December 9, 2011
U.S. Supreme Court Confronts Biotech Patenting Controversies
Two significant developments in life science patenting this week: first, the Supreme Court heard oral argument in Prometheus v. Mayo, which involves an attempt to patent a method of optimizing drug treatment by monitoring the metabolism of the drug. At issue is whether Prometheus received a patent on a natural phenomenon, that is, the relationship between metabolite levels and drug effectiveness. U.S. patent law does not allow the patenting of natural phenomena or laws of nature, so this lawsuit challenges the validity of the patent claims. At stake here are implications for many kinds of patent claims in medical testing, all of which are increasing as molecular medicine continues to uncover the foundational relationships between molecules and unravels how molecules achieve clinical effect. The Federal Circuit had endorsed the patent eligibility of the claims, so the Supreme Court is reviewing that decision. In the second life science patenting development, the plaintiffs in AMP v. Myriad Genetics (a coalition of patients, researchers, physicians, the ACLU and PubPat) had challenged the patent eligibility of the breast cancer-susceptibility genes (BRCA1/2) and some genetic testing methods, arguing that these were not patentable because they are either products of nature or natural phenomena. In a victory for the plaintiffs, the lower court ruled that both kinds of patent claims were not patentable subject matter; the Federal Circuit this year reversed the ruling on genes, declaring that genes are not patentable subject matter, deciding that isolated genes are not products of nature. I filed an amicus brief in support of the plaintiffs in that case; link here. This week, the plaintiffs filed a petition for certiorari to the Supreme Court, asking that it review the issue of genes as patentable subject matter. If the Court agrees to also hear this case, it would mean that the biotechnology field could expect a pair of rulings that would clarify several of the most vexing and controversial types of patenting in the life sciences.