Dive Brief:
- The District Court for the Northern District of California dismissed last week the AIDS Healthcare Foundation's (AHF) complaint to invalidate the patent for tenofovir alafenamide (TAF), a combination ingredient used by Gilead in several of its HIV drugs.
- The advocacy group claimed Gilead, the primary defendant, had delayed the release of TAF technology in order to extend patent protection of its HIV franchise and maintain high list prices at payers' expense.
- The court ruled in Gilead's favor, claiming TAF technology has never been sold as a stand-alone product and therefore the plaintiff's claims of monopolization did not stand. The advocacy group stated on Monday it would appeal the decision.
Dive Insight:
The decision was a big blow for the AHF and HIV-generic hopefuls and a win for Gilead, as it cemented the definition of monopolization as market-based rather than technology-based.
Since Gilead had received no economic power over TAF given the lack of an existing market, the company could not: monopolize said power; tie list-prices of combination drugs to a non-existent standalone product; or foreclose competition for a non-existing market in California or Nevada, the court ruled.
AHF's main argument for invalidating the patent was that Gilead had delayed the release of TAF until their TDF medications were close to patent expiry in order to ensure extensions and longer market dominance. But the court also dismissed this claim, stating, "[Gilead] had no obligation to introduce the improved product at an earlier date. Any competitor could have beaten Gilead to market (and thus NCE exclusivity)."
AHF also contended Gilead deliberately sought approval for fixed-dose combinations including TAF to better protect TAF from competition. "The drugs at the heart of AHF's lawsuit are Gilead's TAF (tenofovir alafenamide), which has fewer negative side effects than TDF (tenofovir disoproxil fumarate), but unlike TDF, is only available as a part of Gilead's FDCs and not as a standalone medication," the AHF said.
Yet the court also left several doors open for the AHF, as the advocacy group was quick to point out in its statement. The group can amend its technically-dismissed arguments before the court this month, and appeal non-amendable arguments (patent invalidation and tying of list-prices) to a higher court.
"We intend to appeal all the way to the Supreme Court, if necessary, should that be required to prevent Gilead from using a faulty patent process to garner more profits at the expense of patient health," said AHF President Michael Weinstein in a statement.