IV certifications and a 30-month automatic stay on FDA approvals during patent litigation. However, bran... Read the full IIPLA article: https://iipla.org/news/serial-patent-litigation-under-hatch-waxman-delays-affordable-generic-drugs-for-years