AstraZeneca has been boosted by a US court backing the Anglo-Swedish drugmaker concerning an agreement with Ranbaxy Laboratories to delay the launch of a generic version of the blockbuster antiulcerant Nexium.
A jury in the US District Court for Massachusetts has returned a verdict in favour of AstraZeneca in a closely-watched multi-district antitrust case filed by various purchaser groups challenging its settlement in 2008 of Nexium (esomeprazole) patent litigation with Ranbaxy. The plaintiffs, who claimed that Ranbaxy had received in the region of $1 billion, had argued that the deal broke competition laws.
However the court in Boston has decreed that the deal was not "unreasonably anticompetitive". Douglas Baldridge of the law firm Venable which represented Ranbaxy, said the jury dismissed 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".
He added that "the system worked. The jury understood the facts of the case and were not swayed by wishful thinking on the part of the plaintiffs". In his closing arguments, Mr Baldridge said “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.”
The verdict is particularly interesting, given that it is the first time a verdict in a ‘pay-for-delay’ case has been made since the US Supreme Court ruled in June 2013 that such agreements between brand and generic drugmakers should be subject to antitrust scrutiny.
AstraZeneca said it is “pleased with the jury’s verdict”, noting that ‘the company has always maintained that the plaintiffs’ allegations were without merit”. The plaintiffs have the right to appeal and there are two cases making similar allegations still pending in Pennsylvania.
Ranbaxy was expected to finally launch its version of Nexium this year but ongoing disputes with the US Food and Drug Administration over manufacturing issues at its Indian facilities mean that the AstraZeneca branded product is still the only one on the US market.