MNTA—What’s astonishing and professionally negligent (IMO) is that the CAFC did not ask the US SG to opine on the legislative intent of the Hatch-Waxman Safe Harbor when the CAFC lifted the District Court’s preliminary injunction in Jan 2012, allowing Amphastar to launch its version of generic Lovenox.
(In the CAFC’s 2-1 ruling against MNTA in Jan 2012 on the preliminary injunction, the one judge siding with MNTA [who is now retired] said in his dissent essentially the same thing that the US SG is now saying in its amicus brief.)
Accepting defendants’ contrary arguments would transform section 271(e)(1) into a royalty-free, open-ended statutory license for the use of patented inventions in commercial drug manufacturing. That result cannot plausibly be attributed to congressional design.
FWIW I would suggest that the MNTA patent rulings are just a symptom of a long history in patent law (and society as a whole) that raw ideas are not 'ownable', no matter how temporarily (this has a long basis in patent law, although it has had to change, slowly, as innovation moved further and further from pure physical objects). And, having read many legal opinions, it is pretty clear that unless the law is completely and absolutely unambiguous many of those judges will find some reason to invalidate. I refer to it as IP Communism.
MNTA—The potential magnitude of the Lovenox patent case is starting to be absorbed by the market, IMO. (This matter was well below Wall Street’s radar screen until MNTA’s 2Q15 CC yesterday.)
p.s. AMPH’s 2Q15 CC is one week from today; should be a good listen.