Leveraging the Lanham Act for Anti-Counterfeiting: A Case Study of Gilead Sciences’ Successful Civil-to-Criminal Enforcement Strategy in the U.S. Pharmaceutical Market
Keywords:
Patient safety, Anti-counterfeiting, Civil litigation strategy, Lanham Act enforcement, Criminal prosecution pipeline, Pharmaceutical brand protection, Intellectual property in pharmaceuticalsAbstract
Over the past five years, Gilead Sciences has used civil enforcement of the Lanham Act, which governs United States trademark law, to stop counterfeiters slipping fake and adulterated HIV medicines into the legitimate drug supply chain. Subsequently, Gilead referred evidence gathered during civil litigation to criminal investigators. This approach led to the fast dismantling of a counterfeit drug operation, effective civil penalties, and the prosecution of bad actors engaging in the distribution of adulterated medicine, forgery, fraud and money laundering. The effective use of Lanham Act civil actions to support criminal prosecutions creates a civil-to-criminal pipeline of counterfeit enforcement. This is a novel model that should be replicated by other healthcare industries in the U.S. and in other countries that have legal frameworks to enable it. By analyzing Gilead’s efforts in this arena, we show these acts have protected patient safety. We believe other pharmaceutical manufacturers have a public health imperative to implement it.
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