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Gilead Faces Off Against Sanders, Ocasio-Cortez Over HIV Drug

Dec. 9, 2019, 8:02 PM

Gilead Sciences Inc. is in the hot seat after Sen. Bernie Sanders (I-Vt.) and Rep. Alexandria Ocasio-Cortez (D-N.Y.) called on the U.S. Patent and Trademark Office to deny a patent extension for one of the company’s HIV medications.

A total of 40 personal injury lawsuits have been brought by roughly 1,500 patients accusing Gilead of delaying release of an improved antiviral medication for more than a decade so that the Foster City, Calif.-based company could profit from its first drug until the patent expired.

The two Democratic lawmakers sent a letter to the USPTO following allegations that Gilead intentionally withheld a safer new HIV medication, Descovy, from the market to maximize profits on Truvada, an existing HIV drug also sold by Gilead.

Plaintiffs allege that Descovy, which is now on the market, is less harmful to kidneys, bones, and teeth, and that Gilead had developed the less toxic drug as early as 2000.

The cases are being coordinated before Judge Andrew Cheng in San Francisco County Superior Court, with the next status conference scheduled for Jan. 17, 2020. The trial is tentatively scheduled for January 2022.

The plaintiffs in the various lawsuits were prescribed Gilead’s antiviral medications—Viread, Truvada, Atripla, Complera, and Stribild—all of which contain tenofovir disoproxil fumarate, or TDF.

The medication works by preventing HIV from replicating within the body, ultimately reducing the transmission rate and supporting the immune system of the affected patient.

The company has been selling TDF-based medications since 2001.

‘Obscene’ Profit

“Gilead has made an obscene $36 billion off of Truvada since 2004, even though thousands of Americans could have been spared injury and even death” had Descovy been introduced earlier, Sanders and Ocasio-Cortez wrote in their Dec. 6 letter to the USPTO.

The lawmakers alleged that Gilead failed to disclose to the USPTO the true reason it halted development of Descovy. “Corporate misconduct must not be rewarded by the U.S. government through extending a government-granted monopoly on this medicine,” they wrote.

Gilead spokesman Brian Plummer said in a statement that the USPTO and Food and Drug Administration will determine the appropriate patent term extension for Descovy.

“Gilead defers to that process,” he said. “With regard to the petition, we strongly believe it lacks merit and is in conflict with the [patent term extension] statute.”

The USPTO declined to comment.

Sanders and Ocasio-Cortez contend that a generic version of Descovy could “quickly and affordably reach hundreds of thousands of Americans.”

A patent extension for Gilead would delay the generic version’s market entry in the U.S.

To do so would set a “very dangerous precedent for other wealthy and powerful corporations that will look to be rewarded for deception and misconduct,” the members of Congress wrote.

To contact the reporter on this story: Valerie Bauman in Washington at vbauman@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com; Randy Kubetin at rkubetin@bloomberglaw.com

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