Charity challenges second European patent on Gilead's hepatitis C therapy Sovaldi

Doctors of the World - Médecins du Monde (MdM) on Monday challenged another European patent covering Gilead Sciences' hepatitis C therapy Sovaldi (sofosbuvir), arguing that it "does not comply with patentability requirements" set out in the 1973 European Patent Convention. MdM has been joined by around 30 civil society organisations from 17 European countries filing coordinated oppositions against a patent granted in June 2016 that is related to the base compound used to produce Sovaldi.

The action by MdM follows a patent challenge against Sovaldi filed by the charity in February 2015, which claimed that "the molecule itself is not sufficiently innovative." In October last year, the European Patent Office ruled that Gilead had not met all the requirements for its patent application, which covered the chemical formula of the drug.

According to MdM, it is taking the latest action in an effort "to reduce exorbitant prices for new hepatitis C drugs in France and in Europe," which the charity claims "bar the way to full access to drugs that cure hepatitis C." MdM added that "this new proceeding should incentivise governments to use the most powerful legal tool they get: compulsory license."

FirstWord reports in this therapy area - KOL Insight Hepatitis C: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.

Sovaldi was approved in Europe in January 2014, with the European Public Health Alliance (EPHA), which joined the latest patent challenge by MdM, pegging the average cost for a 12-week regimen of the therapy at 55 000 euros ($59 757) per patient. EPHA added that this compares with an estimated production cost of less than 1 euro ($1.09) per tablet. "For governments in Europe, the asking prices are either entirely unaffordable or force rationing to a very limited number of patients at critical stages of the disease," EPHA commented.

Last month, Gilead said that it expects sales of hepatitis C drugs this year to be in the range of $7.5 billion to $9 billion, down from $14.8 billion for 2016 and below analyst forecasts of $11.6 billion. The dugmaker explained that competition from other therapies and shorter treatment duration for patients will reduce sales, while fewer new patients starting on the drugs will also hit revenue. For related analysis, see ViewPoints: Gilead's hepatitis heyday is officially over and an M&A conundrum awaits.

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