In its latest bid to thwart anti-competitive behavior in the pharmaceutical industry, the European Commission has charged Lundbeck and eight other drugmakers, including Merck KGgA and Ranbaxy Laboratories, with blocking the entry of generic versions of the best-selling Celexa antidepressant. Although Lundbeck has the right to appeal, if the decision is upheld, the drugmaker faces a fine of up to 10 percent of its annual sales.
Further action is planned "in coming days" in a three-year investigation concerning the Aceon high blood pressure med that was originally developed by Les Laboratoires Servier and several generic rivals (read here). At the same time, deals between Johnson & Johnson and Novartis are being probed to determine whether they illegally conspired to delay the entry of a generic version of the Fentanyl painkiller from entering the Netherlands (see this). Another probe is under way into Teva and Cephalon, which the generic drugmaker purchased last year (look here).
The moves come as the European Commission steps up its scrutiny of drugmakers that are suspected of striking these pay=to-delay deals to block the sale of cheaper generics. As part of several investigations over the past few years, antitrust regulators have raided offices as they seek documents pertaining to so-called pay-to-delay patent deals that were struck among rivals as part of their investigations.
These deals are controversial in the US, as well. Earlier this month, a federal appeals court ruled that a pair of patent settlements between Merck’s Schering-Plough and two generic drugmakers over the K-Dur blood pressure medication amounted to “evidence of an unreasonable restraint of trade." The ruling was hailed by the US Federal Trade Commission chair Jon Leibowitz, who is trying to restrict these arrangements (read here).
As for Lundbeck, the European Commission charged the drugmaker and its rivals struck deals that "foresaw substantial value transfers" to the generic competitors, which subsequently did not sell lower-cost versions of the antidepressant. These value transfers included direct payments from Lundbeck to the generic drugmakers, well as purchasing of generic Celexa stock for destruction or guaranteed profits in a distribution agreement, the EC says (look here).
Meanwhile, AstraZeneca recently appealed a decision in which the European Union General Court upheld a finding that the drugmaker abused its dominant market position and prevented competing generics from becoming available to consumers (see this). Despite the various probes, the European Commission also noted that the proportion of potentially problematic patent settlements has stabilized at a low level of 11 percent.