Gilead loses its challenge to a pair – In a setback to Gilead Sciences (GILD), a federal panel rejected its bid to invalidate a pair of patents owned by the U.S. government for using the Truvada pill to prevent HIV, a drug that has sparked controversy due to its cost and the extent to which taxpayer dollars funded crucial research.
The Patent Trial and Appeals Board ruled that Gilead failed to demonstrate it was likely to win its argument for overturning the patents held by the Centers for Disease Control and Prevention, which helped fund academic work into HIV prevention that later formed the basis for the best-selling medicine that is also known as PrEP (here is one ruling and here is the other).
Although a Gilead challenge to yet another set of CDC patents has not been decided, the ruling comes amid a bruising fight between the company and the U.S. government over the rights to the discovery. Three months ago, the Department of Health and Human Services filed a lawsuit claiming Gilead infringed on government patents for a pair of HIV medicines and refused to reach a licensing deal.
In its challenges, Gilead maintained published materials show that “well before HHS claims to have invented” the concept of HIV prevention in 2006, “others had conceived of using an antiretroviral therapy, including Truvada” to prevent infection with the virus. Gilead was referring to guidelines published in 2005 by the Center for HIV Identification, Prevention, and Treatment Services and AIDS Partnership California.
A Gilead spokesman sent us a statement saying the company is reviewing the decision, but argued that the denial “does not mean that the HHS patents are valid. The Patent Trial Appeal Board simply did not find the limited evidence we were permitted to introduce… was sufficient to justify a full hearing on the merits using its expedited procedure… Gilead continues to believe all four HHS PrEP patents are invalid and should not have been granted… There is compelling evidence demonstrating that the HHS patents are invalid.”
Gilead loses its challenge to a pair – AIDS activists, meanwhile, cheered the decision.
For months, activists have pushed HHS to collect royalties from Gilead, arguing the drug maker exploited the federal government by using the benefits of the intellectual property to charge ever-higher prices for Truvada. The activists have maintained the federal government could use royalties to fund HIV prevention and treatment services. The issue prompted a congressional hearing last June.
AIDS activists have further claimed high pricing has limited patient access. The pill costs about $1,750 a month, or $21,100 a year, but its cost has climbed steadily since it was approved in 2004 for treating HIV. At that time, the wholesale cost for a month’s supply was $650. In 2012, Truvada was approved to prevent HIV, at which point the cost rose to $1,159, according to Truven Health Analytics.
“This is a major victory for activists and the U.S. government,” said James Krellenstein, a member of the PrEP4All Collaboration. “This reinforces the position that the CDC patents are fully valid and enforceable, and that Gilead willfully and recklessly infringed on valid patents that form a major revenue center in their product pipeline.”
Last year, Truvada generated $2.6 billion in U.S. sales. Recently, though, Gilead won Food and Drug Administration approval to sell Descovy, a newer-generation HIV prevention pill that Wall Street expects will become a big seller. So far, the predictions appear true: Descovy generated nearly $1.1 billion in U.S. sales in 2019. Patents that Gilead holds on Truvada start expiring next year, although a generic version will appear later this year under a deal with Teva Pharmaceuticals (TEVA).
Separately, yet another but related matter is before the patent appeals board. Two months ago, the PreP4All Collaboration filed an emergency petition, arguing that Gilead allegedly lied about important information in a patent application with the U. S. Patent and Trademark Office. For its part, the drug maker denied doing so.
As we noted, PrEP4All offered evidence suggesting Gilead concealed a decision to delay development of the component in Descovy, called tenofovir alafenamide, or TAF, in order to thwart generic competition and “game” the patent system. The activists also contended Gilead reaped billions of dollars in additional sales while knowingly marketing the older Truvada, which is based on tenofovir disoproxil fumarate, or TDF, which the company believed was not as safe.