Federal Circuit Snubs Pfizer On Norvasc Rehearing discusses a recent legal dispute that involves the FDA and patents and exemplifies what a mess and waste the FDA and patent system are.
So let me summarize in plain terms: Pfizer got a patent on its hypertension drug Norvasc, and also, of course, had FDA approval. So for a while it had a monopoly. As a result of a lawsuit with Apotex, who wanted to make a generic version of Norvasc, Pfizer’s patent was invalidated.
Now, because Mylan Labs already had obtained FDA approval to make the generic, as soon as the patent was invalidated, Mylan Labs ramped up plans to make a generic version of Norvasc. I.e., Apotex’s suit against Pfizer resulted in Mylan being unshackled. Meantime (from what I can tell from the convoluted reports about this), Mylan sues to try to prevent Apotex from getting FDA approval. Amazing: Apotex removes Pfizer’s patent monopoly, thus freeing up Mylan to sell the generic; while Mylan seeks to keep the FDA’s block of Apotex in place.
Can any sane person believe either the patent or FDA system does any good at all here?
