HIV drug dispute appeal ruling favours generics

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 raised the appeal before the court 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 in 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.

SPCs serve to extend the life of a patent by up to a maximum of five years for products which are authorised under the relevant regulatory framework in the field of medicinal and plant products. Under EU regulations, SPCs can only be granted if, in the EU country in which the application is submitted, the product is protected by a basic patent in force and market authorisation has been issued to place that product on the market as a medicinal product, so long as that authorisation is the first of its kind and an SPC has not already been issued for the product.

In 2018 the Court of Justice of the EU (CJEU) was asked to clarify what criteria need to be satisfied for an SPC to be said to cover a product that is 'protected' by a basic patent, under the terms of the legislation. It set out a two limb test that needs to be satisfied.

The CJEU said that the combination of the active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and that each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent. The assessment of whether that criteria is met must be carried out through the eyes of a "person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent", it said.

In its ruling, the CJEU said that the combination of active ingredients does not need to be expressly mentioned in the claims of the basic patent if those claims relate necessarily and specifically to that combination.

Gilead's appeal before the Court of Appeal concerned the way in which the High Court had interpreted the CJEU's ruling when applying it to its case. The Court of Appeal decision focused on the first limb of the CJEU's test – that the combination of the active ingredients falls under the invention covered by the basic patent.

In elaborating on that part of the test, the CJEU had said that "it is necessary to understand without any doubt, on the basis of their general knowledge and in light of the description and drawings of the invention in the basic patent, that the product to which the claims of the basic patent relate is a specification required for the solution of the technical problem disclosed by that patent".

The Court of Appeal said that the relevant test is simply an extension of another legal test previously established in a case involving Eli Lilly, in which the court had confirmed that the claims should relate "necessarily" to the active ingredient in question.

Extending that test to cases where there is more than one active ingredient, 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. It held that the word 'optional' is no different in principle to a claim that relies on the word 'comprising' to describe the ingredients of a product, which previous case law has established is insufficient to protect a combination.

Having decided Gilead's SPC did not satisfy the first limb, the court did not go on to consider the second limb.

Pinsent Masons acted for Teva in this case.