Biotech Values

[DewDiligence]

MNTA TEVA re: Lovenox label carve-out

Are there any uses of Lovenox that are still protected under patent or otherwise? If so, the label might exclude those even if approved as a generic.

Pursuant to decisions by the federal courts, there are no remaining US patents on Lovenox. However, Lovenox has the standard H-W exclusivity for approval in a new indication (STEMI), which was granted on 5/16/07 and runs until 5/16/10.

Even if we assume that FDA approval(s) of generic Lovenox issued prior to 5/16/10 will contain a carve-out for the STEMI indication, the carve-out would be clear-cut and it would not seem to be a matter for negotiation between the applicant and the FDA. Hence, the existence of a label carve-out does not fully explain Bill Marth’s comment on yesterday’s CC, IMO.

What do you think?