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Patent Thickets and Product Hops: Challenges and Opportunities for Legislative Reform

Published online by Cambridge University Press:  08 April 2025

William B. Feldman Open the ORCID record for William B. Feldman [Opens in a new window]
William B. Feldman*
Affiliation:
Brigham and Women’s Hospital and Harvard Medical School
*
Email: wbfeldman@bwh.harvard.edu
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Abstract

Two key strategies that brand-name pharmaceutical manufacturers employ to limit generic competition are patent thickets and product hops. The former strategy entails obtaining numerous patents on peripheral features of products (not just the active ingredients), and the latter involves shifting active ingredients into reformulations with new patent protection that can extend periods of market exclusivity. These strategies have become particularly problematic for drug-device combinations like inhalers and glucagon-like peptide-1 receptor agonists, which contain pharmaceutical compounds that are sold together with their delivery devices. The Senate Judiciary Committee moved three bipartisan bills out of committee during the last legislative session aimed at facilitating more timely generic competition. Although these bills offer a valuable step forward, more is needed to limit the sort of patent gamesmanship that has become pervasive in the US pharmaceutical industry. Such reforms should include routine reexamination by the US Patent and Trademark Office of patents submitted for listing with the Food and Drug Administration (FDA), a greater role for the FDA in reviewing such listings, limits on the number of patents that brand-name firms can assert when suing for infringement following patent challenges, stronger incentives for patent challenges, and more flexibility for the FDA to approve complex generic drugs.

Keywords

patent thicketsproduct hopsinhalerGLP-1 receptor agonistFood and Drug Administration

Information

Type
Independent Articles
Information
Journal of Law, Medicine & Ethics , Volume 53 , Issue 1: Institutional Obligations to Promote Research Integrity , Spring 2025 , pp. 158 - 163
Copyright
© The Author(s), 2025. Published by Cambridge University Press on behalf of American Society of Law, Medicine & Ethics

