Replies to post #33778 on Biotech Values

[DewDiligence]

Re: IN Byetta

>Any idea what the patent protection differences would be going BLA vs. 505b2? I assume there could be differences in defense as well as Hatch period. Although I assume the technology patents on formulation might have teeth in such a case.<

The patents themselves are not affected by whether IN Byetta is approved under 505b2 or under a regular NDA/BLA. If the patents were somehow knocked out, Hatch-Waxman exclusivity would come into play; exclusivity would run for five years if the drug were deemed a new molecular entity or three years if not. Your question is a good one because it might be hard for the companies to argue that IN Byetta was an NME if the approval was granted under 505b2.

For NSTK in particular, it would be a major embarrassment if the patents on IN Byetta did not hold up or if somebody managed to work around them. Dr. Quay has been boastful on many occasions regarding his company’s and his personal acumen in the realm of IP.