Replies to post #101756 on Biotech Values

[Mpower]

Agreed. There are numerous reasons that make it difficult for Sanofi to meet the high threshold for a PI. The sovereign immunity argument was interesting, but it doesn't give Sanofi "per se" irreparable harm.e

FDA cited to "Gulf Oil Corp. vs. DOE", where the court did a wonderful job analyzing "irretrievable losses" (i.e. sovereign immunity) in the context of a PI/irreparable harm analysis.

I found the excerpt below from that case particularly insightful ... with respect to irreparable damage, it appears indistinguishable from Sanofi v. FDA.

"Thus, in every case cited by Gulf, there are two elements to irreparable injury; these are an irretrievable monetary loss, and resulting damage which cannot be estimated in terms of money, and cannot be redressed by money. In this case, only the former element is present. The court concludes that this is not enough. This is a close question, because there is some appeal to the proposition that any damage, however slight, which cannot be made whole at a later time, should justify injunctive relief. However, some concept of magnitude of injury is implicit in the Virginia Petroleum standards, under which, if plaintiff shows irreparable injury and likelihood of success on the merits, the court must then weigh against this the injury to defendant, and the public interest. While perhaps leading to some confusion, the courts appear to treat some threshold level of this balancing, sub silentio, under the irreparable injury prong of the analysis. The result of this balancing process appears to be that the injury must be more than simply irretrievable; it must also be serious in terms of its effect on the plaintiff. Under this standard, it is apparent that Gulf will not suffer irreparable harm even if the monetary loss is irretrievable...."


The $2.5 billion in U.S. sales generated by Lovenox in 2009 amounted to only 6 percent of the company’s overall annual revenue. Even if Sanofi were to lose some portion of those sales as a result of competition from Sandoz, the resulting financial harm would be far too insignificant to cause “extreme hardship” to Sanofi overall, much less threaten its existence.