Last week, humanitarian not-for-profit Médecins du Monde, together with Médecins Sans Frontières and organisations from 17 countries, challenged a patent on a pharmaceutical component of Gilead’s hepatitis drug, Sovaldi (sofosbuvir).
Sovaldi received US approval in December 2013, and European authorisation in January 2014, for the treatment of chronic hepatitis C infection. At the time of approval, the drug attracted criticism over its price tag, which equated to around $1,000 (€857) a pill.
On September 14, 2018, patent 2,604,620 was upheld by the European Patent Office (EPO), despite Médecins du Monde’s claim that the related component is “inactive”, and its patent, therefore “unmerited”.
According to Médecins du Monde, the patent “contributes to Gilead’s monopoly and prevents hundreds of thousands of patients in Europe to receive affordable treatment.
“The verdict demonstrates how pharmaceutical companies abuse the patent system by using patents only for their own interests instead of their original purpose: patents were devised to improve the well-being of society,” the non-government organisation added.
Gilead defended the patent protection of its treatment in an emailed statement, highlighting that last week’s hearing related to one of a number of patents protecting the manufacture of Sofosbuvir.
“As the EPO has previously granted and maintained a separate patent that covers the sofosbuvir molecule itself, this patent does not impact Gilead’s exclusive right to make and sell our hepatitis C medicines in the EU,” the firm explained.
According to Gilead, its Hepatitis C treatment range, which includes Sovaldi, Harvoni, Epclusa and Vosevi, has “transformed the treatment of HCV.”
The firm also highlighted its access programmes in developing countries, which include an agreement with the Medicines Patent Pool – an organisation that can sub-license production to generic drug companies in India, China and South Africa.