Patent Protection for Genetic Diagnostic Testing for Down's Syndrome

摘要

The article seeks to explore the issue of patent protection for diagnostic testing for Down s syndrome in the United States and in Europe. It explores decisions of the TBA, applying the learning of the EBA in CYGNUS/Diagnostic method, that have accepted that a claim relating to a screening method for determining if a pregnant woman was carrying a foetus with Down s syndrome does not offend art. 53(c) EPC. The article also considers decisions of the Federal Circuit, in particular, PerkinElmer v Intema, that have applied the decision of the United States Supreme Court in Mayo Collaborative Services v Prometheus Labs to invalidate the patent for a method of diagnosis for Down's syndrome.