India rejects Gilead’s patent application for sofosbuvir

29 January 2015. Related: Treatment access, Hepatitis coinfection.

Simon Collins, HIV i-Base

On 20 January 2015, the Indian court made a landmark decision to reject a patent application for the hepatitis C drug sofosbuvir. [1]

This decision could enable an affordable option for effective treatment globally, especially for people in resource-limited settings. It may also enable access for people in middle- and high-income settings who are unable to afford treatment, or where access to treatment is restricted.

This is a victory for civil society activists in India, including the Lawyers Collective, the Hepatitis Coalition of Nagaland, and Network of PLHIV living in the Asia Pacific region (APN+) who filed a challenge to the patent in India. [2]

The main challenge was that sofosbuvir lacks novelty, or inventive manufacturing steps required under the Indian Patents Act.

Existing patents in many countries will still block access to generic sofosbuvir. This includes in South Africa, where a joint press release from the Treatment Action Campaign, Section 27 and Médecins Sans Frontières noted “…sofosbuvir is not yet registered or available in South Africa, and existing patent barriers could hinder the country from looking for multiple generic sources of the drug in order to get the most affordable prices”. [1]

Originator manufacturer Gilead has been widely criticised for setting a price for sofosbuvir that will dramatically restrict use even in Western countries. A 12-week course costs £34,000 in the UK and $84,000 in the US. Even with cure rates, Western economies will only be able to treat a fraction of people with hepatitis C, many of whom are not yet diagnosed.

i-Base have also reported the analysis from Hill and colleagues showing that the production and manufacturing costs for sofosbuvir and other direct acting HCV drugs, are estimated to be less than $150 for a three-month course of treatment. [3]

Comment

Last week Gilead stepped up pressure on India and is trying to reverse the decision of the Indian Patent Office through the courts. The company is currently also putting pressure on the Department of Industrial Policy in India, which oversees the patent office, using the argument that there will be no problem accessing sofosbuvir in India (or in other developing countries) because last September Gilead issued a voluntary license to Indian generic companies enabling them to produce generic versions for some countries, determined by Gilead.

This license has been criticised by many groups of civil society and experts working in intellectual property and access to medicines. The voluntary license has a number of problems that call into question whether Gilead will really allow access, or just inhibit open generic competition, which is proven to be the most effective way to bring down the price of medications. Problems with the voluntary license include:

• The exclusion of 50 developing countries from the territories covered by the voluntary license (mainly middle-income countries). These include countries severely affected by the HCV epidemic that will not be able to afford the prices charged by Gilead. This is even if there is no patent protection in those countries,
• Banning the sale of raw materials used in the manufacture of generics outside few Indian generic producers selected by Gilead in the volutary license, including exclusion of manufacturers in countries where there is no patent eg Egypt,
• Anti-diversion measures in total violation of the principles of human rights and medical ethics disclosing confidential data of the patients. Even in countries included in the license these measures permit the exclusion of all people not eligible for government programmes to access treatment, as well as people who are treated in the private sector and foreign residents.

References:

1. Joint press release: Treatment Action Campaign, Section 27 and Médecins Sans Frontières. TAC, Section 27 and MSF applaud India’s rejection of patent on new hepatitis C medicine. (20 January 2015).
   http://www.tac.org.za/news/tac-section27-and-msf-applaud-india’s-rejection-patent-new-hepatitis-c-medicine
2. Lawyer Collective. Civil society opposes patent on sofosbuvir. (10 September 2014).
   http://www.lawyerscollective.org/updates/civil-society-opposes-patent-on-sofosbuvir.html
3. Hill A et al. What is the minimum cost per person to cure HCV? 7th IAS Conference on HIV Pathogenesis, Treatment and Prevention, 30 June – 3 July 2013, Kuala Lumpur. Late breaker poster TULBPE16.
   http://pag.ias2013.org/abstracts.aspx?aid=3142
   https://i-base.info/htb/21803