Patent Situation of Key Products for Treatment of Hepatitis C – Sofosbuvir. Working Paper, Updated and Revised Version June 2016
(2016; 37 pages)

Abstract

Resolution WHA67.6, adopted by the Sixty-Seventh World Health Assembly, requested the Director-General “to work with national authorities, upon their request, to promote comprehensive, equitable access to prevention, diagnosis and treatment for viral hepatitis” and “to assist Member States to ensure equitable access to quality, effective, affordable and safe hepatitis B and HCV treatments and diagnostics, in particular in developing countries”. Ensuring access to new treatments is a challenging task. In order for countries to identify ways of increasing access and affordability of new HCV medicines, they need clarity about patent status. To assess whether a medicine is patent protected in a certain country requires expert knowledge and access to specialized databases that are not easily available. The WHO Global strategy and plan of action on public health, innovation and intellectual property provides WHO with a mandate to support efforts to determine the patent status of health products (element 5.1c). Despite the possibility of filing patents under the World Intellectual Property Organization (WIPO) Patent Cooperation Treaty (PCT) in 148 jurisdictions, worldwide patents do not exist. Patents are granted individually under each jurisdiction, depending on the national patent law and the outcome of the examination process. National patents that relate to the same basic patent (i.e. the same invention) are called family members and together constitute a patent family. In the present study, patent families are based on the Derwent World Patent Index (DWPI). In 2014, the WHO Secretariat mandated Thomson Reuters to carry out an analysis of the patent situation of seven new hepatitis treatments. The draft and updated reports were shared with the respective sponsor companies before publication. Due to the fast developing patent situation, in August 2015 WHO mandated another service provider, Pharmathen, to update and revise reports and the relevance of the different patents included in these reports.

The objectives of the patent working papers are to:

  1. identify the most relevant patents with respect to the medicines of interest
  2. identify in which countries these patents have been filed and granted
  3. identify secondary patents that might delay the entry of generic medicines
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