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Re: DewDiligence post# 120059

Sunday, 05/15/2011 7:55:58 PM

Sunday, May 15, 2011 7:55:58 PM

Post# of 257259
2 questions

I am asking these questions in the context of Characterization of complex drugs or for that matter biologics that MNTA does

1) don't you think patenting has more benefits than risks esp because FDA would be anyway disclosing some details of the "sameness" criteria and methods used to prove it, when it responds to CP ?

Also ,I don't think the case of biologic would be different as I expect innovators to file CP's over there too...So FDA would again disclose "characterization work" at the time it approves a biosimilar just like how they did for generic lovenox

2) Do you think these characterization patents would hold in patent challenge ?
If i look at MNTA's patent on characterization of Heparin, everything under the sun is being claimed
For ex: 100 different methods used to identify/characterize Heparin is claimed.
does it mean no other company can use the same method to characterize Heparin ?
Also, they found P8 for the 1st time. Even Sanofi was not aware. Does it mean no other company can find/characterize P8 in Heparin ?
Also, they found correlation of P8 to marker activity ? So does it mean no other company can use P8 as a means of doing QA so their product conforms to reference value of marker activity in the RLD

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