Background & Methods

I-MAK Drug Patent Book


What is the problem?

The number of patents a pharmaceutical company will take out on a drug product is a closely guarded secret. Publicly available patent information in the U.S. FDA Orange and Purple Book, or in court filings, do not disclose the full extent of patenting activity and potential monopoly protection a company may have on a drug. This lack of transparency keeps the power with the pharmaceutical companies while preventing policymakers, regulators, and the public from being able to fully see how pharmaceutical patenting works in practice and how it impacts drug prices.

Why did I-MAK create this database?

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.

Who is it for?

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.

What will I learn from looking at this data?

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.

Which drugs are covered?

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.

What information is included?

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.

How is the expiry date of a patent calculated?

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.

Why hasn’t someone created a public database covering these drugs before?

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.

How often will it be updated?

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.

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The patent data provided in the Drug Patent Book does not constitute a legal opinion of any kind or nature. Whether a patent is related to a particular drug is subject to legal interpretation of the claims in a patent or patent application. Users should obtain the opinion of legal counsel if they are seeking more detailed analysis as to the relevance of a patent or patent application in relation to a drug covered in the database.

The patent search methodology for building the data in the Drug Patent Book is subject to various limitations. Wherever possible, I-MAK has attempted to identify all relevant patents related to the drugs included in the database through its patent search methodology described above. However, due to the nature of pharmaceutical patents and the various terminologies that companies can use to describe the same invention, it is possible that our patent searches may not have captured all relevant patents on a drug. As a public interest project, we welcome any corrections and additions to the data to help improve the database. The data compiled in the database is also subject to the public patent information made available by the United States Patent and Trademark Office (USPTO), Google Patents and other proprietary databases described in the Methods section, for which I-MAK assumes no liability. Patent applications filed with the USPTO that have not yet been published and available for public viewing as of June 2022 were not included in the patent searches that make up the data in the database.

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