Missing drug pedigrees not a ‘material difference’ under Lanham Act, US judge says
By Melissa Ritti ( April 2, 2025, 19:26 GMT | Insight) -- Pill bottles with fake caps, damaged labels and certain other defects infringed the trademarks of Janssen Sciences and Johnson & Johnson, a US judge ruled yesterday. But he stopped short of endorsing the drugmakers’ view that bottles with invalid or missing pedigrees — transactional information required by the federal Food, Drug, and Cosmetic Act — render the drugs they contain “materially different” from genuine drugs without proof the pedigrees are part of an established quality control procedure. The setback for Janssen and J&J comes the same day Gilead Sciences, which also sued under the Lanham Act in connection with a criminal counterfeit HIV drug ring, settled with different suppliers and almost two years after the judge assigned to that case reached a different conclusion on the same pedigree-related question.Janssen Sciences Ireland Unlimited Company, Janssen Products, L.P. and Johnson & Johnson (Janssen, collectively) partly prevailed yesterday in a trademark case against two pharmacies, a distributor and their principals who took part in a sweeping criminal conspiracy involving black-market HIV drugs....
Prepare for tomorrow’s regulatory change, today
MLex identifies risk to business wherever it emerges, with specialist reporters across the globe providing exclusive news and deep-dive analysis on the proposals, probes, enforcement actions and rulings that matter to your organization and clients, now and in the longer term.
Know what others in the room don’t, with features including:
Daily newsletters for Antitrust, M&A, Trade, Data Privacy & Security, Technology, AI and more
Custom alerts on specific filters including geographies, industries, topics and companies to suit your practice needs
Predictive analysis from expert journalists across North America, the UK and Europe, Latin America and Asia-Pacific
Curated case files bringing together news, analysis and source documents in a single timeline