Patent Review Standard To Get Supreme Court Scrutiny
This article was originally published in The Pink Sheet Daily
Biopharma firms' best chance so far to change Patent Trial and Appeal Board's 'broadest reasonable interpretation' standard doesn't even involve a drug patent.
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Revised North American trade deal touted as enabling Congress to address crisis of high drug prices; requirement for 10 years biologic exclusivity is removed and language to allow incentives for generics added.
US FDA's Pediatric Experts, Not Review Division, Should Have Final Say On Pediatric Trials, Former Official Says
Former Associate Commissioner Janice Soreth says views of pediatric experts should take precedence over those of division directors regarding pediatric trials.