The Pick-and-Shovel Play: Bioethics for Gene-Editing Vector Patents

Concerns over patent protection covering new forms of gene editing have largely focused on the intellectual property covering the editing mechanism itself, most notably CRISPR (clustered regularly interspaced short palindromic repeats), but also ZFNs (zinc finger nucleases) and TALENs (transcription activator-like effector nucleases). Some of the most important technical advances in these areas, however, relate not to these technologies themselves but to vectors—the means for introducing the gene- editing machinery into human cells. In this Article, we discuss the implications of one intellectual property strategy used by some commercial developers of gene-editing vectors: a divided strategy of keeping some of the most significant information about vectors secret while patenting, cryptically, other aspects. We liken this to the business strategy of a “pick-and-shovel play”: using secrecy as informational arbitrage to sell gene editing’s necessary equipment. Such a strategy raises specific ethical and safety issues pertaining to many gene therapy interventions—namely, the uncertainty of risk, a reliance on insufficient preclinical evidence, the detriment of patient-physician decisionmaking, and increases in monetary costs. At the same time, these bioethical issues seem to illuminate the importance of patents’ disclosure function to, perhaps surprisingly, consumers, users, and standards developers.Ope