<reply> GTXI is not the same company from the High Pin days. They have gtx-758 data coming this Q.
Switch to some Ot replies, catching up for the last month or two. Beyond those, you don't really want my old stale thoughts. EXEL hits on MTC. 11 months vs. 4 months in PFS as you pointed out in the PR. It is powered for OS for full approval under the SPA. They have been playing with the formulation so 175mg in MTC is (I think) 100mg in prostate. They are down to 40mg equivalent and like 20mg equivalent in the Smith(?) study for bone effect. I don't know the answer to your question but IR may so you can call.
Switch again. MNTA is a long story and I only have time for a short answer. Things have changed from your message to me. Suggest Pacer.gov for court stuff, even though a bunch of the filings are under seal. So 466 patent is not being used by Amstar. 886 is being used key claims 6,15, 53 (uspto search, 7575886). Classen vs. Biogen trumps the Amstar safe harbor defense. Nothing is a 100% but pretty good.
cafc.uscourts.gov
The good stuff is in the ~second half. 2 to 1 decision for safe harbor being pre-approval only. There is a main sentence/paragraph about something like you don't get to use the protection forever. Very much on topic and directed. Since the Supreme Court only looks at a few cases, CAFC is the boss of patent. There is only one CAFC so this ruling must be followed by district courts. Yes, the ruling addresses Merck vs. Integral. The dissent means nothing because it was 2 to 1. It may go to the Supreme Court and they are the ultimate boss. But the safe harbor was intended to balance the rights of patents with the need for timely generic drugs. If the dissent is correct, that would mean that one can step on patents as part of 271e1. I don't think the Supreme Court is going to rule/go for that. The intent of congress is clear.
Running out of time. So the safe harbor is mostly a smoke screen. Amstar uses HPLC to look for 1,6 ring. The keys are Claims 6,15, and 53 in the 886 patent. And if HPLC is covered by these claims, most directly claim 53 and claim 54. Is CE setting in the Rhomberg good enough disclosure. How do you know when you have found what is in Peak 9. Was HPLC estoppeled. Meaning of determined vs. separate. More but have to run. Other than likelihood of winning, judge has to figure out harm, balance, etc for PI. One can take a decent guess here with the available info but judge/human factor is the toughest. GL. |
