Gilead Sciences, an American pharmaceutical company, recently settled a billion-dollar patent infringement lawsuit with the U.S. Department of Justice and the U.S. Department of Health and Human Services. The settlement followed a 5-year-long battle between Big Pharma and the U.S. government, illustrating how the health of the American public is still heavily influenced by capitalism.
In the mid-2000s, Gilead entered a contract with the Centers for Disease Control and Prevention (CDC) to research whether two successful HIV-treatments, Truvada® and Descovy®, could also be used to prevent HIV. Over a decade later, the CDC discovered that the two drugs successfully prevented HIV. The U.S. government obtained four patents covering the HIV regimen in 2015 and required that Gilead obtain a license from the CDC in exchange for royalties. Gilead refused to license the patents and continued to use the research in the promotion of the two drugs. In addition, Gilead petitioned the U.S. patent office to invalidate the patents and claimed that the CDC was in breach of contract. By the end of 2019, Gilead amassed $1.06 billion in sales of Descovy® and $2.05 billion in sales of Truvada®. In response, the Trump administration made an unprecedented move and sued Gilead for patent infringement.
The suit traveled through the district courts, resulting in two federal decisions in 2022 and 2024, both in favor of Gilead. The D.C. federal circuit stated that the U.S. government breached five contracts with Gilead from their research collaboration by granting the CDC patents. In addition, in 2023, a federal jury found all four of the government’s patents to be invalid. The case finally came to an end in January of this year with a settlement agreement between the two parties. However, despite litigation ending, the case has stirred commentary around public access to life-saving drugs such as Truvada® and Descovy®.
Many have argued that Gilead should not be allowed to profit from research that is funded by taxpayer dollars. Given that the public has paid billions of dollars into the creation of the drug, many public health advocates argue that the U.S. government should be allowed to leverage its patents against Gilead. This leverage could force the pharmaceutical giant to pay royalties on the findings and lower drug prices nationwide. Both Truvada® and Descovy® cost roughly $2,000 for a month’s supply, which many argue has severely limited public access.
Alternatively, there is ample evidence to suggest that the U.S. government impinged on Gilead’s rights within the context of their business arrangement. Through its decision, the court has made clear that the law of contracts governs over public health concerns. The U.S. government entered into a contract with Gilead with hopes of providing a reliable preventative treatment for HIV to the public. In addition, the two entities entered multiple contracts that prevented the U.S. government from patenting findings to ensure broad public access. The practice of patenting scientific findings has proved worrisome regarding public access, motivating many companies, such as Gilead, to ensure information is kept freely available. By allowing the information to remain in the public domain, smaller pharmaceutical companies are empowered to create generic versions of drugs like Truvada® and Descovy®.
Litigation between the U.S. Government and Gilead raises many questions concerning the government’s role in the pharmaceutical industry. For example, should the U.S. government have the responsibility to fight for lower drug costs through business transactions? Or perhaps, should the government focus more on regulating Big Pharma? In addition, should the U.S. government ever be allowed to patent major scientific findings, precluding the public from potential generic alternatives? While the resolution between Gilead and the CDC did not provide answers to many of these questions, legislatures should look to this debate when considering policy changes in the future. The American public should not be forced to live in a world of ever-increasing drug prices, and this settlement could be the perfect springboard to more effective policies.
Sami Vincent is a 2L at Wake Forest University School of Law. She received her bachelor’s degree in biochemistry and molecular biology from Wake Forest University. Following law school, she plans to pursue a career in patent litigation.
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