The nonprofit AIDS Healthcare Foundation (AHF) recently filed a petition for writ of certiorari with the US Supreme Court seeking a review of its lawsuit against Gilead Sciences, alleging the company's patent for a key HIV/AIDS drug is invalid because Gilead manipulated the patent system.
The filing follows the US District Court for the Northern District of California granting of a Motion to Dismiss by Gilead, though AHF says the court’s order suggested that the case was “ripe for reconsideration” by higher courts.
According to the petition to SCOTUS, tenofovir was first discovered in 1984 by scientists in Czechoslovakia. In 1997, Gilead bought the rights to sell tenofovir and modified the chemical composition so it could be taken orally.
That modified version, known as TDF, won FDA approval in 2001 under the brand name Viread (tenofovir disoproxil fumarate).
According to AHF, the US Food and Drug Administration (FDA) repeatedly warned Gilead about its sales tactics regarding TDF. For example, in 2003, FDA required Gilead to re-train its sales representatives about the side effects associated with TDF.
Seeking a safer version of TDF, Gilead developed tenofovir alafenamide (TAF) but did not seek FDA approval for it until 2015, which also coincided with the first time generic drugmakers could legally introduce generic versions of TDF.
“Notably, even after Gilead made TAF available, it did not release it as a standalone product (unlike TDF, which Gilead released both as a standalone product and as part of various combination drugs),” the filing says.
“Instead, Gilead entered into licensing agreements with Japan Tobacco and others to sell fixed-dose combination therapies that enjoy the patent protections of not only the weak TAF patents, but also patents that cover the other pharmaceutical compounds in these combination drugs.”
The moves were economically advantageous for Gilead but not for patients, the nonprofit charges.
“Consequently, patients that might have been treated with TAF, which was known to be effective and less toxic as early as 2002, were forced to wait more than a decade so that Gilead could profit from its patent and regulatory monopoly first on TDF and then on TAF for as long as possible,” the petition says. “Gilead waited until TDF was about to go off patent to seek FDA approval and New Chemical Entity exclusivity for TAF,” AHF claims, noting that NCE exclusivity prevents potential competitors from filing for FDA approval of any TAF-containing product until November 2019.
However, AHF, the largest nonprofit provider of HIV and AIDS medical care in the US, said it wants to introduce generic versions of TAF to its patients as soon as possible because it is less toxic than TDF.
And because of the five-year exclusivity for TAF, meaning an abbreviated new drug application (ANDA) cannot legally be filed until November 2019, AHF seeks to challenge the validity of Gilead’s TAF patents.
“Respondents’ patents stand in the way,” AHF says
Michael Carrier, distinguished professor at Rutgers Law School, told Focus
: "The Court doesn’t take many cases, but this is one that it might. It involves a precise legal issue (whether a party can obtain a declaratory judgment before an ANDA is filed) and also has broad public policy consequences."