GlaxoSmithKline is planning to adopt a new intellectual property (IP) framework under which it will not file for patent protection in the world’s poorest nations, to help widen access to its medicines.

The UK drugs giant said it recognises that improving access around the world, and better addressing pressing health challenges in developing countries, requires a flexible and multi-faceted approach to IP protection. 

Under the new approach, whether the firm will seek IP protection will depend on a country’s economic maturity. For Least Developed Countries (LDCs) and Low Income Countries (LICs), GSK will not file patents for its medicines, so as to give clarity and confidence to generic companies seeking to manufacture and supply generic versions of GSK medicines in those countries. 

For Lower Middle Income Countries generally, GSK will file for patents but will seek to offer and agree licences to allow supplies of generic versions of its medicines for 10 years, seeking a small royalty on sales in those countries. For High Income Countries, Upper Middle Income Countries and G20 countries, GSK will continue to seek full patent protection.

GSK also said it intends to commit its future portfolio of cancer treatments to patent pooling and will explore the concept with the Medicines Patent Pool (MPP) - a UN-backed initiative designed to facilitate voluntary licensing of innovative treatments in low and middle income countries - to help address the increasing burden of cancer in developing countries. 

Since it was established in 2010, the MPP has accelerated access to HIV, TB and hepatitis C medicines in LICs and MICs through voluntary licensing arrangements. Expanding this approach to oncology would enable generic versions of GSK’s next generation immuno-oncology and epigenetic therapies, currently in clinical development, to be made available such nations on their approval.

Improving generic supply

“The changes we are setting out aim to make it as clear and simple as possible for generic manufacturers to make and supply versions of GSK medicines in LDCs, LICs and most LMICs [lower middle income countries],” noted GSK chief executive Sir Andrew Witty.

Matthew Royle, Partner in the IP/IT group at legal services firm Taylor Wessing, said the move is “very positive news for access to medicines in the developing world”. 

“Previous attempts to improve access have not had the intended impact. For instance the Aricle 31bis of TRIPS, which introduced a route to obtain a compulsory licence to supply drugs to developing countries, has still only been used once - by Canadian company Apotex to supply a triple combination HIV therapy to Rwanda. It will be interesting to see whether or not other drugmakers follow GSK’s lead."