Replies to post #198146 on Biotech Values

[DewDiligence]

NVS seeks SCOTUS ruling on 180-day notice period for FoBs:

http://www.law360.com/topnews/articles/759945/breaking-sandoz-seeks-high-court-take-on-biosimilar-law

NVS has a reasonable argument, IMO. If Congress intended the notice provision to confer an additional six months of marketing exclusivity for the reference branded drug, Congress could have simply added six months to the statutory 12-year exclusivity period in the BCPIA portion of the ObamaCare legislation.

[DewDiligence]

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.)