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25 November 2021Big Pharma

Court denies Sun Pharma’s bid to avoid trial

Sun Pharma’s bid to avoid facing a trial over allegations of antitrust behaviour by an Indian drugmaker it acquired has been denied by a Massachusetts court.

District Judge Nathaniel Gorton of the US District Court for the District of Massachusetts denied both the motion for summary judgment filed by Sun Pharma’s subsidiary Ranbaxy and the motion for partial summary judgment filed by the plaintiffs on Monday, November 22.

The two plaintiff classes—which are composed of direct purchaser plaintiffs and end-payor plaintiffs—alleged that Ranbaxy had caused the delayed market entry of three generic drugs.

According to the class-action suit, in 2004 and 2005, Ranbaxy filed applications with the US Food and Drug Administration seeking approval to manufacture and market generic versions of Diovan, Nexium and Valcyte.

Under the Hatch-Waxman Act, the first generic drug manufacturer to submit a substantially complete Abbreviated New Drug Application (ANDA) is entitled to a 180-day period of exclusivity.

During this period, no other manufacturer is permitted to market a generic version of the subject drug. However, the exclusivity period may be revoked if the generic manufacturer fails to obtain tentative approval from the FDA within 30 months of submission, among other reasons.

While Ranbaxy obtained tentative approval for all three drugs in 2007 and 2008, it failed to secure final approval for its generic version of Diovan until June 2014.

Then, before Ranbaxy could secure final approval for its generic Nexium and Valcyte ANDAs, the FDA revoked its tentative approval for both drugs. Ranbaxy’s generic versions of these two drugs were never brought to market.

The plaintiffs allege that they overpaid for these medicines because Ranbaxy submitted ANDAs with missing, incorrect or fraudulent information, leading it to wrongfully acquire exclusivity periods.

“Plaintiffs assert that but for defendants’ allegedly anti-competitive conduct, generic versions of those three drugs would have entered the market and been available at lower prices much sooner. As a result, plaintiffs contend they paid artificially inflated prices for Diovan, Nexium and Valcyte during the class periods,” said Gorton.

Before the court, Ranbaxy’s lawyers argued that the plaintiffs had failed to show that Ranbaxy’s alleged fraud induced the FDA to grant tentative approval for Diovan, Nexium and Valcyte. However, Gorton rejected this argument, along with Ranbaxy’s argument that it never had monopoly power over Nexium and Valcyte.

The court’s decision clears the way for a jury trial, set for January 10, 2021.

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