An HIV-prevention advocacy group recently filed a petition with the U.S. Patent and Trademark Office, asking the patent office to reject a request by Gilead Sciences to extend its patent on the HIV drug tenofovir alafenamide (TAF) for another three years. According to the petition, Gilead intentionally delayed the development of TAF in order to maximize profits from its older tenofovir disoproxil (TDF)-based HIV drugs, despite knowing that TAF was safer and less toxic than TDF. In doing so, the company allegedly put thousands of HIV patients at risk for severe kidney- and bone-related side effects that could have been avoided had the company not deliberately postponed the development of TAF. If you believe you have been adversely affected by alleged TDF drug side effects, like severe bone and kidney damage, contact an experienced drug injury attorney today to discuss your options for legal recourse.
Gilead Sciences is the company behind widely used HIV drugs like Truvada and Viread, its brand-name version of TDF. TDF was originally approved by the FDA in 2001 for the treatment of HIV infection in adults and is used in combination with other medications to keep the HIV virus under control. In 2008, TDF was additionally approved for use in patients with hepatitis B, and in 2012, it was approved again for the treatment of HIV in children over the age of two. Viread was Gilead’s first brand-name TDF product, but the company later combined the drug with other HIV medications and sold it under other brand names, like Truvada, Complera, Atripla and Stribild. Compared to TAF, the newer and safer version of the HIV drug, TDF delivers the drug at a much higher dose and has been linked to a range of serious bone and kidney injuries, including chronic kidney disease, bone density loss, osteoporosis and bone breaks or fractures.
Gilead is facing criticism right now because the company is accused of misusing the patent system and postponing the development of TAF in order to increase its profits from TDF. Once a drug company loses patent protection, generic versions are free to enter the market and this increased competition can significantly reduce prices and profits. According to reports, it was way back in 2005 that Gilead was initially developing TAF for HIV treatment, but the company suspended the development of the drug, which it now claims is a safer alternative to TDF. It wasn’t until 2010 that Gilead resumed the development of TAF, which requires a lower dose than TDF and is also associated with fewer side effects. Gilead received its TAF patent in 2010 and garnered approval from the FDA in 2015. If the patent office grants Gilead’s TAF extension, the company would hold what many are calling “monopoly pricing” on the HIV drug until 2025, meaning a cheaper generic version of TAF could not enter the market for five more years.
Gilead Sciences faces a growing number of lawsuits filed by patients who suffered kidney and bone injuries allegedly caused by the company’s TDF-based HIV therapy. Each lawsuit involves similar allegations that Gilead knew TAF was safer than TDF and intentionally postponed the development of TAF in order to continue profiting from its older TDF medications without competition from the newer, safer medication. For its part, Gilead has denied claims that the company delayed its development of TAF to the detriment of patients taking TDF medications. Says Ryan McKeel, a spokesperson for Gilead. “Patient safety is of foremost importance to us, and any implication that Gilead delayed the development of a drug known to be safer than [the older drug] is false.”
In the midst of increasing allegations against Gilead Sciences regarding its decision to suspend development of tenofovir alafenamide, eleven senators and the Chairwoman of the House Committee on Oversight and Reform, recently sent a letter to the U.S. Patent and Trademark Office, urging the office to conduct a thorough review of the company’s alleged conduct in requesting a term extension for patents related to its TAF-based HIV medications. “We are particularly troubled by the allegation that they may have intentionally delayed development of Descovy in order to maximize profits from Truvada, despite taking the position that Descovy is a safer formulation with fewer potential harmful side effects,” the letter states. “Bringing a safer version of a drug that could potentially save thousands of lives to market is in the public interest. However, intentionally keeping safer versions of drugs off the market in order to maximize corporate profits is clearly not.”