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References

“Frequently Asked Questions on Patents and Exclusivity,” US Food and Drug Administration, https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity. (last visited October 11, 2024).Google Scholar
“Trends in Prescription Drug Spending, 2016–2021,” Department of Health and Human Services, Assistant Secretary for Planning and Evaluation, https://aspe.hhs.gov/sites/default/files/documents/88c547c976e915fc31fe2c6903ac0bc9/sdp-trends-prescription-drug-spending.pdf. (last visited October 11, 2024).Google Scholar
Dave, C.V., et al., “High Generic Drug Prices and Market Competition: A Retrospective Cohort Study,” Annals of Internal Medicine 167, no. 3 (2017): 145–151.CrossRefGoogle ScholarPubMed
“Combination Products,” US Food and Drug Administration, https://www.fda.gov/combination-products. (last visited October 11, 2024).Google Scholar
Feldman, R., “May your drug price be evergreen” Journal of Law and Bioscience 5, no. 3 (2018): 590–647.Google Scholar
Beall, R F. and Kesselheim, A. S., “Tertiary patenting on drug-device combination products in the United States,” Nature Biotechnology 36, no. 2 (2018): 142–145.CrossRefGoogle ScholarPubMed
Tu, S.S., et al., “Changes in the Number of Continuation Patents on Drugs Approved by the FDA,” JAMA 330, no. 5 (2023): 469–470.Google ScholarPubMed
Horrow, C., et al., “Patent Portfolios Protecting 10 Top-Selling Prescription Drugs,” JAMA Internal Medicine 184, no. 7 (2024): 810–817.Google ScholarPubMed
“Patent Certifications and Suitability Petitions,” US Food and Drug Administration, https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/patent-certifications-and-suitability-petitions (last visited October 11, 2024).Google Scholar
Report to Congress. The Listing of Patent Information in the Orange Book, (FDA, Submitted under Section 2(e) of the Orange Book Transparency Act of 2020), https://www.fda.gov/media/155200/download (last visited October 11, 2024).Google Scholar
Darrow, J.J., Chong, J.E., and Kesselheim, A.S., “Reconsidering the scope of US state laws allowing pharmacist substitution of generic drugs,” BMJ 369 (2020): m2236.CrossRefGoogle ScholarPubMed
Gowda, V., et al., “Identifying potential prescription drug product hopping,” Nature Biotechnology 39, no. 4 (2021): 414–417.CrossRefGoogle ScholarPubMed
Long, A.S., et al., “Evaluation of Trials Comparing Single-Enantiomer Drugs to Their Racemic Precursors: A Systematic Review,” JAMA Network Open. 4, no. 5 (2021): e215731.CrossRefGoogle ScholarPubMed
Sinha, M., “Costly Gadgets: Barriers to Market Entry and Price Competition for Generic Drug-Device Combinations in the United States,” Minnesota Journal of Law, Science & Technology 23, no. 1 (2022): 293–361.Google Scholar
“Medicare Part D Drug Spending Dashboard,” Center for Medicare & Medicaid Services, https://data.cms.gov/tools/medicare-part-d-drug-spending-dashboard (last visited October 11, 2024).Google Scholar
“Asthma Facts and Figures,” Asthma and Allergy Foundation of America, https://aafa.org/asthma/asthma-facts/ (last visited October 11, 2024).Google Scholar
“COPD Trends Brief: Prevalence,” American Lung Association, https://www.lung.org/research/trends-in-lung-disease/copd-trends-brief/copd-prevalence (last visited October 11, 2024).Google Scholar
Global Strategy for Prevention, Diagnosis and Management of COPD: 2024 Report (Global Initiative for Chronic Lung Disease, 2024) https://goldcopd.org/2024-gold-report/ (last visited October 11, 2024); 2024 GINA Main Report: Global Strategy for Asthma Management and Prevention (Global Initiative for Asthma, 2024) https://ginasthma.org/gina-reports/ (last visited October 11, 2024).Google Scholar
“Pricing and Market Access Database,” Navlin, https://data.navlin.com/alspc/ (last visited October 11, 2024).Google Scholar
Feldman, W.B., Gagne, J.J., and Kesselheim, A.S., “Trends in Medicare Part D Inhaler Spending: 2012-2018,” Annals of the American Thoracic Society 18, no. 3 (2021): 548–550.Google ScholarPubMed
Feldman, W.B., et al., “Patents And Regulatory Exclusivities On Inhalers For Asthma And COPD, 1986-2020,” Health Affairs (Millwood). 41, no. 6 (2022): 787–796.; B J. Demkowicz, et al., “Patenting Strategies on Inhaler Delivery Devices,” Chest Journal 164, no. 2 (2023): 450–460.Google ScholarPubMed
See Feldman, supra note 21.Google Scholar
Patent Listing in FDA’s Orange Book, (Congressional Research Service, 2024), https://crsreports.congress.gov/product/pdf/IF/IF12644 (last visited October 11, 2024).Google Scholar
In re Lantus Direct Purchaser Antitrust Litig., 512 F. Supp. 3d 106 (D. Mass. 2020).Google Scholar
See Demkowicz, supra note 21.Google Scholar
