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Re: DewDiligence post# 198146

Tuesday, 07/05/2016 3:22:26 PM

Tuesday, July 05, 2016 3:22:26 PM

Post# of 257266
Re: FoB “patent dance”/180-day launch delay

CAFC sustains US District Court ruling (#msg-119067389) that 180-day notice is required for FoB launches even when the BCPIA “patent dance” has been followed:

http://raps.org/Regulatory-Focus/News/2016/07/05/25268/Biosimilar-%E2%80%98Patent-Dance%E2%80%99-Federal-Circuit-Rules-180-Day-Notice-is-Mandatory/

https://t.co/SekqhfVAvL

This ruling is good for companies who sell branded biologics and is bad for companies who want to sell US FoBs. (Some companies fall into both buckets.)

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