Para IV Filing

Bypassing Patents for Para IV Filing

ByPharma Lesson March 14, 2025March 14, 2025 Reading Time: 2 minutes

Filing a Paragraph IV (Para IV) certification for a generic drug requires either proving non-infringement or challenging the validity of the patent covering the reference listed drug (RLD). A deep understanding of independent and dependent claims is crucial to designing around a patent. Understanding Patent Claims Patent claims define the legal protection granted to an…

Patent and Exclusivity

Paragraph IV (Para IV) Filing | Overview & Strategies

ByPharma Lesson March 14, 2025March 14, 2025 Reading Time: 2 minutes

Paragraph IV (Para IV) Filing is a certification under the Hatch-Waxman Act that allows a generic drug applicant to challenge a brand-name drug’s patent by claiming either non-infringement or patent invalidity. If successful, the first applicant receives 180 days of market exclusivity, creating a significant commercial advantage. However, the brand-name company can sue within 45…

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