Biotech Values

[DewDiligence]

NVS/AMGN/etc—Appellate Court says NVS can launch Zarxio on 9/2/15, despite not engaging in the 351(k) patent-exchange process:

http://www.bloomberg.com/news/articles/2015-07-21/amgen-loses-appeals-court-ruling-in-bid-to-stop-novartis-drug

The 9/2/15 date is 180 days from the FDA approval of Zarxio (#msg-111475426). I.e., if today’s CAFC ruling becomes the precedent for US FoB launches, then FoB sponsors opting not to participate in the 351(k) patent-exchange process will instead be subject to a 180-day delay from the date of FDA approval to the date of launch.

The CAFC’s actual ruling can be found at:
http://t.co/PN85UMcG61