Emboldened by the U.S. Supreme Court ruling on "pay-for-delay" patent settlements, the Federal Trade Commission is looking for opportunities to sue drugmakers over suspect deals.
While members of the U.S. Congress argue over whether there is a need to make so-called pay-for-delay patent settlements illegal in light of the recent Supreme Court ruling, organizations on both sides of the issue are pumping out studies to influence their thinking.
Two days ago the U.S. Supreme Court said pharma companies can be sued for pay-for-delay deals, and now the European Commission has fined Lundbeck and a cadre of companies €146 million ($195.5 million) for the same thing.
The pay-for-delay ruling is in. That means legal experts and industry analysts are poring over the decision, trying to assess its consequences. Any consensus? By eschewing the Federal Trade Commission's position--that patent-settlement payments should be assumed anticompetitive--the Supreme Court left pharma some leeway. That's better than it might have been. But the choice also leaves a lot of uncertainty on the table. Here's a roundup of opinions and commentary >>
The U.S. Supreme Court has ruled in the big pay-for-delay case. In a 5-3 vote, the court ruled that the Federal Trade Commission has the right to challenge brand-name drugmakers' patent settlements with generics companies. It's a slap in the face for the drug industry, which has united behind the settlements, saying they speed generics to market rather than impeding competition.
A new AARP study worries that Pfizer's aggressive use of price hikes, pay-for-delay deals, and discounts and coupons when Lipitor faced generic competition will become the blueprint for the industry.
Regulators in both the U.S. and the U.K. have been cracking down on pay-for-delay deals in recent months, with the issue going before the U.S. Supreme Court in March. Now, it seems, EU regulators will join them. The EU's anti-trust regulator, is set to fine 9 generic drugmakers for accepting money to keep their low-cost products off the market.
Pay-for-delay deals are disliked by regulators on both sides of the Atlantic. A month after the U.S. Supreme Court heard arguments on the practices, regulators in the U.K. have turned to a decade-old deal, no longer in place, to accuse GlaxoSmithKline of paying competitors to keep generics off the market.
Now that Obamacare has had its day at the Supreme Court, pharma has another case to worry about. The longstanding debate over "pay-for-delay" deals with generics companies could soon make its way to the high court, legal experts say. And if it does, branded drugmakers and generics companies would face a wholesale shift in their business strategies.
A federal appeals court pulled a pay-to-delay challenge out of mothballs, forcing Merck to fight claims that its Schering-Plough unit delayed generic versions of its potassium drug K-Dur. But Merck isn't the only drugmaker that should keep an eye on this case.