Ten patents on two TB drugs

There is a complex set of links between TB and liver problems..

An online tool launched last week sheds light on what patents have been granted for which medicines in a number of developing countries. While the tool is still a work in progress, it is a massive step forward for the transparency of patent status information in South Africa relating to medicines for HIV, tuberculosis (TB) and hepatitis.

The tool called MedsPaL was developed by the Geneva-based Medicines Patent Pool. It can be accessed at www.medspal.org

TB kills 1.8 million people per year and is currently the infectious disease that kills most people on the planet. After 50 years of stagnation, two new TB drugs – bedaquiline and delamanid – have recently been developed. While trials to determine their optimal use are still ongoing, they seem set to revolutionise the way TB is treated, especially drug-resistant forms of TB (DR-TB).

Bedaquiline patents in SA

A search on MedsPaL shows that South Africa has granted five different patents on bedaquiline. The base patent was granted in 2005 and will expire in 2025.

Two so-called ‘new use’ patents were granted in 2006 (for treatment of DR-TB) and 2007 (for treatment of latent TB). South Africa currently grants patents for mere new uses of existing medicines, even though this is not a requirement under international law and these two patents would not have been granted in a number of other countries.

A process patent (2007) and a new formulation patent (2009) were also granted – the latter expiring in 2029, four years after the base patent. New formulation patents are mere reformulations of existing drugs and contains no new active pharmaceutical ingredient. Argentina, for example, does not grant such new formulation patents. India only grants them when they provide a therapeutic benefit.

Delamanid patents in SA

MedsPaL also finds five patents on delamanid in South Africa. We see a similar pattern as with bedaquiline. A base patent was granted in 2005. The base patent was followed by a new use patent (for the treatment of TB) in 2006. There then follows what appears to be two new formulation patents – delamanid in combination with other TB drugs (2008) and delamanid compositions (2007).

As with bedaquiline, South Africa is under no obligation in international law to grant these new use and new formulation patents. Should we wish, we could change our laws to prohibit such secondary patents.

The fifth patent, granted for ‘delamanid intermediate compounds’, only expires in 2032 – more than seven years after the base patent.

Secondary patents like these eight patents on bedaquiline and delamanid often delay generic competition. Due to this lack of competition the prices of medicines in South Africa are often higher than prices for the same medicines in countries with laws that restrict secondary patenting.