- GlaxoSmithKline on Wednesday pledged not to seek patent protection for its drugs in low income countries to help expand access to its medicines for the poorest regions of the world. GSK also plans to offer licenses for its drugs to generic manufactures in "lower middle income" countries.
- For drugs licensed in lower middle income countries, GSK will seek a royalty on generic sales of its drugs. In explaining the new approach, CEO Andrew Witty said the global challenges in healthcare required a flexible approach to intellectual property (IP) protection.
- Additionally, GSK said it intends to commit future cancer treatments to patent pooling through the Medicines Patent Pool, a UN-support initiative to boost licensing of drugs in lower income countries.
GSK and other drugmakers have utilized tiered pricing models to widen access for their drugs in lower income countries, but the commitment to not seek patent protection is a step further. For some countries, this will formalize GSK's de facto approach. In essence, GSK's plan will port the graduated pricing model to IP protection.
"In itself, IP is not a barrier to access to medicines. However, we recognise that the global healthcare challenge requires us to be flexible in our approach and responsive to different needs, particularly as the disease burden shifts from infectious to non-communicable diseases," said Witty.
GSK will not file patents for its drugs in countries classified as either "least developed countries" or "low income countries" (by the UN and World Bank, respectively), roughly 50 countries mostly in Africa and Oceania. The World Bank defines low income countries as those with gross national income below $1,045 per capita.
The pledge will make it clearer for generic manufacturers seeking to supply generic versions of GSK drugs in those countries, the company said.
For lower middle income countries (LMIC), the drugmaker will offer licenses permitting generic versions of its drugs for 10 years, getting a royalty on sales in return. However, India and Indonesia, which are both classified as LMIC, will not be included for GSK's purposes. For high income countries, upper middle income countries, and G20 countries (India and Indonesia are in the G20), GSK will continue to seek full patent protection.
GSK will also be the first drug company to commit oncology treatments to the UN-backed Medicines Patent Pool. The pool currently facilitates licensing of HIV, Hep C, and tuberculosis medicines in low and middle income countries. But as the disease burden is shifting toward cancer and other non-communicable diseases, GSK plans to expand the patent pooling approach to oncology.
"“The experience GSK has with the Medicines Patent Pool for Tivicay – our newest HIV medicine and one of our most commercially successful products – gives us confidence that increasing access, incentivising innovation appropriately and achieving business success can go hand in hand," Witty said.
Pharma companies have typically priced drugs at different levels based on country income as patients in developing countries are often unable to pay the price charged in U.S. or European markets. Recently, however, IP protection has also received attention as a barrier to access for poorer patients.
Earlier this month, the humanitarian organization Doctors Without Borders (MSF) began legal proceedings to block Pfizer's attempt to patent an important pneumonia vaccine in India. MSF is seeking to preserve the ability of generic drug companies in India to manufacture the vaccine at lower cost, as it purchases large amounts of the drug for its vaccination work.
India has adopted stricter approaches to patenting and been more willing to consider the use of compulsory licensing to allow generic companies to make branded drugs. The U.S. pharma industry has been critical of this and pushed for strong patent protection in India, arguing protection is needed for its innovative products.
GSK will continue to seek full patent protection for its drugs in India due to its status as a G20 country.