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Replies to #99541 on Biotech Values
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DewDiligence

07/23/10 7:03 PM

#99544 RE: pollyvonwog #99541

I was under impression that TEVA's [Copaxone] patents could potentially block it through 2014.

It depends what you mean by block.

Once the 30-month Hatch-Waxman clock expires, the FDA is no longer blocked from granting final approval for the ANDA. However, if Teva’s US patents remained valid, NVS/MNTA could potentially be ordered by a court to pay damages to Teva for launching an infringing product.

My guess is that NVS/MNTA won’t launch until Teva’s patents have expired or have been invalidated by a lower court. But NVS/MNTA could launch as soon as Feb 2011 if they have final FDA approval and they are willing to incur the risk of an adverse legal judgment.