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Full-Text Articles in Medical Jurisprudence
Patent Law's Reproducibility Paradox, Jacob S. Sherkow
Patent Law's Reproducibility Paradox, Jacob S. Sherkow
Articles & Chapters
Clinical research faces a reproducibility crisis. Many recent clinical and preclinical studies appear to be irreproducible; their results cannot be verified by outside researchers. This is problematic for not only scientific reasons but legal ones: patents grounded in irreproducible research appear to fail their constitutional bargain of property rights in exchange for working disclosures of inventions. The culprit is likely patent law’s doctrine of enablement. Although the doctrine requires patents to enable others to make and use their claimed inventions, current difficulties in applying the doctrine mitigate or even actively dissuade reproducible data in patents. This Article assesses the difficulties …
Key Challenges In Bringing Crispr-Mediated Somatic Cell Therapy Into The Clinic, Jacob S. Sherkow
Key Challenges In Bringing Crispr-Mediated Somatic Cell Therapy Into The Clinic, Jacob S. Sherkow
Other Publications
Genome editing using clustered regularly interspersed short palindromic repeats (CRISPR) and CRISPR-associated proteins offers the potential to facilitate safe and effective treatment of genetic diseases refractory to other types of intervention. Here, we identify some of the major challenges for clinicians, regulators, and human research ethics committees in the clinical translation of CRISPR-mediated somatic cell therapy.