Gilead to lose protections for HIV drug

In a judgment seen by Out-Law.com, Mr Justice Arnold concluded that Gilead was not entitled to a supplementary protection certificate (SPC) because its patent's claims were not specific to a product it argued was covered by a now expired European patent – a link that is necessary under EU law for SPCs to be granted.

SPCs serve to extend the life of a patent by up to a maximum of five years with respect to products which are authorised under the relevant regulatory framework in the field of medicinal and plant products. SPCs are provided for under EU regulations which are directly applicable across the whole of the EU, although they have to be applied for separately in each EU country.

The rationale for SPCs is to compensate patent holders for the period of patent protection during which they are prevented from commercialising their products owing to the lengthy approval process. Patent protection lasts 20 years but it often takes drugs companies around a decade to develop new medicines and gain marketing authorisation.

Generic drug companies Teva, Accord Healthcare, Lupin and Mylan challenged Gilead's rights to hold an SPC for its HIV drug, which is sold under the Truvada brand name. The product consists of two active ingredients, tenofovir disoproxil and emtricitabine, in a single, fixed dose tablet.

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.

The requirements of the SPC Regulation in respect of products composed of several active ingredients were further clarified in EU case law earlier this year after the High Court asked the Court of Justice of the EU (CJEU) 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.

The CJEU ruled in July that, in accordance with previous CJEU case law, the combination of active ingredients do not need to be expressly mentioned in the claims of the basic patent if those claims relate necessarily and specifically to that combination.

However, it clarified 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", the EU court said.

In its ruling, the CJEU gave its view that Gilead could not rely on the claims it had made in its SPC application to satisfy the criteria it had set. However, it confirmed that it was up to the High Court to reach its own conclusion on the matter. The High Court has now applied the CJEU's case law to the facts of the dispute between Gilead and the rival generic drug manufacturers.

Mr Justice Arnold backed Teva, Accord Healthcare, Lupin and Mylan's argument that one of the ingredients contained in the combination product covered by Gilead's SPC, emtricitabine,  was not specifically included within the scope of Gilead's former European patent, and that this undermined the product's eligibility for an SPC.

The judge rejected Gilead's application for the case, which was subject to an earlier hearing before the High Court, to be re-heard with new evidence from experts considered. He considered the application "an abuse of process".

"In substance it amounts to an attempt by Gilead to amend its case and adduce fresh evidence after trial and judgment, and thereby get a second bite at the cherry, in circumstances where it could and should have brought its whole case, including any expert evidence, before the [High] Court at the trial," Mr Justice Arnold said. "It is true that the Court has not yet delivered final judgment, but that is only because the case raised an issue of European law upon which a preliminary ruling by the CJEU was required first. Now that the CJEU has given its ruling, the Court is in a position to give its final judgment and make an order accordingly."

Mr Justice Arnold said, though, that even if he was wrong about Gilead's application being an abuse of process, he said Gilead had already adduced evidence relating to the 'prior art' at the trial and was not entitled to broach the subject again.

The judge further concluded that even if he allowed Gilead to present new evidence on the issue, it would not help the company to satisfy the second part of the CJEU's test to prove the product is protected by a basic patent in force – that each of the active ingredients in its product had been specifically identifiable in the information disclosed by the underlying patent.

He also accepted Teva, Accord Healthcare, Lupin and Mylan's argument that Gilead had also failed to satisfy the first part of the CJEU's test – that the combination of the active ingredients fall under the invention covered by the patent. The judge said that the underlying patent "says nothing" about the two ingredients in the product being combined to treat HIV or even reference one of the ingredients of the combination at all.

"All [the patent] says … is that the claimed compounds may be administered as pharmaceutical formulations with optionally other therapeutic ingredients," Mr Justice Arnold said. "Accordingly … there is no basis for the skilled person to understand that the combination embodies the technical contribution of the patent."

Pinsent Masons, the law firm behind Out-Law.com, acted for Teva in this case. Gilead could yet seek permission to appeal the High Court's ruling.

"In my view the decision rightly balances the objectives underpinning the SPC Regulation, in that an SPC should protect what the patentee actually invented at the filing or priority date of the basic patent and not something which they did not," said intellectual property law expert Samantha Carter of Pinsent Masons.