FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

IP Think Tank Cautions Against Breaking Gilead’s Truvada Patent

March 22, 2019
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As HIV patient advocates urge the federal government to “break” drug patents in an effort to lower the prices of HIV drugs, an intellectual property think tank cautioned that the tactic could backfire.

The advocacy group PrEP4All recently called on the government to invoke the 1980 Bayh-Dole Act’s “march-in” provision, which would allow licenses to be revoked for patented inventions in specific circumstances. Such a step, the organization claims, is necessary to introduce generic versions of Gilead’s Truvada (emtricitabine/tenofovir), which is the only form of pre-exposure prophylaxis (PrEP) approved by the FDA. The drug’s average retail price is almost $2,000 per dose.

In a new report, the Information Technology and Innovation Foundation (ITIF) expressed concerns about such a move, warning that the proposal contradicts the intent of the statute and would result in fewer new drugs.

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