Biotech Values

[DewDiligence]

Teva’s PR on the Copaxone ruling has caused confusion by some readers as to whether the FDA can approve NVS/MNTA’s Copaxone ANDA. The language that caused the confusion is this:

http://finance.yahoo.com/news/teva-announces-favorable-court-ruling-062800629.html

This ruling should [emphasis added] prevent the FDA from approving, and the defendants from selling their purported generic versions of COPAXONE in the U.S. until the Orange Book patents expire on May 24, 2014.

In fact, The FDA can approve NVS/MNTA’s Copaxone ANDA irrespective of the patent litigation. Pursuant to Hatch-Waxman, there’s a 30-month stay on FDA approval following a Paragraph-IV challenge, but this 30-month stay for NVS/MNTA’s Copaxone ANDA expired on 1/11/11. (The clock on the 30-month stay started when the FDA accepted NVS/MNTA’s Copaxone ANDA for review on 7/11/08 [#msg-30621490] and NVS/MNTA notified Teva of their Paragraph-IV challenge, triggering the patent lawsuit by Teva.)

NVS/MNTA have clearly decided not to launch Copaxone “at risk” unless the Appellate Court reverses the District Court’s ruling. Hence, even following FDA approval of NVS/MNTA’s ANDA, there will no actual launch of generic Copaxone prior to the conclusion of the appeal unless there is a settlement between the parties.

Nevertheless, from the standpoint of MNTA’s shareholders, FDA approval of the Copaxone ANDA is consequential insofar as it can be expected to boost the share price substantially by re-validating MNTA’s technical prowess in replicating complex drugs and by guaranteeing that a generic-Copaxone launch is possible following the expiration (or settlement) of Teva’s patents.

Getting back to Teva’s PR cited above, why did Teva say that the District Court ruling “should” prevent FDA approval of NVS/MNTA’s Copaxone ANDA if the FDA is free to approve the ANDA at any time? Answer: Teva’s PR used the word should rather than the word will because Teva was stating an opinion rather than a matter of Hatch-Waxman law. It has always been Teva’s contention that Copaxone cannot be replicated, and Teva’s latest PR re-iterates this opinion.