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A patient advocacy group has filed a lawsuit to block the federal government from awarding an exclusive license to Gilead Sciences (GILD) for an experimental cancer therapy, arguing that the potential for a high price may preclude access to many Americans.

At issue is a CAR-T treatment, which relies on the immune system to attack cancer cells. Last December, the National Institutes of Health indicated plans to award a worldwide exclusive license to a CAR-T treatment that is being developed with taxpayer funds to Kite Pharma, which had recently been purchased by Gilead.


The advocacy group, Knowledge Ecology International, contended in its lawsuit filed on Thursday that the federal government should not award a license to Gilead without securing an agreement that any emerging medicine is affordable to Americans. The group also believes the NIH should not consider licenses until development work is done in order to assess the effectiveness of the medicine and wield greater leverage in any negotiation.

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