Just so I'm clear on the issues now:
1) This law basically says that a company (Teva) can not import and sell a product that it made abroad using a process that is currently under patent protection in the US. The consequence of this is that if Teva gets approval in the US and attempts to sell, MNTA can block sales. Technically, Teva is saying they have a stockpile of drug that was made outside the US and hasn't yet entered the US, so this lawsuit is without merit.
2) As for 35 U.S.C. 271, even though this metabolite is produced / detected under a patented US process, Teva can still import the drug provided that the final product is substantially different than the intermediate covered by the patent. Or, this metabolite can be present in the final product as long as it is irrelevant to the safety or efficacy of the final product.
Is this correct?
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