Replies to post #129814 on Biotech Values

[DewDiligence]

We can add two additional columns to the table in #msg-68490452 showing the ultimate resolution and the resolution date (i.e. when a permanent injunction was granted or the preliminary injunction was lifted).

Feel free to expand the table accordingly; all I ask is that the expended table be formatted for easy reading.

[mouton29]

Re MNTA grant of PI, cases where PI issued <<I googled each of those instances to see if the PI was unheld. Looks like they all (exclude aL) were upheld >>

I was curious what the standard of review by the appellate court would be. Based on some brief research, I came across this from a Microsoft legal memo in which they appealed a grant of a PI against them. In discussing the standards for appeal, Microsoft stated the law as follows:

The grant of a preliminary injunction will be reversed where the district court "abused its discretion or based its decision on an erroneous legal standard or on clearly erroneous findings of fact." Federal Deposit Ins. Corp. v. Garner , 125 F.3d 1272, 1276 (9th Cir. 1997), cert. denied , 118 S. Ct. 1299 (1998). Review is plenary where the district court is alleged to have relied on erroneous legal premises. See id. The district court relies on an erroneous legal premise "if the court does not employ the appropriate legal standards which govern the issuance of a preliminary injunction." Sports Form, Inc. v. United Press Intl, Inc. , 686 F.2d 750 , 752 (9th Cir. 1982).

http://www.microsoft.com/presspass/legal/01-15appealsbrief.mspx

Needless to say, to the extent that the Court of Appeals has to find that the District Court "abused its discretion" in granting the PI, Amphastar will have a tough burden.

[iwfal]

I googled each of those instances to see if the PI was unheld. Looks like they all (exclude aL) were upheld and the blocked drugs were kept off the market for years and in some cases until expiration of the patent.

Unless the CAFC lifts the stay (which seems unlikely since I haven't yet found any instances of that in patent litigation) this will be a precedent. Given that the damages are not different here than in other instances I'd guess that it is confusion (by the judges) over a patent on a generic - e.g. safe harbor (as the judge himself said - and the CAFC has ruled earlier - it doesn't apply) or concept of momenta patents blocking all gL competition (it doesn't).

PS Anyone found any examples of monetary damages awarded (or settlement) from an 'at risk' generic launch? It would interesting to see if it accounts for not only the loss incurred during marketing, but the more permanent erosion in price. And whether the damages (or settlement) were actually treble.