According to HIV advocates, pharmaceutical company Gilead may have exploited the U.S. patent system by postponing development of a patented HIV drug that is safer than the company’s other drug therapies, leaving patients to deal with HIV medication side effects.

Advocates Claim Gilead Delayed Safer HIV Drug Tenofovir Alafenamide to Retain Profits

HIV advocacy group PrEP4All Collaboration filed a petition on Dec. 4, 2019, with the U.S. Patent and Trademark Office, claiming that Gilead knew that it had the ability to create a safer HIV drug, and intentionally chose to suppress the drug in order to retain maximum profitability.

The petition claims that Gilead suspended development of the potentially safer and more effective HIV drug known as tenofovir alafenamide (TAF) in 2005, and did not restart development until 2010. According to advocates, this five year delay may have harmed countless people diagnosed with HIV, due to the dangerous side effects associated with Gilead’s other HIV drugs.

Additionally, PrEP4All claims that this five year delay was caused intentionally by Gilead so that the company could continue to rake in profits from its older HIV drugs while they were still under the company’s patents and not subject to generic competition.

PrEP4All has asked the Patent and Trademark Office to reject Gilead’s request to extend the patent life for tenofovir alafenamide. Extending the patent would allow Gilead’s monopoly on HIV drugs to continue, and would prevent other companies from coming out with generic versions of the expensive and life-saving medication. The extension would allow Gilead to continue to keep the sole rights to TAF until 2025. As Gilead reportedly sold $14.6 billion of HIV drugs in 2018, this extension would potentially result in tens of billions of dollars in sales for the company.

While the request for an extension on the patent for tenofovir alafenamide has not yet been denied or approved, the patent on one Gilead HIV drug has since expired. Gilead’s patent for the drug Truvada expired in September 2020, potentially giving competitors a chance to begin manufacturing their own generic versions of the medication.

Gilead spokesman Ryan McKeel has denied the accusations that Gilead purposefully delayed the production of safer HIV drugs. “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,” he told the Washington Post.

HIV Drugs May Lead to Dangerous Side Effects

The possibility that Gilead intentionally delayed the production of a safer drug is important to HIV advocates due to the dangerous side effects associated with older HIV treatments. Common side effects of Truvada and other older HIV drug treatments include bone density problems such as mineral loss, bone necrosis, and fractures, as well as kidney damage, kidney toxicity, and chronic kidney disease. Additional side effects of these drugs may include neuropathy, skin rashes or changes, nausea, vomiting, headaches, and insomnia.

Victims who have suffered from kidney or bone problems after taking HIV medications such as Atripla, Complera, Stribild, Truvada, and Viread may be eligible to hire a qualified attorney and seek compensation from the drug manufacturer. Victims may be able to collect compensation for injuries, pain and suffering, loss of income or earning capacity, medical expenses, and other costs.

Several lawsuits, including class action lawsuits from other companies, have been filed against the pharmaceutical company by consumers who claim that Gilead’s alleged monopoly scheme was catastrophic for HIV positive patients who need HIV drugs to survive. The damage done to these patients by keeping a safer and more cost effective HIV drug from the market may have been both physically and financially harmful.

According to plaintiff Peter S., who filed his lawsuit against Gilead in August 2019, the company’s inflated drug costs priced more than 400,000 people in the U.S. out of their necessary HIV medications. As Gilead has held a monopoly on HIV drug patents, the company has been able to charge high premiums for these medications. Peter also claims that Gilead has violated state and federal laws by allegedly scheming with other drug manufacturers to prevent them from creating generic versions of these drugs, even after the patents on them expired.

Peter’s lawsuit is seeking compensation for himself and all other victims harmed by Gilead’s actions. He is also seeking damages for Gilead’s alleged violations of antitrust and consumer protection laws.

Peter’s Gilead HIV Drug Lawsuit is Case No: 3:19-cv-02573-EMC, filed in the U.S. District Court for the Northern District of California, San Francisco division.