{"title":"USPTO's Lax Policy Leads to Humira Formulation Thicket.","authors":"Bernard Chao","doi":"10.1017/jme.2024.132","DOIUrl":null,"url":null,"abstract":"<p><p>Biosimilar drugs enter the United States market well after they enter the European market. That is likely because pharmaceutical companies have many more patents in the United States than in Europe. But why is patent coverage of biological drugs so much more extensive in United States? This case study seeks to answer this question for drug formulation patents.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":"52 2","pages":"429-438"},"PeriodicalIF":1.6000,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Law Medicine & Ethics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1017/jme.2024.132","RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/10/22 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"ETHICS","Score":null,"Total":0}
引用次数: 0
Abstract
Biosimilar drugs enter the United States market well after they enter the European market. That is likely because pharmaceutical companies have many more patents in the United States than in Europe. But why is patent coverage of biological drugs so much more extensive in United States? This case study seeks to answer this question for drug formulation patents.
期刊介绍:
Material published in The Journal of Law, Medicine & Ethics (JLME) contributes to the educational mission of The American Society of Law, Medicine & Ethics, covering public health, health disparities, patient safety and quality of care, and biomedical science and research. It provides articles on such timely topics as health care quality and access, managed care, pain relief, genetics, child/maternal health, reproductive health, informed consent, assisted dying, ethics committees, HIV/AIDS, and public health. Symposium issues review significant policy developments, health law court decisions, and books.