Activists Say Gilead Delayed Safer Version of PrEP

Lawsuit News from OnderLaw

There is no question that PrEP has saved lives. At issue is Gilead's strategy to exploit consumers financially and physically for the sake of profits.

Monday, January 6, 2020 - Safer Version DelayedPrEP4All Collaboration, an activist group whose goal is to ensure HIV prevention meds are affordable and available to those who need them most, has filed a petition with the U.S. Patent and Trademark Office. The group is requesting that the office deny PrEP manufacturer Gilead a 3-year extension on their patent for PrEP HIV prevention.

The group is the latest among a growing list of advocates who maintain that Gilead has "gamed the system," abusing the patent system in order to establish a monopoly and price-gouge the life-saving drug, sold under the names Truvada, Stribild, Complera, and Atripla, and is commonly referred to as PrEP.

No one is arguing that the HIV prevention PrEP has been anything less than vital. In fact, there is no question that the drugs have saved lives. At issue is Gilead's strategy to exploit consumers financially and physically for the sake of profits.

By extending the patent, Gilead would be able to continue to control consumer costs for PrEP and charge exorbitant prices for the drugs in the U.S.

Currently, a month's supply of PrEP in the United States costs $1,600 to $2,000 per month. In other countries where patent laws differ, PrEP HIV prevention is much more affordable. For example, it is available for as little as $8 per month in Australia, and $20 a month in Sweden.

Even in the UK, where PrEP is approximately $500 a month, it is far more cost-effective than in the U.S.

PrEP Toxicity

Just as significant in this case, PrEP4All and other groups contends that Gilead withheld research and development of tenofovir alafenamide fumarate (TAF), a component of HIV preventative medications they knew was a safer alternative than tenofovir disoproxil fumarate (TDF) used in Truvada and its earlier iterations.

They say that Gilead began developing drugs based on both TAF and TDF at about the same time. According to their own studies, Gilead developers realized early on that TAF was less toxic.

TAF-based alternatives, sold under the names Odefsey, Genvoya, Biktarvy, and Descovy, are absorbed into the body more readily, so they require lower doses in order to be effective. Higher-dosed TDF has been found to cause kidney damage, loss of bone density, and other detrimental side effects.

Yet, once the patent was approved for Truvada, documents show that Gilead not only halted the release of its TAF-based drugs for six years, but they also withheld studies that showed TAF was safer.

The patent allowed Gilead to keep charging high prices for what, at the time, were the only HIV prevention drugs available.

Currently, the patent for PrEP expires in 2022, but the drug maker is seeking an additional three years, until 2025, during which time the advocacy group argued the company will unfairly rack up huge sales to the detriment of those whose lives depend on the drugs.

Current Litigation against Gilead

Thousands of lawsuits against Gilead are currently awaiting trial, including one filed by the U.S. Department of Health and Human Services, which alleges the government owns the patent for both Truvada and Descovy versions of PrEP.

Onder Law Firm in St. Louis, MO is currently representing a large number of plaintiffs who say they suffered kidney damage, bone density loss, and other serious side effects they believe are a result of use of TDF-based PrEP drugs.

We believe that Gilead should be held accountable for practices that put profits over people. We acknowledge that HIV prevention is critical to the lives of so many, and that one life lost to AIDS is one too many lives.

However, the facts that Gilead has gouged the price of drugs that people desperately need, and at the same time, has knowingly and needlessly put consumers' health at risk in order to make billions of dollars is unacceptable.

If you have taken TDF-based PrEP and been diagnosed with kidney failure or bone density loss, contact the attorneys at Onder Law Firm. We are dedicated to holding corporations accountable for exploitative practices.

Click here to schedule a free consultation, or call 314-963-9000. We will fight for you.

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