WASHINGTON - The Open Markets Institute filed an amicus brief with the U.S. Court of Appeals for the Third Circuit, urging the court to grant a rehearing In re Merck Mumps Vaccine Antitrust Litigation. A class of physicians alleged that Merck misled the Food and Drug Administration about the shelf-life of its vaccine and thereby kept out a competing vaccine.

Authored by Sandeep Vaheesan, Tara Pincock, and counsel of record Jason Rathod, the brief supports the plaintiffs-appellees’ petition for an en banc rehearing, emphasizing that granting absolute immunity for material misrepresentations to agencies like the FDA encourages firms to build and maintain monopolies by lying to regulators.

“Allowing corporations to abuse judicial and regulatory processes through misrepresentations is dangerous,” said Sandeep Vaheesan, Legal Director at the Open Markets Institute and an author of the brief. “It empowers corporations like Merck to extend their monopolies through regulatory mischief and undermines the decision-making of agencies like the FDA.”

Key Points from the Brief: 

1. Deviation from Established Precedents: The brief highlights that the Supreme Court and the majority of federal appellate courts have stated that misrepresentations to regulators and judges do not constitute protected “petitioning” activity. For example, the Supreme Court ruled that obtaining a patent through fraud on the Patent and Trademark Office can violate the antitrust laws. By granting absolute immunity to firms that deceive FDA and other regulators, however, the Third CIrcuit deviates from this substantial body of precedent.

2. Protecting Public Interest: Misrepresentations to regulatory bodies can be an unfair competitive weapon against rivals and harm consumers by preserving monopolistic pricing and limiting access to affordable medication. The brief stresses that generic drug competition saves the public billions annually.

3. Ensuring Consistency Across Agencies: The brief criticizes the Third Circuit’s disparate treatment of fraud before different federal agencies. For example, fraudulent conduct to obtain patents via the U.S. Patent and Trademark Office is actionable under prevailing Supreme Court precedent, while similar misrepresentations to the FDA are insulated under the current approach.