In 2018, Professor Robin Feldman, Arthur J. Goldberg Distinguished Professor of Law and Director of the Center for Innovation at UC Law, published the first comprehensive study of drug patent evergreening, which can be defined as pharmaceutical company actions that artificially extend or expand the protection horizon, or cliff, of their patents.

In her study, Feldman analyzed the patents filed with the United States Patent and Trademark Office between 2005 and 2015 for all brand-name, small-molecule drugs on the market, as identified by the Federal Drug Administration’s “Orange Book” of approved drugs. The analysis required combing through 160,000 data points to examine every instance where a company added a new patent or exclusivity. The analysis plus additional data through 2018 are included in the Drug Patent Search Database. (See About the Data below for more info.)

The drug patent extensions are recorded in this database and identified in her paper, May Your Drug Price be Evergreen, which was published in the peer-reviewed Oxford Journal of Law and the Biosciences. The results of Feldman’s analysis show a startling departure from the classic conceptualization of intellectual property protection for pharmaceuticals. Rather than creating new medicines, pharmaceutical companies are largely recycling and repurposing old ones. Specifically, 78% of the drugs associated with new patents were not new drugs, but existing ones, and extending protection is particularly pronounced among blockbuster drugs.

Now, interested stakeholders and the public can search the Evergreen Drug Patent Database to learn more about the extensions, expansions, or exclusivities sought by pharmaceutical firms. If we like certain aspects of the current protection system, we should keep them; if we don’t like certain aspects, we should amend them. Either way, it is important to understand the system in which we live.

Read our official announcement about the drug patent database.

Statement on the Evergreen Drug Patent Database in response to George Mason University’s blog post.

How to Use the Evergreen Drug Patent Database

This tool allows searches by New Drug Application (NDA) number, product name, ingredient name, company, or other attributes in order to provide insights into pharmaceutical evergreening. The database is organized as a table containing 12 columns.

Column 1)
The New Drug Application (NDA) Number

The New Drug Application number is a 6-digit number assigned by the FDA to each application by a drug company for approval to market a new drug in the United States. It is important to note that companies are often able to obtain more than one NDA number for a pharmaceutical substance by developing multiple, slightly different product formulations.

Column 2)
Ingredients

This is the drug’s active ingredient(s) as identified within the accompanying NDA.

Column 3)
Company Name

“Company” or “manufacturer” information provided in the data is sourced from Drugs@FDA. Note that the company selling a drug product may change as a result of mergers, acquisitions, or licensing deals, so the company listed here is not necessarily the original seller of the drug product.

Column 4)
Product Name

This is the brand name under which the drug commonly sells.

Column 5)
Approval Date

This refers to the date when the New Drug Application was approved by the FDA.

Column 6)
First Cliff Expiration Date 
Among the group of protections that were initially entered, we chose the latest expiration date to be the first cliff expiration date.

Column 7)
Latest Protection End Date as of 2018

The latest protection end date refers to the latest expiration date of any of the protections granted for a drug.[2]      

Column 8)
Months Added to the Protection Time via Extensions and Exclusivities

This is the number of months between the latest and earliest protection end dates, rounded down to ensure a conservative estimate. This column represents the amount of additional time for which a company may have limited generic competition and monopolized a drug product.

Column 9)
Years and Months Added to the Protection Time via Extensions and Exclusivities

This is the number of years and months between the latest and earliest protection end dates, rounded down to ensure a conservative estimate. This column represents the amount of additional time for which a company may have limited generic competition and monopolized a drug product.

Column 10)
Number of Protections

The number of protections is the total number of patents, exclusivities, and new use codes that are associated with an NDA and listed in the Orange Book. For example, a company may add a new use code to the Orange Book in relation to a patent already listed. As a result, the patent now covers additional use cases for the medication. This column counts these additions as an increase in the number of protections. Please note that this calculation does not include the patent term adjustment or extension in the count any longer.

Column 11)
Number of Unique Patents Associated with a New Drug Application

The number of unique patents represents the total count of all patents associated with an NDA.[5] It should be noted that a single patent can form the basis of multiple protections. For example, a company may add a new use code associated with a patent to the Orange Book, such that the patent can subsequently be interpreted as covering additional use cases for the medication. This would increase the number of protections but not increase the number of patents.

Column 12)
Number of Orphan Drug Exclusivities (Orphans)

Orphan Drug designation adds seven years of protection for a drug that treats, prevents, or diagnoses a disease affecting fewer than 200,000 people in the United States.[6]

Column 13)
Total Number of Time Extensions Associated with a New Drug Application

The total number of time extensions represents the number of protections that: 1) were added after the initial set of protections[7] and 2) extended the time period of protection.

Column 14)
Total Number of Patent Extensions Associated with a New Drug Application

The number of extensions that are patents. This number is derived from the total number of time extensions column (column 13).

Column 15)
Total Number of Exclusivity Extensions Associated with a New Drug Application

The number of extensions that are exclusivities. This number is derived from the total number of time extensions column (column 13).

