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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Court finds government failed to promptly notify Gilead of its PrEP-related patent applications as required under agreements for supply of HIV drugs used in CDC studies. Whether Gilead will have to license government patents remains undecided.
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.