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Treatment for Hepatitis C: The Patent System is Standing in the Way of Access to Medicine

(Paris, 12 September 2023) Following the appeal filed by AIDES, Médecins du Monde and Médecins sans Frontières, the European Patent Office (EPO) has decided to uphold the patent on the base compound of sofosbuvir, a treatment for hepatitis C owned by the American pharmaceutical company Gilead. This decision reinforces the abusive monopoly and ignores the factors that could have allowed the launch of an affordable generic version of the drug in Europe. Our healthcare system is going through an unprecedented crisis, and it is urgent that the state assumes its responsibility to protect public health.

Following the public hearing of the Board of Appeal, the European Patent Office (EPO) has decided to uphold its October 2018 decision when it found Gilead’s claims legitimate and upheld the patent on the base compound of sofosbuvir, thereby supporting once again an unmerited patent.

“The sofosbuvir case is an edifying example of the diversion of the patents system that Médecins du Monde fights against, and the decision of the EPO is quite worrying because it reveals its weakness. It shows that there is a complete disconnect between the application of patent law and the needs of the public healthcare systems. Reforming patent policies has become an urgent matter in Europe”, Head of the Drug Pricing campaign at Médecins du Monde Olivier Maguet said.

“One of the essential criteria of patenting is inventive step. However, this is not part of the sofosbuvir patent!” he continued.

“In our opposition procedure, we produced clear arguments proving that most of the compounds covered by the patent have no technical effect. However, ignoring the logic that a patent must cover a genuine invention, the Board of Appeal still decided to maintain the patent” intellectual property Advisor for the organisations Quentin Jorget explained.

“Let’s remember that the state remains the regulator of the entire chain of provision of the drug: health security, granting of a patent, pricing, but also solvency of the market. However, when the State grants unmerited patents, it does not assume its responsibility to defend the fundamental right to protecting health for everyone” President of Médecins du Monde Dr Florence Rigal claimed.

Sofosbuvir is used to treat hepatitis C; it benefits from the monopoly granted by patents whose legitimacy our organisations argue against. Between 2014 and 2021, industrialists have received 4.5 billion euros of public funds, a figure that corresponds to the sum reimbursed by the Health Insurance, the French social security, to cover the treatment of almost 95,500 patients*. These public funds could have been allocated to the healthcare system that is currently in a crisis. Generic versions of the drug would have cost less than 10 million euros in total in total.

“To this day, we still receive testimonies from people being refused hepatitis C treatment because of its exorbitant price, especially for people who use drugs and/or people who live on the streets. This issue also affects people who are not registered with the French social security, and for whom treatment has been stalled as their social security registration is pending, or depending on the state of their liver” Head of Institutional Advocacy for AIDES Ines Alaoui said.

According to the WHO, millions of people across the world still live with undiagnosed and untreated hepatitis C. France is far from attaining its goal of eliminating hepatitis C by 2025. “It is unacceptable that our country and our institutions have decided to yield to the demands of excessive pricing of a firm, at the expense of public health and of individuals. The State must assume its responsibility and play its role of regulator. The health minister must impose the use of the ex officio licence*** to allow the production or importation of affordable generic versions of treatments for hepatitis C” President of AIDES Camille Spire claimed.

At a time when the government is reviewing its industrial pharmaceutical policy, the ex officio licence on sofosbuvir is an opportunity to be seized to finally demonstrate that there is an actual will to restore the balance of powers between the French state and pharmaceutical companies.

* According to the European Patent Convention, an invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art.

** Améliorer la qualité du système de santé et maîtriser les dépenses, Propositions de l’Assurance Maladie pour 2023 (“Improving the quality of the health system and controlling expenses, proposals for 2023 from l’Assurance Maladie”; document from the French social security published in July 2022)

*** The ex officio licence is a tool for regulation that can lift a monopoly granted by a patent, against a fair compensation for the holder, thus allowing access to affordable generic versions.

Note to editors:
 Sofosbuvir is the first interferon-free drug for hepatitis C with very little side effects, marketed in France under the name Sovaldi.
 Sofosbuvir is considered a turning point in drug pricing for innovative drugs in France. Its exorbitant price (€56,000 euros in 2013 then €41,000 in 2014) had led to the rationing and triage of patients. Before expanding access in 2017, and against all recommendations based on medical criteria to contain the epidemic, sofosbuvir was only reimbursed by social security for the most severely affected hepatitis C patients. Thus, chronically infected patients at a less advanced stage were excluded.
 To this day, the French state has refused to use the ex officio licence. The public prices of hepatitis C treatments, exclusively sold by Gilead, amounts to €24,905 for three months of treatment using Solvaldi and Epclusa, and €37,158 for Harvoni. The production cost for the generic version of the drug is estimated somewhere between €63 and €127 per treatment.

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Source: Médecins du Monde