Late last month, Sequenom, Inc. filed a Petition for Writ of Certiorari requesting the United States Supreme Court to clarify the scope of its Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012) decision, as applied to Sequenom’s claimed inventions. The Mayo decision, which held that a method correlating a drug dosage regimen and levels of the drug in the blood was an unpatentable law of nature, has had the profound effect of narrowing the scope of patent-eligible subject matter in the United States and has cast doubt on the validity and enforceability of previously-issued United States patents.
Sequenom’s discovery related to the discovery of cell-free fetal DNA circulating in maternal plasma, which was used to invent a test for detecting fetal genetic conditions in early pregnancy, and thereby avoid subjecting the mother to dangerous, invasive techniques such as amniocentesis. The Federal Circuit agreed that Sequenom’s invention combined and utilized man-made tools of biotechnology in a new way that revolutionized prenatal care; however, in view of Mayo, such inventions were deemed patent-ineligible as a matter of law, since their new combination involved only a “natural phenomenon” and techniques that were “routine” or “conventional” on their own.
Despite the Federal Circuit’s reluctant holding that Sequenom’s claimed inventions were not patent-ineligible, multiple judges wrote separately to explain that while this result was probably not intended by Mayo, that decision controlled and only the Supreme Court could clarify Mayo’s reach to prevent a “crisis of patent law and medical innovation.” Sequenom’s petition now asks the Supreme Court to clarify the scope of its Mayo decision in view of Sequenom’s claimed inventions, and to determine whether a novel method is patent-eligible where: (1) a researcher is the first to discover a natural phenomenon; (2) that unique knowledge motivates him to apply a new combination of known techniques to that discovery; and (3) he thereby achieves a previously impossible result without preempting other uses of the discovery.
If the Supreme Court grants certiorari it will have a compelling set of facts before it to clarify the scope of Mayo, and we patiently await its decision, which will have high stakes for the life sciences community.
For more information, contact Patent Attorney Stan Chalvire.