InvestorsHub Logo
Boards
News
Market Data
Markets
Discover
Discover
Subscribe Login/Register
S&P 500
5,127.79
(
1.26%
)
US TECH 100
17,446.00
(
2.17%
)
Dow Jones
38,675.68
(
1.18%
)
Brent Oil
83.16
(
0.04%
)
Bitcoin
64,155.79
(
0.24%
)
Post# of 251721
Next 10
Reply Private New
Public Reply Private Reply New Post
Keep Last Read
Replies (2) Keep Next 10 Report Keyboard Shortcuts
Replies (2) Next 10 Prev Next

DewDiligence

Send PM Follow Ignore
Followers 826
Posts 119569
Boards Moderated 14
Alias Born 09/05/2002

DewDiligence

Member Level

Re: DewDiligence post# 198146

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

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

Post# of 251721
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.)

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

Public Reply Private Reply New Post
Keep Last Read
Replies (2) Keep Last Read Next 10 Report Keyboard Shortcuts
Replies (2) Next 10 Prev Next

Join the InvestorsHub Community

Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.

Sign Up