Given the high stakes involved, the generic exclusivity period’s effects on competition should be scrutinized.

When should a brand company expect generic companies to file inter partes review petitions, seeking to invalidate a patent, and how should the brand company handle it? When the Delaware district court ...

SUNRISE, Fla., May 11, 2026 /PRNewswire/ -- Transpire Bio Inc., an integrated clinical-stage biopharmaceutical company developing inhaled therapeutics for pulmonary and systemic diseases, today ...

Thanks to Congress’ administrative alternative to court litigation of patents, generic drug manufacturers have embraced a new process, known as inter partes review (IPR), and successfully challenged ...

How should the US Food and Drug Administration (FDA) define the term "first-to-file" when it comes to approving new generic drug products? While the question seems small, at stake is nothing less than ...