The 37 new Paragraph IV infringement lawsuits filed against ANDAs indicate that litigation remains a viable strategy for ensuring market exclusivity for innovators.
The Hatch-Waxman Act enables patent holders to initiate lawsuits in response to Paragraph IV certifications, allowing innovators a potential 30-month delay in FDA approval.
The system balances the interests of patent owners and generic manufacturers, as successful patent challenges provide generic firms with a significant 180 days of market exclusivity.
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