Federal Trade Commission, “FTC Issues Policy Statement on Brand Pharmaceutical Manufacturers’ Improper Listing of Patents in the Food and Drug Administration’s ‘Orange Book’,” press release, September 14, 2023, https://www.ftc.gov/news-events/news/press-releases/2023/09/ftc-issues-policy-statement-brand-pharmaceutical-manufacturers-improper-listing-patents-food-drug (last visited October 11, 2024); Federal Trade Commission, “FTC Challenges More Than 100 Patents as Improperly Listed in the FDA’s Orange Book,” press release, November 7, 2023, https://www.ftc.gov/news-events/news/press-releases/2023/11/ftc-challenges-more-100-patents-improperly-listed-fdas-orange-book (last visited October 11, 2024); Federal Trade Commission, “FTC Expands Patent Listing Challenges, Targeting More Than 300 Junk Listings for Diabetes, Weight Loss, Asthma and COPD Drugs,” press release, April 30, 2024, https://www.ftc.gov/news-events/news/press-releases/2024/04/ftc-expands-patent-listing-challenges-targeting-more-300-junk-listings-diabetes-weight-loss-asthma (last visited October 11, 2024).Google Scholar
Reddy, S. et al., “Patent Challenges And Litigation On Inhalers For Asthma And COPD,” Health Affairs (Millwood) 42, no. 3 (2023): 398–406.Google ScholarPubMed
Wouters, O.J., Feldman, W.B., and Tu, S.S., “Product Hopping in the Drug Industry - Lessons from Albuterol,” New England Journal of Medicine 387, 13 (2022): 1153–1156.Google ScholarPubMed
See Feldman, supra note 21.Google Scholar
Feldman, W.B., et al., “Manufacturer Revenue on Inhalers After Expiration of Primary Patents, 2000-2021,” JAMA. 329, 1 (2023): 87–89.Google ScholarPubMed
See Feldman, supra note 30.Google Scholar
Tirrell, M., “Bernie Sanders, Senate Democrats open investigation into price of asthma inhalers,” CNN, January 8, 2024, https://www.cnn.com/2024/01/08/health/senate-democrats-investigate-price-of-asthma-inhalers/index.html (last visted October 11, 2024).Google Scholar
Becker, Z., “GSK joins AstraZeneca, Boehringer in capping US out-of-pocket inhaler prices at $35 per month,” Fierce Pharma, March 21, 2024, https://www.fiercepharma.com/pharma/gsk-latest-inhaler-maker-commit-35-out-pocket-price-cap-us-following-peers-boehringer (last visited October 11, 2024).Google Scholar
Hernandez, I. and Sullivan, S.D., “Net prices of new antiobesity medications,” Obesity 32, no. 3 (2024): 472–475.Google ScholarPubMed
See Navlin, supra note 19.Google Scholar
Olsen, A. et al., “Patents and regulatory exclusivities on FDA-approved insulin products: A longitudinal database study, 1986-2019,” PLoS Medicine 20, no. 11 (2023): e1004309.Google ScholarPubMed
Id. Google Scholar
Alhiary, R., et al., “Patents and Regulatory Exclusivities on GLP-1 Receptor Agonists,” JAMA 330, no. 7 (2023): 650–657.; R. Alhiary et al., “Delivery Device Patents on GLP-1 Receptor Agonists,” JAMA 331, no. 9 (2024): 794–796.Google ScholarPubMed
See Tu, supra note 7.Google Scholar
Tu, S.S. and Sarpatwari, A.A., “‘Method of Use’ to Prevent Generic and Biosimilar Market Entry,” New England Journal of Medicine 388, no. 6 (2023): 483–485.Google ScholarPubMed
Sarpatwari, A., et al., “Patents on Risk Evaluation and Mitigation Strategies for Prescription Drugs and Generic Competition,” JAMA. 331, no. 11 (2024): 976–978.Google ScholarPubMed
See Tu, supra note 7.Google Scholar
See Horrow, supra note 8.Google Scholar
Tu, S.S. and Feldman, W.B., “Use of Track One Prioritized Examination for Pharmaceutical Patents,” JAMA Health Forum 5, no. 7 (2024): e241886.Google ScholarPubMed
Silverman, E. and Zhang, R.C., “A Senate bill was touted as a cure for ‘patent thickets.’ Some say the drug industry watered it down” STAT, July 17, 2024, https://www.statnews.com/pharmalot/2024/07/17/drug-patent-reform-affordable-prescriptions-for-patients-act-big-pharma-lobbying/ (last viseted October 11, 2024).Google Scholar
Id. Google Scholar
Cost Estimate: S. 150, Affordable Prescriptions for Patients Act of 2023, (Congressional Budget Office, 2024), https://www.cbo.gov/system/files/2024-06/s150.pdf (last visited October 11, 2024).Google Scholar
Carrier, M.A., Wander, D., “Citizen Petitions: An Empirical Study,” Cardozo Law Review 34 (2012): 249–252; M.A. Carrier, C. Minniti, “Citizen Petitions: Long, Late-Filed, and At-Last Denied,” American University Law Review 66, no. 2 (2017): 305–352.; R. Sachs et al., The FDA Could do More to Promote Generic Competition: Here’s How, (USC-Brookings Schaeffer Initiative for Health Policy, 2022), https://healthpolicy.usc.edu/research/the-fda-could-do-more-to-promote-genric-competition-heres-how/ (last visited October 11, 2024).Google Scholar
Tu, S.S., “FDA Reexamination: Increased Communication between the FDA and USPTO to improve patent quality,” Houston Law Review 60 (2022): 403–465.Google Scholar
Id. Google Scholar
Generic Drugs: Stakeholder Views on FDA’s Information on Patents, (US Government Accountability Office, March 15, 2023), https://www.gao.gov/products/gao-23-105477 (last visited October 11, 2024).Google Scholar
“Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book),” US Food and Drug Administration, last visited October 11, 2024, https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book.Google Scholar
Welch, Peter, “Welch, Braun, and Klobuchar Introduce Bipartisan Legislation to Streamline Drug Patent Litigation, Lower Cost of Prescription Drugs,” press release, January 12, 2024, https://www.welch.senate.gov/welch-braun-and-klobuchar-introduce-bipartisan-legislation-to-streamline-drug-patent-litigation-lower-cost-of-prescription-drugs/ (last visited October 11, 2024).Google Scholar