The Long CON: An Empirical Analysis of Pharmaceutical Patent Thickets
DOI:
https://doi.org/10.5195/lawreview.2024.1049Abstract
Over the past two decades, drug manufacturers have tripled the intensity of patenting around their drugs with 1.86 patents per active ingredient in 2001 to almost six patents per active ingredient in 2019. This three-fold increase in patenting has led to a dense web of overlapping intellectual property rights called “patent thickets.” These thickets can include dozens and sometimes hundreds of less innovative “secondary” patents. Many of these secondary patents use a special “continuation” application (“CON”), which allows brand manufacturers to spawn additional patents from a previous patent family member without disclosing anything new. CONs allow brand manufacturers to quickly create less innovative nuisance patents that are designed to delay or deter generic market entry. This Article focuses on the use of CONs in the creation and enforcement of pharmaceutical patent thickets.
This study analyzes data on all continuation applications from 2000 to 2022 (over 7.5 million patent applications) and links these applications to subsequent patent litigation from 2000 to 2022. This study also focuses on continuation applications filed more than five years after the original application’s priority date (“Long CONs”). When we compare pharmaceutical patents against all other technology groups, we show that Long CONs are usually part of large patent thickets and are strategically important components of brand firm litigation. We find that the use of Long CONs has steadily increased over the last three decades for some technology types, but this increase is more pronounced for pharmaceutical patents.
Long CON patents represent only 8.3% (639,308/7,692,046) of all patent applications; however, Long CONs represent 23% (9,836/43,220) of all litigated patents. Additionally, 51% (323,908/639,308) of all Long CONs come from just a few industries. The pharmaceutical industry disproportionately files and litigates Long CONs patents. We find that Long CONs represent 33% (2,126/6,432) of all small molecule pharmaceutical patents and 36% (900/2,534) of all litigated small molecule pharmaceutical patents. This data shows that patent thickets built upon continuation applications have a disproportionate effect on litigation, which may result in higher drug prices for longer periods of time.
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2024 S. Sean Tu
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Authors who publish with this journal agree to the following terms:
- The Author retains copyright in the Work, where the term “Work” shall include all digital objects that may result in subsequent electronic publication or distribution.
- Upon acceptance of the Work, the author shall grant to the Publisher the right of first publication of the Work.
- The Author shall grant to the Publisher and its agents the nonexclusive perpetual right and license to publish, archive, and make accessible the Work in whole or in part in all forms of media now or hereafter known under a Creative Commons 4.0 License (Attribution-Noncommercial-No Derivative Works), or its equivalent, which, for the avoidance of doubt, allows others to copy, distribute, and transmit the Work under the following conditions:
- Attribution—other users must attribute the Work in the manner specified by the author as indicated on the journal Web site;
- Noncommercial—other users (including Publisher) may not use this Work for commercial purposes;
- No Derivative Works—other users (including Publisher) may not alter, transform, or build upon this Work,with the understanding that any of the above conditions can be waived with permission from the Author and that where the Work or any of its elements is in the public domain under applicable law, that status is in no way affected by the license.
- The Author is able to enter into separate, additional contractual arrangements for the nonexclusive distribution of the journal's published version of the Work (e.g., post it to an institutional repository or publish it in a book), as long as there is provided in the document an acknowledgement of its initial publication in this journal.
- Authors are permitted and encouraged to post online a pre-publication manuscript (but not the Publisher’s final formatted PDF version of the Work) in institutional repositories or on their Websites prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work. Any such posting made before acceptance and publication of the Work shall be updated upon publication to include a reference to the Publisher-assigned DOI (Digital Object Identifier) and a link to the online abstract for the final published Work in the Journal.
- Upon Publisher’s request, the Author agrees to furnish promptly to Publisher, at the Author’s own expense, written evidence of the permissions, licenses, and consents for use of third-party material included within the Work, except as determined by Publisher to be covered by the principles of Fair Use.
- The Author represents and warrants that:
- the Work is the Author’s original work;
- the Author has not transferred, and will not transfer, exclusive rights in the Work to any third party;
- the Work is not pending review or under consideration by another publisher;
- the Work has not previously been published;
- the Work contains no misrepresentation or infringement of the Work or property of other authors or third parties; and
- the Work contains no libel, invasion of privacy, or other unlawful matter.
- The Author agrees to indemnify and hold Publisher harmless from Author’s breach of the representations and warranties contained in Paragraph 6 above, as well as any claim or proceeding relating to Publisher’s use and publication of any content contained in the Work, including third-party content.