Generic drug manufacturers win HIV-drug appeal against Gilead

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The Court of Appeal in London has ruled in favour of several generic drug manufacturers, dismissing an appeal brought by pharmaceutical giant Gilead in a dispute over intellectual property rights for an HIV drug. According to a report on the Out-Law.com site, the case before the Court of Appeal concerned the validity of Gilead’s supplementary protection certificate (SPC) for its product marketed under the Truvada brand.

Gilead had appealed after the High Court had previously ruled in favour of generic drug manufacturers Teva, Accord Healthcare, Lupin and Mylan. The Truvada product consists of two active ingredients, tenofovir disoproxil and emtricitabine, in a single, fixed dose tablet. The High Court had found that the claim relied, on an underlying European patent, was not specific enough to the combination of active ingredients in Gilead’s product.

The Court of Appeal has now upheld that decision, but in doing so it has clarified the legal test for determining whether or not a combination of active ingredients falls under the invention covered by the basic patent. The Court of Appeal said that ‘to protect a combination product, a claim must require the presence of two compounds, not just one’.

The Court of Appeal said Gilead had not satisfied this requirement in this case because the second ingredient in its combination is expressly stated in the patent claim to be optional. Having decided Gilead’s SPC did not satisfy the first limb, the court did not go on to consider the second limb.

Report on the Out-Law.com site

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