Truvada Maker Gilead Faces Patent Lawsuit From U.S. Gov.

Truvada maker Gilead Sciences, Inc. has recently become the target of over 1,000 lawsuits alleging bone loss and related injuries. However, the company is facing a new lawsuit of a different sort – and from an unlikely party. On November 6, 2019, the United States, on behalf of the Department of Health and Human Services, filed a lawsuit alleging that the popular HIV drug violates its patent.

The lawsuit, filed in federal court in Delaware, alleges that the Centers for Disease Control (CDC) has not received compensation for developing the drug regimen. Gilead has responded that it is aware of the lawsuit but believes that the patents issued to HHS are invalid on the basis that the use of Truvada’s active ingredient to prevent HIV was known years earlier.

Government patent lawsuit against Gilead Sciences

For roughly two decades, beginning in the mid-1980s, scientists around the world researched drugs to prevent the spread of HIV. The government alleges that the breakthrough came in the mid-2000s when the U.S. taxpayer-funded CDC developed a two-drug regimen known as Pre-exposure Prophylaxis or PrEP. A series of trials has shown that, when taken as directed, the PrEP regimens discovered by the CDC are 99% effective in preventing the spread of HIV among at-risk patients.

The Department of Health and Human Services (HHS) received four U.S. Patents. These allow HHS to license the regimens and receive a royalty in return. Licensees include two companies that manufacture generic versions of Truvada in other countries. However, Gilead has responded that it discovered years earlier that Truvada’s active ingredient was an effective anti-retroviral, and that the HHS patent wrongfully failed to disclose it as “prior art.” If this allegation is true, it could invalidate the HHS patents.

Other lawsuits over Truvada

It may take years to see how the patent lawsuit will affect the availability of Truvada. Critics have long complained that the high prices of Truvada prevent many who need it from accessing the drug. The government’s lawsuit is believed to be aimed at pressuring Gilead Sciences into dropping the medication’s cost.

There is also no way to tell whether the patent litigation will affect the thousands of claims by Truvada patients across the country over kidney disease and bone injuries. Those lawsuits allege that Gilead delayed the introduction of safer medication for over a decade in order to boost profits. If the government’s claims are true, they can also affect Gilead’s right to a monopoly over the newer medication.

Those who have been injured by medication like Truvada may be entitled to recover compensation. If you or a loved one were prescribed Truvada and developed bone density loss or related injuries, kidney disease, liver damage, or lactic acidosis that you believe is connected to the drug, speak with a Truvada lawyer today. At Showard Law Firm, we are committed to helping those who have been injured by dangerous drugs by holding the manufacturers and distributors accountable. Consultations are free and confidential, and you pay no legal fee unless we recover compensation on your behalf.

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