The 180 day excusivity is a seperate issue. Its intent is to incentivise the generic companies to develop generic equivalent ASAP. This part of the law, pay to delay is just that, a tactic.

Want to save consumers and tax payers money? Congress, FDA, and others should accelerate the effort to create a pathway for approval of biosimilars. PS We may see a little headway here if generic enoxaparin is approved although this is not a biotech drug.

I think yours is interesting, but in almost all cases, it is the branded pharma manufacturer paying the generic maker to stay off market for a period of time.

SO, your proposal would mean that if a generic maker settled its patent litigation with the branded co., and then brought the generic to market after the time-frame established in the agreement, there would be no six-month exclusivity?

I don’t think that would adequately deter many of the more egregious generic makers’ deals. [They'd just demand -- and get -- a bit bigger payment, from the branded companies, to cover the difference.]

No, I think each deal ought to be tested for arms’ length bona-fides, before it is allowed by FTC/DoJ. That is, the deals’ proponents ought to be able to show, by clear and convincing evidence, that their deals increase/improve — not hinder/thwart — price competition, in the relevant drugs’ markets.

I think that’s the most effective way to stop collusive “pay for delay” deals (which are, afterall, more akin to a bribery payment).

Namaste

The problem is that this is too logical, and therefore probably would not pass.

If the ban passes, these poor little generics will be more afraid of the FTC/DoJ — declaring invalid any settlement, pre-trial — than they will be, of the (potential) patent litigation fight, with Big Branded Pharma, directly.

That is, generics won’t bother, if they think they will be sued by the DoJ/FTC if they settle, and will have to spend to defend patent litigation, if they enter with a generic prior to patent expiry.

Of course, generics already are well-underway on dozens of pieces of such litigation (as we saw in the Teva Merck Temodar delay on appeal deal, of just yesterday), the world over. And there are billions of dollars at stake — so, certainly, the generics will come. If one or two bigger generics (Teva?) don’t — the others (smaller, hungrier ones) will.

So, this is a trolls’-concern, almost exclusively.

Of course, that’s just my opinion.

In addition, the full CBO “scorecard” report is now linked, as a giant, honkin’ PDF, here.

Namste

Now, though — it will be a sidecar bill, later in 2010, or early 2011, I predict.

Of even greater importance, the CBO score on the newest “reconciliation version” of the omnibus bill is out — it has passed all the bugetary formulae/tests!

This means it is cleared for a vote, perhpas later this week or early next. [I guess all legislation is ultimately about compromises, right? Time, money and (special) interests.]

Namaste