Gene patenting was not struck down by a politician or a protest. It was dismantled the slow way — by scientists and patients who kept turning up in court for four years, and by one geneticist whose injury the courts agreed was real. These are the years and the names, sourced from the public record.
The BRCA1 sequence is published in August 1994 by a team led at the University of Utah; Myriad Genetics, a Utah spinout, files its first BRCA1 patent in 1994 (granted 1998 as US 5,747,282) and its first BRCA2 patent in 1995 (granted 1998 as US 5,837,492). The patents claim the isolated genes themselves — the sequences every human carries.
Myriad launches its BRCA test, BRACAnalysis. With the gene patents behind it, Myriad becomes the sole US provider of full BRCA1/2 testing. The list price settles around $3,340 — commonly reported as $3,000–$4,000.
Myriad enforces. The University of Pennsylvania's Genetic Diagnostic Laboratory receives cease-and-desist letters in 1998. In 1999 a letter reaches Dr. Harry Ostrer at NYU School of Medicine, asserting that the BRCA testing he performs for his patients infringes Myriad's patents. He stops. The Supreme Court's opinion later records this episode verbatim, citing the Ostrer letter in the appendix.
On May 12, 2009, the ACLU and the Public Patent Foundation file Association for Molecular Pathology v. Myriad Genetics on behalf of some twenty plaintiffs — medical associations representing 150,000 professionals, researchers, genetic counselors, and women who needed testing. Harry Ostrer puts his name on it.
Judge Robert Sweet of the Southern District of New York holds Myriad's isolated-DNA claims invalid — the first time a US court strikes down gene patents. Myriad appeals to the Federal Circuit, the patent-specialist appeals court.
The Federal Circuit asks who is actually injured here. Of all twenty plaintiffs, the court holds — with every judge who reached the issue in agreement — that only Dr. Ostrer has Article III standing: Myriad's letter stopped his testing, and he stands ready to resume it the moment he may. The Federal Circuit partially reverses on the merits (isolated DNA patentable, in its view); the Supreme Court takes the case, sends it back once after Mayo v. Prometheus (2012), then grants full review.
The Supreme Court, in a unanimous judgment with the opinion by Justice Clarence Thomas (Scalia concurring in part), holds that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated. Footnote 3 of the opinion expressly confirms Dr. Ostrer's standing. Within hours, DNATraits announces BRCA testing at $995; Ambry Genetics announces a competitor at about $2,200. Myriad's stock spikes, then closes down 5.6% on the day.
Myriad does not fold: cDNA claims survived, only the isolated-natural-DNA claims at issue fell, and Myriad sues new entrants — Ambry in July 2013, then others. Most of those suits settle. Science reports Ostrer is "thrilled" and planning to resume the BRCA testing he gave up in 1999.
The USPTO's 2014 Interim Guidance on patent subject-matter eligibility applies the Myriad/Mayo "markedly different" framework to nature-based products generally — including purified natural products and proteins. The product-of-nature principle now covers the chemistry of peptides: natural sequences cannot be claimed as compositions of matter; engineered analogues still can be.
We publish this site because the fight Ostrer joined is the fight every peptide researcher still lives in: who may own a molecule nature wrote? Our position is the Court's position — nature's sequences are a commons; invention is what you build on them. Our editorial analysis of today's peptide regulation and public trust is on Our View; the Court-side story is at justiceclarence.com.
First BRCA1 patent filed 1994 (US 5,747,282, granted 1998); first BRCA2 patent filed 1995 (US 5,837,492, granted 1998). BRACAnalysis launched 1996.
1999 — letters asserting infringement went to Ostrer at NYU and to the University of Pennsylvania's Genetic Diagnostic Laboratory. Both stopped BRCA testing.
May 12, 2009, by the ACLU and the Public Patent Foundation for about twenty plaintiffs, including the Association for Molecular Pathology and Dr. Ostrer.
June 13, 2013 — unanimous judgment, opinion by Justice Thomas: natural DNA is a product of nature; cDNA remains patent eligible.