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In 2012, the United States Food and Drug Administration (FDA) approved Truvada as the first drug for use in the prevention of HIV infection in healthy people who are at high risk of acquiring HIV through sexual activity. Developed and marketed by Gilead Sciences, Inc., Truvada is a fixed-dose combination of two antiretroviral compounds, tenofovir disoproxil fumarate (TDF) and emtricitabine. The World Health Organization (WHO) has identified both TDF and the combination of TDF and emtricitabine found in Truvada as “essential medicines.” In 2015, Gilead began marketing products containing tenofovir alafenamide fumarate (TAF) as a safer and more effective alternative to TDF. Recently, Gilead became the target of multiple lawsuits filed in California state courts accusing the company of negligence, strict product liability, and fraud, based on the company’s decision not to bring TAF-based products to market sooner. The plaintiffs are individuals who took TDF-containing products like Truvada and claim that they suffered injury caused by TDF that could have been avoided if a TAF-containing product had been available. Ironically, Congress is currently considering legislation that would make so-called “product hopping” a presumptive antitrust violation. A “product hop” occurs when a drug company brings a “follow-on” version of an already approved drug to market, such as a combination product containing an already approved product (e.g., Truvada), or a new prodrug version of an existing drug (e.g., TAF) . This Article describes Gilead’s work developing and marketing tenofovir-based drugs like Truvada, as well as the company’s efforts aimed at making the drug more readily available worldwide. It then review the allegations to be found in one of the lawsuits recently filed against Gilead in California. This is followed by a discussion of the proposed legislation intended to deter pharmaceutical product hopping, including some analysis showing how, if enacted, the proposed legislation could have rendered it a presumptive antitrust violation for Gilead to bring TAF-containing products to market after the company had already begun marketing a TDF-based product.

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Biotechnology Law Report