FTC: Cash isn't required to qualify as pay-for-delay

The Federal Trade Commission marches on in its crusade against drug patent settlements. The agency filed a friends-of-the-court brief, broadening its no-no's beyond outright cash settlements. To the FTC, branded drugmakers that promise not to launch their own authorized generics are "paying" for generics delays just as well. And that, FTC says, breaks antitrust rules.

FTC officials filed the brief in a New Jersey court that's considering that sort of arrangement between Teva Pharmaceutical Industries ($TEVA) and Pfizer's ($PFE) Wyeth unit. A group of drugstores sued the companies, saying their Effexor XR patent settlement held off cheaper versions of the drug, costing them and patients money. According to the lawsuit, Teva agreed to delay its copycat version of Effexor XR, and Wyeth promised not to sell an authorized knockoff of the blockbuster antidepressant.

What makes this really interesting--and important--is why the judge in this case asked FTC (and other parties, apparently) for advice. The Third Circuit Court of Appeals recently ruled that "pay-for-delay" deals, in which a branded drugmaker pays a generics maker to hold off on selling a copycat version, are prima facie anti-competitive. Drugmakers have to prove otherwise.

So, FTC weighed in with its opinion that foregoing an authorized generic is a "payment" of sorts, albeit not in cash. Those sorts of agreements are a "convenient method" of inducing generics makers to delay their own launches, because branded generics would siphon off some sales of the independent companies' versions, the agency said in a statement.

That opinion is to be expected, given FTC's stance on pay-for-delay arrangements. Whether the judge takes that advice is the real question.

- read the FTC statement
- get more from Reuters

Related Articles:
Drugstores accuse Pfizer, Teva of blocking Effexor generics
Drug retailers sue Pfizer, Teva over Effexor XR copycats
Supreme Court could upend pay-for-delay deals
Appeals court ruling threatens pay-to-delay deals
Less cash, more promises in pay-to-delay deals

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