Biotech Values

[DewDiligence]

(MNTA)—TEVA’s European patent on 40mg Copaxone appears to be valid, based on a ruling by the EPO yesterday:

http://www.sec.gov/Archives/edgar/data/818686/000130901415000782/exhibit1.htm

The opposition division of the European Patent Office (“EPO”) today upheld, in an oral ruling, the validity of Teva’s European Patent No. 2405749 covering COPAXONE 40mg/mL (glatiramer acetate) administered three times per week. Synthon, Actavis and Mylan had challenged Teva’s patent on various grounds. The EPO is expected to issue a detailed written decision within a few weeks. The ruling is subject to appeal, but it is expected that any appeal will take up to two years to be heard. Teva’s patent does not expire until 2030.

Note that NVS and MNTA were not parties to this patent challenge; inasmuch as NVS/MNTA have no announced plans to develop generic Copaxone for the European market, it makes sense for them to stay out of the Copaxone patent interference/litigation in the EU.

The ruling by the EPO is not necessarily a harbinger of whether TEVA’s Orange Book patents on 40mg Copaxone will stand up to challenge in the US. An IPR at the USPTO is scheduled for 5/2/16 (#msg-116691993, #msg-116704965, #msg-116497178).