The Case for Prohibiting the Sale of Individual Genetic Testing Data to Third Parties
Nathaniel Jaffe Genetic technology is getting cheaper, and millions of individuals are using direct-to-consumer genetic testing (DTC-GT) services. At the same time, the scientific understanding of genetics is improving, making sequencing information more valuable for predictive medicine, research, forensics, and many other fields. In turn, genetic information has become more valuable for third parties like insurers, researchers, and pharmaceutical companies. DTC-GT providers are in a position to provide increasingly low-cost services to a growing consumer base, while stockpiling data of increasing commercial value. The sale of genetic data threatens the privacy of the individuals who provided it and opens them...
Interoperability’s Role in Striving for Precision Medicine
Martha Koroshetz President Obama announced the Precision Medicine Initiative in his 2015 State of the Union address, a research effort to find treatments that are tailored to specific genetic profiles and characteristics. This personalized and context-specific treatment approach will require big data analysis of patient outcomes and their genetic sequence, which must then be accessible and comprehensible to caregivers. The initiative must therefore be able to reconcile genetic data, demographic information, and health information, in the electronic health record. To achieve data interoperability, the organizations engaged in the initiative must confront questions of data privacy, standardize data exchange, and incentivize...
The CRISPR Patent Battle: Who Will be “Cut” Out of Patent Rights to One of the Greatest Scientific Discoveries of Our Generation?
Kristin Beale At the center of the United States patent system lies an intricate balance between creating monetary incentives that lead to creation, invention, and discovery, and impeding the flow of the very information that might permit invention. One such invention, that of a novel gene-editing technology called CRISPR-Cas9, has been called one of the “greatest scientific discoveries in the last century.” In simplest terms, the ability to edit genes (the basis of hereditary traits in living organisms made up of DNA) allows scientists to target a specific mutated gene sequence that leads to disease, cut that region out, and,...
Copyright Protection of Biotechnology Works: Into the Dustbin of History?
James G. Silva Starting in the early 1980s, and ending in the very beginning of the 1990s, a number of scholarly commentators proposed that biotechnology works are proper subject matter for copyright protection. Typically, these commentators focused on the idea that DNA sequences may be copyrightable works of authorship. Many commentators argued that copyrighting biotechnology might be a good idea because it would allow protection of works that would not qualify for patent protection. The idea of copyrighting biotechnology arose in the early 1980s at the time when patent protection of biotechnology seemed doubtful. Analogies of computer programs and DNA...