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DewDiligence

10/14/11 3:11 PM

#128465 RE: biomaven0 #128464

You also posted that Teva’s Lovenox ANDA had a 95% chance of near-term approval following their receipt of a “minor” deficiency letter in January.
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exwannabe

10/14/11 3:32 PM

#128467 RE: biomaven0 #128464

As far as I am concerned, the only remaining substantial uncertainty is whether MNTA can demonstrate Amphastar is infringing during the testing in the manufacturing process.



I disagree.

If they infringed in the submission only, they would be safe by the literal law, but clearly not by the intent of the law.

Part of the basis for the exemption was that it could never harm the patent owner during the life of the patent, and clearly this is false here.

Furthermore, it was obvious that the exclusion was intended to be for patents on the invention being submitted, and not every patent in existence (which is what A is arguing).

Courts do look at intent the law.

I would put the odds at well over 50% that if hey infringed in the submission the courts final appeal decision will go to MNTA.