European court decision may lead to more affordable access to HIV drug

Biopharma firm Gilead unsuccessful in patent row over its pre-exposure prophylaxis drug

The drug Truvada   came off patent in July last year, but its Irish exclusivity was extended until 2020 by a supplementary protection certificate. Photograph: Getty Images

The drug Truvada came off patent in July last year, but its Irish exclusivity was extended until 2020 by a supplementary protection certificate. Photograph: Getty Images

 

Biopharmaceutical giant Gilead has been unsuccessful in a European court in a row that could ultimately lead to affordable access to a drug used in the prevention and treatment of HIV.

The case involving the US company with a $100 billion (€86bn) market value relates to its blockbuster HIV drug Truvada. The drug came off patent in July last year, but its Irish exclusivity was extended until 2020 by a supplementary protection certificate.

Generic giants Mylan and Teva sell a version of Truvada on the Irish market, with Mylan’s product coming in 85 per cent less expensive.

In 2017 Gilead sought an injunction against the generics manufacturers to prevent them from selling their cheaper drug which is used to treat patients with HIV and also as a treatment immediately after possible exposure to HIV to prevent contraction.

Gilead’s injunctive action was unsuccessful in the High Court, and last month it withdrew its appeal against that court’s refusal to grant the injunction.

Mylan, Teva and the other applicants argued the summary of product characteristics (SPC) does not meet a key condition laid down under a European regulation which effectively means a combination of drugs used in the manufacturing of Truvada cannot be covered under the SPC.

Combination

Although the European Court of Justice did not make a final determination on the question of the SPC’s validity, it did suggest the original patent didn’t specify the combination of drugs in Truvada.

“It does not seem possible that a person skilled in the art, on the basis of the prior art at the filing date or priority date of that patent, would be able to understand how emtricitabine, in combination with TD, necessarily falls under the invention covered by that patent,” the court said, referring to the combination in question. It noted that the onus is nevertheless on the referring court.

While negative for Gilead, considering it has generated around $14 billion globally in recent years from Truvada, Aids campaigners welcomed the judgment which will, until the issue is resolved in the Irish courts later this year, allow unfettered access to the generic alternative.

‘Day in the sun’

Adam Shanley, a HIV prevention activist, said the decision was a positive one, setting a precedent that “Gilead have had their day in the sun”.

“We’re in the middle of a HIV crisis in Ireland, ” he added, noting that it was “nearly solely caused by a lack of access” to drugs.

It is expected that Gilead’s case to keep SPC protection in Ireland will come before the courts later this year.

Wednesday’s judgment come after Government signals that pre-exposure prophylaxis, or PrEP, could be funded by the public health service in certain circumstances. PrEP is the drug under dispute by Gilead, Mylan and Teva.