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Full-Text Articles in Law
Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg
Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg
Articles
This article examines the intersection of patent law, FDA regulation, and Medicare coverage in a particularly promising field of biomedical innovation: genetic diagnostic testing. First, I will discuss current clinical uses of genetic testing and directions for further research, with a focus on cancer, the field in which genetic testing has had the greatest impact to date. Second, I will turn to patent law and address two recent Supreme Court decisions that called into question the patentability of many of the most important advances in genetic testing. Third, I will step outside patent law to take a broader view of …
Computational Experimentation, Tabrez Y. Ebrahim
Computational Experimentation, Tabrez Y. Ebrahim
Vanderbilt Journal of Entertainment & Technology Law
Experimentation conjures images of laboratories and equipment in biotechnology, chemistry, materials science, and pharmaceuticals. Yet modern day experimentation is not limited to only chemical synthesis, but is increasingly computational. Researchers in the unpredictable arts can experiment upon the functions, properties, reactions, and structures of chemical compounds with highly accurate computational techniques. These computational capabilities challenge the enablement and utility patentability requirements. The patent statute requires that the inventor explain how to make and use the invention without undue experimentation and that the invention have at least substantial and specific utility. These patentability requirements do not align with computational research capabilities, …
Is Dna Really A Natural Product? It's Time To Separate Fact From (Legal) Fiction: An Examination Of Dna Patentability As A Biological Algorithm In The Post-Myriad Era, Nicholas Ulen
Chicago-Kent Law Review
In 2013, the United States Supreme Court delivered its landmark decision in Ass’n for Molecular Pathology v. Myriad Genetics, Inc., holding isolated DNA unpatentable, thereby invalidating the claims of thousands of DNA patents in the process. The opinion, delivered by Justice Thomas, reasoned that the act of separating DNA from the body did not sufficiently transform the molecule beyond what naturally exists. Yet the Court found that line to be crossed when it held certain artificially synthesized complementary DNA molecules coding for the exact same gene patentable. Unlike the Federal Circuit, the Court focused its analysis not on the …
Patenting The Unexplained, Sean B. Seymore
Patenting The Unexplained, Sean B. Seymore
Vanderbilt Law School Faculty Publications
It is a bedrock principle of patent law that an inventor need not understand how or why an invention works. The patent statute simply requires that the inventor explain how to make and use the invention. But explaining how to make and use something without understanding how or why it works yields patents with uninformative disclosures. Their teaching function is limited; one who wants to understand or figure out the underlying scientific principles must turn elsewhere. This limited disclosure rule does not align with the norms of science and tends to make patent documents a less robust form of technical …
Computational Experimentation, Tabrez Y. Ebrahim
Computational Experimentation, Tabrez Y. Ebrahim
Faculty Scholarship
Experimentation conjures images of laboratories and equipment in biotechnology, chemistry, materials science, and pharmaceuticals. Yet modern day experimentation is not limited to only chemical synthesis, but is increasingly computational. Researchers in the unpredictable arts can experiment upon the functions, properties, reactions, and structures of chemical compounds with highly accurate computational techniques. These computational capabilities challenge the enablement and utility patentability requirements. The patent statute requires that the inventor explain how to make and use the invention without undue experimentation and that the invention have at least substantial and specific utility. These patentability requirements do not align with computational research capabilities, …