Gilead loses appeal to prevent generic HIV drug entering Irish market

Gilead have lost their appeal case claiming that combinations of two anti-retroviral agents in Truvada are protected against generic alternatives.

A hand holding a Truvada pill, which Gilead recently lose patent rights during an appeal case
Image: NPR

The Court of Appeal has dismissed an appeal by Gilead Sciences aiming to halt two companies who produce and supply generic HIV drugs from putting any product containing a combination of two particular anti-retroviral agents on the Irish market. 

On Tuesday, February 2, the Court of Appeal upheld a High Court decision revoking Gilead’s supplemental protection certificate for Truvada, a combination antiretroviral medication predominantly used to treat and prevent HIV. The pharmaceutical firm initially brought proceedings against Teva and Norton (Waterford) Ltd, trading as Teva Pharmaceuticals Ireland, and against Mylan SAS, Generics UK Ltd (trading as Mylan) and McDermot Laboratories Ltd, trading as Gerard Laboratories Ltd and as Mylan Dublin.

Gilead were seeking to prevent the two companies from placing any product on the Irish market which contains a combination of two anti-retroviral agents; Tenofovir disoproxil (TD) and emtricitabine (FTC), which are key components in the firm’s development of Truvada

The pharmaceutical firm claimed that the supplemental protection certificate would be infringed if Teva and Mylan placed any product containing a combination of these agents on the Irish market. In an October 2019 judgement, Mr Justice Denis McDonald agreed with the defendants that this drug combination was not protected by the relevant patent.

Mr Justice McDonald further rejected Gilead’s claims about the validity of the certificate. He noted evidence that the patent was relevant to a number of viruses and subsequently dismissed the pharmaceutical’s case. 

While giving judgement following a three judge Court of Appeal, Ms Justice Caroline Costello outlined that the trial judge had engaged with essential evidence and clearly set out his reasons for rejecting the case put forth by Gilead. She also rejected arguments that he failed in his approach to accurately interpret the patent, noting that he correctly read it in accordance with EU and domestic law.

Ms Justice Costello further spoke on Gilead’s “true complaint” regarding the trial judge giving weight to the clinical need for other viral infections, such as Hepatitis B, herpes and cytomegalovirus among others. She ruled that his approach was “unimpeachable” in this regard. 

Gilead also argued that Mr Justice McDonald effectively ignored evidence as to the urgent unmet clinical need for dealing with HIV in 1996, which was the priority date of the patent. However, Ms Justice Costello judged that this was “untenable” and the trial judge showed a full awareness of the AIDS crisis in his judgment.

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