Replies to post #208004 on Biotech Values

[DewDiligence]

Musings on the BCPIA Patent Dance:

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2017/03/the-demise-of-the-bpcia-patent-dance.html

For now, 351(k) filers can opt out of the patent dance with essentially no penalty. However, this may change when the US Supreme Court hears the Amgen-v-Sandoz case (#msg-120581818) in about two months (#msg-127876293).

[DewDiligence]

USSC says 351(k) “patent dance” is optional—and 6-month notice to reference-drug company may be given before obtaining FDA approval, eliminating a delay in FoB launches:

https://t.co/g75KCzVLk0

This is a win for all companies seeking to commercialize FoBs for the US market, although it will inevitably lead to more litigation than would have occurred if the Supreme Court had ruled the other way.