European antitrust watchdogs are handing out fines for generics-delaying deals. U.S. regulators still want to slap drugmakers around for similar deals, which they say cost consumers--and taxpayers--$3.5 billion per year. And they're hoping that slap-fest will come soon.
In the wake of a Supreme Court ruling that affirmed its anti-pay-to-delay powers, the Federal Trade Commission has launched several new investigations this year, the agency's healthcare chief told Bloomberg. The enforcers are hoping to hit some unlucky pharma company with a $1 billion settlement this year, an FTC official said earlier this year.
Among the agency's latest targets: Forest Laboratories ($FRX), under scrutiny for patent settlements on Bystolic, a hypertension med. Endo Health Solutions ($ENDP), whose deals to protect the pain drug Opana ER are in the spotlight. And the various generics makers party to those settlements, of course.
By the FTC's count, drugmakers inked 40 suspect patent settlements in the 12 months ended September 2012, the highest tally since the agency starting counting. "Our goal is to bring an end to this practice by whatever means are available to us," the FTC's Markus Meier told the news service.
Industry types contend that the settlements FTC despises don't actually stave off generic competition. Patent deals usher generics onto the U.S. market an average of two months before patent expiration, they say. The FTC, however, figures that some of those patents would have been struck down if lawsuits went to trial, which would have put copycats into the mix even earlier.
Not that the FTC has had much success in nailing drugmakers for the deals. European watchdogs have already handed out a series of fines. Denmark's Lundbeck and Germany's Merck KGaA, in a case involving generics of the antidepressant Celexa, for one. And Johnson & Johnson ($JNJ) and Novartis ($NVS) in another.
The EU fines haven't amounted to much--about €160 million for those two cases. Nowhere near the $1 billion FTC is aiming for, thanks to the Supreme Court ruling that backed its powers to investigate suspect patent deals.
Meanwhile, in the wake of the Supreme Court decision, payers are stepping up their fights against pay-for-delay settlements, too, saying that the deals cost them money. In November, a federal judge allowed some insurance companies and union benefits plans to join up in a class action against AstraZeneca ($AZN), Teva Pharmaceutical Industries ($TEVA), Dr. Reddy's Laboratories and Ranbaxy Laboratories over a Nexium patent settlement.
- read the Bloomberg story
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