WHO Updates Patent Status Info For New Hepatitis C Medicines

The World Health Organization has issued updated information on the patent status of hepatitis C medicines, including assessments of hurdles for affordable generic versions of latest drugs. 

The reports were updated on seven new treatments, including sofosbuvir, ledipasvir and daclatasvir, which were included in the latest WHO Essential Medicines List. Data was provided for 40 countries and regions.

The patent landscape reports are available on the WHO website here.

“Knowledge of the patent status of new medicines is important for governments who are trying to make those medicines available to their populations,” WHO said in the summary of the reports.

Looking at the report on daclatasvir as an example, it says in August 2015 WHO mandated another service provider, Pharmathen, to update and revise reports and the relevance of the different patents included in earlier reports by a different company.

The report states that 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

It found eight relevant patents, and walked through their possible effect on the availability of cheaper generics. It also described patent licence agreements

The WHO website summary is reprinted below:

“WHO updates patent information on treatments for Hepatitis C

New medicines on the market have given hope to the millions of people who suffer from Hepatitis C, a liver disease that kills approximately 700,000 people annually.

In 2016, the World Health Assembly, WHO’s policy-making body, endorsed the Global health sector strategy on viral hepatitis 2016-2021 that requests WHO to “advocate for comprehensive strategies to reduce prices of viral hepatitis vaccines, medicines, diagnostics and other commodities.”

WHO works closely with Member States to assess and promote policy options for increasing access to these medicines, which remain unaffordable to many of those who need them and put an enormous financial strain even on the health systems of high-income countries.

Knowledge of the patent status of new medicines is important for governments who are trying to make those medicines available to their populations. To that end, WHO has carried out an analysis of the patent situation for seven of the new treatments, including sofosbuvir, ledipasvir and daclatasvir, all of which have been included in the WHO List of Essential Medicines in 2015. The reports provide clarity on whether the medicines are patent protected or not in individual countries.

The dataset was completed for more than 40 countries, territories and regions.”