A federal appeals court ruled that pharmaceutical company Merck is immune from allegations that it violated antitrust laws.
While Merck “sought to extend its apparent monopoly by artificially raising the bar that [GlaxoSmithKline] had to clear to obtain FDA approval for its competing mumps vaccine,” U.S. Circuit Judge Tamika Montgomery-Reeves wrote, the behavior did not violate the law under the Noerr-Pennington doctrine.
The Noerr-Pennington doctrine protects companies that petition the government, even if the petitioning harms a competitor.
The case surrounded Merck’s mumps vaccine, which was available in the United States from 1967-2022. When asked to run tests on the vaccine, the desired results were not had. “After the results failed to yield Merck’s desired efficacy, Merck abandoned the methodology and concealed the study’s findings,” the lawsuit alleged.
“Merck then designed another even more scientifically flawed methodology, this time incorporating the use of animal antibodies to artificially inflate the results, but this methodology too failed to achieve Merck’s desired efficacy rate,” the lawsuit continued. After falsifying the test data, the pharmaceutical company submitted the “fraudulent” results to the U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMA).
The plaintiffs, GSK, said it would have entered the mumps market had Merck not falsified the data.
“When the FDA approached Merck with concerns about the end-of-shelf-life potency of its mumps vaccine, Merck had two main options: (1) reveal that its mumps vaccine might be misbranded and then consider remedial actions, like reducing the 24-month shelf life that Merck listed on the drug label; or (2) persuade the FDA that overfilling doses fixed that problem with end-of-shelf-life potency even though Merck knew that was not true and then file an [supplemental license application] requesting the FDA’s permission to maintain the existing drug-label claims about seroconversion with a less potent, and hence longer-lasting, mumps vaccine. Merck chose the second option,” the judge wrote.
“That gambit worked,” Montgomery-Reeves continued. “And the FDA did not order Merck to change its drug label or take any action against Merck after learning the truth about the purported problems with its vaccine.”
“[T]here is no genuine dispute of material fact that GSK’s delay was caused by the FDA’s exercise of regulatory discretion in response to Merck’s successful petitioning. And Noerr-Pennington immunity bars Appellees’ § 2 claim against Merck as a matter of law because the antitrust injury that Appellees assert is the result of government action, not private conduct,” Montgomery-Reeves added.
U.S. Circuit Judge Patty Shwartz wrote in a dissenting opinion that a “reasonable jury could still conclude that Merck engaged in anticompetitive conduct by maintaining misrepresentations on its vaccine’s label to protect its monopoly in the mumps vaccine market.”
