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20 September 2018Europe

Gilead HIV drug not entitled to SPC, says UK court

The English High Court has ruled that Gilead’s drug Truvada is not entitled to a supplementary protection certificate (SPC) because it failed to meet the standards set out by Europe’s highest court earlier this year.

The decision was handed down by Mr Justice Arnold on Tuesday, September 18.

Truvada (emtricitabine/tenofovir disoproxil fumarate) is an anti-retroviral medication used to treat HIV and is protected by European patent number 0,915,894.

Gilead’s SPC application had originally been rejected by the comptroller-general of patents, but Gilead appealed and was granted the SPC in July 2008.

But, in 2016, generic drug makers Teva, Accord Healthcare and Mylan challenged the validity of the SPC for Truvada, claiming that it does not comply with article 3(a) of regulation 469/2009 (the SPC regulation).

The generic companies claimed that emtricitabine isn’t specified in the wording of claim 27 and that the expression ‘other therapeutic ingredients’ doesn’t specify any active ingredient.

In response, Gilead claimed that for article 3(a) to be satisfied, it is sufficient that the product falls within the scope of protection of at least one claim of the basic patent.

In a judgment dated January 2017, Arnold ruled that the test to be applied in order to determine whether a product is protected by a basic patent within the meaning of article 3(a) remains unclear, so he referred the case to the CJEU.

The CJEU handed down its decision in July this year, concluding that the combination of active ingredients does not need to be expressly mentioned in the claims of the basic patent if the claims “relate necessarily and specifically to that combination”.

It added that each of the ingredients must be “specifically identifiable” in light of all the information disclosed by the patent.

According to the CJEU, it fell to the English High Court to determine whether the expression ‘other therapeutic ingredients’ satisfies the requirement that the claims of the basic patent relate necessarily and specifically to the product.

Earlier this week, Arnold followed the CJEU’s line of reasoning, finding that “there is no basis for the skilled person to understand that the combination embodies the technical contribution of the patent”.

In addition, Arnold added that emtricitabine is not specifically identifiable.

“It is not even a member of a specific class of compounds mentioned in the patent, whether by reference to their structure or activity, as being suitable for combination with the compounds of the invention,” Arnold explained.

He noted that there was no evidence that emtricitabine is an effective agent for treating HIV in humans at the patent’s priority date.

Arnold concluded that Gilead had made no invention in devising the combination which warranted the grant of a patent, “let alone an SPC”.

An application from Gilead to file further evidence before the CJEU was also rejected by Arnold.

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More on this story

Americas
23 August 2018   A non-profit called AIDS Healthcare Foundation has filed a petition for certiorari with the US Supreme Court in a patent dispute with Gilead.
Big Pharma
4 June 2018   The Paris Court of First Instance has nullified a supplementary protection certificate covering Gilead’s HIV/AIDS treatment Truvada.

More on this story

Americas
23 August 2018   A non-profit called AIDS Healthcare Foundation has filed a petition for certiorari with the US Supreme Court in a patent dispute with Gilead.
Big Pharma
4 June 2018   The Paris Court of First Instance has nullified a supplementary protection certificate covering Gilead’s HIV/AIDS treatment Truvada.