Biotech Values

[iwfal]

MNTA -

The Judge in the Lovenox patent case scheduled a trial for Feb 2013 after determining that Teva was not close to obtaining FDA approval (#msg-64632121).

This particular argument is not one I have seen before - that the judge made a determination based upon the facts that the trial would not be relevant until at least Feb 2013. Does the judge even have that mandate if the two parties mutually agree to a date? I would assume he does not have that mandate in a civil case.

As for the previous "tea reading" I've seen based upon this date:

1) Teva would be scared of Preliminary Injunction if they launched before settling the suit - Teva would never have agreed to this date if they thought they would get approval before then because then they could have a PI screw them up. My counter argument is:

a) PI's are hard to get - "likely to prevail" will be hard to do without someone spilling the beans at Teva or substantial discovery at FDA and "irreparable harm" seems unlikely since market share could easily be recovered and Teva has deep pockets to pay the penalty.

2) Teva would scared of 2x additional damages if launch before settled because Teva "knowingly infringed". I consider this potentially a substantially stronger argument but have some substantial unknowns:

a) First, I don't believe "knowingly infringed" is part of the actual law - so what is the defacto standard by which judges decide to multiply the damages? My guess is that it isn't trivial to get multiple damages - e.g. just because Momenta asserted their patents via a suit does not mean that Teva was obligated to take it at face value.

b) Does the fact that Momenta agreed to slip the trial date act as evidence in Teva's favor when the court is deciding on the topic of multiple damages?

And note that another possible reason that Teva would want a longer time to trial (one that I do not remember having seen on the board) would be to try to adjust their processes and their ANDA submittals to minimize infringement.

Altogether I do consider the fact that Teva agreed to Feb 2013 as a mild indication that Teva doesn't expect approval soon - but only mild because I don't think it will be that easy to get a PI or to get multiple damages.

PS Separate, but related, topic - has it been noted before on this board that Teva actually referenced Momenta patents in their 2004 response to Sanofi's Citizen Petition?

For example, Momenta Pharmaceuticals’ International Patent Application WO 03/078960 A2 contains results of studies of the variability of Lovenox®’s disaccharide “building blocks,” concluding that “the variation between batches of commercially available Lovenox® is substantial.” The table below (from International Patent Application WO 03/078960 A2), presents the results of enzymatic depolymerization followed by capillary electrophoresis of three batches of Lovenox

http://www.fda.gov/ohrms/dockets/dailys/04/sep04/091504/03P-0064-emc00001-01.pdf