Open Markets Institute Calls on the Supreme Court to Take Case Challenging Merck’s Deceptive Practices to Preserve Mumps Vaccine Monopoly
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The Open Markets Institute filed an amicus brief in the Supreme Court, urging the Court to address Merck’s alleged misrepresentations to the Food and Drug Administration to extend its monopoly in the mumps vaccine market.
WASHINGTON, DC — The Open Markets Institute today filed an amicus brief in the Supreme Court, urging the Court to address Merck’s alleged misrepresentations to the Food and Drug Administration to extend its monopoly in the mumps vaccine market. In the case Chatom Primary Care v. Merck & Co., a group of physicians accuses Merck of misleading the Food and Drug Administration (FDA) about the potency of its vaccine to block biosimilar competition and extend its monopoly for a decade.
Authored by Open Markets Legal Director Sandeep Vaheesan and Policy Counsel Tara Pincock and outside counsel Brendan Benedict, the brief argues that material misrepresentations to regulatory agencies, like the FDA, should not be shielded by the Noerr-Pennington doctrine. This doctrine protects the public's right to petition the government, but this right is not and should not be absolute. While most courts of appeals have ruled that lying to regulators and judges is not protected conduct, the Third Circuit, which handles appeals from federal district courts in Delaware, New Jersey, Pennsylvania, and the U.S. Virgin Islands, ruled that such deception is protected by Noerr-Pennington. The brief argues that the Third Circuit's decision to immunize Merck’s lying to the FDA is out of step with the other courts of appeals and encourages corporations to build monopolies through deception.
“Corporations should not be allowed to use lies as weapons to maintain monopolies,” said Vaheesan. “Merck’s actions, if allowed to stand, would send a dangerous message that companies can abuse the regulatory system to protect their monopolies at the expense of honest rivals, consumers, and public health.”
Key Points from the Brief:
Misrepresentations to Regulators Should Not Be Protected: The brief argues that misrepresentations to regulators, like the FDA, should not be shielded by the Noerr-Pennington doctrine. Allowing corporations to deceive federal agencies undermines the regulatory system, enabling them to maintain monopolies and inflated prices at the expense of consumers.
Protecting Public Health and Fair Competition: The brief highlights the harm monopolistic practices cause in the pharmaceutical industry. By blocking generic competition, companies like Merck deprive patients of affordable generic drugs, which save the United States tens of billions of dollars annually in healthcare costs.
Ensuring Consistent Legal Standards: Open Markets argues that the Third Circuit’s decision is out of step with what other courts of appeals have ruled. Except for the Third Circuit, other circuits that have addressed whether misrepresentations to federal agencies are immune have been clear: Lying to regulators like the FDA is not protected petitioning activity.