I’ve also tried to set out, in plain English, what the “clear and convincing” evidence might look like, to avoid the delay agreement being declared unlawful, under Kohl’s formulation of the seven tests.

Do take a look. “Whiskey for my men; beer for my horses.”

Namaste

If that is her lead example, then phrma’s in trouble.

That patent suit was likely going to invalidate the Provigil patents, making the generic available in 2005. As it now stands, it will be several years yet before the generics launch. And all the while the consumer suffers (while in this case, both the braned, and the generic pharma manufacturer line their pockets) — is there ANY evidence that Cephalon has not made at least a 10,000% return (ROI) on Provigil? None.

So, a “clear and convincing” evidence standard is a reasonable political compromise to acheive a fairly effective ban on the practice, as it now stands. Last month, I detailed a Schering-Poulgh drug on which patent exclusivity has now run 32 years (compared to the 17 Congress intended, when last it addressed duration). That drug? A cancer treatment called Temodar.

That practice needs to end. We are spending billions more than we need to, for the very same compounds — many of which have been on the market, as exclusively branded drugs for more than twelve years, now. The ROIs here are staggering.

Great post, Ed.

Namaste