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« Four Senators Write in Support of 12-Year Data Exclusivity Period | Main | Dr. Tafas Files Reply to USPTO/GSK Motion to Dismiss Appeal and Vacate District Court Judgment »

October 20, 2009

Comments

Kevin,

Grassley is a Republican, not a Democrat.

Thanks, Incognito. Just a typo, but one we are happy to fix and grateful for the heads-up.

Kevin,

As someone else has said, it would be much easier (and more logical) to amend Hatch-Waxman to make such "reverse payments" a nullity by causing the 180-day exlusivity to roll over to later ANDA filers once the 1st ANDA filer enters into such a "reverse payment" settlement.

As I read this, it seems to me that a patentee could simply agree to let the first ANDA filer go to market one day before the first expiration of a patent in suit; this would put the first ANDA filer's invalidity challenge to bed. Since the bill would do nothing to change the first ANDA filer's 180-day exclusivity period, a later ANDA filer would gain nothing by challenging the validity of the first-expiring patent. So in this scenario, assuming I haven't missed something (feel free to jump if I have), it's not clear what benefit would accrue to the public.

Obviously, the time remaining between the first patent expiration and the date of the settlement, as well as the existence of later-expiring patents would affect this calculus. Which is why I agree with EG that if one views reverse payments as a problem, there are simpler ways to address the matter, that don't necessarily reduce incentives to challenge the validity of patents.

As I've argued before, making reverse payments illegal is not the right way to approach this problem. Instead, Congress should remove the incentive to enter pay-for-delay settlements. This could most easily be done by revising Hatch-Waxman so that the 180-day exclusivity period rolls over to later ANDA filers if the 1st filer enters into a settlement agreement.

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