By Ed Silverman @Pharmalot
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.
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Charity scores small win in Hep C drug battle
October 5, 2016
Patient groups around the world have accused Gilead Sciences of charging exorbitant prices for its blockbuster sofosbuvir drug, which is highly effective but can cost up to $1,000 per pill.
In France, a 12-week course of treatment costs 41,000 euros ($46,000).
To open the way to a low-cost generic version of the drug, sold under the brand name Sovaldi, the group Medecins du Monde (Doctors of the World) had launched a legal challenge against the firm's patent.
Ruling on the claim, the European Patent Office in Munich said it had upheld the patent filed by Gilead but "in an amended form", leaving only the components used in the drug under intellectual protection, not sofosbuvir itself.
The MdM charity said the impact of the ruling was difficult to interpret but it at least created a legal limbo that could give European governments leverage to renegotiate prices with Gilead.
October 5, 2016
Patient groups around the world have accused Gilead Sciences of charging exorbitant prices for its blockbuster sofosbuvir drug, which is highly effective but can cost up to $1,000 per pill.
In France, a 12-week course of treatment costs 41,000 euros ($46,000).
To open the way to a low-cost generic version of the drug, sold under the brand name Sovaldi, the group Medecins du Monde (Doctors of the World) had launched a legal challenge against the firm's patent.
Ruling on the claim, the European Patent Office in Munich said it had upheld the patent filed by Gilead but "in an amended form", leaving only the components used in the drug under intellectual protection, not sofosbuvir itself.
The MdM charity said the impact of the ruling was difficult to interpret but it at least created a legal limbo that could give European governments leverage to renegotiate prices with Gilead.
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