Important federal court victory in first test of what limits may be placed on reverse payment deals among drugmakers to protect steady streams of revenue on popular drugs
The case against AstraZeneca and Venable client, Indian generics maker Ranbaxy Laboratories Ltd., challenged a 2008 settlement of a patent lawsuit that stalled sales of a cheaper version of Nexium in the U.S. until AstraZeneca’s patents expired last May. The case is the first reverse payment suit to go to trial since the U.S. Supreme Court ruled in June 2013 that the Hatch-Waxman Act settlements could be challenged under federal antitrust law.
The Venable trial team, led by Douglas Baldridge, emphasized the fact that even though the date for generic entry had come and gone, no generic received even tentative approval from the FDA for another similar drug. He pointed to the fact that the jury clearly agreed with the defendants' argument dismissing the idea that "but for so-called 'illegal' payments by the defendants the plaintiffs could have entered the market at an earlier date. Clearly that did not occur," Baldridge said. "The system worked. The jury understood the facts of the case and were not swayed by wishful thinking on the part of the plaintiffs," he said, arguing in his closing arguments, "the drug buyer groups were living in a fantasy world during the trial. No company could have produced generic Nexium sooner because none of the generics makers had FDA approval."
Ranbaxy had said in an earlier court filing that, "The buyers failed to show they were actually harmed by the deal between the companies, relying instead upon strained opinions of experts who each proffer a version of what could have or would have happened in a hypothetical world that has no connection to the evidence."
The Venable team for the six week trial consisted of partners J. Douglas Baldridge, Lisa Jose Fales, and Danielle R. Foley, associates Vincent Verrocchio, Paul Feinstein, Sarah Choi and Molly Cusson with Marta Markowska and Jeanne Mooney.
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