I don't think this is necessarily problematic that the approved product cannot be duplicated.
The patentee has to enable what they claim in their patent. The claim in the copaxone patent may be (I haven't read it) something along the lines of a mixture of peptides with a formula indicating a certain amino acid composition. As long as the public could make products within (and throughout) the claim, I don't really see the problem. There is no requirement that the exact same product that is registered need to be made. I don't even think that any one product in a patent need to be reproducible exactly (if the level of detail beyond what is claimed), as long as you can reproduce what's in the claim, but maybe I need to think about this one...
For example, one can claim a protein in a patent, but when proteins are produced they will have different glycosylation depending on cell culture. Nobody argues that if a patentee changes cell line after patenting, and the exact glycan pattern cannot be reproduced, that the patent is invalid.
O.
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