AMP v. Myriad reads as a short, almost quiet opinion because the work had been done over decades. The Court drew a line through six earlier generations of its own case law — and then let the scientists' facts speak. This is the doctrine's chronicle, told from the opinions themselves.
In Funk Brothers Seed Co. v. Kalo Inoculant Co., the Court refuses a patent on a mixture of naturally occurring nitrogen-fixing bacteria. Each strain did what it had always done; combining them added no inventive act. The seed of the product-of-nature doctrine is planted.
The Court upholds a patent on a bacterium engineered to digest crude oil, because its maker gave it "markedly different characteristics from any found in nature." That phrase — markedly different — becomes the test the Myriad Court applies thirty-three years later. Human-made life: patentable. Nature's own: not.
Myriad Genetics files its first BRCA1 patent in 1994 and its first BRCA2 patent in 1995, launches BRACAnalysis in 1996 at a list price around $3,340, and sends infringement letters to university laboratories — including, in 1999, to Dr. Harry Ostrer at NYU. By the late 1990s Myriad is the sole US provider of BRCA testing.
On May 12, 2009, the ACLU and the Public Patent Foundation sue for some twenty plaintiffs — medical associations, researchers, counselors, patients. In 2010 Judge Robert Sweet (SDNY) invalidates Myriad's isolated-DNA claims: DNA in the body and isolated DNA are the same information, and the patents reach too far.
The Federal Circuit reverses in part, holding isolated DNA patentable — while agreeing that of all the plaintiffs, only Dr. Ostrer has standing. In March 2012 the Supreme Court decides Mayo v. Prometheus (natural correlations unpatentable), then vacates the Federal Circuit's Myriad judgment and sends it back for reconsideration under Mayo. The Federal Circuit reaches the same result again. This time the Court grants full review.
Argued April 15, decided June 13. Justice Clarence Thomas writes for a Court unanimous in judgment: isolated natural DNA is a product of nature and not patent eligible; cDNA, which does not exist in nature, remains eligible. Justice Scalia concurs in part, declining to vouch for the molecular-biology details "on my own knowledge or even my own belief." The New York Times headline: "Justices, 9-0, Bar Patenting Human Genes."
Within hours, DNATraits announces BRCA1/2 testing at $995 — under a third of Myriad's list price. Ambry Genetics announces a competing test at about $2,200. Myriad's stock spikes on relief that cDNA claims survived, then closes down 5.6% at $32.01. A month later Myriad sues Ambry; most of the follow-on suits settle. The monopoly chapter closes; the competition chapter opens.
The USPTO's 2014 Interim Guidance on patent subject-matter eligibility instructs examiners to run the Myriad/Mayo analysis on nature-based products broadly — including purified natural products and proteins. The doctrine the Court built for DNA now stands over the whole of natural-product chemistry, peptides included.
We are a peptide company. The line Justice Thomas drew is the line we operate on: nature's sequences are a commons; invention is what you build on them. Our editorial on what the ruling means for peptide science — and on the trust regulators must now re-earn — is on Our View. The scientist whose standing carried the case is honoured at harryostrer.com.
Funk Brothers (1948), Diamond v. Chakrabarty (1980) — source of the "markedly different characteristics" test — and Mayo v. Prometheus (2012).
Argued April 15, 2013; decided June 13, 2013, as No. 12-398, reported at 569 U.S. 576.
Effectively yes — after Mayo (2012) it vacated and remanded the Federal Circuit's first judgment; after the same result on remand, it granted full review.
DNATraits announced $995 BRCA testing within hours, Ambry a ~$2,200 test; Myriad's stock spiked intraday then closed down 5.6% at $32.01.