Biotech Values

[mouton29]

<<From the FDA Brief -

Even if Lovenox’s monthly U.S. sales revenue of $210 million were reduced by 60 percent due to competition with Sandoz’s generic product, the resultant loss of $378 million over the next three months comprises less than 1% of Sanofi’s total annual revenue – a significant figure to be sure, but not of sufficient magnitude to cause irreparable harm to a company the size of Sanofi, as courts in this Circuit have repeatedly held. >>

I thought that SNY's reply memo filed on Wednesday had a reasonable response to that particular argument, which is, that the cases cited by the FDA can be distinguished because they involve situations where the plaintiff will be able to recover monetary damages subsequently. Here, because of the FDA's sovereign immunity, SNY will not be able to recover monetary damages. From the reply memo:

Numerous recent decisions of this court reiterate this common-sense conclusion.
In Smoking Everywhere, Inc. v. U.S. Food and Drug Admin., 680 F. Supp. 2d 62, 77 n.19
(D.D.C. 2010), for example, this court explained that “even if the claimed economic injury did
not threaten plaintiffs’ viability, it is still irreparable because plaintiffs cannot recover money
damages against FDA.” Similarly, in Alf v. Donley, 666 F. Supp. 2d 60, 70 (D.D.C. 2009), this
court found that the plaintiff demonstrated irreparable harm because, among other reasons, “by
virtue of the government’s sovereign immunity, the plaintiff will be unable to recoup his lost
income.” In stark contrast to these decisions, virtually all of the cases cited by FDA do not so
much as mention sovereign immunity or the Eleventh Amendment.

However, there are other elements required to obtain a TRO, such as that SNY is likely to succeed on the merits, and there I found the reply memo less convincing, though I don't think it is as clear cut as I had after I had only read the briefs from one side.