Momenta Pharmaceuticals, Inc. (MNTA)

[GrthzGd]

Here is the nub of MNTA vs. Amphastar/Watson, C.A. No. 11-11681 (D. Mass.):

27. On information and belief, in order for the FDA to have approved Defendants’ manufacture of generic enoxaparin, defendants Amphastar and IMS will have included in their process for manufacturing batches of enoxaparin sodium for commercial sale: (a) a method for determining that a defined percentage of the oligosaccharide chains that make up enoxaparin include, at their reducing ends, a non-naturally occurring sugar that includes a 1,6-anhydro ring structure, which method infringes the '886 patent; and (b) a method for determining the presence, in the tetrasaccharide chains of its enoxaparin, of particular chain sequences or particular chain sequences in particular relative amounts, which method infringes the '466 patent.

28. On information and belief, in order to be prepared to launch their generic enoxaparin product in the fourth quarter of 2011, Amphastar and IMS have manufactured, and/or are in the process of manufacturing, commercial quantities of generic enoxaparin sodium using the methods claimed in the '886 and '466 patents.