GSK changes approach to patents in developing countries

GlaxoSmithKline (GSK), one of the world's leading pharmaceutical companies, recently announced that it is adopting a new approach to patenting its products around the world with the aim of widening access to its medicines in the world's poorest countries.

In future, GSK will not file patents for its medicinal products in Least Developed Countries (LDCs) and Low Income Countries (LICs).  The World Bank currently defines such countries as those having a gross national income (GNI) per capita of USD 1045 or less in 2014.  GSK hopes that this will encourage generic companies to manufacture and supply generic versions of its medicines in these countries, the majority of which are in Africa.

At the same time, in Lower Middle Income Countries (defined as those having a GNI between USD 1045 and 4125 in 2014), GSK will file for patents but will generally seek to offer and agree licences to allow supplies of generic versions of its medicines for 10 years.  GSK intends to seek a small royalty on such licensed sales.  GSK will however continue to seek full patent protection for its products in High Income and Upper Middle Income countries and in the G20 countries.  Importantly, this includes India, China and Brazil which are all members of the G20.

This change in patent policy by GSK may not have an immediate effect on the availability of medicines in the world's poorest countries, as the major generics companies are unlikely to have significant manufacturing capability in these countries at present.  Generic companies will still therefore have to consider the patent situation in the countries where they manufacture any generic GSK products.  In this they will be assisted by GSK's simultaneous commitment to making information regarding its current and future patent portfolio freely available to 3rd parties.

In the longer term, and particularly if other innovative pharmaceutical companies follow GSK's lead, supply of affordable generic medicines in the world's poorest countries should increase.

The changes in GSK's patent filing policy go hand-in-hand with a commitment to make its future portfolio of cancer treatments available for patent pooling to help address the increasing burden of cancer in developing countries.  The Medicines Patent Pool (MPP) is an UN-backed initiative which was established in 2010 and has been successful in accelerating access to HIV, TB and hepatitis C medicines in low and middle-income countries through voluntary patent licensing arrangements.  Expanding this approach to cancer treatments will enable generic versions of GSK's next generation of cancer therapies, currently in clinical development, to be made available to LDCs, LICs and certain middle-income countries once they receive regulatory approval.

In addition, as part of its long term strategy to provide medicines in some of the poorest nations, GSK was one of the major pharmaceutical companies leading the research and development into an Ebola vaccine (ChAd3-ZEBOV) during the 2015 crisis, working in collaboration with the US National Institute of Allergy and Infectious Diseases (NIAID).

From an IP perspective, GSK's most recent announcement also highlights how important strong patent protection for their products in the world's major economies continues to be for innovative pharmaceutical companies. Only by maintaining exclusivity in major markets through IP protection can innovative pharmaceutical companies continue to fund investment in the research and development of new medicines, such as the Ebola vaccine, whilst making current medicines available in poorer countries.