{"title":"有希望的病毒对细菌耐药性的威胁:噬菌体治疗的不确定可专利性和替代激励的必要性。","authors":"Kelly Todd","doi":"","DOIUrl":null,"url":null,"abstract":"<p><p>Bacteriophages, or \"phages,\" are a category of highly adept and adaptable viruses that can infect and kill bacteria. With concerns over the burgeoning antibiotic-resistance crisis looming in recent years, scientists and policymakers have expressed a growing interest in developing novel treatments for bacterial infections that utilize bacteriophages. Because of the great expense associated with bringing a new drug to market, patents are usually considered the gold standard for incentivizing research and development in the pharmaceutical field. Absent such strong protection for a developer’s front end investment, pharmaceutical development remains financially risky and unattractive. Unfortunately, recent Supreme Court jurisprudence analyzing patentable subject matter under 35 U.S.C. subsection 101 has cast doubt on whether phage therapeutics would be eligible for strong patent protection. In order for the promise of phage therapeutics to become a reality, alternative protections or incentives are likely necessary. Such a framework would likely include trade secrecy, regulatory exclusivities, research support, alternative payment models, or some combination thereof.</p>","PeriodicalId":47625,"journal":{"name":"Duke Law Journal","volume":"68 4","pages":"767-805"},"PeriodicalIF":1.8000,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The Promising Viral Threat to Bacterial Resistance: the Uncertain Patentability of Phage Therapeutics and the Necessity of Alternative Incentives.\",\"authors\":\"Kelly Todd\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Bacteriophages, or \\\"phages,\\\" are a category of highly adept and adaptable viruses that can infect and kill bacteria. With concerns over the burgeoning antibiotic-resistance crisis looming in recent years, scientists and policymakers have expressed a growing interest in developing novel treatments for bacterial infections that utilize bacteriophages. Because of the great expense associated with bringing a new drug to market, patents are usually considered the gold standard for incentivizing research and development in the pharmaceutical field. Absent such strong protection for a developer’s front end investment, pharmaceutical development remains financially risky and unattractive. Unfortunately, recent Supreme Court jurisprudence analyzing patentable subject matter under 35 U.S.C. subsection 101 has cast doubt on whether phage therapeutics would be eligible for strong patent protection. In order for the promise of phage therapeutics to become a reality, alternative protections or incentives are likely necessary. Such a framework would likely include trade secrecy, regulatory exclusivities, research support, alternative payment models, or some combination thereof.</p>\",\"PeriodicalId\":47625,\"journal\":{\"name\":\"Duke Law Journal\",\"volume\":\"68 4\",\"pages\":\"767-805\"},\"PeriodicalIF\":1.8000,\"publicationDate\":\"2019-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Duke Law Journal\",\"FirstCategoryId\":\"90\",\"ListUrlMain\":\"\",\"RegionNum\":2,\"RegionCategory\":\"社会学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"LAW\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Duke Law Journal","FirstCategoryId":"90","ListUrlMain":"","RegionNum":2,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"LAW","Score":null,"Total":0}
The Promising Viral Threat to Bacterial Resistance: the Uncertain Patentability of Phage Therapeutics and the Necessity of Alternative Incentives.
Bacteriophages, or "phages," are a category of highly adept and adaptable viruses that can infect and kill bacteria. With concerns over the burgeoning antibiotic-resistance crisis looming in recent years, scientists and policymakers have expressed a growing interest in developing novel treatments for bacterial infections that utilize bacteriophages. Because of the great expense associated with bringing a new drug to market, patents are usually considered the gold standard for incentivizing research and development in the pharmaceutical field. Absent such strong protection for a developer’s front end investment, pharmaceutical development remains financially risky and unattractive. Unfortunately, recent Supreme Court jurisprudence analyzing patentable subject matter under 35 U.S.C. subsection 101 has cast doubt on whether phage therapeutics would be eligible for strong patent protection. In order for the promise of phage therapeutics to become a reality, alternative protections or incentives are likely necessary. Such a framework would likely include trade secrecy, regulatory exclusivities, research support, alternative payment models, or some combination thereof.
期刊介绍:
The first issue of what was to become the Duke Law Journal was published in March 1951 as the Duke Bar Journal. Created to provide a medium for student expression, the Duke Bar Journal consisted entirely of student-written and student-edited work until 1953, when it began publishing faculty contributions. To reflect the inclusion of faculty scholarship, the Duke Bar Journal became the Duke Law Journal in 1957. In 1969, the Journal published its inaugural Administrative Law Symposium issue, a tradition that continues today. Volume 1 of the Duke Bar Journal spanned two issues and 259 pages. In 1959, the Journal grew to four issues and 649 pages, growing again in 1970 to six issues and 1263 pages. Today, the Duke Law Journal publishes eight issues per volume. Our staff is committed to the purpose set forth in our constitution: to publish legal writing of superior quality. We seek to publish a collection of outstanding scholarship from established legal writers, up-and-coming authors, and our own student editors.