Biotech Values

[DewDiligence]

Re: FoB patent dance/180-day launch delay

In the AMGN vs Apotex case pertaining to Apotex’s Neulasta FoB, a US District Court ruled that Apotex must furnish 180-day notice of launch after obtaining FDA approval—effectively delaying the FoB launch by 180 days—even though Apotex followed the “patent dance” procedures set forth in the statutes for the 351(k) pathway:

http://www.law360.com/lifesciences/articles/736258

This is a change from the CAFC’s ruling in the Zarxio case (#msg-115571193), where the Court said NVS had to wait 180 days from FDA approval until launching Zarxio as a penalty for not having followed the patent dance procedures, implying that FoB applicants had a choice of whether to adhere to the patent dance or wait 180 days before launching.

US Supreme Court intervention is likely at some point, IMO.