Biotech Values

[DewDiligence]

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.

Someone who is facile with patent law and has time for a detailed read of MNTA’s ‘187 patent on Copaxone (http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=7884187.PN.&OS=PN/7884187&RS=PN/7884187 ) can probably make a more educated guess about the outcome of a hypothetical MNTA suit against MYL for patent infringement. Absent that, I think it’s reasonable to surmise that MNTA does not intend to sue.