Drug–device combination products are becoming increasingly prevalent, with many lasting years beyond the expiration date of primary and secondary patents on the drug itself.
This is a preview of subscription content, access via your institution
Relevant articles
Open Access articles citing this article.
-
Has the EU Incentive for Drug Repositioning Been Effective? An Empirical Analysis of the “+1” Regulatory Exclusivity
IIC - International Review of Intellectual Property and Competition Law Open Access 20 July 2021
Access options
Access Nature and 54 other Nature Portfolio journals
Get Nature+, our best-value online-access subscription
$29.99 / 30 days
cancel any time
Subscribe to this journal
Receive 12 print issues and online access
$209.00 per year
only $17.42 per issue
Buy this article
- Purchase on Springer Link
- Instant access to full article PDF
Prices may be subject to local taxes which are calculated during checkout
References
Rubin, R. Lancet 388, 1266 (2016).
Duhigg, C. Outcry over EpiPen prices hasn't made them lower. The New York Times (4 June 2017).
Kasperkevic, J. New York investigates EpiPen maker Mylan after price hike of medication. The Guardian (6 September 2016).
Cha, A.E. US lawmakers demand investigation of $100 price hike of lifesaving EpiPens. The Washington Post (23 August 2016).
US Food and Drug Administration. Approved Drug Products with Therapeutic Equivalence Evaluations 2017 (FDA, 2017).
Beall, R.F., Nickerson, J.W., Kaplan, W.A. & Attaran, A. PLoS One 11, e0148939 (2016).
AstraZeneca. Health Canada endorsed important safety information on Pulmicort Turbuhaler (budesonide) powder for oral inhalation, 200 μg per metered dose (23 July 2012). http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2012/15087a-eng.php
Rosenthal, E. The soaring cost of a simple breath. The New York Times (12 October 2013).
Rosenthal, E. Even small medical advances can mean big jumps in bills. The New York Times (5 April 2014).
Mahn, T.G. et al. Pharm. Law Industry Report 9 PLIR 1500 (2 December 2011).
Luo, J. & Kesselheim, A.S. Lancet Diabetes Endocrinol. 3, 835–837 (2015).
Hunter, N.L. & Sherman, R.E. Nat. Rev. Drug Discov. 16, 513–514 (2017).
Grabowski, H.G. & Kyle, M. Manage. Decis. Econ. 28, 491–502 (2007).
The GoodRx Pharmacist. FDA recalls Ventolin HFA for asthma. GoodRx https://www.goodrx.com/blog/fda-recalls-ventolin-hfa-for-asthma/ (14 April 2017).
Herbert, G. Asthma inhaler recall: GSK says nearly 600,000 may have defect. The Post-Standard (6 April 2017).
Palmer, E. AstraZeneca again recalling inhalers. FiercePharma (24 March 2016).
US Food and Drug Administration. Enforcement Report https://www.accessdata.fda.gov/scripts/ires/index.cfm (FDA, 2017).
Government of Canada. Guidance Document: Patented Medicines (Notice of Compliance) Regulations (27 October, 2016). https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/patented-medicines/notice-compliance-regulations.html
US Food and Drug Administration. Combination Products https://www.fda.gov/combinationproducts/default.htm (FDA, 2017).
Greene, J.A. & Riggs, K.R. N. Engl. J. Med. 372, 1171–1175 (2015).
US Food and Drug Administration. Phase-out of CFC metered-dose inhalers https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm193896.htm (2013).
Acknowledgements
A.S.K.'s work is supported by the Laura and John Arnold Foundation and Harvard Program in Therapeutic Science, with additional support from the Engelberg Foundation. The authors are grateful to J.W. Nickerson, W.A. Kaplan, and A. Attaran for their feedback on developing this idea, as well as to J.J. Darrow and M.S. Sinha for their insights on earlier drafts.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Competing interests
The authors declare no competing financial interests.
Supplementary information
Supplementary Table 1
Products listing tertiary patents in 2000, 2005, 2010, and/or 2016 (XLSX 19 kb)
Supplementary Table 2
Products listing tertiary patents in 2000, 2005, 2010, and 2016 (XLSX 74 kb)
Rights and permissions
About this article
Cite this article
Beall, R., Kesselheim, A. Tertiary patenting on drug–device combination products in the United States. Nat Biotechnol 36, 142–145 (2018). https://doi.org/10.1038/nbt.4078
Published:
Issue Date:
DOI: https://doi.org/10.1038/nbt.4078
This article is cited by
-
Recent Orange and Purple Book legislation suggests a need to bridge drug and biologic patent regimes
Nature Biotechnology (2022)
-
Brand-name market exclusivity for nebulizer therapy to treat asthma and COPD
Nature Biotechnology (2022)
-
Combination therapy patents: a new front in evergreening
Nature Biotechnology (2021)
-
Has the EU Incentive for Drug Repositioning Been Effective? An Empirical Analysis of the “+1” Regulatory Exclusivity
IIC - International Review of Intellectual Property and Competition Law (2021)
-
Novelty of Active Ingredients in High-Cost Brand-Name Drugs
Journal of General Internal Medicine (2020)