The Court of Appeal has refused an appeal by Gilead Sciences over a supplementary protection certificate (SPC) for Truvada, a combination of tenofovir disoproxil (TD) and emtricitabine (FTC). The decision leaves in place a High Court order declaring the certificate invalid and revoking it.
The dispute concerned whether the combination was protected by Gilead’s patent under EU rules governing SPCs. TD was expressly identified in the patent, but FTC was not. Gilead argued that FTC was covered by a claim allowing a pharmaceutical composition to include “optionally other therapeutic ingredients”.
The Court of Appeal, in a judgment delivered by Ms Justice Costello on 2 February 2021, upheld the trial judge’s conclusion that the patent was broad and was not primarily focused on HIV treatment. It covered possible treatments for a range of viral infections. The court accepted the trial judge’s view that the relevant skilled team would include a medicinal chemist and a clinician involved in managing a range of viral infections, including herpes, hepatitis B and HIV.
Under the EU Court of Justice test considered in the appeal, an unlisted ingredient in a combination must necessarily fall under the invention covered by the patent, and each ingredient must be specifically identifiable from the patent’s information. The Court of Appeal held that the first requirement was not met. It said “optionally” could not be read as meaning mandatory, even though combination treatment was the standard approach for HIV at the patent’s priority date.
The court also declined to depart from a UK Court of Appeal decision concerning the same product and patent. It found that differences in the evidence presented in Ireland did not justify a different result. The court said it was not necessary to decide the appeal grounds concerning the second part of the EU test once the first part had failed.
The High Court had ruled in October 2019 that the combination was not protected by the patent and made an order revoking the SPC on 8 November 2019. The Court of Appeal refused Gilead’s appeal. It provisionally considered that Teva and Mylan were entitled to their appeal costs, subject to adjudication if the parties could not agree. Gilead had 10 days to request a short hearing to argue for a different costs order.