United States sues Gilead for patent violation on HIV prevention drugs

By Daniel Uria

Nov. 7 (UPI) -- The United States sued biotechnology company Gilead Sciences over the patent rights to an HIV prevention drug.

The U.S. Department of Justice announced the lawsuit Thursday alleging that Gilead's drugs Truvada and Descovy infringe on four U.S. patents for pre-exposure prophylaxis, or PrEP, drugs awarded to the U.S. Department of Health and Human Services.


According to the suit, Gilead had originally obtained FDA approvals for both Truvada and Descovy to be used solely for treating HIV in combination with other drugs but now markets and sells the two drugs for PrEP regimens the Centers for Disease Control and Prevention developed and patented.

Gilead has repeatedly refused to obtain a license to use the patented drug regimens and has challenged the validity of the patents rather than paying royalties, the government said.

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"HHS recognizes Gilead's role in selling Truvada and Descovy to patients for prevention of HIV. Communities have put these drugs to use in saving lives and reducing the spread of HIV," HHS Secretary Alex Azar II said. "However, Gilead must respect the U.S. patent system, the groundbreaking work by CDC researchers and the substantial taxpayer contributions to the development of these drugs. The complaint filed today seeks to ensure that they do."


Gilead responded to the government's complaint saying the company has acted "above board and in good faith" to resolve the issue and will await the patent office's decision.

"We are surprised that the government has requested that a district court judge and jury look at the same issues of patent validity that the Patent Office will be deciding," the company said. "We will be asking the district court to stay the litigation until the Patent Office has an opportunity to undertake the review that we have already requested."

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