I-MAK Drug Patent Book

The Drug Patent Book was created to redress the power imbalance that comes with a lack of publicly available information. This database is designed to improve transparency and inform evidence-based policy. Ultimately, this will lead to a more equitable and just patent system that protects the public interest when it comes to drug patents, competition, and affordable access to medicines for all.

The Drug Patent Book is a public resource for everyone: policymakers, researchers, lawyers, the media, and those simply wanting to learn more about how the patent system works. The goal is that by sharing this data with everyone, it will help foster a more robust public conversation about pharmaceutical patents, their impact on competition, and the prices we pay for our medicines.

The Drug Patent Book consists of a comprehensive list of patents for each of the top selling drugs in the U.S., with detailed information on each patent (see What information is included?, below). By reviewing the data, you will gain an understanding of how pharmaceutical companies build a patent thicket around a drug, including the various types of patents and filing strategies pharmaceutical companies use. Additionally, you can use the “Analysis Builder” to summarize and analyze the data in various ways, such as through a table or in a chart.

This database provides patent information for the following ten top selling drugs in the U.S (2021): Biktarvy, Eliquis, Enbrel, Eylea, Humira, Imbruvica, Keytruda, Revlimid, Stelara, and Trulicity.

The Drug Patent Book contains the following current information:

• Drug information: drug name and the primary condition it treats.
• Patent filing information: publication number of an application, patent applicant (assignee), priority date of the patent, filing date of the patent, if the patent was filed before or after FDA approval.
• Patent status information: status of the patent, granted patent number, expiry date of the patent.
• Additional patent information: patent family grouping, patent type, if the patent is listed in the U.S FDA Orange or Purple Book, and a brief description of what each patent covers.

For definitions of these terms, see the Methods section below.

The expiry date for each patent was taken from the information provided in Google Patents, and, where applicable, cross-checked with information provided in the FDA Orange Book and Purple Book.

It is a complex, resource- and time-intensive exercise requiring a team with specific and unique skill sets, and these resources are rarely available and accessible in the public’s interest. Identifying all the patents that exist on a specific drug (beyond what is already publicly available) requires access to costly subscription databases and practitioners that are skilled in patent informatics and patent searching. Highly skilled scientists and patent/IP attorneys must analyze each of the hundreds of patents identified. Additionally, researchers conduct data quality checks and developers must build a multifunctional database.

This data in the database is current as of June 2022. We will review and assess feedback for the database to learn how transparency around drug patent information can be improved (submit feedback here). For now, the database is a demonstration to policymakers and other interested stakeholders about the importance of making all patent information relating to a drug public. To learn more about how to support I-MAK’s work to increase data transparency, visit our Donate page.