{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T03:34:26Z","timestamp":1790652866935,"version":"4.1.0"},"reference-count":10,"publisher":"Oxford University Press (OUP)","issue":"12","license":[{"start":{"date-parts":[[2025,12,17]],"date-time":"2025-12-17T00:00:00Z","timestamp":1765929600000},"content-version":"vor","delay-in-days":16,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100014848","name":"Arnold Ventures","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100014848","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000905","name":"Commonwealth Fund","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000905","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,12,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>The Hatch\u2013Waxman Act of 1984 was designed to accelerate generic drug entry by establishing a framework for resolving patent disputes between brand-name and generic manufacturers. While the Act has facilitated competition and expanded the availability of affordable medicines, brand-name firms have increasingly exploited its procedural structure to delay or deter generic competition through \u201cserial litigation.\u201d This strategy involves filing successive, questionable lawsuits, often based on non-innovative continuation patents. Even if the brand ultimately loses, the delays and litigation costs can discourage generic firms from entering the market or compel them to settle on terms that undermine patients\u2019 timely access to affordable generics. In the case of Astellas's overactive bladder drug mirabegron (Myrbetriq), after an initial Hatch\u2013Waxman case settled in 2020 with generic entry expected in 2024, Astellas pursued 4 additional lawsuits, each built on new but substantively indistinguishable patents. These tactics have delayed broad competition, leaving only 2 firms to launch in 2024 under the threat of massive damages. Similar patterns are observed with other drugs, including bimatoprost (Latisse), aflibercept (Eylea), and tasimelteon (Hetlioz).<\/jats:p>","DOI":"10.1093\/haschl\/qxaf240","type":"journal-article","created":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T12:48:17Z","timestamp":1765889297000},"source":"Crossref","is-referenced-by-count":1,"title":["Serial patent litigation: an emerging strategy to delay entry of generic competition"],"prefix":"10.1093","volume":"3","author":[{"given":"Timothy","family":"Bonis","sequence":"first","affiliation":[{"name":"Dartmouth College , Hanover, NH 03755, United States"},{"name":"Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital , Boston, MA 02120, United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8867-2666","authenticated-orcid":false,"given":"Aaron S","family":"Kesselheim","sequence":"additional","affiliation":[{"name":"Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital , Boston, MA 02120, United States"},{"name":"Harvard Medical School , Boston, MA 02115, United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0391-8186","authenticated-orcid":false,"given":"Sean","family":"Tu","sequence":"additional","affiliation":[{"name":"Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital , Boston, MA 02120, United States"},{"name":"University of Alabama School of Law , Tuscaloosa, AL 35487, United States"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2025,12,17]]},"reference":[{"key":"2026010203412282400_qxaf240-B1","volume-title":"2023 Report of the Economic Survey","author":"American Intellectual Property Law Association","year":"2023"},{"key":"2026010203412282400_qxaf240-B2"},{"key":"2026010203412282400_qxaf240-B3"},{"key":"2026010203412282400_qxaf240-B4"},{"issue":"2","key":"2026010203412282400_qxaf240-B5","doi-asserted-by":"publisher","first-page":"lsac022","DOI":"10.1093\/jlb\/lsac022","article-title":"Biological patent thickets and delayed access to biosimilar, an American problem","volume":"9","author":"Good","year":"2022","journal-title":"J Law Biosci"},{"key":"2026010203412282400_qxaf240-B6"},{"issue":"2","key":"2026010203412282400_qxaf240-B7","doi-asserted-by":"publisher","first-page":"27","DOI":"10.1257\/jep.20241423","article-title":"Patents, innovation, and competition in pharmaceuticals: the Hatch-Waxman act after 40 years","volume":"39","author":"Hemphill","year":"2025","journal-title":"J Econ Perspect"},{"issue":"10","key":"2026010203412282400_qxaf240-B8","doi-asserted-by":"publisher","first-page":"837","DOI":"10.1001\/jama.2024.14350","article-title":"Extent of drug patents with terminal disclaimers and obviousness-type double patenting rejections","volume":"332","author":"Tu","year":"2024","journal-title":"JAMA"},{"issue":"5","key":"2026010203412282400_qxaf240-B9","doi-asserted-by":"publisher","first-page":"469","DOI":"10.1001\/jama.2023.11525","article-title":"Changes in the number of continuation patents on drugs approved by the FDA","volume":"330","author":"Tu","year":"2023","journal-title":"JAMA"},{"key":"2026010203412282400_qxaf240-B10"}],"container-title":["Health Affairs Scholar"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/healthaffairsscholar\/advance-article-pdf\/doi\/10.1093\/haschl\/qxaf240\/65932166\/qxaf240.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/healthaffairsscholar\/article-pdf\/3\/12\/qxaf240\/65932166\/qxaf240.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/healthaffairsscholar\/article-pdf\/3\/12\/qxaf240\/65932166\/qxaf240.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,2]],"date-time":"2026-01-02T08:41:31Z","timestamp":1767343291000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/healthaffairsscholar\/article\/doi\/10.1093\/haschl\/qxaf240\/8382246"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,12,1]]},"references-count":10,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2025,12,1]]}},"URL":"https:\/\/doi.org\/10.1093\/haschl\/qxaf240","relation":{},"ISSN":["2976-5390"],"issn-type":[{"value":"2976-5390","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2025,12]]},"published":{"date-parts":[[2025,12,1]]},"article-number":"qxaf240"}}