Sofosbuvir faces fresh patent challenge in Europe

BMJ 2017; 356 doi: (Published 30 March 2017) Cite this as: BMJ 2017;356:j1632
  1. Ned Stafford
  1. Hamburg

The medical aid charity Doctors Without Borders (Médecins Sans Frontières) and other non-governmental organisations have begun a new legal challenge aimed at revoking the European patent for the blockbuster hepatitis C treatment sofosbuvir, to allow the sale in Europe of cheaper generic versions of the drug.

The patent is held by the US drug firm Gilead Sciences, which markets sofosbuvir under the highly profitable brand name Sovaldi. Sofosbuvir is also a component of Harvoni and Epclusa, two other hepatitis C treatments marketed in Europe by Gilead Sciences.

The new patent challenge, filed on 27 March 2017 at the European Patent Office in Munich, is the second major challenge to one of Gilead’s European patents for sofosbuvir. The first challenge was filed in 2015 by several groups, including Doctors of the World (Médecins du Monde),1 which is also involved in the new challenge.

In both patent challenges the organisations argue that the patents in question are for drugs that are not sufficiently novel or do not involve enough inventive steps to warrant patent protection.

In a statement explaining the fresh legal challenge, Aliénor Devalière, EU policy adviser for Doctors Without Borders’ access campaign, said, “The science behind sofosbuvir isn’t new.”

Key patents on sofosbuvir have already been revoked in China and Ukraine, and decisions are pending in other countries, including Argentina, India, Brazil, Russia, and Thailand, said the charity.

The European Patent Office issued a ruling on the first challenge in October 2016, saying that it would not revoke the patent. However, it stipulated that Gilead Sciences must accept amendments to keep the patent.2

Olivier Maguet, who is responsible for Doctors of the World’s drug pricing campaign, told The BMJ that his organisation appealed the European Patent Office’s ruling in December 2016, adding: “We still ask for patent revocation.” The appeal, which is likely to include public hearings, could last up to two years, he said.

Hu Yuan Qiong, legal adviser for the Doctors Without Borders access campaign, told The BMJ that drugs were usually protected by several patents. The two most important patent protections are the drug’s base compound patent and the prodrug patent. Hu said that the first challenge against sofosbuvir filed in 2015 was aimed at the prodrug patent, while the new legal challenge targets the base compound patent, which was granted in 2016 after the first challenge had been filed.

Hu said that the new legal challenge could last around 18 months. If both the base compound patent and the prodrug patent were revoked, then the door would be open for sales of generic forms in Europe. “This may not happen overnight,” she said, “because there are also regulatory processes required. But removing key patent barriers is a critical step toward this goal.”

Hu said that in Europe the highest price for a 12 week course of treatment of sofosbuvir was in Poland, at a cost of $59 000 (£47 500; €55 000). This compares with $38 783 in the UK, $44 503 in Germany, and $41 885 in France.

Hu declined to say what Doctors Without Borders would consider a fair price for a 12 week course of treatment. “It’s hard to say,” she said. “What we want to tell is that, first, the drug can be produced for less than $1 per pill and, second, the cheapest generic version now can provide a treatment for around $211.”

A spokesman for Gilead Sciences told The BMJ that the new legal challenge would have “no immediate impact on Gilead’s patents or on our exclusive right to make and sell Sovaldi, Harvoni, and Epclusa in the EU.” He noted that the EU patent targeted by the new challenge had been granted in 19 other nations, “reflecting the innovation involved in the development of this medicine and its unprecedented value to patients.”


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