The first question of patentability – whether the invention falls within the scope of patentable subject matter – will have been addressed by the Supreme Court twice in three years once the Court issues its opinion in Mayo Collaborative Services v. Prometheus Laboratories.
For most of 2009 and the first half of 2010, many eagerly anticipated the Supreme Court’s decision in Bilski v. Kappos, expecting clarification of the scope of patentable subject matter under 35 U.S.C. § 101. When the Court finally handed down its decision in Bilski, those who hoped for an end to business method patents were left disappointed, as the Court declined to rule business methods unpatentable as a matter of law. The Court also declined to endorse the Federal Circuit’s “machine-or-transformation” test, leaving the boundaries of patentable subject matter less clear than many would have desired.
Early next year, the Supreme Court will once again consider the scope of patentable subject matter, having granted cert in Mayo Collaborative Services v. Prometheus Laboratories. The case concerns patents that, among other things, claim the process of observing the correlation between blood test results and the patient’s heath. Mayo asserts that the claims “monopolize basic, natural biological relationships,” and thus seek patent protection for unpatentable “laws of nature.” Following the Federal Circuit’s ruling upholding the claim, it now appears that the Supreme Court will consider whether patentable subject matter includes biological relationships and will have an opportunity to opine on the scope of patentable subject matter more generally–perhaps providing defendants in patent infringement litigation another tool for challenging patent validity.