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Could Gilead face early Sovaldi generics in Europe?

EU patent protection for the hepatitis C virus drug will end in 2024

The European Patent Office has partially revoked patent protection for Gilead Sciences' hepatitis C virus drug Sovaldi, which could open the door to generic competition four years earlier than expected.

The EPO ruled on an opposition to the European patent on Sovaldi (sofosbuvir) filed by medical charity Médecins du Monde (MdM) last year, which questioned the validity of the patent.

After a two-day hearing at the EPO headquarters in Munich, the EPO decided that Gilead's patent claims "extended beyond the content of the patent application as filed".

As it stands, the ruling means that protection for Sovaldi will now extend out to 2024 rather than 2028, according to an article in STAT citing Tahir Amin, co-founder and director of intellectual property of the initiative for Medicines, Access & Knowledge (iMAK).

Gilead insists that the patent remains valid and it has full protection for its drug out to 2028, while the EPO says some of the claims in the patent are no longer admissible. The verdict can be appealed according to EPO procedure.

Gilead has already had to field a lot of criticism over the price of Sovaldi, which is often name-checked in the ongoing debate about the sustainability of medicine pricing. MdM's challenge centred on a prodrug of sofosbuvir, which it says was described in the literature ahead of Gilead's patent filings for Sovaldi.

"Sofosbuvir is a genuine example of this diversion of patent principles while the 12-weeks treatment course being priced 41,680 euros to French Social Security whereas the Indian generic version is sold 220 euros," said MdM.

The charity welcomed the partial revocation of the patent but reiterated calls for a compulsory license, which would allow generic competition immediately.

Patents on Sovaldi have already been rejected in China, Ukraine and Egypt, but the loss of protection in a high-income region like Europe will be particularly uncomfortable for Gilead.

The company licensed rights to the drug to Indian generics companies in 2014 to improve access to the drug in low-income countries, but was criticised for not putting measures in place for hepatitis C patients in middle-income countries.

"Today's decision highlights the growing global movement of rejecting unjustified patents. This decision significantly weakens Gilead's protection on Sovaldi," said Amin.

iMAK brought the cases against Sovaldi patents in China and Ukraine, and has also challenged Gilead's intellectual property in other middle income countries, namely Argentina, Brazil, Russia and India, which initially revoked patent protection and then reversed the decision last year.

“Patent oppositions are critical to improving the quality of examination and we applaud the EPO for revoking key claims that were not in compliance with the law," he continued.

"What is really needed is more rigorous patent examination before patents are granted in order to improve patent quality."

Article by
Phil Taylor

7th October 2016

From: Sales



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