Biotech Values

[HattieTheWitch]

Isn't his point that if the FDA concludes that tailoring their sameness criteria to the submissions of one company is going to lead to that company having a monopoly (as that company will patent their techniques), they may look for an alternative if possible? I suppose that depends if the FDA mandate includes fostering greater competition, which seems to me clearly a purpose of Hatch-Waxman.

IF that is his point I can certainly see the FDA looking for alternative proof of sameness, BUT that doesn't address the matter of HOW the other company produces and monitors sameness.

If the other company, in production uses MNTA's IP, then I consider that stealing, and appropriate consequences for the infringer/stealer should result.