New Article on Myriad Litigation and the Company’s Evolving Strategy
GLR editor John Conley has just co-authored a new article in the North Carolina Journal of law & Technology about Myriad Genetics’ response to last summer’s Supreme Court case that invalidated its broadest gene patents. The article focuses on Myriad’s business decision to rely less on patents and more on its vast proprietary database, especially in its growing European operations. The co-authors are Robert Cook-Deegan, M.D., a research professor of public policy and medicine at Duke, and Gabriel Lazaro-Munoz, J.D., Ph.D., a post-doctoral fellow at UNC’s Center for Genomics and Society (where John is also an investigator). The article was included in NC JOLT’s 2014 Symposium, “Gene Patents After Myriad.” The Symposium also includes articles by Sandra Park of the ACLU, who was involved in the Supreme Court case, and law professors Lori Andrews and Christopher Holman. The Symposium can be accessed at http://ncjolt.org/. Here are links to the full Conley, Cook-Deegan and Lazaro-Munoz article the abstract (NC JOLT is Open Access):
Myriad After Myriad: The Proprietary Data Dilemma
John M. Conley, Robert Cook-Deegan & Gabriel Lázaro-Muñoz
Volume 15, Issue 4 (Jun 2014)
Myriad Genetics’ long-time monopoly on BRCA gene testing was significantly narrowed by the Supreme Court’s decision in Association of Molecular Pathology v. Myriad Genetics, Inc., and will be further narrowed in the next few years as many of its still-valid patents expire. But these developments have not caused the company to acquiesce in competition. Instead, it has launched a litigation offensive against a number of actual and potential competitors, suing them for infringement of numerous unexpired patents that survived the Supreme Court case.
A parallel strategy may have even greater long-term significance, however. In announcing expanded operations in Europe, Myriad has emphasized that it will rely less on patents and more on its huge proprietary database of genetic mutations and associated health outcomes—a strategy that could be used in the United States as well. Myriad has built that database over its many years as a patent-based monopolist in the BRCA testing field, and has not shared it with the medical community for more than a decade. Consequently, Myriad has a unique ability to interpret the health significance of patients’ genetic mutations, particularly in the case of rare “variants of unknown significance.”
This Article reviews the current state of Myriad’s patent portfolio, describes its ongoing litigation offensive, and then analyzes its proprietary database strategy. The Article argues that Myriad’s strategy, while legally feasible, undercuts important values and objectives in medical research and health policy. The Article identifies several ways in which the research and health care communities might fight back, but acknowledges that it will be a difficult uphill fight.