Gilead Sciences Accused of Delaying Development of Safer HIV Drug for Profit Maximization
Leading pharmaceutical company Gilead Sciences has come under scrutiny for allegedly delaying the development of a new HIV drug to maximize profits. Internal documents that have been made public in litigation against the company suggest that Gilead had devised a plan to delay the release of the drug to protect the patents on its existing treatments.
In 2004, Gilead decided to halt the development of the drug, citing its lack of differentiation from an existing treatment. However, internal memos reveal that executives were aware of the potential benefits of the new drug, including its potential to be safer for patients. Despite this knowledge, Gilead concluded that the new drug posed a risk of competing with its existing, patent-protected formulation.
By delaying the release of the new drug until shortly before the existing patents expired, Gilead aimed to extend the period of time in which it could retain a monopoly on its HIV treatments. This strategy, referred to as “patent extension,” would allow the company to keep prices high and switch patients to the new drug just before cheaper generic alternatives hit the market. The potential worth of this strategy was estimated to be in the billions of dollars.
Gilead eventually introduced a version of the new treatment in 2015, nearly a decade after it could have been available if the development had not been paused. The company’s patents on the new drug now extend until at least 2031.
This delayed release of the new treatment has sparked lawsuits from around 26,000 patients who took Gilead’s older HIV drugs and claim that they were unnecessarily exposed to kidney and bone problems. Gilead denies the allegations, stating that its decisions were not motivated by profit alone and that the development of the new drug was not purposely delayed. The company’s lawyers argue that an internal memo from 2004 estimated a potential revenue increase of $1 billion over six years if the new version was released in 2008.
Gilead’s drugs containing the updated iteration of the tenofovir drug now account for half of the market for HIV treatment and prevention. However, they also come with a high price tag, with one product, Descovy, costing $26,000 annually. Generic versions of the previous drug, Truvada, which has lost its patent protection, now cost less than $400 per year.
A long-time AIDS activist, James Krellenstein, has called attention to Gilead’s actions, stating that intentionally delaying the development of an HIV drug for monopolistic purposes is a significant concern. The alleged maneuver of prolonging a drug’s monopoly through the introduction of a newer patented version just before generic competition, known as “product hopping,” is a common practice in the pharmaceutical industry.
Experts argue that this case highlights a flaw in the U.S. patent system, as it creates incentives for companies to delay innovation. They question how such practices have been allowed to occur and call for further examination of the patent system and its impact on healthcare access and affordability.
Gilead is not the only company accused of engaging in such practices. Merck, another pharmaceutical giant, is developing a new version of its blockbuster cancer drug Keytruda, which is expected to extend the company’s revenue streams beyond the arrival of generic competition. Merck denies any allegations of product hopping and asserts that the new version offers greater convenience for patients and their families.
As lawsuits against Gilead continue, patients like David Swisher, who experienced kidney disease and osteoporosis after taking Gilead’s older HIV drug, hope for accountability and justice. Swisher believes that valuable time was taken away from him due to the delayed release of the newer, safer version of the drug.
The case involving Gilead raises concerns about the way pharmaceutical companies navigate the patent system to protect their profits, potentially at the expense of patient well-being. It urges the industry and regulators to scrutinize the practices that hinder innovation and affordability in healthcare.