A New Global Orange Book: WIPO Launches Public-Private Partnership Database of Pharmaceutical Patents


On September 25, 2018, WIPO launched the Patent Information Initiative for Medicines, or "Pat-INFORMED," in collaboration with the International Federation of Pharmaceutical Manufacturers and Associations. Pat-INFORMED is the first free, open access database that directly links granted patents to marketed medicines across the globe.

The stated goal of Pat-INFORMED is "to provide easily accessible and understandable information about the patent status of a specific medicine in a particular country." The public may search Pat-INFORMED records by the drug's international nonproprietary name. Procurement agencies that register with Pat-INFORMED may also use the site to follow-up directly with participating companies.

Currently, Pat-INFORMED lists qualifying patent information for products submitted by industry participants in six therapeutic areas: HIV/AIDS, cardiovascular disease, diabetes, hepatitis C, oncology, and respiratory conditions. Pat-INFORMED also covers all products on the WHO Essential Medicines List not within these areas. Qualifying patents must meet what Pat-INFORMED calls a "global Orange Book" standard. In other words, they must "(1) claim a small molecule drug product approved or marketed anywhere in the world and (2) not fall into one of the categories excluded in the (US) Orange Book." Non-small-molecule products may also be listed if they are listable in the Orange Book.

So far, 20 companies have uploaded data to Pat-INFORMED linking over 14,000 patents to 169 products. According to Pat-INFORMED's Terms of Use, product additions will be phased in with priority given to "those disease areas of greatest public health need . . . until all Qualifying Patents in all fields are ultimately listed."

See WIPO press release here.