An announcement today in Europe (press release below) brings a new angle to the copious US coverage of drug pricing, such as predatory pricing of the EpiPen and the smirking, seemingly sociopathic Martin Shkreli. For the drug described below, the Médecins du Monde (Doctors of the World, below) blog says, “While [this drug is] a major therapeutic advance, the molecule itself, which is the result of work by many public and private researchers, is not sufficiently innovative to warrant a patent.”

That touches on another hot topic in the US: the use and re-use of data from government-funded research – whose data is it? Who owns the intellectual property? That’s what Vice President Biden spoke about (my video) at Health Datapalooza last year, and it’s at the core of the New England Journal’s SPRINT Data Analysis Challenge, which we blogged about last fall – its winners have been announced and there will be a free live two-day web event April 3-4 in Boston. That challenge arose out of a controversial editorial that said some people consider data sharing to be a “parasite” problem.

Whose data is it? Whose IP is it? What are the rights of investors vs the people who have the problem, aka “patients”?

Brussels,  27 March 2017

The European Public Health Alliance (EPHA) is among 30 civil society organisations from 17 European countries filing coordinated patent oppositions on Hepatitis C medicine Sofosbuvir with the European Patent Office (EPO).

The development of highly effective new treatments for Hepatitis C has been accompanied by outcry from patients and governments against exorbitant prices charged by the drug-makers.  The patent for Sofosbuvir – the basis for Hep C treatments including Sovaldi® and Harvoni® – is held by American pharmaceutical giant Gilead. Patent-based monopolies and exclusivities encourage price-setting at extreme levels, such as the average EUR55,000 Gilead charged per patient in Europe for a 12-week regimen, in contrast to production costs estimated at less than EUR1 per pill.

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. Patent opposition is a mechanism provided for in the European Patent Office rules, which can shorten the duration of a patent or remove it, if validated. This can pave the way to restrict the monopolistic price setting and to enable competition, including from generics.

EPHA President Archie Turnbull says,

EPHA respects today’s medicine patents system, and with this filing aims to ensure that drug-makers play by the rules. The successful first patent opposition launched by our member Médecins du Monde (MdM) in 2015, vindicated their concerns that this is not always the case. Today’s filing builds on this important precedent and is another step towards better access to medicines.

Yannis Natsis, lead of EPHA’s Access to Affordable Medicines Campaign reiterates,

With this filing, we are questioning the grounds on which the patent was granted and we emphasize the possible non-compliance with the current patentability criteria. It is no longer off-limits to discuss these matters in Europe, particularly given the gravity of the access to medicines problems Europeans face today.

Notes for editors:
1) List of supporting organisations:

• 11 European Médecins du Monde chapters (MdM)
• 13 European Médecins Sans Frontières sections (MSF)
• Access to Medicines Ireland (Ireland)
• AIDES (France)
• European Public Health Alliance (EPHA)
• Just treatment (UK)
• PRAKSIS (Greece)
• Salud por Derecho (Spain)

2) Background information (available in French):
La procédure utilisée et les décisions prononcées par la division d’opposition de l’OEB en première instance

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