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« Biopharmaceutical Companies Weigh-In on Myriad Case | Main | Supplemental Brief for Appellees in AMP v. USPTO »

July 18, 2012



Nice review of this case and the FTC's "never ending" effort to find a circuit that agrees with its position on reverse payments. As others have noted, the Third Circuit's view about what the "presumption of patent validity" means is, at the very least, problematic. Also, the Third Circuit's view that reverse payments are "presumptively" an unreasonable restraint of trade is in complete conflict with other decisions on reverse payments and is pretty close to a per se rule of illegality. Now the interesting questions are will the Third Circuit hear this case en banc, and will SCOTUS enter the fray to resolve the obvious circuit conflict?

I think it's good news that we've finally seen an end to knee-jerk deference to reverse-payment settlement agreements. In my opinion, these so-called pay-for-delay arrangements are potentially abusive of consumers, wildly undemocratic, and poster children for antitrust concerns. Bravo.

Dear PL:

Except when they are not. I am not taking an ideological position: the courts that have found the reverse payment arrangements to be lawful have based their decisions on the pertinent economics of those agreements and their effects, while courts that have not have done so in situations where there were factors that sugggested (or showed) that the agreement was in fact anti-competitive.

Until now. I do object to the FTC encouraging consumer groups to be their stalking horses, if that happened, and also to the "knee-jerk" reaction by the FTC that the practice should be per se illegal.

I also consider the situation in the context of other reports (having nothing to do with reverse payments) that show the economic cost of the Hatch-Waxman regime in terms of monies spent on litigation rather than, say, drug development. We may weigh those costs against the "savings" generic drugs have brought US consumers and may decide those costs are worth it.

But almost nothing is an unalloyed good (or evil) so the place where the Third Circuit landed is probably a reasonable compromise. It puts the burden onthe parties to the agreement to make their case without the assumption that the patent is valid or not or that the generic drugmaker will prevail or not. But is does focus the inquiry on the economic effects of the agreement, and so the parties should be able (if not particularly willing) to set forth the bases for entering into an agreement rather than pursuing the ANDA litigation.

And I also think that all these considerations are more relevant in ANDA litigation that does not assert invalidity or unenforceability but rather non-infringement. Much of the rationale for the 2d, 11th and Fed. Cir. opinions falls aside under those facts.

Thanks for the comment.

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