Impact of court decisions on the future of diagnostics and personalized medicine
Intellectual property protection in the form of secured patents has played an integral role in the growth and advancement of the biotechnology industry. The protection of intellectual properties is considered very important asset in this evolving industry. As a result, patent disputes often end up in the courts with long lasting consequences. Here we examined two recent and highly publicized patent dispute cases, namely, Mayo Collaborative Services et al. v. Prometheus Laboratories, Inc. (2012) and Association for Molecular Pathology et al. v. Myriad Genetics (2011), and wish to assess how the rulings will impact diagnostics and personalized medicine industries. In doing so, we learned that decisions involving patents are complex and interconnected, with previous court rulings influencing subsequent cases. It also became clear that in general, the biotechnology industry favored patent protection while healthcare providers and their patients favored less stringent patent protection. The case is made by the biotechnology industry that the current system has allowed both the diagnostics and personalized medicine industries to flourish. Patents are a crucial incentive that not only promotes but also protects innovation. Any disruption on the legal front with regards to patents will have a negative effect. On the other hand, healthcare providers and their patients voiced their concerns that the current system limits the affordability and accessibility of healthcare. Patent protected drugs are often expensive, making it difficult for some patients to afford. In addition, these drugs have no generic counterparts and are often without alternatives, limiting their accessibility. The providers and their patients argue that relaxing the current regulations is needed and that doing so will not impact innovation. It is believed that increased competition will have a two-fold effect—driving down prices and forcing innovation as a means of differentiation. In the end, the decisions themselves have provided little guidance regarding how the biotechnology industry should proceed, but this much is clear—a balance needs to be struck between the two opposing viewpoints for the biotech industry to survive and continue to grow.