No. 15-___ IN THE SEQUENOM, INC., Petitioner, v. ARIOSA DIAGNOSTICS, INC., NATERA, INC., AND DNA DIAGNOSTICS CENTER, INC. Respondents. On Petition for a Writ of Certiorari to the United States Court of Appeals for the Federal Circuit PETITION FOR A WRIT OF CERTIORARI Michael J. Malecek Thomas C. Goldstein Robert Barnes Counsel of Record KAYE SCHOLER LLP Eric F. Citron Two Palo Alto Square G OLDSTEIN & RUSSELL, P.C. Suite 400 7475 Wisconsin Ave. 3000 El Camino Real Suite 850 Palo Alto, CA 94306 Bethesda, MD 20814 (650) 319-4500 (202) 362-0636
[email protected] QUESTION PRESENTED In 1996, two doctors discovered cell-free fetal DNA (cffDNA) circulating in maternal plasma. They used that discovery to invent a test for detecting fetal genetic conditions in early pregnancy that avoided dangerous, invasive techniques. Their patent teaches technicians to take a maternal blood sample, keep the non-cellular portion (which was “previously discarded as medical waste”), amplify the genetic material with- in (which they alone knew about), and identify pater- nally inherited sequences as a means of distinguish- ing fetal and maternal DNA. Notably, this method does not preempt other demonstrated uses of cffDNA. The Federal Circuit “agree[d]” that this invention “combined and utilized man-made tools of biotechnol- ogy in a new way that revolutionized prenatal care.” Pet.App. 18a. But it still held that Mayo Collabora- tive Servs. v. Prometheus Labs., 132 S. Ct. 1289 (2012), makes all such inventions patent-ineligible as a matter of law if their new combination involves only a “natural phenomenon” and techniques that were “routine” or “conventional” on their own.