European regulator amends some Gilead hep C patent claims

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In a setback for Gilead Sciences, European regulators decided not to uphold all of its patent claims for the best-selling Sovaldi hepatitis C treatment, a move that could lead to generic versions of the medicine becoming available four years sooner than had been expected.

The European Patent Office on Tuesday amended several patent claims that were challenged by Medicins Du Monde, a medical aid charity, which argued that Gilead was abusing the patent system and charging prices that hindered access for many patients. The patents that were challenged were for the so-called pro-drug, which allows the body to metabolize the medicine, on the grounds that Gilead failed to fully disclose the nature of its innovation, among other things.

“This is a flawed patent that has been used by the pharmaceutical company to impose a huge pressure on [European] states that have accepted exorbitant prices leading to treatment restrictions for patients in many European countries,” said Dr. Françoise Sivignon, the president of Medicins du Monde, which filed its challenge last year, in a statement.

As a result, a generic version of Sovaldi — the first of the new crop of hepatitis C medications to revolutionize treatment — could become available in Europe in 2024 instead of 2028, according to Tahir Amin, the who heads intellectual property at IMAK, the Initiative for Medicines, Access & Knowledge, a nonprofit that works with patient advocacy groups in challenging patents.

A Gilead spokesman sent us a statement maintaining the patent, as a whole, was not revoked. “The European Patent Office “confirmed that Sovaldi was covered by a valid European patent,” he wrote us. The patent office “found that claims covering [Sovaldi] within the patent were valid. The board believed that these claims were novel and inventive.” He also insisted there will be no impact on the possibility of generics arriving before 2028.