Gilead Sciences won a victory last week when a federal court judge tossed a lawsuit in which an AIDS activist group accused the drug maker of manipulating the patent system in order to thwart competition for its HIV medicines.
In its lawsuit, the AIDS Healthcare Foundation had charged that Gilead not only violated antitrust laws, but also prevented countless HIV patients from access to a newer and safer treatment. The battle was framed by AIDS activists as another instance in which the company had placed profits over patient safety, a criticism that has dogged Gilead over its pricing on hepatitis C drugs for more than two years.
At issue was tenofovir, or TDF, which until recently had been a cornerstone of the widely used combination HIV treatments sold by the company. The patent on the TDF compound expires in December 2017, and Gilead is replacing it with a modified version known as TAF. But the patent on TAF doesn’t expire until May 2022, providing another five valuable years without generic competition.
TAF is also more potent and causes fewer side effects, notably bone damage and kidney toxicity. AHF argued Gilead knew of the safety benefits dating back to 2001, but the company delayed testing TAF in humans until 2011. In doing so, AHF charged Gilead purposely waited to seek regulatory approval for drugs containing TAF until shortly before its older TDF-based products lost patent protection.
This maneuvering meant that Gilead would be able to forestall patent challenges on its TAF-based drugs for a few years, but meanwhile, HIV patients faced side effects unnecessarily. Moreover, AHF maintained that since TAF is simply a modified form of TDF, the drug maker does not deserve patent protection and sought to have the TAF patents invalidated.
But in a ruling last Wednesday, Judge William Alsup of the US District Court in San Francisco shot down the arguments made by the nonprofit, which buys medicines for the 46 health centers it operates in the United States. “Gilead’s patents gave it a monopoly over both TDF and TAF. It had no obligation to introduce the improved product at an earlier date,” he wrote.
AHF said it intends to appeal the decision.
“The court stated that AHF should have standing to bring its patent invalidity claims to clear the way for generic manufactures to obtain FDA approval,” said Arti Bhimani, the group’s assistant general counsel, in a statement. AHF “firmly believes that pharmaceutical companies should not be permitted to game the patent system to prolong profits at the expense of patient welfare.”
As for Gilead, a company spokesman wrote that the drug maker is “pleased” with the decision. “In our opinion, AHF’s complaint lacked merit and we believe our position has been validated.”
The decision, by the way, came less than a week after Gilead raised prices on two older HIV medications — Complera and Stribild — that contain TDF and face patent expiration. In fact, it was the second time in six months the company boosted list prices — which do not reflect rebates offered payers — a break from its usual strategy of increasing prices annually.
At the same time, Gilead left intact prices for two much newer versions of these drugs — Odefsey and Genvoya — which contain TAF. And these newer medicines are now priced higher than the older treatments. AIDS activists criticized the company for raising payer and patient costs.