Biotech Values

[DewDiligence]

Re: Timing of Copaxone patent expirations

Teva’s 5,800,808 patent expires 9/1/15 (#msg-75185398); it is not listed in the Orange Book because it describes a process rather than a composition or a method of use.

Since the District Court’s injunction against final FDA approval of MNTA’s Copaxone ANDA applies only to Teva’s Orange Book patents, if the FDA has issued a tentative approval of MNTA’s Copaxone ANDA prior to 5/24/14, the tentative approval will be converted to a final approval on 5/24/14; similarly, any FDA approval of MNTA’s ANDA after 5/24/14 will be a final approval.

Thus, NVS/MNTA could theoretically launch generic Copaxone “at risk” between 5/25/14 and 9/1/15, although they are unlikely to do so. That’s why Rick Shea mentioned Sep 2015 in the webcast passage you cited pertaining to the Copaxone market opportunity and MNTA’s sufficient liquidity to reach the launch date.