We the Pat[i]ents: HHS v Gilead

On November 6, 2019, the US Department of Health and Human Services (HHS) filed suit against pharmaceutical manufacturer Gilead Sciences, Inc., seeking damages against the company for infringing on HHS patents for pre-exposure prophylaxis (known as “PrEP”) for HIV prevention.  Gilead manufactures and sells two pills—Descovy and Truvada—for use in a PrEP regimen.  In an online statement released the same day, HHS claims that Gilead received approval from the US Food and Drug Administration (FDA) to produce Descovy and Truvada for post-infection HIV treatment, and following taxpayer-funded research by the US Centers for Disease Control and Prevention (CDC), Gilead obtained FDA approval to use the drugs as preventative treatment—despite not obtaining licenses to use the patents.

Two decades after the AIDS epidemic began, CDC researchers developed medications to prevent HIV infection after exposure.  According to the CDC, the government’s patented regimens are 99 percent effective at preventing HIV contraction after exposure to the virus.  According to HHS, the US Patent and Trademark Office granted four patents allowing HHS to license (and receive royalties for) CDC’s PrEP regimens.  HHS alleges Gilead refused to reach a licensure agreement with the government on multiple occasions.

AIDS activist organizations, such as PrEP4All, have urged HHS to collect royalties from Gilead, arguing the manufacturer used the government’s (and taxpayer-funded) intellectual property to raise prices for Truvada.  Accusations of Gilead’s “price-gouging” practices led to a House Committee on Oversight and Government Reform hearing in May.  During the hearing, lawmakers asked Gilead’s CEO about Truvada’s prices overseas—in Australia, the drug only costs $8 per person per month.

Gilead has argued that rising costs support research.  In 2004, when Truvada was first approved as HIV treatment, its monthly wholesale cost was $650.  When the drug was approved for a PrEP regimen in 2012, its cost rose to $1,159, according to research from Truven Health Analytics.  The pill is now over $1,750 per month, or $21,100 per year, though health insurance can offset out-of-pocket costs.  The drug brought Gilead $3 billion in sales last year.

To help patients obtain the drug, the company offers the Gilead Advancing Access program to help eligible patients pay for their medication—and even patients with commercial health insurance might not have a copay.  In the spring of 2019, Gilead donated enough medication to cover up to 200,000 patients over the next 11 years.  However, only 10 percent of those who need the drug receive it.

This past summer, Gilead challenged the government’s patents.  A Gilead executive corroborated HHS’ claim that the manufacturer and the agency could not reach a license agreement during several years of discussions.  In a November 7 statement published in STAT, a Gilead spokesperson claimed the patents granted to HHS for PrEP and PEP (post-exposure prophylaxis) are not valid, and that HHS filed for patents without alerting the manufacturer, which it was obligated to do.  The company argues that HHS’ patents are not valid because other entities developed antiretroviral therapies for PrEP and PEP before HHS claimed invention in 2006.  The company also claims that it invented Truvada, funded the clinical trials that led to FDA’s 2004 approval, spent $1.1 billion in research and development for the drug—including for subsequent studies on PrEP regimens—and similarly bore costs for Descovy.

According to the activists, HHS could use royalties to fund HIV prevention efforts and treatments.  On the same day that HHS filed suit, the Journal of Acquired Immune Deficiency Syndromes published a study from Abbott Laboratories and the University of Missouri, Kansas City, announcing that scientists discovered a new strain of the HIV virus—the first in 19 years.

SOURCES: Available upon request.