Well Teva's lawyers really are working overtime with the 7th Citizens Petition.
Looks like they do a really good job bashing the Natco Copaxone product which was obtainable from India I believe and another product "Probioglat" obtained in Mexico.
Seems like this CP might slow down any Mylan approval in the near term depending on how different the Mylan product really is from the Natco version on the market??? And at the very least require much more analysis by the FDA prior to an approval.
Since the MNTA product was unavailable they were not able to come up with anything negative about it. Yet leave it to the Teva folks to put a negative spin on a positive. The mention of MNTA was based solely on a patent review as that was all that was in the public domain. See quote below on how they found no difference in the gene sample of MNTA, but then say the sample must be too small....(lol)
"when we examined only the small subset of genes coding for proteins identified in the Momenta patent, there were no significant differences in expression (see Figure 15). This demonstrates that methods focusing on only a small selected subset of genes may miss important differences between two glatiramoids." (Pg 47 of CP)
Overall, the CP seems like a slight positive for MNTA and a negative for Mylan IMHO.
Anyone read it differently?
PS- tomorrow marks 6 years since MNTA Copaxone application was accepted by the FDA under the 505j pathway!
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