Replies to post #16460 on Momenta Pharmaceuticals, Inc. (MNTA)

[alternatepatel]

Poor FDA calling it a priority and not approving generics in time

[DewDiligence]

Scorecard of Teva’s patents on 40mg Copaxone

On 1/30/17, the US District Court invalidated TEVA’s ‘250, ‘413, ‘302, and ‘776 patents on 40mg Copaxone; this is MNTA’s PR on the Court judgment:

http://ir.momentapharma.com/releasedetail.cfm?ReleaseID=1009734

TEVA has a fifth Orange Book patent on 40mg Copaxone: the ‘874 patent (http://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=003&Appl_No=020622&Appl_type=N ), which was filed by TEVA after MNTA submitted its 40mg-Copaxone ANDA and hence did not trigger a Paragraph-IV challenge by MNTA. Craig Wheeler has asserted on MNTA’s CCs that the ‘874 patent will have no consequence on MNTA because it’s an obvious follow-on to TEVA’s other four Orange Book patents on 40mg Copaxone that were recently invalidated.

TEVA also has a (non-Orange-Book) manufacturing process patent (the ‘775 patent) on 40mg Copaxone; however, Craig Wheeler has asserted on MNTA’s CCs that MNTA’s Copaxone manufacturing was designed around this patent and hence MNTA does not infringe it.

All told, there are no longer any legal impediments to NVS/MNTA’s launching 40mg Glatopa as soon as they obtain FDA approval.