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 government may add provisions to future agreements to ensure its inventorship rights and make terms more favorable to the public. Lawyers say it will be difficult for Moderna to exclude NIH as co-inventor. But NIH lost a similar battle over AZT patents.
Patent board won't review IPR petitions challenging HHS patents, but Gilead says it has additional defenses against government's infringement suit, including a breach of contract claim.
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.