In 2004, Gilead Sciences decided to stop pursuing a new HIV drug. The public explanation was that it did not differ enough from an existing treatment to warrant further development.
However, in private Gilead had devised a plan to delay the launch of the new drug to maximize profits.although executives had reason to believe it might carry fewer risks for patients, according to internal documents made public in litigation against the company.
Gilead, one of the world’s largest drugmakers, seemed to be embracing a well-known industry tactic: tinkering with the US patent system to protect lucrative drug monopolies.
Back then, Gilead had a couple of successful HIV treatments. Both were based on a version of the drug tenofovir. The former would lose patent protection in 2017, and competitors would have been free to launch cheaper alternatives.
The promising drug, then in the early stages of testing, was an updated version of tenofovir. Gilead executives knew it had the potential to be less toxic to patients’ kidneys and bones than the previous version.according to internal memos.
Despite those potential benefits, executives concluded that the new version risked competing with the company’s existing patent-protected formula. If they delayed launching the new product until just before the existing patents expired, the company could substantially increase the period of time in which at least one of its HIV treatments remains protected by patents.
The “patent extension strategy,” as Gilead’s documents repeatedly call it, would allow the company to keep the prices of its tenofovir-based drugs high. Gilead could switch patients to its new drug just before cheap generics hit the market. The strategy was potentially worth billions of dollars.
Gilead released a version of the new treatment in 2015, nearly a decade after it could have been available without the delay. His patents now extend to at least 2031.
The delayed launch is now the subject of state and federal lawsuits in which some 26,000 patients who took Gilead’s old HIV drugs say the company needlessly exposed them to kidney and bone problems.
In court documents, Gilead’s lawyers said the allegations were without merit.
Today, Gilead’s expensive drugs containing the new version of tenofovir account for half of the HIV treatment and prevention market, reports IQVIA, an industry data provider. One widely used product, Descovy, is officially priced at $26,000 a year. Generic versions of its predecessor, Truvada, whose patents have expired, cost less than $400 a year.
David Swisher, who lives in Florida, is one of the plaintiffs taking action against Gilead in federal court. She took Truvada for 12 years, starting in 2004, and developed kidney disease and osteoporosis. Four years ago, when she was 62, she claimed, her doctor told her that she had “the bones of a 90-year-old woman.” In 2016, when Descovy finally hit the market, Swisher stopped taking Truvada. By then, he said, he was too sick to work and had retired from his job as an airline operations manager.
“I feel like all that time was taken from me“, said.
If Gilead had gone ahead with development of the updated version of the drug in 2004, its patents would have expired or soon.
“I feel like all that time was taken from me”: David Swisher, who took Truvada for 12 years and developed kidney disease and osteoporosis.
REBECCA ROBBINS AND SHERYL GAY STOLBERG. THE NEW YORK TIMES
BBC-NEWS-SRC: http://www.nytsyn.com/subscribed/stories/6827625, IMPORTING DATE: 2023-07-31 19:20:06
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