Thu, Sep 18, 2014, 4:20 PM EDT - U.S. Markets closed

Recent

% | $
Quotes you view appear here for quick access.

Momenta Pharmaceuticals Inc. Message Board

  • fib1_1_2_3_5 fib1_1_2_3_5 Jan 25, 2012 8:04 AM Flag

    Amphastar appeal hearing was yesterday

    If anybody cares you can listen to it hear, only 30 minutes and kind of interesting if you have never heard one of these before.

    http://www.cafc.uscourts.gov/oral-argument-recordings/search/audio.html

    Summary:

    The focus was almost 100% on the Hatch-Waxman exemption (which allows companies to infringe in order to provide the FDA with the needed data to obtain the ANDA). The Chief Judge shot this down fairly hard, so I suspect the odds are very good that the PI holds.

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • "The focus was almost 100% on the Hatch-Waxman exemption (which allows companies to infringe in order to provide the FDA with the needed data to obtain the ANDA). The Chief Judge shot this down fairly hard, so I suspect the odds are very good that the PI holds. "

      The exemption allows company to file data with the fda prior to a patent expires so that the generic applicant can be approved day 1 when a patent expires. it does not allow an applicant to sell product violating a valid patent. Amphastar can use the violating data to prove to the fda their product is equivalent but they will not be able to sell their product until MNTA's patent expires (see you in 2020+) because they also use this data to show that each batch passes as well which is not covered by exemption

 
MNTA
11.60+0.20(+1.75%)4:00 PMEDT

Trending Tickers

i
Trending Tickers features significant U.S. stocks showing the most dramatic increase in user interest in Yahoo Finance in the previous hour over historic norms. The list is limited to those equities which trade at least 100,000 shares on an average day and have a market cap of more than $300 million.