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In Ambiguous Battle: The Promise (And Pathos) Of Public Domain Day, 2014, Jennifer Jenkins
In Ambiguous Battle: The Promise (And Pathos) Of Public Domain Day, 2014, Jennifer Jenkins
Duke Law & Technology Review
On the first day of each year, Public Domain Day celebrates the moment when copyrights expire, and books, films, songs, and other creative works enter the public domain, where they become, in Justice Brandeis’s words, “free as the air to common use.” Educators, students, artists, and fans can use them with neither permission nor payment. Online archives can digitize and make them fully available without the threat of lawsuits or licensing demands. Sadly, in the United States, as a result of copyright term extensions, not a single published work will enter the public domain in 2014. In fact, almost no …
After Prometheus, Are Human Genes Patentable Subject Matter?, Douglas L. Rogers
After Prometheus, Are Human Genes Patentable Subject Matter?, Douglas L. Rogers
Duke Law & Technology Review
On April 15, 2013, the U.S. Supreme Court heard oral arguments in Association for Molecular Pathology v. Myriad Genetics, Inc. on the question, “Are human genes patentable?” This article argues that human genes are not patentable and that isolating a gene from its surroundings in a human body—or creating synthetically what exists in nature as DNA—does not cause the DNA to become patentable subject matter. The isolated DNA segments of claim 1 have the identical nucleotide sequence and the same function as native DNA, and the isolated DNA of claim 1 do not reflect the marked changes required under Chakrabarty, …
Lack Of Transparency In The Premarket Approval Process For Aquadvantage Salmon, Michael P. Mcevilly
Lack Of Transparency In The Premarket Approval Process For Aquadvantage Salmon, Michael P. Mcevilly
Duke Law & Technology Review
After a lengthy premarket approval process, the Food and Drug Administration (FDA) has just deemed AquAdvantage Salmon, a fast-growing, genetically engineered salmon, safe for human consumption. AquAdvantage Salmon is the first genetically engineered animal designed for human consumption to go to market in the United States. Because there have been no significant changes to the statutory or regulatory framework governing agricultural biotechnology since it was established in the 1980s, the FDA reviews applications of genetically engineered animals under the New Animal Drug Application (NADA) provisions of the Federal Food, Drug, and Cosmetic Act (FDCA). The FDA’s treatment of genetically engineered …
The Promise Of Priority Review Vouchers As A Legislative Tool To Encourage Drugs For Neglected Diseases, Lesley Hamming
The Promise Of Priority Review Vouchers As A Legislative Tool To Encourage Drugs For Neglected Diseases, Lesley Hamming
Duke Law & Technology Review
Despite the intellectual property system’s success in promoting the economic well-being of the United States, this system has not achieved all socially valuable ends. Insufficient treatments are applied both to diseases endemic in developing countries, such as malaria, and rare diseases, such as rare childhood cancers. Several legislative tools aim to promote socially valuable drugs and biologics through market incentives. The priority review voucher (PRV) program is the latest and most unique of these legislative tools aimed at encouraging the development of drugs for neglected diseases without burdening taxpayers. The Creating Hope Act—recently signed into law as part of the …