Sofosbuvir access: new patent challenges to sofosbuvir

Simon Collins, HIV i-Base

The ongoing struggle to enable access to sofosbuvir globally at affordable prices continues with several new developments.

On May 20th, additional patent challenges against Gilead’s sofosbuvir in Argentina, Brazil, China, Russia and Ukraine were filed by community organisations. [1]

The challenges were filed by Initiative of Medicines, Access and Knowledge (I-MAK), Grupo de Trabalho sobre Propriedade Intelectual (Brazil), All-Ukrainian Network of People Living with HIV/AIDS, Treatment Preparedness Coalition (Russia) and Fundación Grupo Efecto Positivo (Argentina).

On the same day, demonstrations and protests were announced in Thailand and Tunisia by AIDS Access Foundation (Thailand), The Tunisian Association of Fight Against STDs and AIDS and International Treatment Preparedness Coalition (Middle East North Africa).

In January, the Indian Patent Controller rejected one of Gilead’s key patent applications for sofosbuvir. [2]

Other activists in Asia are tracking the approval status and price of eleven current generic versions of sofosbuvir being manufactured in India under license form Gilead. This is updated when new information becomes available. [3]

A month later, the Paris-based Médecins du Monde (MDM) group challenged the patent in the EU, alleging that the active ingredient in Sovaldi (sofosbuvir) “is the result of work by many public and private researchers [and] is not sufficiently innovative to warrant a patent.” [4]

In England, delays and restrictions to access – especially for anyone who does not have cirrhosis – were highlights by the Hepatitis C Trust. [5]

“Sofosbuvir will be available from 1 August 2015 – with peginterferon and ribavirin for genotype 1 and for those with cirrhosis who have genotypes 3, 4, 5 or 6 (or who have previously tried treatment for those with genotype 3) and in very limited cases without interferon. NICE’s assessments of sofosbuvir in combination with ledipasvir (Harvoni), daclatasvir in combination with one or more other drugs and ombitasvir with paritaprevir and dasabuvir have all been paused while NICE considers a request from NHS England to limit availability because of the cost.”

The Hepatitis C Trust is urging patients to write to their MPs and include a template letter online. [6]


  1. Pollack A. High cost of Sovaldi hepatitis C drug prompts a call to void its patents. The New York Times (19 May 2015)
  2. MSF. Gilead denied patent for hepatitis C drug sofosbuvir in India. (14 January 2015).
  3. Summary of generic sofosbuvir availability in India and pricing. (18 May 2015). (PDF)
  4. Doctors of the World. Médecins du monde opposes sofosbuvir patent in Europe. (10 February 2015).
  5. Hepatitis C Trust newsletter.

Links to other websites are current at date of posting but not maintained.