Biotech Values

[DewDiligence]

Re: Norvasc case / Apotex, Mylan

>Can anybody educate the board on how Apotex can claim the 6-month exclusivity for being first to file does not hold anymore?<

Apotex is taking the position that MYL is not entitled to the six-month Hatch-Waxman exclusivity because MYL will not launch its generic Norvasc until after the patent in question was set to expire on its own on 3/25/07. I.e. the earlier than previously-expected launch of generic Norvasc will be due to PFE’s loss of the pediatric extension period (which would have run until 9/25/07) rather than the loss of the patent per se.

In my opinion, Apotex’s argument is a bluff; what Apotex actually wants is to negotiate with Mylan from a position of strength.