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IPR Challenge of '348 Mife Mental Disorders Patent Since several here have e-mailed me, below are some thoughts about the IPR challenge of Corcept's '348 patent by Neptune Generics. For those that want to read it: https://t.co/RJhLUCycwa (HT @tradehawk). IPR is an alternative to Fed Court litigation and a way to challenge an existing issued patent. '348 deals with dosing of Mife to treat mental disorders (CORT many years ago tried but failed in P3 trials to show Mife could help with severe depression). Neptune Generics is a shell company that has no products on market but exists to challenge and if successful win costs (padded of course) of such challenges. Maybe Teva is behind them on this, but that is just speculation. So what does this mean for CORT / Cushing's -- initially nothing. However if Neptune is successful could they or others try challenging some of the Mife Cushing's patents via IPR? Yes...but remember that Corcept has Relacorliant in P3s and is thus playing for time. They have to file an IPR and then it takes some months to get a IPR granted, then another 12 months for a decision. And yes, one can appeal the IPR decision to Fed courts further extend the time to final outcome. For the '348 mental disorders IPR, by early 2020 we should have the PTAB decision and that may have some readthrough to the Cushing's patents. That is because the '348 IPR IMHO is a probe and test of Corcept -- good thing that they have a CFO who is smart and also a Harvard trained lawyer (was on Law Review) and has hired the best lawyers to represent CORT. Note that CORT uses different firms for Patent prosecution (getting patents), for Fed court litigation, and for IPR (Latham Watkins). That is what big pharma do to get best legal team, and midsize biotech's often make the mistake of going with one firm they know -- yet another way in which Charlie is well worth the 250K options. Lastly the play within a play in District court litigation (with Teva) -- the pre-trial conference about consolidating the two Corcept complaints is related to potential IPR challenge. Teva is willing to consolidate all the diagnostic orange book patents but seems to want to keep the new combo CYP3A drug patent separate since that one is a bigger road block. Yes, you guessed it, Teva is I am sure thinking about an IPR for that one tough patent as an alternative to the District Court. Lastly remember all of the above is IMHO -- you get what you pay for, which for the above is nothing. Key thing not to forget is that is everything goes against Corcept you could see a generic launch in 2020, but with so many balls in the air, any generic would IMHO by at the earliest in 2021. Odds are pretty good that CORT will be able to prevail on some aspects of the multiple litigations and thus keep the any generic threat off until the Relacorliant readout in Q1 2021 -- that in my book is what winning means. |
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