Venable law firm celebrates victory in Nexium reverse payment case - Global Banking & Finance Review
The image captures the Venable law firm team celebrating their victory in the landmark Nexium reverse payment case, which impacts generic drug market access and antitrust laws in the U.S.
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VENABLE VICTORIOUS IN NEXIUM REVERSE PAYMENT CASE

Published by Gbaf News

Posted on December 10, 2014

2 min read

· Last updated: December 12, 2018

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Venable Wins Key Boston Case

Venable scored an important victory in Federal District Court in Boston on behalf of its client, Ranbaxy, in the first test of what limits may be placed on reverse payment deals among drugmakers to protect steady streams of revenue on popular drugs.

Background of Nexium Reverse Payment Dispute

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.

Arguments Highlighting FDA Approval Issues

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.”

Venable Trial Team Members Detailed

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.

Key Takeaways

  • Venable won the first reverse‑payment (pay‑for‑delay) trial post‑Actavis in federal court in Boston.
  • The jury found the settlement included a ‘large and unjustified payment’ and was ‘unreasonably anticompetitive,’ but plaintiffs failed to prove earlier generic entry.
  • Ranbaxy and AstraZeneca prevailed because no generic manufacturer had FDA approval to enter earlier, undermining causation claims.
  • The six‑week trial was led by Douglas Baldridge and a Venable team including Fales, Foley, and associates.
  • The decision established that proving antitrust harm requires showing both unlawful payments and actual market harm or delay.

References

Frequently Asked Questions

What is a reverse‑payment (pay‑for‑delay) settlement?
A reverse‑payment settlement is when a branded drugmaker pays a generic challenger to delay entering the market, effectively extending monopoly profits, and is scrutinized under antitrust law following the Supreme Court’s Actavis ruling.
Why did the jury rule in Venable’s favor despite finding anticompetitive conduct?
Although the jury found the settlement included a large unjustified payment and was anticompetitive, plaintiffs failed to prove that generics could have entered sooner absent the deal, so there was no demonstrated harm.
Why was this case significant?
It was the first reverse‑payment case to proceed to trial after the Supreme Court’s 2013 Actavis decision, setting important precedent for causation burdens in antitrust litigation.
Who led Venable’s trial team?
The trial was led by partners J. Douglas Baldridge, Lisa Jose Fales, and Danielle R. Foley, supported by associates Vincent Verrocchio, Paul Feinstein, Sarah Choi, Molly Cusson, Marta Markowska, and Jeanne Mooney.

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