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TastyTheElf

02/20/20 2:06 PM

#247272 RE: CalMustang #247269

All of the obviousness arguments that the defendants are propounding are the kind that courts are supposed to be wary of -- they are the "hindsight is 20/20" type arguments. That's why the defendants wanted all the FDA correspondence with AMRN. They wanted to mine them for lines of arguments to use to reverse engineer hindsight obviousness arguments.

But Judge Du is going to be too smart for that. She has already shown that she knows very well all the precedent that warns against those arguments. It isn't what NOW appears to be "obvious" given what we learned since the relevant date. It's what was obvious back then, with no benefit of future learnings.
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sts66

02/20/20 4:16 PM

#247300 RE: CalMustang #247269

When Eddingham started the approval process in China, regs required all drugs to be tested on the Chinese population, forcing Eddingham to create and run a Chinese MARINE trial to get approval for TGs >500. Obviousness and JELIS had nothing to do with it, the regulatory scheme in place did. We still don't know if they accept R-IT data to change the label once V is approved - they'd better, or their population will never get V prescribed for that indication.