As published in Genetic Engineering & Biotechnology News, May 1, 2012. Reprinted with permission.

On March 20, 2012, the U.S. Supreme Court unanimously held in Mayo Collaborative Services v. Prometheus Laboratories that a method for administering a drug and determining a personalized medicine dosing level constituted patent ineligible subject matter because it fell within the prohibition against patenting laws of nature. The decision was very surprising to many observers given recent guidance by the Supreme Court in Bilski v. Kappos (2010), which suggested that including transformative steps would qualify a method of harnessing a natural law or abstract idea into a patentable application.

The first aftershocks of this decision were felt on March 26 when the Court vacated and remanded the Federal Circuit’s decision in AMP v. Myriad, directed to patent eligibility of genes, mutated gene fragments, and diagnostic tests. The surprising Mayo decision prompts method patent owners to re-evaluate their existing patents and applications and to consider pursuing narrowing re-issues or claim amendments to add “additional features” sufficient to render the claims valid.