The U.S. Supreme Court’s much anticipated decision in Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., et al., 569 U.S. ___, issued June 13, 2013. In short, the Supreme Court analyzed whether an isolated DNA sequence is patent eligible in light of the fundamental principle that laws of nature, natural phenomena, and abstract ideas are not patentable. The Supreme Court held that mere isolation of an otherwise naturally occuring genetic sequence of DNA is not patent eligible but that a non-naturally occuring DNA sequence may be subject matter eligible for patenting, so long as the other conditions for patenting are met (e.g., novelty, non-obviousness, written description).
While many divergent views are forming on the impact this decision will have on the biotech industry, its impact on patent litigation in Delaware is broadly predictable. In appropriate circumstances, new patent validity challenges can be anticipated against DNA sequence claims asserted in this District and new litigation may flow from the entry of several new competitors expected to offer genentic tests for various diagnostics, some of which will undoubtedly be the subject of a patent controversy within Delaware’s jurisdiction.