[1] Drug protections can include both patents and exclusivities, which are similar but distinct forms of protection. It is therefore important to note that earliest and latest protection end dates as reported in the database may reflect the expiration of either patents or exclusivities, depending on the drug in question. More information on the subject can be found on the FDA’s website: https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity. Note that some other forms of protection, such as use codes added after initial drug approval, do not have their own independent expiration dates and as such do not affect the values in columns 6, 7, and 8. Furthermore, the records in this dataset begin in 2005 and therefore do not include pre-2005 protection end dates.

[2] See supra note i.

[3] Regarding the number of patents, individual patents with different numbers may stem from a single, original patent application. The original application, known as the parent, can be separated into divisional and continuations applications, each of which retains the patent expiration date of the original application. The “Number of Protections Added” column counts each individual patent separately, which may avoid substantial confusion for website users. As we noted in the paper, calculating the metrics both ways produced little difference in our qualitative takeaways. See Robin Feldman, May Your Drug Price Be Evergreen, 5 Oxford J.L. & Biosciences 590 (2018) (peer-reviewed), https://academic.oup.com/jlb/article/5/3/590/5232981.

[4] For an explanation of use code additions and how they can improperly block competition, see id. at 603.

[5] See supra note iii.

[6] For a more detailed explanation of the Orphan Drug exclusivity and the various ways manufacturers can game the system to extend their monopolies and increase profits, see Robin Feldman, May Your Drug Price Be Evergreen, 5 Oxford J.L. & Biosciences (2018) (peer-reviewed), https://academic.oup.com/jlb/article/5/3/590/5232981 at 623-26.

[7] Please note that this research defines the original set of protections slightly differently from the article May Your Drug Price Be Evergreen, 5 Oxford J.L. & Biosciences 590 (2018) (peer-reviewed), https://academic.oup.com/jlb/article/5/3/590/5232981. In the article, we used any patent or exclusivity added within two months following the month of drug approval to define the original set of protections. See id. at n. 112 and accompanying text. For this website, we used any patent or exclusivity that was added within one month following the month of drug approval to define the original set of protections. We believe this more accurately separates between ordinary filing and certain types of strategic behavior.

About the Drug Patent Data

The dataset is developed using the Food and Drug Administration’s (FDA) Orange Book compendium of patented, small-molecule drugs and patent data from the US Patent and Trademark Office. The research reflected in the database involved combing through and analyzing over 160,000 data points, including every instance in which a company added a patent or exclusivity between 2005 and 2018.

For the published law journal article including a detailed methodology, results, and analysis of the dataset, please see:

Robin Feldman, May Your Drug Price Be Evergreen, 5 OXFORD J. OF L. & THE BIOSCIENCES 590 (2018) (peer-reviewed), https://academic.oup.com/jlb/article/5/3/590/5232981.

To download the original dataset, that was used to develop the results for the article May Your Drug Price Be Evergreen, along with information about researching the FDA’s Orange Book, please see:

For the data: Archive page phase 1 (link)

For information about researching the FDA’s Orangebook:

Robin Feldman, Identifying Extensions of Protection in Prescription Drugs: Navigating the Data Landscape for Large-Scale Analysis, ANN ARBOR, MI: INTER-UNIVERSITY CONSORTIUM FOR POLITICAL AND SOCIAL RESEARCH (2018), https://doi.org/10.3886/E104781V2.

Please note: The publications linked in this “About the Data” section only include Orange Book data from 2005 to 2015, but the Evergreen Drug Patent Search database includes data through 2018. 

What’s Wrong with Drug Patent Evergreening?

Once pharmaceutical companies start down the road of extending their protections, they show a tendency to return to the well, with the majority adding more than one extension and half becoming serial offenders. The problem is growing across time.

This behavior may limit low-cost generic drug competition and keep drug prices high in two primary ways:

  1. If a generic seeks market entry through the expedited Hatch-Waxman Act process, the generic must establish that the brand’s patents are expired, invalid, unenforceable, or not infringed upon. The sheer volume of a brand’s patents or exclusivities (“number of protections”) increases the obstacles a generic must overcome to gain market entry.
  2. Additional patents or exclusivities can also extend the amount of time a drug is protected (“total amount of extra protection”).

In discussing the pharmaceutical industry, the broader term “intellectual property” should be used, rather than the narrower term “patent.” Although patent protection is a critical component of the incentive structure society provides for pharmaceutical development, it is not the only component. The federal government offers more than 10 other forms of exclusivity that can be used to keep competitors at bay. Companies can earn exclusivity benefits for activities such as the development of drugs for smaller populations or for conducting pediatric studies.

Whether society grants intellectual property in the form of a patent or a regulatory exclusivity, the systems are designed such that after a period of time, competitors may enter the market. The information revealed in the patent allows others to create a competing drug (rather than going through the research again, themselves). Data used in clinical trials for the drug are available, after a period of exclusivity, so that follow-on, lower-cost generics need only prove their drug is the same, rather than repeating the original company’s safety and efficacy trials.

Thus, when the patent benefit expires, competitors should step in and competition should drive prices down to competitive levels—at least in theory. The reality for pharmaceutical products, however, lies far from the system’s theoretical design, and evergreening strategies are one tactic companies use to manipulate the system.

Questions? Need Help?

Contact the Center of Innovation (C4i) at UC Law with questions or media inquiries about this database by sending an email to c4i@uclawsf.edu.

The database is supported in part by The Laura & John Arnold Foundation.