Safety Trolls?: Generic Firms Seek To Invalidate Xyrem REMS Patent Via PTO
This article was originally published in The Pink Sheet Daily
In a first by drug makers seeking covered business method patent review, Amneal, Par and Roxane petition PTO appeal board to cancel patent claims covering distribution of Jazz’s Xyrem.
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Pink Sheet Podcast: Another Coronavirus Stimulus Bill, Remdesivir’s Brief Orphan Status, Teva Sues Over Copaxone Regulation
Pink Sheet editor and reporters discuss the effects of the latest coronavirus stimulus package on pharma, Gilead’s request for rescission of an orphan designation, and Teva’s suit over Copaxone regulation.
Teva and US FDA disagree over whether Copaxone is a protein. While generics are already on the market, Teva wants to assert process patents against future would-be competitors, which the firm cannot do through the ANDA pathway.