Biotech Values

[stockbettor]

The Pulmicort reference you added includes a cite to the Federal Circuit affirmance of the DC's PI. I read the Fed. Cir's opinion and came away quite confident that the Ampha PI will be affirmed. Pulmicort did not involve infringement of a CoM patent, which is what I expected would be the issue in the cases listed in the table, but rather "kit" and methods of "kit" use claims (the kit being an inhalation device for a specified asthma drug). Interestingly, the DC ruled, and a 2/3 majority of the Fed. Cir. panel affimed, that the "kit" claims were invalid as obvious but that Apotex's use of the FDA-approved label (to titrate to the lowest effective dose) encouraged a method of use (once daily dosing) that would violate AZN's once daily method claim for the kit (Apotex received approval for twice daily dosing of its generic kit). One judge in the 3-judge appellate panel would have reversed the DC's finding as to method of use infringement.

Based on the majority opinion, it's my opinion, FWIW, that the Fed. Cir. will uphold Judge Gorton's findings as to Ampha infringement of MNTA's process claims, the validity of those claims, and the irreparable harm likely to be suffered by MNTA/Sandoz, especially MNTA. Here's a direct link to the Fed. Cir. opinion (and I welcome any contrary views as I am not a patent lawyer and may add more MNTA tomorrow based in part on my view of the case):

http://www.cafc.uscourts.gov/images/stories/opinions-orders/09-1381-1424.pdf