Momenta Pharmaceuticals, Inc. (MNTA)

[biopearl]

<<This plan didn’t work, of course (except for the ‘808 non-Orange-Book patent). >>

True so far but I am not sure the '808 patent will hold up too for reasons mentioned earlier, (but at least having an Appellate ruling in hand as you have suggested will allow a "safer" market release even if they ultimately "fail")

<<No, IMO. Reverse-engineering a product as complex as Copaxone is a hugely difficult task—perhaps even more difficult than developing a de novo (non-infringing) process.>>

From my reading, the patents are very specific and would certainly provide a roadmap to a skilled company like Sandoz or Momenta should they deliberately choose to make a copy, rather than start with a gemish of a completely unknown substance and reverse engineer it. Not to say it was easy but basically they admitted to copying the patents so it might not have been as hard as you suggest especially since newer analytic and synthetic techniques were available (the history of copolymer 1 seems to go back a long way. ) The court proceeding suggested the early relationship between MNTA and Sandoz was based on a plan to develop a de novo non infringing process and that this was abandoned but since there was a contract in place to co develop the drug they went forward with a different plan, one that I am suggesting was not exactly what Sandoz, or Momenta might have wanted early on and one that might have influenced the development of their relationship in certain directions later on. bp