On the morning of 18 September 2018, the English High Court handed down its judgment concerning Gilead’s SPC (Supplementary Protection Certificate) for its antiretroviral product Truvada.
On the morning of 18 September 2018, the English High Court handed down its judgment concerning Gilead’s SPC (Supplementary Protection Certificate) for its antiretroviral product Truvada. The Court held Gilead’s SPC to be invalid for failing to satisfy Article 3(a) of the SPC Regulation – i.e. the product of the SPC was not considered to be protected by the basic patent.
Truvada is a combination of active ingredients tenofovir disoproxil and emtricitabine and is used in the treatment of HIV and other viral infections. The decision from the English High Court follows a long-running battle between Accord (with other generic companies) and Gilead, which included the case being referred to the Court of Justice of the European Union (CJEU). Both the English High Court and the CJEU held that Gilead’s SPC had been granted contrary to the policies and regulations that govern the granting of SPCs and that Gilead’s SPC was therefore invalid and should be revoked.
Accord continues to invest heavily in pursuing patent and regulatory challenges through European courts. These court decisions vindicate the challenge brought by Accord that can now provide patients with an affordable alternative tenofovir and emtricitabine combination product.
About Accord Healthcare
Headquartered in the United Kingdom (UK), Accord Healthcare Europe is the fastest growing generic pharmaceutical companies in Europe. Accord has an extensive supply chain through its four UK based sites, helping to ensure a consistent supply of life-enhancing medicines for patients, whilst supporting customers to react quickly to dynamic market conditions.
