Replies to post #128324 on Biotech Values

[DewDiligence]

The Judge granted MNTA’s Motion for expedited discovery pertaining to certain sections of Amphastar’s ANDA. The items that Amphastar must produce on or before 10/17/11 include the following sections of Amphastar’s ANDA: i) release testing related to detecting 1,6-anhydro ring structures; ii) release testing related to sequencing of tetrasaccharides; and ii) master batch records. These are precisely the documents that can best determine whether Amphastar is infringing on MNTA’s patent claims at issue (#msg-67941277).

MNTA had also requested other sections of the ANDA as well as Amphastar’s Lovenox launch plans, but it seemed far-fetched that the Judge would allow MNTA to see that (#msg-68011256), and indeed he didn’t.

[DewDiligence]

Patent Claims Asserted by MNTA against Amphastar

[Updated for MNTA’s dropping the infringement
claims in the ‘886 patent (#msg-68233182).]


Patent number 7,790,466

1) A method of analyzing an enoxaparin preparation, comprising:
providing an isolated tetrasaccharide fraction from a size fractioned enoxaparin preparation;
analyzing the tetrasaccharide fraction using strong anion exchange high performance liquid chromatography (HPLC) to determine if one or more chains shown in the following table is present or is present in amount identified in the following table:xxx and if one or more of said chains is present or is present in an amount identified in the table, processing said preparation, wherein processing includes one or more of selecting, accepting, processing into drug product, shipping, formulating, labeling, packaging or selling said preparation,
thus analyzing the enoxaparin preparation.

8) A method of processing an enoxaparin preparation comprising:
providing a high performance liquid chromatography (HPLC) determination of whether a tetrasaccharide structure is present in an enoxaparin preparation in an amount provided in the following table: yyy and if said structures are present in an amount provided in the table, processing said preparation, wherein processing includes one or more of selecting, accepting, processing into drug product, shipping, formulating, labeling, packaging or selling said preparation.