- All > Medicine Information and Evidence for Policy > Medicines Policy
- All > Public Health, Innovation, Intellectual Property and Trade > Intellectual Property (IP) and Trade
- Keywords > access to medicines
- Keywords > availability, affordability, and quality of pharmaceutical products
- Keywords > diabetes medicines
- Keywords > generic medicines
- Keywords > innovation and intellectual property
- Keywords > insulin access
- Keywords > intellectual property laws
- Keywords > patent and exclusivity status
- Keywords > patents - examination of pharmaceutical patents
- Keywords > Trade Related Aspects of the Intellectual Property Rights (TRIPS)
(2016; 64 pages)
This study on insulin patents was undertaken as part of Addressing the Challenge and Constraints of Insulin Sources and Supply (ACCISS) Study. Insulin is an essential medicine that is needed for all people with type 1 diabetes, and a growing number of people with type 2 diabetes. It is crucially important that people in need can access this life-saving medicine.
Patents confer a 20 year period in which the patented product has market exclusivity, therefore third parties need permission from the patent owner to manufacture the product. Whether or not patents on insulins are a barrier to access is an important issue. This research looked at which insulins are not patented, or no longer patented. Publicly-accessible databases from the United States (US), European, Chinese and Indian patent offices, as well as the US Food and Drug Administration (US FDA) and Health Canada, were reviewed to determine the patent status of human and analogue insulins.
Patents on analogue insulins in the market in the US and Canada have already expired or will soon expire in these countries and elsewhere. Only four companies own these key patents: Novo Nordisk, Sanofi, Eli Lilly and Pfizer. Patents on these insulins are geographically restricted roughly to North America, Europe, Australia, and China. In general, where US or Canadian patents were detected, about half were found in high-income countries, a quarter in middle-income countries, and the remainder in lower-middle-income countries. Patents in low-income settings were rare.
Patents and patent applications on insulins that are being developed have a wider geographic scope than insulins marketed in the US and Canada. Across the four companies, the patent expiration dates are delayed so any insulin patents that might eventually be granted will expire as late as 2030.
Patent applications or issued patents filed by other companies (i.e. excluding Novo Nordisk, Sanofi, Eli Lilly and Pfizer), such as those in India and China, appear to be surprisingly limited in number and scope. The ACCISS Study has identified about 40 insulin manufacturers, however, less than 10 percent have filed for any sort of intellectual property (IP) protection with respect to insulin. Based on this, it is expected that the major companies will continue to dominate the global market.