Re: Manufacturing/quality-control patents for US FoBs
Why have a mfg. patent then? You can always dodge that simply by manufacturing out of US? I don't think it would be that simple...
You’re right—it’s not that simple.
In the Lovenox patent case, TEVA sidestepped liability for infringing MNTA’s ‘886 patent because: 1) they produced generic Lovenox in Italy; and 2) the Court deemed MNTA’s patent a “quality control” invention rather than a “making something” invention.
Unfortunately (for MNTA and other FoB companies), much of the IP for FoBs pertains to producing FoBs that are within a small quality-control tolerance of the branded reference product. Hence, US courts may allow the importation exemption afforded to TEVA’s generic Lovenox in many instances.