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The U.S. government has long played a significant role in pharmaceutical innovation, often through the funding of research, or collaboration in clinical trials. Unfortunately, government involvement can come at a cost for innovative drug companies, leading to allegations that taxpayers are being required to “pay twice” for the resulting drugs, particularly when the drug is considered essential and is offered at a price that is seen as “unreasonably” high. This Article discusses two aspects of ongoing efforts to leverage government involvement in pharmaceutical development and commercialization as a means for regulating of drug prices. The first is the assertion that the government can invoke various provisions of the Bayh-Dole Act, including, but not limited to march-in rights, to compel companies that have built upon federally-funded research to lower the price it charges for the resulting drug and/or license competing companies to commercialize generic versions of the drug. The other is an attempt by the federal government to use its own patents, which arose out research conducted in collaboration with a private company, as leverage to force that company to lower the price of its drug and/or to fund programs intended to expand access to the drug.

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Biotechnology Law Report