RockRat,at the moment, w/o doing some research for which there is no time today, neither do I know the answer to Hattie's question for sure.
To earlier question(s) raised by Thomas, I think I have it on good authority that the FDA does not have a biologic or drug sample in its possession at any time it reviews a BLA or NDA. FDA does not ordinarily test drugs, but deals with documentary, evidentiary results stated in those papers.
FDA may have authority to request a sample, but whether that would rise to an import of a drug into the U.S. for infringement analysis purposes is a question on which I would not express any opinion currently.
A potential issue raised by an earlier post by M-rambles is whether MNTA may be attempting to construct an offer to sell in this country by TEVA from the various exhibits sourced from TEVA that were attached to the complaint. Unusual argument, IMO. Whether a judge would be persuaded by a preponderance of the evidence that those exhibits amount to an offer for sale in this country is doubtful, IMO.
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