Gilead Faces Lawsuits over AIDS Drug Patents, Threats of Lawsuits for Hepatitis C Treatments
January 28, 2016
By Alex Keown, BioSpace.com Breaking News Staff
FOSTER CITY, Calif. – Gilead Sciences continues to face scrutiny over the pricing of some of its drug treatments, most noticeably its blockbuster hepatitis C treatments Harvoni and Sovaldi. In addition, the company is also facing challenges to patents it holds on its AIDS drug, Tenofovir.
On Tuesday, the AIDS Healthcare Foundation filed a lawsuit challenging the patents on Tenofovir, a component in Genvoya, Gilead’s four-in-one fixed-dose combination to treat HIV/AIDS patients as well as in Gilead’s combination drug, Stribild. In its lawsuit, the foundation alleges that Gilead “manipulated the patent system and engaged in anticompetitive practices to prevent economical access” to TAF, a prodrug of the Tenofovir compound. The foundation said in its lawsuit that TAF is more than 30 years old and was developed in the Czech Republic. In addition, the foundation claimed that Gilead also tightened its patents on a similar prodrug called Tenofovir Disoproxil, which will allow the company to “illegally… extend the period of patent exclusivity for drugs incorporating Tenofovir by decades.”
Michael Weinstein, president of the AIDS Healthcare Foundation, said two years ago that Gilead unsuccessfully petitioned the FDA for a patent extension from three to five years on Stribild. He said the drug had an annual cost of $28,500 per year per patient, making it the most expensive fixed-dose, first-line combination HIV/AIDS therapy on the market.
“In November 2015, after the FDA approved Gilead’s Genvoya, we said the updated combination, with admittedly fewer potential side effects, was also developed as a means to extend prior patent protections. We believed then—as now—that Gilead is trying to monopolize the market by price gouging on its HIV/AIDS treatments, actions that severely diminish access to these lifesaving medications and serve as catalyst for our legal action today,” Weinstein said in a statement.
Daniel Kipskind, the foundation’s attorney, decried Gilead’s patent protection maneuvers as “illegal acts” that “prevent people living with HIV/AIDS from accessing lifesaving treatment and cost the public billions of dollars because of Gilead’s unwarranted monopoly.”
While Gilead faces this lawsuit, the company is also under scrutiny for the pricing of its hepatitis C drugs Harvoni and Sovaldi, which have treatment costs of $84,000 and $94,500, respectively, for 12-week regimens. Emails obtained by Bloomberg show how Gilead executives priced their $20 billion blockbuster treatments. The emails show how the company pushed the price of the treatments up from $65,000 to $84,000 over the course of two years when pricing Sovaldi. Bloomberg reported the emails show company executives “homed in on a price that was just below where they thought insurers would add significant restrictions for the breakthrough hepatitis C remedy.” The emails were obtained after a report released by a U.S. Senate investigation said that the company was maximizing profits over providing needed care to patients.
On Wednesday, Massachusetts Attorney General Maura Healey threatened Gilead with a lawsuit over the pricing of the two hepatitis C treatments. In a letter submitted to Gilead by Healey and obtained by the Boston Globe, Healey said the pricing of the drugs “may constitute an unfair trade practice in violation of Massachusetts law.” The letter said the attorney general’s office was looking at the possibility of bringing an unfair commercial conduct complaint against Gilead, the Globe reported.
Despite the price, Gilead’s hepatitis C treatments have proven to be highly effective since they were launched. Sovaldi has had a 90 percent efficacy in curing, not treating, but curing the liver disease when used with other treatments.
The high cost of Gilead’s drugs has led some prescription services, such as to drop coverage of Sovaldi because of the costs. Likewise, the Southeastern Pennsylvania Transportation Authority filed a lawsuit against drugmaker Gilead claiming that the company is abusing its rights as a patent holder “by charging discriminatory prices that apparently have no other rational basis other than to inflate the company's bottom line.” In addition, the U.S. Senate report said the high cost of the drugs has also been damaging to Medicaid programs. According to the investigation, Medicaid programs spent $1.3 billion before rebates for the hepatitis C drugs to treat fewer than 2.4 percent of enrollees diagnosed with the liver disease. More than 700,000 hepatitis C patients on state Medicaid programs are still waiting to receive their medications.