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Sunday, 06/19/2011 10:27:52 AM

Sunday, June 19, 2011 10:27:52 AM

Post# of 20689
Copaxone Clarification?

I've been following these boards intermittently for several weeks but this is my first post. The MNTA/TEVA situation with Copaxone is the first time I've had any real exposure to the details of the generic drug process and patent litigation. I apologize in advance if anything I say seems obvious or stupid.

I've read through Dew's MNTA Read Me First post, as well as countless other posts, but there are a few things about this situation that I'm having trouble understanding. If someone would be so kind as to confirm the following points, or explain where I am wrong I would greatly appreciate it.

1) If MNTA's Copaxone ANDA is approved by the FDA, do they still have to contend with TEVA's patents before they can begin selling their generic?

2) If they can't get around TEVA's patents would MNTA have to wait until the patents expire in 2014 to sell generic Copaxone?

3) Can anyone explain the basis for claiming patents are invalid due to "Obviousness/double patenting"(in regards to Copaxone ideally, but even a more generalized explanation would help)?

4) Can anyone explain the basis for claiming patents are invalid due to "Indefiniteness"(in regards to Copaxone ideally, but even a more generalized explanation would help)?

4) Can anyone explain the basis for claiming patents are invalid due to "Non-infringement"(in regards to Copaxone ideally, but even a more generalized explanation would help)?

5) What kind of timeline should we expect in regards to the patent litigation? Specifically, how long might we reasonably expect before there is some resolution with the 7/11/11 start for inequitable conduct and 9/7/11 start on the remaining issues?

Thanks!