US Government Sues Gilead for HIV Drug Patent Infringement

Despite his deep ties to the pharmaceutical industry, Secretary of Health and Human Services Alex M. Azar is critical of Gilead over allegations of patent infringement.|Activists in May protested Gilead’s PrEP monopoly in Columbus Circle, at the nearby Trump International Hotel and Tower, and outside the East 52nd Street headquarters of BlackRock Financial Group, the pharma giant’s leading investor.
US DEPARTMENT OF HEALTH AND HUMAN SERVICES|DONNA ACETO

The US government is suing Gilead for patent infringement just months after AIDS activists cried foul over the pharmaceutical company’s collection of taxpayer dollars to fund research of drugs that cost consumers up to $2,000 per month.

The Department of Health and Human Services’ 76-page complaint, filed in the US District Court in Delaware, asserts that Gilead deliberately violated the department’s patents related to HIV prevention drugs approved for use as pre-exposure prophylaxis or PrEP, and has raked in cash by having taxpayers foot the bill for research, only to turn around and charge patients high prices for those drugs.

The lawsuit notes that government research costing “hundreds of millions of taxpayer dollars” confirmed the effectiveness of the PrEP treatments and that the US Patent and Trademark Office granted the CDC four patents protecting PrEP regimens, entitling the CDC to license those regimens and receive royalties for their use.

“As its PrEP sales have skyrocketed, Gilead has exaggerated its role in developing PrEP,” the lawsuit states. “In so doing, Gilead has ignored CDC’s clear contributions and baselessly denied the validity of CDC’s patents. Gilead’s only contribution to CDC’s patented research was providing samples of the drugs that CDC used for testing purposes.”

The suit goes on to allege that Gilead “has repeatedly refused to obtain a license from CDC to use the patented regimens” while profiting from research, and that “Gilead has reaped billions from PrEP through the sale of Truvada and Descovy, but has not paid any royalties to CDC.”

The government directly blames Gilead in the suit for having “willfully and deliberately induced infringement of CDC’s patents” and says it “continues to do so.”

HHS Secretary Alex M. Azar II, who has deep ties to the pharmaceutical industry, said in a written statement on November 6 that Gilead “must respect the US 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.” Azar spent about five years as the president of the US division of Eli Lilly and Company and served on the board of Biotechnology Innovation Organization.

The lawsuit drew quick reaction from the PrEP4All Collaboration, a coalition dedicated to channeling political activism into the effort to boost the accessibility of HIV prevention medication. The group published a document earlier this year thoroughly outlining the millions in taxpayer dollars that have been used for the research.

“While yesterday’s action is important, the lawsuit alone will do little to increase access to PrEP,” James Krellenstein, an HIV/ AIDS activist and co-founder of PrEP4All, said on November 7. “The government must now use these patents to get PrEP to everyone who needs it and create a universal HIV prevention program that alleviates all of the barriers perpetuating the HIV epidemic. This step wouldn’t cost taxpayers a dime.”

The lawsuit represents the latest wave of developments during a year of increased scrutiny of pharmaceutical giants for hindering the effort to eradicate HIV/ AIDS. Following pressure from activists, Gilead announced in May that it would release its patent on PrEP next year to allow for generic medication, and in a separate development activists and union health plans sued four pharma giants — Gilead, Bristol-Myers Squibb, Johnson & Johnson, and Japan Tobacco — for allegedly joining forces to avoid selling combination medications that exclusively consist of generic drugs, a strategy aimed at maintaining up higher prices and profits.

Activists in May protested Gilead’s PrEP monopoly in Columbus Circle, at the nearby Trump International Hotel and Tower, and outside the East 52nd Street headquarters of BlackRock Financial Group, the pharma giant’s leading investor.
DONNA ACETO

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