Biotech Values

[mouton29]

Preliminary Injunction case

Here is a link to a case (http://www.fr.com/files/uploads/attachments/AstraZeneca%20v%20Apotex_120.pdf) -- Astrazeneca LP v. Apotex (Dist Ct NJ 2009) in which Astrazeneca obtained a preliminary injunction against the launch by Apotex of a generic version of its asthma drug. The injunction was granted prior to launch but after FDA approval. The decision was affirmed on appeal, see http://www.cafc.uscourts.gov/images/stories/opinions-orders/09-1381-1424.pdf

The discussion, starting on page 60, of "irreparable harm" is interesting, basically the court says that damages, even if significant, are not irreparable if they are "calculable and compensable". The court holds that while several aspects of the threatened loss, such as loss of preferred formulary position, were calculable but that other aspects, such loss of personnel and loss of goodwill and consumer confusion, were not.

As in so many cases involving generics, Teva was involved, they had settled a similar dispute with Astrazeneca and as part of the settlement it was agreed they could launch their product after about a year. The details of that agreement played a roled in the court's analysis of irreparable harm.