>>For example, it's quite possible that Teva "infringed" during their development process (outside the US), but are no longer infringing during the manufacturing and quality control process.<<
If this were a small molecule drug we were talking about, I'd agree instantly. While it may be possible with enoxaparin, I would think it is much harder. Heparin has to be depolymerized at specific places in the chains, requiring certain temperature, pH, for certain times, and such. In other words, the manufacturing process has to be much closer to the development process in this instance, versus the case of a small molecule drug. Depolymerizing enzymes that work under different conditions might allow one to use a different set of conditions. Not sure about the impact of the bioinformatics and algorithms here. Both that and proprietary enzymes are more in Momenta's area of expertise than Teva's.
I'm not saying it is impossible to do this without Momenta's specific technology, but that it is much harder than doing an end run around someone's small molecule process technology. If Teva has any such capability, I have yet to see it in their IP, and I have looked. Of course, they could be hiding all this stuff as trade secrets, but that seems a risky IP strategy. Especially given their assertion that Sandoz swiped Copaxone knowhow from a Teva supplier.
Put me in the camp that says this minor deficiency letter is not so minor for Teva, regardless of spin. Thus my odds of t-nox getting approved in 6 months are substantially lower than yours, more like 50:50. FWIW.
Cheers, Tuck |
