As we have previously reported, on July 25th, Coherus filed a motion to stay discovery pending the result of its motion to dismiss in its litigation against Amgen regarding pegfilgrastim, and Amgen filed an opposition on August 8th . Yesterday, Coherus filed its reply.
In reply, Coherus argued that Amgen’s principal complaint, that a stay would prejudice Amgen by forcing the court to consider disputed issues on an expedited bases before Coherus’s anticipated launch, was a strawman, because under Amgen’s proposed schedule, document production would not even be substantially complete before the proposed time for Coherus’s launch. Accordingly, to the extent Amgen seeks preliminary relief, the issues would need to be decided on an expedited basis anyway.
Coherus further argued that a stay would simplify the case no matter what happens – either the court would grant Coherus’s motion to dismiss, thus achieving ultimate simplification, or the decision likely would narrow the issues in the case.
Coherus also argued that the status of the litigation (specifically, that discovery had not been conducted) weighed in favor of a stay, even though Amgen noted that significant pre-litigation exchanges had already taken place pursuant to the BPCIA.
In response to Amgen’s alternative proposal that Coherus defer launch until six months after the stay is lifted, Coherus agreed that any stay can be lifted upon the resumption of FDA’s review of Coherus’s aBLA. Coherus also agreed to produce correspondence with FDA, subject to an agreement that permits Coherus to redact certain testing information and limit that correspondence to outside counsel and in-house counsel who agree to not take part in any regulatory proceedings with the FDA or any other regulatory authority.
However, Coherus did not agree to Amgen’s request that, in the event of a stay, Coherus be precluded from discussing pegfilgrastim with potential customers, because if a stay were not granted, there would be no prohibition on that activity, and thus this condition was not necessary to put Amgen in the same position it would otherwise have been absent a stay.
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