HIV PrEP Patent Dispute Escalates As HHS Files Suit Against Gilead
Trump administration wants the HIV drug maker to license HHS patents related to pre-exposure prophylaxis. Lawsuit follows Gilead’s request in August for the USPTO’s PTAB to conduct an inter partes review of the four-year-old patents.
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US FDA approves a PrEP indication for emtricitabine/tenofovir alafenamide that excludes cisgender women due to a lack of efficacy evidence; Gilead will conduct a new randomized trial with a novel design in women comparing Descovy's efficacy and safety against external controls and Truvada.
KEI vows to continue battle over Bayh-Doyle restrictions after US Commerce Department suggests it may issue regulations to exclude pricing as a basis for requiring companies to license their patents.
Legislators are urging the National Institutes of Health to use intellectual property levers to put pressure on prescription drug pricing. NIH has historically been reluctant to play the role of the price police – and it still is.