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

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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.

The opinions expressed are those of the authors on the date noted above and do not necessarily reflect the views of Fish & Richardson P.C., any other of its lawyers, its clients, or any of its or their respective affiliates. This post is for general information purposes only and is not intended to be and should not be taken as legal advice. No attorney-client relationship is formed.